{"ID":100692,"post_author":"26","post_date":"2022-01-20 17:24:59","post_date_gmt":"2022-01-20 22:24:59","post_content":"","post_title":"Laboratory Informatics Buyer\\'s Guide for Medical Diagnostics and Research","post_excerpt":"","post_status":"publish","comment_status":"closed","ping_status":"closed","post_password":"","post_name":"laboratory-informatics-buyers-guide-for-medical-diagnostics-and-research","to_ping":"","pinged":"","post_modified":"2022-01-25 17:22:05","post_modified_gmt":"2022-01-25 22:22:05","post_content_filtered":"","post_parent":0,"guid":"https:\/\/www.limsforum.com\/?post_type=ebook&p=100692","menu_order":0,"post_type":"ebook","post_mime_type":"","comment_count":"0","filter":"","_ebook_metadata":{"enabled":"on","private":"0","guid":"6557AA74-62E4-4B33-9CCB-CB452AD7676F","title":"Laboratory Informatics Buyer\\'s Guide for Medical Diagnostics and Research","subtitle":"2022 Edition","cover_theme":"nico_6","cover_image":"https:\/\/www.limsforum.com\/wp-content\/plugins\/rdp-ebook-builder\/pl\/cover.php?cover_style=nico_6&subtitle=2022+Edition&editor=Shawn+Douglas&title=Laboratory+Informatics+Buyer%5C%27s+Guide+for+Medical+Diagnostics+and+Research&title_image=https%3A%2F%2Fs3.limswiki.org%2Fwww.limswiki.org%2Fimages%2F1%2F1d%2FVial_of_blood_to_be_tested.jpg&publisher=LabLynx+Press","editor":"Shawn Douglas","publisher":"LabLynx Press","author_id":"26","image_url":"https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/1\/1d\/Vial_of_blood_to_be_tested.jpg","items":{"727cd9645b5336c185a6bee5f330b7e1_type":"article","727cd9645b5336c185a6bee5f330b7e1_title":"A8. LIMSpec in Microsoft Word format","727cd9645b5336c185a6bee5f330b7e1_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/LIMSpec_in_Microsoft_Word_format","727cd9645b5336c185a6bee5f330b7e1_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Taking the next step\/Blank LIMSpec template for medical diagnostics and research 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 Medical Diagnostics and Research Labs.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 medical diagnostics and research labs\nTitle: Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\nEdition: 2022 Edition\nAuthor for citation: Shawn E. Douglas\nLicense for content: Creative Commons Attribution-ShareAlike 4.0 International\nPublication date: January 2022\n\r\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/LIMSpec_in_Microsoft_Word_format\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/LIMSpec_in_Microsoft_Word_format<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:19.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 24 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","727cd9645b5336c185a6bee5f330b7e1_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Taking_the_next_step_Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs_LIMSpec_in_Microsoft_Word_format rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Taking_the_next_step_Blank_LIMSpec_template_for_medical_diagnostics_and_research_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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Taking the next step\/Blank LIMSpec template for medical diagnostics and research 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">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_Medical_Diagnostics_and_Research_Labs.docx\" title=\"File:LIMSpec for Medical Diagnostics and Research Labs.docx\" class=\"wiki-link\" data-key=\"a0d444d3f08636430ba22e599a214039\">File:LIMSpec for Medical Diagnostics and Research Labs.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 medical diagnostics and research labs\n<\/p><p><b>Title<\/b>: <i>Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research<\/i>\n<\/p><p><b>Edition<\/b>: 2022 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 2022\n<\/p><p><br \/>\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20220125221431\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.011 seconds\nReal time usage: 0.068 seconds\nPreprocessor visited node count: 10\/1000000\nPost\u2010expand include size: 1718\/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% 11.050 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/LIMSpec_in_Microsoft_Word_format\n100.00% 11.050 1 -total\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12965-0!canonical and timestamp 20220125221431 and revision id 45862. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/LIMSpec_in_Microsoft_Word_format\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_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>","727cd9645b5336c185a6bee5f330b7e1_images":[],"727cd9645b5336c185a6bee5f330b7e1_timestamp":1643149337,"488ce8378512c73be759ec36b893ed7d_type":"article","488ce8378512c73be759ec36b893ed7d_title":"A7. Putting those requirements to practical use and caveats","488ce8378512c73be759ec36b893ed7d_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Putting_LIMSpec_to_Use","488ce8378512c73be759ec36b893ed7d_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Taking the next step\/Blank LIMSpec template for medical diagnostics and research labs\/Putting LIMSpec to UseFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\nContents \n\n1 A7. Putting those requirements to practical use and caveats \n\n1.1 Software developer considerations \n1.2 Buyer considerations \n\n1.2.1 Software vendor selection \n\n\n1.3 Caveats \n\n\n2 References \n\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 out 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 making 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 they are part of your own software requirements specification. If the software solution you're developing hits a particular industry (e.g., clinical diagnostics, 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 advise 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 change too with such changes. 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 them also the regulations and standards that affect those specialty laboratories. As such, this first time compiling these requirements surely missed some public-facing sources that affect how laboratories run, and by extension how their laboratory informatics applications should run. 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 20 September 2019 .   \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 20 September 2019 .   \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 20 September 2019 .   \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 20 September 2019 .   \n \n\n\u2191 Persaud, D. (4 February 2016). \"Business Requirements Gathering for Enterprise Software Selection\". SelectHub Blog. Abuyo, Inc. https:\/\/selecthub.com\/technology-selection\/business-requirements-gathering-enterprise-software-selection\/ . Retrieved 20 September 2019 .   \n \n\n\u2191 Lichtenberger, A. (23 July 2012). \"Six Steps for a Successful Vendor Selection\". ITIL.org. https:\/\/blog.itil.org\/2012\/07\/allgemein\/six-steps-for-a-successful-vendor-selection\/ . Retrieved 20 September 2019 .   \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 \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 20 September 2019 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Putting_LIMSpec_to_Use\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Putting_LIMSpec_to_Use<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:18.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 39 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","488ce8378512c73be759ec36b893ed7d_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Taking_the_next_step_Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs_Putting_LIMSpec_to_Use rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Taking_the_next_step_Blank_LIMSpec_template_for_medical_diagnostics_and_research_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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Taking the next step\/Blank LIMSpec template for medical diagnostics and research 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">the beginning<\/a> of this guide-----<\/div>\n\n\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 out 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 making 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 they are part of your own software requirements specification. If the software solution you're developing hits a particular industry (e.g., clinical diagnostics, 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 advise 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 change too with such changes. 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 them also the regulations and standards that affect those specialty laboratories. As such, this first time compiling these requirements surely missed some public-facing sources that affect how laboratories run, and by extension how their laboratory informatics applications should run. 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 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=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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_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 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=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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_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 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=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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_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 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=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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_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:\/\/selecthub.com\/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:\/\/selecthub.com\/technology-selection\/business-requirements-gathering-enterprise-software-selection\/\" target=\"_blank\">https:\/\/selecthub.com\/technology-selection\/business-requirements-gathering-enterprise-software-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=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%2Fselecthub.com%2Ftechnology-selection%2Fbusiness-requirements-gathering-enterprise-software-selection%2F&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_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\/allgemein\/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\/allgemein\/six-steps-for-a-successful-vendor-selection\/\" target=\"_blank\">https:\/\/blog.itil.org\/2012\/07\/allgemein\/six-steps-for-a-successful-vendor-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=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%2Fallgemein%2Fsix-steps-for-a-successful-vendor-selection%2F&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Putting_LIMSpec_to_Use\"><span style=\"display: none;\"> <\/span><\/span>\n<\/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 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=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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_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: 20220125221431\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.114 seconds\nReal time usage: 0.811 seconds\nPreprocessor visited node count: 5768\/1000000\nPost\u2010expand include size: 56348\/2097152 bytes\nTemplate argument size: 15465\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 13424\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 92.183 1 -total\n 79.11% 72.926 1 Template:Reflist\n 65.46% 60.339 8 Template:Cite_web\n 58.51% 53.932 8 Template:Citation\/core\n 20.83% 19.199 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Putting_LIMSpec_to_Use\n 17.28% 15.931 1 Template:LIMSpec\/Putting_LIMSpec_to_use\n 15.04% 13.866 7 Template:Date\n 6.22% 5.733 15 Template:Citation\/make_link\n 3.10% 2.861 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12964-0!canonical and timestamp 20220125221430 and revision id 45861. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Putting_LIMSpec_to_Use\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_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>","488ce8378512c73be759ec36b893ed7d_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/c\/cf\/Requirements_Allocation_Sheet.jpg"],"488ce8378512c73be759ec36b893ed7d_timestamp":1643149337,"3422ca64d9ebd76c06ab76244ed50483_type":"article","3422ca64d9ebd76c06ab76244ed50483_title":"A6. Security and integrity of systems and operations","3422ca64d9ebd76c06ab76244ed50483_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Security_and_integrity_of_systems_and_operations","3422ca64d9ebd76c06ab76244ed50483_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Taking the next step\/Blank LIMSpec template for medical diagnostics and research 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\n\n31.1 System functionality should support ALCOA principles.\n\n\n\nASTM E1578-18 E-17-2\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8\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. 4, 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\nASTM E1578-18 E-17-3\r\n\n21 CFR Part 58.190\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. 4, SI-12\r\n\nOECD GLP Principles 10\r\n\nUSDA Administrative Procedures for the PDP 5.2.1\r\n\nUSDA Data and Instrumentation for PDP 8.1.3\n\n\n31.3 The system shall maintain a true, readable copy of an instrument's original (raw) data for on-demand review.\n\n\n\n7 CFR Part 331.17 (c)\r\n\n9 CFR Part 121.17 (c)\r\n\n21 CFR Part 11.10 (c)\r\n\n21 CFR Part 58.195\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 606.160 (d)\r\n\n21 CFR Part 812.140 (d)\r\n\n21 CFR Part 820.180 (b)\r\n\n29 CFR Part 1910.1030 (h-2)\r\n\n40 CFR Part 141.33\r\n\n40 CFR Part 141.722\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 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\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\nAIHA-LAP Policies 2018 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\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\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\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\nISO 15189:2012 4.3\r\n\nISO\/IEC 17025:2017 8.4.2\r\n\nNIST 800-53, Rev. 4, AT-4\r\n\nNIST 800-53, Rev. 4, AU-11 and AU-11(1)\r\n\nNIST 800-53, Rev. 4, SI-12\r\n\nOECD GLP Principles 10\r\n\nUSDA Administrative Procedures for the PDP 5.4\r\n\nUSDA Sampling Procedures for PDP 6.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.8\u20139\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. 4, AU-8\n\n31.5 The system shall accurately reflect the system date and time in its use of electronic record time stamps.\n\n\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. 4, 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. 4, AU-5\r\nNIST 800-53, Rev. 4, 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\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\n40 CFR Part 3.10\r\n40 CFR Part 3.2000\r\nASTM E1578-18 S-1-5\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\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\n\n32.12 The system should provide a means for importing lookup or master data.\n\n\n\nAIHA-LAP Policies 2018 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\n\nCJIS Security Policy 5.7.1\r\n\nNIST 800-53, Rev. 4, AC-6(1)\r\n\nNIST 800-53, Rev. 4, CM-7\n\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\n\n32.19 The system should allow administrators to programmatically customize system modules or build calculations within the application.\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\n\nASTM E1578-18 S-1-20\r\n\nE.U. Annex 11-14\r\n\nNIST 800-53, Rev. 4, CM-5(1)\n\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\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\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\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\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\nISO\/IEC 17025:2017 7.11.3\r\n\nNIST 800-53, Rev. 4, CM-5 and CM-5(1)\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\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\nCJIS Security Policy 5.5.2.2\u20133\r\nEPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\nNIST 800-53, Rev. 4, 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. 4, 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\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\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. 4, AC-2(7) and AC-3\r\n\nNIST 800-53, Rev. 4, IA-2, IA-5, and IA-8\r\n\nNIST 800-53, Rev. 4, MA-4\r\n\nWHO Technical Report Series, #986, Annex 2, 15.9\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. 4, 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\nASTM E1578-18 E17-5 and S-3-1\r\nISO 15189:2012 5.10.3\r\nNIST 800-53, Rev. 4, 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. 4, AC-2(3)\r\n\nNIST 800-53, Rev. 4, IA-4 and IA-5(1)\r\n\nNIST 800-53, Rev. 4, PS-4\n\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. 4, 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. 4, 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\nASTM E1578-18 E17-5 and S-3-1\r\n\nCJIS Security Policy 5.4.1.1\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. 4, CM-5(1)\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 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. 4, 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. 4, 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. 4, AC-3\r\n\nNIST 800-53, Rev. 4, 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\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\nASTM E1578-18 S-1-26\n\n32.39 The system should provide a means to migrate static data into the system.\n\n\nNIST 800-53, Rev. 4, IA-5(1) and IA-5(4)\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. 4, 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. 4, 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. 4, 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\nASTM E1578-18 S-2-4\r\nISO 15189:2012 5.10.3\r\nISO\/IEC 17025:2017 7.11.5\r\nNIST 800-53, Rev. 4, SA-4(1), SA-4(2), and SA-5\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\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\nOECD GLP Principles 4.1\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\nE.U. Annex 11-4\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\nNIST 800-53, Rev. 4, AC-11\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.\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\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\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\nNIST 800-53, Rev. 4, AC-2(7) and AC-3\r\n\nNIST 800-53, Rev. 4, IA-2 and IA-8\r\n\nNIST 800-53, Rev. 4, MA-4\r\n\nNIST 800-53, Rev. 4, 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\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\n\nE.U. Annex 11-3.3\r\n\nNIST 800-53, Rev. 4, SA-16\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\n\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. 4, MA-5\r\n\nNIST 800-53, Rev. 4, MP-2\r\n\nNIST 800-53, Rev. 4, 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\nASTM E1578-18 S-3-11\r\n\nCJIS Security Policy 5.10.4.1\r\n\nEPA ERLN Laboratory Requirements 4.9.13\r\n\nNIST 800-53, Rev. 4, SI-2(5)\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\nASTM E1578-18 S-3-13\n\n34.12 The system should be expedient with the retrieval of stored items.\n\n\n21 CFR Part 11.10 (b)\r\nE.U. Annex 11-5\r\nE.U. Annex 11-8.1\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\n\nEPA ERLN Laboratory Requirements 4.9.13\r\n\nNIST 800-53, Rev. 4, CM-3(2)\r\n\nNIST 800-53, Rev. 4, SI-2\n\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\nNIST 800-53, Rev. 4, 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\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. 4, 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\n\nCJIS Security Policy 5.6.2.2.1\r\n\nNIST 800-53, Rev. 4, AC-3\r\n\nNIST 800-53, Rev. 4, IA-2, IA-2(1\u20134), and IA-8\r\n\nNIST 800-53, Rev. 4, MA-4\n\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. 4, 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. 4, 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\nASTM E1578-18 S-5-1\n\n36.1 The system shall comply with privacy protection compliance like that found in HIPAA provisions.\n\n\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\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\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\n\nNIST 800-53, Rev. 4, AC-6\n\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\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Security_and_integrity_of_systems_and_operations\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Security_and_integrity_of_systems_and_operations<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:18.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 30 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","3422ca64d9ebd76c06ab76244ed50483_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Taking_the_next_step_Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs_Security_and_integrity_of_systems_and_operations rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Taking_the_next_step_Blank_LIMSpec_template_for_medical_diagnostics_and_research_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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Taking the next step\/Blank LIMSpec template for medical diagnostics and research 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-17-1<\/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.astm.org\/Standards\/E1578.htm\" 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.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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, 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.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-17-3<\/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:\/\/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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, SI-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/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 Data and Instrumentation for PDP 8.1.3<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>31.3<\/b> The system shall 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\/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\/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\/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\/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\/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\/1910.1030\" 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\/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\/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.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=\"http:\/\/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.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2018 2A.7.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/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=\"http:\/\/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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-17-4<\/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 5.3.4<\/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:\/\/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\/LexUriServ\/LexUriServ.do?uri=OJ:L:2003:262:0022:0026:en:PDF\" 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\/LexUriServ\/LexUriServ.do?uri=OJ:L:2003:262:0022:0026:en:PDF\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11.4<\/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. 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:\/\/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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AT-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AU-11 and AU-11(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, SI-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/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 5.4<\/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 6.5<\/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, 15.8\u20139<\/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\/Standards\/E1578.htm\" 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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AU-8<\/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.astm.org\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, 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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AU-5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, 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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 S-1-1<\/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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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;\"><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 \/><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 \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 S-1-5<\/a>\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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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.astm.org\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 S-1-10<\/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 2018 2A.7.8.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 S-1-17<\/a><br \/>\n<p><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 \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, CM-7<\/a>\n<\/p>\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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 S-1-18<\/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.\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 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 \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 S-1-20<\/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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, CM-5(1)<\/a>\n<\/p>\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\/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.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=\"http:\/\/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\/Standards\/E1492.htm\" target=\"_blank\">ASTM E1492-11 4.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 S-1-16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" 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:\/\/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:\/\/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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, CM-5 and CM-5(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.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;\"><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 \/><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<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, 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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 S-1-22<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, 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=\"http:\/\/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\/Standards\/E1578.htm\" 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:\/\/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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-2(7) and AC-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IA-2, IA-5, and IA-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, MA-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, 15.9<\/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\/Standards\/E1578.htm\" 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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, 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 \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, 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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-2(3)<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IA-4 and IA-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, PS-4<\/a>\n<\/p>\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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, 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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, 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.astm.org\/Standards\/E1578.htm\" 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 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/LexUriServ\/LexUriServ.do?uri=OJ:L:2003:262:0022:0026:en:PDF\" 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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, CM-5(1)<\/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 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\/Standards\/E1578.htm\" 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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, 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\/Standards\/E1578.htm\" 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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, 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\/Standards\/E1578.htm\" 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>\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\/Standards\/E1578.htm\" 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;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 S-1-26<\/a>\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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IA-5(1) and IA-5(4)<\/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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, 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\/Standards\/E1578.htm\" 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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, 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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 S-2-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, 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\/Standards\/E1578.htm\" 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;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 S-2-4<\/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:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, SA-4(1), SA-4(2), and SA-5<\/a>\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:\/\/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\/LexUriServ\/LexUriServ.do?uri=OJ:L:2003:262:0022:0026:en:PDF\" 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=\"http:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.1<\/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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 S-2-2<\/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>\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\/Standards\/E1578.htm\" 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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-11<\/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.\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 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\/Standards\/E1578.htm\" 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.astm.org\/Standards\/E1578.htm\" 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:\/\/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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-2(7) and AC-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IA-2 and IA-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, MA-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, 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>\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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 S-3-9<\/a><br \/>\n<p><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 \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, SA-16<\/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>\n<\/p>\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=\"http:\/\/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=\"http:\/\/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\/Standards\/E1492.htm\" 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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, MA-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, MP-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, 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\/Standards\/E1578.htm\" 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.astm.org\/Standards\/E1578.htm\" 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:\/\/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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, SI-2(5)<\/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\/Standards\/E1578.htm\" 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.astm.org\/Standards\/E1578.htm\" 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;\"><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 \/><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 \/><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<\/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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 S-3-15<\/a><br \/>\n<p><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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, CM-3(2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, SI-2<\/a>\n<\/p>\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\/Standards\/E1578.htm\" 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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, 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.astm.org\/Standards\/E1578.htm\" 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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, 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 \/>\n<p><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 \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IA-2, IA-2(1\u20134), and IA-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, MA-4<\/a>\n<\/p>\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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, 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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, 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.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 S-5-1<\/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\/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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 S-5-2<\/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>\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 \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-6<\/a>\n<\/p>\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<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20220125221429\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.057 seconds\nReal time usage: 0.081 seconds\nPreprocessor visited node count: 319\/1000000\nPost\u2010expand include size: 117031\/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% 32.499 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Security_and_integrity_of_systems_and_operations\n100.00% 32.499 1 -total\n 15.26% 4.959 1 Template:LIMSpec\/Data_integrity\n 15.19% 4.937 1 Template:LIMSpec\/System_administration\n 14.89% 4.838 1 Template:LIMSpec\/Information_privacy\n 13.78% 4.480 1 Template:LIMSpec\/Configuration_management\n 13.10% 4.259 1 Template:LIMSpec\/System_validation_and_commission\n 12.76% 4.146 1 Template:LIMSpec\/Cybersecurity\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12963-0!canonical and timestamp 20220125221429 and revision id 45860. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Security_and_integrity_of_systems_and_operations\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_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>","3422ca64d9ebd76c06ab76244ed50483_images":[],"3422ca64d9ebd76c06ab76244ed50483_timestamp":1643149337,"e91eefa29426c6f1d266b09551f97e2f_type":"article","e91eefa29426c6f1d266b09551f97e2f_title":"A5. Technology and performance improvements","e91eefa29426c6f1d266b09551f97e2f_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Technology_and_performance_improvements","e91eefa29426c6f1d266b09551f97e2f_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Taking the next step\/Blank LIMSpec template for medical diagnostics and research 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\n\n26.1 The system should be able to use an application programming interface or web services to communicate with instrument data systems.\n\n\nASTM E1578-18 E-12-2\n\n26.2 The system should be capable of sending samples and test orders to instrument data systems.\n\n\nASTM E1578-18 E-12-3\r\nEPA ERLN Laboratory Requirements 4.9.16\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\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\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\nOECD GLP Principles 3.4\r\n\nOECD GLP Principles 10\r\n\nUSDA Administrative Procedures for the PDP 5.5\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\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\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\nASTM E1578-18 C-6-6\r\nASTM E1578-18 E-13-6\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\nAAVLD Requirements for an AVMDL Sec. 4.10.1.4\r\n\nASTM E1578-18 E-13-11\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. 4, CP-9 and CP-10\r\n\nWHO Technical Report Series, #986, Annex 2, 15.9\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 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\nASTM E1578-18 E-13-15\r\nE.U. Annex 11-5\r\nISO 15189:2012 5.10.3\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\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. 4, 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\nISO 15189:2012 5.10.3\r\nNIST 800-53, Rev. 4, 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\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\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\nNIST 800-53, Rev. 4, MP-2\r\n\nNIST 800-53, Rev. 4, 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\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\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\nOECD GLP Principles 10\r\n\nUSDA Sample Processing and Analysis Procedures for PDP 5.2\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\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Technology_and_performance_improvements\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Technology_and_performance_improvements<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:18.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 32 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","e91eefa29426c6f1d266b09551f97e2f_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Taking_the_next_step_Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs_Technology_and_performance_improvements rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Taking_the_next_step_Blank_LIMSpec_template_for_medical_diagnostics_and_research_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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Taking the next step\/Blank LIMSpec template for medical diagnostics and research 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-12-1<\/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.\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-12-2<\/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;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-12-3<\/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 4.9.16<\/a>\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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-12-4<\/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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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=\"http:\/\/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\/Standards\/E1578.htm\" 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=\"http:\/\/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=\"http:\/\/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>\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=\"http:\/\/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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-13-4<\/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 4.9.5<\/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=\"http:\/\/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=\"http:\/\/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>\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\/Standards\/E1578.htm\" 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;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-6-6<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-13-6<\/a>\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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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.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.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-13-11<\/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<\/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\/LexUriServ\/LexUriServ.do?uri=OJ:L:2003:262:0022:0026:en:PDF\" 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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, CP-9 and CP-10<\/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>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 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-13-15<\/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 11-5<\/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>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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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.astm.org\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-16-5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-16-8<\/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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, 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.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=\"http:\/\/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\/Standards\/E1492.htm\" target=\"_blank\">ASTM E1492-11 4.1.8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1492.htm\" target=\"_blank\">ASTM E1492-11 4.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" 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:\/\/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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, MP-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, 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\/Standards\/E1578.htm\" 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.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=\"http:\/\/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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-16-11<\/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=\"http:\/\/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 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, 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<!-- \nNewPP limit report\nCached time: 20220125221429\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.029 seconds\nReal time usage: 0.046 seconds\nPreprocessor visited node count: 114\/1000000\nPost\u2010expand include size: 47683\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 3\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 22.142 1 -total\n100.00% 22.142 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Technology_and_performance_improvements\n 17.84% 3.951 1 Template:LIMSpec\/Artificial_intelligence_and_smart_systems\n 17.75% 3.930 1 Template:LIMSpec\/Laboratory_scheduling_and_capacity_planning\n 16.77% 3.714 1 Template:LIMSpec\/Lean_laboratory_and_continuous_improvement\n 16.61% 3.677 1 Template:LIMSpec\/Systems_integration\n 15.84% 3.506 1 Template:LIMSpec\/Instrument_data_systems_functions\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12962-0!canonical and timestamp 20220125221429 and revision id 45859. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Technology_and_performance_improvements\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_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>","e91eefa29426c6f1d266b09551f97e2f_images":[],"e91eefa29426c6f1d266b09551f97e2f_timestamp":1643149337,"99a472907793b0329005214e41a83a39_type":"article","99a472907793b0329005214e41a83a39_title":"A4. Specialty laboratory functions","99a472907793b0329005214e41a83a39_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Specialty_laboratory_functions","99a472907793b0329005214e41a83a39_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Taking the next step\/Blank LIMSpec template for medical diagnostics and research 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 \nNot relevant to medical diagnostic and research labs\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\nFDA Hazard Analysis Critical Control Point Principle 4\n\n\n18.1 The system should allow authorized users to configure the generation of 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\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 \nNot relevant to medical diagnostic and research labs\n\r\n\n\n20. Environmental data management \nNot relevant to medical diagnostic and research labs\n\r\n\n\n21. Forensic case and data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.4.3\nASTM E1188-11 3.2.3\r\n\nASTM E1188-11 3.4.1\r\n\nASTM E1459-13 2.1\r\n\nASTM E1459-13 4.1.1\u20132\r\n\nASTM E1459-13 4.1.4.2\r\n\nASTM E1459-13 4.2.2\u20133\r\n\nASTM E1492-11 4.1.1\r\n\nASTM E1492-11 4.1.5\n\n\n21.1 The system shall be able to assign each piece of collected evidence and each scene a unique identifier using methodologies such as an ID with an incrementing integer (for sequential evidence numbers) or a user-defined naming format for meeting regulatory requirements.\n\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.6\u201310\r\nASTM E1492-11 4.1.1\r\n\n\n21.2 The system shall be able to assign each case a unique case identifier that, in addition to an electronic signature, is able to be automatically placed on, at a maximum, each page of the case's associated examination and administration records.\n\n\n\nASTM E1492-11 4.1.1.1\u20132\r\n\nASTM E1492-11 4.1.4\u20135\r\n\nASTM E1492-11 4.2.2\u20133\r\n\nASTM E1492-11 4.5.1.1\n\n\n21.3 In addition to a unique case number, the system shall provide a means to add additional information to a case file, including, but not limited to, submitting agency, agency case number, date of case receipt, name of recipient, shipping and receipt details, items associated with the case and their unique designators, notes, test data, related reports, and other documentation.\n\n\nASTM E1188-11 (throughout)\r\nASTM E1459-13 (throughout)\r\nASTM E1492-11 4.4.3 and 4.5.1\n\n21.4 The system should be able to document evidence using an ASTM-compliant evidence log, including, but not limited to, unique identifiers, investigator and custodian names, key dates and times, evidence conditions, and storage location.\n\n\nASTM E1492-11 4.3.1.1\n\n21.5 The system should be able to prevent a piece of evidence from being scheduled for destructive testing until an appropriate authorization for such analysis is acquired and documented.\n\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.8.1.1.1\r\nASTM E1492-11 4.1.2\n\n21.6 The system shall be able to record and maintain chain of custody of evidence that is subdivided in the laboratory in the same way that original evidence items are tracked.\n\n\nCJIS Security Policy 5.1.3\n\n21.7 The system shall be capable of recording the secondary dissemination to an authorized agency or organization of criminal history record information (CHRI) sourced from U.S. Criminal Justice Information Services (CJIS).\n\n\nCJIS Security Policy 5.4.7\n\n21.8 The system shall be able to record all National Crime Information Center (NCIC) and Interstate Identification Index (III) data transactions, clearly identifying the operator and authorized receiving agency or organization. III records shall also identify requester and recipient using a unique identifier.\n\n\nCJIS Security Policy 5.5.6\r\nNIST 800-53, Rev. 4, AC-17(1) \r\n\n\n21.9 If the system provides remote access to authorized users over authorized devices, the remote access shall be monitored, controlled and documented, particularly for privileged functions. If remote access to privileged functions is allowed, virtual escorting that meets CJIS Security Policy 5.5.6 conditions will be required.\n\n\nCJIS Security Policy 5.6.2.1.1.1\u20132\r\nCJIS Security Policy 5.6.2.1.2\u20133\r\nNIST 800-53, Rev. 4, IA-5(4) \r\n\n\n21.10 The system shall be capable of putting into place, in their entirety, either the \"basic password standards\" or \"advanced password standards\" described in CJIS Security Policy 5.6.2.1.1.1 and 5.6.2.1.1.2. If PIN and\/or one-time password is also used, the attributes in 5.6.2.1.2 and 5.6.2.1.3 shall also be required.\n\n\nCJIS Security Policy 5.6.2.2\n\n21.11 If the system supports user-based certificates for authentication, the system shall be configurable enough to require them to be 1. user-specific, not device-specific, 2. used only by one user at any given time, and 3. activated for each use by, e.g., a passphrase or PIN.\n\n\nCJIS Security Policy 5.10.1.2.1\u20132\r\n\nCJIS Security Policy Appendix G.6\r\n\nNIST 800-53, Rev. 4, AC-17(2) \r\n\nNIST 800-53, Rev. 4, SC-13, SC-28, and SC-28(1)\r\n\n\n\n21.12 The system shall allow \"encryption in transit\" and \"encryption at rest\" of criminal justice information (CJI) that meets or exceeds the requirements of CJIS Security Policy 5.10.1.2.1 and 5.10.1.2.2.\n\n\nCJIS Security Policy 5.10.1.5\n\n21.13 If the system is cloud-based, the vendor shall ensure that CJI is stored in databases located within the physical boundaries of APB-member countries and within the legal authority of APB-member agencies. Additionally, the vendor shall agree to not use any metadata derived from unencrypted CJI for commercial, advertising, or other purposes, unless specifically permitted for limited within the service agreement.\n\n\nCJIS Security Policy 5.11.1\u20132\n\n21.14 If the system is cloud-based, the vendor should agree to FBI and CSA compliance and security audits of CJI.\n\n\nCJIS Security Policy 5.10.3.2\r\nCJIS Security Policy Appendix G.1\n\n21.15 If the system is capable of being run in a virtual environment, it shall meet the virtualization requirements set forth in CJIS Security Policy 5.10.3.2 and best practices set forth in CJIS Security Policy Appendix G.1.\n\n\nCJIS Security Policy Appendix G.5\r\nNIST 800-53, Rev. 4, AC-6(4)\r\n\nNIST 800-53, Rev. 4, SC-39\r\n\n\n\n21.16 The system should provide separate processing domains in order to not only allow for more granular allocation of user privileges, but also to prevent one process from modifying the executing code of another process.\n\n\nNIST 800-53, Rev. 4, IA-2(12), IA-5(11), and IA-8(1)\n\n21.17 The system should support the use of personal identity verification\u2014a U.S. Federal government-wide credential system\u2014and other forms of hardware-based (i.e., public key infrastructure or PKI) token authentication, while electronically verifying those credentials and any configured token quality requirements.\n\n\n\n\r\n\n\n22. Public health data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nCDC PHIN Messaging System\n\n22.1 The system should be capable of interfacing with the Center for Disease Control and Prevention's PHIN Messaging System.\n\n\n\n\r\n\n\n23. Veterinary data management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nNAHLN Information Technology System\r\nVeNom Coding Group\r\nVeterinary Terminology Services Laboratory\n\n23.1 The system should support standardized veterinary clinical terminology such as that found in the Veterinary Extension of SNOMED CT and the Veterinary Nomenclature (VeNom) Codes.\n\n\nICAR 15 Data Exchange\r\nVICH GL53\n\n23.2 The system should be able to exchange data, when necessary, in a fashion that meets International Committee for Animal Recording (ICAR) and Veterinary International Conference on Harmonization (VICH) electronic data exchange guidelines.\n\n\nNAHLN HL7 Messaging Quick User Guide\n\n23.3 The system should support National Animal Health Laboratory Network (NAHLN), and, by extension, Health Level 7 (HL7) result messaging.\n\n\n\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 \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n45 CFR Part 170.315 (a-1\u2013a-4)\n\n25.1 The electronic health record (EHR) module should provide computerized provider order entry (CPOE) functionality for medication orders, laboratory orders, and diagnostic imaging, including making checks for potential drug-drug and drug-allergy interactions.\n\n\n45 CFR Part 170.315 (a-5)\r\n45 CFR Part 170.315 (a-11\u2013a-12)\r\n45 CFR Part 170.315 (a-15)\n\n25.2 The EHR module should allow authorized personnel to record, change, and access patient demographic data, including, but not limited to, race and ethnicity, patient's preferred language, birth sex, current sex, sexual orientation, gender identity, birth date, smoking status, alcohol use, family health history, psychological aspects, social aspects, and behavioral aspects.\n\n\n45 CFR Part 170.315 (a-6\u2013a-8)\r\n45 CFR Part 170.315 (a-10)\r\n45 CFR Part 170.315 (a-14)\n\n25.3 The EHR module should allow authorized personnel to record, change, and access a patient's active problem list, medication list, medication allergy list, preferred drug list, and implantable device list, incorporating, where appropriate, at a minimum the SNOMED CT nomenclature standard.\n\n\n45 CFR Part 170.315 (a-19)\n\n25.4 The EHR module should incorporate configurable, role-based clinical decision support tools capable of allowing authorized personnel to trigger electronic interventions based on liked reference information standardized to Health Level 7 (HL7) Version 3 implementation guides. The reference information should be sourced.\n\n\n45 CFR Part 170.315 (a-13)\n\n25.5 The EHR module should be able to identify education resources specific to a patient's active problem and medication lists. The educational resources should be standardized to Health Level 7 (HL7) Version 3 implementation guides.\n\n\n45 CFR Part 170.315 (b-1\u2013b-2; b-4\u2013b-5)\n\n25.6 The EHR module should allow authorized personnel to create, view, send, and receive transition of care or referral summaries in such a way that the summary is properly formatted, matched to the correct patient, and reconciled according to the standards and protocols outlined in 45 CFR Part 170.315 (b-1), (b-2), (b-4), and (b-5).\n\n\n45 CFR Part 170.315 (b-3)\n\n25.7 The EHR module should allow authorized personnel to conduct electronic prescribing actions such as creating, changing, cancelling, and refilling prescriptions, incorporating at least the RxNorm and NCPDP SCRIPT standards.\n\n\n45 CFR Part 170.315 (b-6)\n\n25.8 The EHR module should allow authorized personnel to configure, create, and store data exports, incorporating at least HL7 Version 3 implementation standards, as well as SNOMED CT and ICD-9 standards.\n\n\n45 CFR Part 170.315 (b-7\u2013b-8)\n\n25.9 The EHR module should allow for the secure creation, sending, and receipt of restricted summary records, incorporating HL7 Version 3 implementation standards.\n\n\n45 CFR Part 170.315 (b-9)\n\n25.10 The EHR module should allow authorized personnel to create, record, change, access, and receive care plan information, incorporating HL7 Version 3 implementation standards.\n\n\n45 CFR Part 170.315 (c)\n\n25.11 The EHR module should provide a means to record, calculate, import, export, filter, and report on clinical quality measures according to the standards outlined in 45 CFR Part 170.315 (c).\n\n\n45 CFR Part 170.315 (d)\n\n25.12 The EHR module shall provide security and access controls for protecting stored data.\n\n\n45 CFR Part 170.315 (d)\n\n25.13 The EHR module shall record an audit trail for each and every record created and modified, using version control.\n\n\n45 CFR Part 170.315 (d-7)\n\n25.14 The EHR module shall either encrypt electronic health information on end-user devices after use of the technology on the device stops or prevent electronic health information from being stored on end-user devices after use of the technology on the device stops.\n\n\n45 CFR Part 170.315 (d-8)\n\n25.15 The EHR module shall ensure that electronically exchanged health information has not been altered during the transfer process, using at least a hashing algorithm secured to SHA-2 or better.\n\n\n45 CFR Part 170.315 (d-11)\n\n25.16 The EHR module should be capable of recording patient disclosures made for treatment, payment, and health care operations.\n\n\n45 CFR Part 170.315 (e-1)\n\n25.17 The EHR module should provide a means for patients and their authorized representatives to view, download, and transmit their personal health information and activity history log from the EHR via an internet-based technology, using the standards outlined in 45 CFR Part 170.315 (e-1).\n\n\n45 CFR Part 170.315 (e-2\u2013e-3)\n\n25.18 The EHR module should provide a means for authorized users to securely send messages to and receive messages from patients, at the same time allowing for the recording, accessing, and linking of information shared by the patient electronically (as well as directly).\n\n\n45 CFR Part 170.315 (f)\n\n25.19 The EHR module should allow vital patient information as it relates to public health to be transmitted to immunization registries, cancer registries, and public health agencies, as well as be accessed after the fact. This includes, but is not limited to, immunization history, surveillance information, laboratory test results, cancer case information, case reports, antimicrobial reporting, and health care survey information.\n\n\n45 CFR Part 170.315 (g-3\u2013g-5)\n\n25.20 The EHR developer should use user-centered and accessibility-centered design processes for creating and testing the EHR's functionality. A quality management system should be used during these processes.\n\n\n45 CFR Part 170.315 (g-6)\n\n25.21 The EHR module's use of clinical document architecture (CDA) should be demonstrated and verified for conformance to the standards identified in 45 CFR Part 170.315 (g-6).\n\n\n45 CFR Part 170.315 (g-7\u2013g-9)\n\n25.22 The EHR module should include an application programming interface (API) that demonstrates the EHR's ability to uniquely identify a patient and corresponding ID\/token in a received records or data category request in order to accurately and securely meet the request for that patient's data. The API should be well documented.\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Specialty_laboratory_functions\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Specialty_laboratory_functions<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:18.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 36 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","99a472907793b0329005214e41a83a39_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Taking_the_next_step_Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs_Specialty_laboratory_functions rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Taking_the_next_step_Blank_LIMSpec_template_for_medical_diagnostics_and_research_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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Taking the next step\/Blank LIMSpec template for medical diagnostics and research 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">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<p>Not relevant to medical diagnostic and research labs\n<\/p><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:\/\/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>18.1<\/b> The system should allow authorized users to configure the generation of 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:\/\/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<p>Not relevant to medical diagnostic and research labs\n<\/p><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 medical diagnostic and research 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<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=\"http:\/\/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 5.8.4.3<\/a>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1188.htm\" target=\"_blank\">ASTM E1188-11 3.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1188.htm\" target=\"_blank\">ASTM E1188-11 3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1188.htm\" target=\"_blank\">ASTM E1459-13 2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1459.htm\" target=\"_blank\">ASTM E1459-13 4.1.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1459.htm\" target=\"_blank\">ASTM E1459-13 4.1.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1459.htm\" target=\"_blank\">ASTM E1459-13 4.2.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1492.htm\" target=\"_blank\">ASTM E1492-11 4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1492.htm\" target=\"_blank\">ASTM E1492-11 4.1.5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.1<\/b> The system shall be able to assign each piece of collected evidence and each scene a unique identifier using methodologies such as an ID with an incrementing integer (for sequential evidence numbers) or a user-defined naming format for meeting regulatory requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/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 4.13.2.6\u201310<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1492.htm\" target=\"_blank\">ASTM E1492-11 4.1.1<\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>21.2<\/b> The system shall be able to assign each case a unique case identifier that, in addition to an electronic signature, is able to be automatically placed on, at a maximum, each page of the case's associated examination and administration 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.astm.org\/Standards\/E1492.htm\" target=\"_blank\">ASTM E1492-11 4.1.1.1\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1492.htm\" target=\"_blank\">ASTM E1492-11 4.1.4\u20135<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1492.htm\" target=\"_blank\">ASTM E1492-11 4.2.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1492.htm\" target=\"_blank\">ASTM E1492-11 4.5.1.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.3<\/b> In addition to a unique case number, the system shall provide a means to add additional information to a case file, including, but not limited to, submitting agency, agency case number, date of case receipt, name of recipient, shipping and receipt details, items associated with the case and their unique designators, notes, test data, related reports, and other documentation.\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\/E1188.htm\" target=\"_blank\">ASTM E1188-11 (throughout)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1459.htm\" target=\"_blank\">ASTM E1459-13 (throughout)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1492.htm\" target=\"_blank\">ASTM E1492-11 4.4.3 and 4.5.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.4<\/b> The system should be able to document evidence using an ASTM-compliant evidence log, including, but not limited to, unique identifiers, investigator and custodian names, key dates and times, evidence conditions, and storage 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\/Standards\/E1492.htm\" target=\"_blank\">ASTM E1492-11 4.3.1.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.5<\/b> The system should be able to prevent a piece of evidence from being scheduled for destructive testing until an appropriate authorization for such analysis is acquired and documented.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/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 5.8.1.1.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1492.htm\" target=\"_blank\">ASTM E1492-11 4.1.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.6<\/b> The system shall be able to record and maintain chain of custody of evidence that is subdivided in the laboratory in the same way that original evidence items are tracked.\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 5.1.3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.7<\/b> The system shall be capable of recording the secondary dissemination to an authorized agency or organization of criminal history record information (CHRI) sourced from U.S. Criminal Justice Information Services (CJIS).\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 5.4.7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.8<\/b> The system shall be able to record all National Crime Information Center (NCIC) and Interstate Identification Index (III) data transactions, clearly identifying the operator and authorized receiving agency or organization. III records shall also identify requester and recipient using a unique identifier.\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 5.5.6<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-17(1) <\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>21.9<\/b> If the system provides remote access to authorized users over authorized devices, the remote access shall be monitored, controlled and documented, particularly for privileged functions. If remote access to privileged functions is allowed, virtual escorting that meets CJIS Security Policy 5.5.6 conditions will be required.\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 5.6.2.1.1.1\u20132<\/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 5.6.2.1.2\u20133<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IA-5(4) <\/a><br \/>\n<\/td>\n<td style=\"background-color:white;\"><b>21.10<\/b> The system shall be capable of putting into place, in their entirety, either the \"basic password standards\" or \"advanced password standards\" described in CJIS Security Policy 5.6.2.1.1.1 and 5.6.2.1.1.2. If PIN and\/or one-time password is also used, the attributes in 5.6.2.1.2 and 5.6.2.1.3 shall also be required.\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 5.6.2.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.11<\/b> If the system supports user-based certificates for authentication, the system shall be configurable enough to require them to be 1. user-specific, not device-specific, 2. used only by one user at any given time, and 3. activated for each use by, e.g., a passphrase or PIN.\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 5.10.1.2.1\u20132<\/a><br \/>\n<p><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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-17(2) <\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, SC-13, SC-28, and SC-28(1)<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.12<\/b> The system shall allow \"encryption in transit\" and \"encryption at rest\" of criminal justice information (CJI) that meets or exceeds the requirements of CJIS Security Policy 5.10.1.2.1 and 5.10.1.2.2.\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 5.10.1.5<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.13<\/b> If the system is cloud-based, the vendor shall ensure that CJI is stored in databases located within the physical boundaries of APB-member countries and within the legal authority of APB-member agencies. Additionally, the vendor shall agree to not use any metadata derived from unencrypted CJI for commercial, advertising, or other purposes, unless specifically permitted for limited within the service agreement.\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 5.11.1\u20132<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.14<\/b> If the system is cloud-based, the vendor should agree to FBI and CSA compliance and security audits of CJI.\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 5.10.3.2<\/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.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.15<\/b> If the system is capable of being run in a virtual environment, it shall meet the virtualization requirements set forth in CJIS Security Policy 5.10.3.2 and best practices set forth in CJIS Security Policy Appendix G.1.\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 Appendix G.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-6(4)<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, SC-39<\/a><br \/>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>21.16<\/b> The system should provide separate processing domains in order to not only allow for more granular allocation of user privileges, but also to prevent one process from modifying the executing code of another process.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IA-2(12), IA-5(11), and IA-8(1)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>21.17<\/b> The system should support the use of personal identity verification\u2014a U.S. Federal government-wide credential system\u2014and other forms of hardware-based (i.e., public key infrastructure or PKI) token authentication, while electronically verifying those credentials and any configured token quality requirements.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<p><br \/>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"22._Public_health_data_management\">22. Public health 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:\/\/www.cdc.gov\/phin\/tools\/phinms\/index.html\" target=\"_blank\">CDC PHIN Messaging System<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>22.1<\/b> The system should be capable of interfacing with the Center for Disease Control and Prevention's PHIN Messaging System.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<p><br \/>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"23._Veterinary_data_management\">23. Veterinary 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:\/\/www.aphis.usda.gov\/aphis\/ourfocus\/animalhealth\/lab-info-services\/nahln\/ct_nahln_it\" target=\"_blank\">NAHLN Information Technology System<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/venomcoding.org\/\" target=\"_blank\">VeNom Coding Group<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/vtsl.vetmed.vt.edu\/\" target=\"_blank\">Veterinary Terminology Services Laboratory<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>23.1<\/b> The system should support standardized veterinary clinical terminology such as that found in the Veterinary Extension of SNOMED CT and the Veterinary Nomenclature (VeNom) Codes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.icar.org\/Guidelines\/15-Data-Exchange.pdf\" target=\"_blank\">ICAR 15 Data Exchange<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/vichsec.org\/en\/guidelines\/general\" target=\"_blank\">VICH GL53<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>23.2<\/b> The system should be able to exchange data, when necessary, in a fashion that meets International Committee for Animal Recording (ICAR) and Veterinary International Conference on Harmonization (VICH) electronic data exchange guidelines.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><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=\"background-color:white;\"><b>23.3<\/b> The system should support National Animal Health Laboratory Network (NAHLN), and, by extension, Health Level 7 (HL7) result messaging.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<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<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\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-1\u2013a-4)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.1<\/b> The electronic health record (EHR) module should provide computerized provider order entry (CPOE) functionality for medication orders, laboratory orders, and diagnostic imaging, including making checks for potential drug-drug and drug-allergy interactions.\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\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-5)<\/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 (a-11\u2013a-12)<\/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 (a-15)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.2<\/b> The EHR module should allow authorized personnel to record, change, and access patient demographic data, including, but not limited to, race and ethnicity, patient's preferred language, birth sex, current sex, sexual orientation, gender identity, birth date, smoking status, alcohol use, family health history, psychological aspects, social aspects, and behavioral aspects.\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\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-6\u2013a-8)<\/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 (a-10)<\/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 (a-14)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.3<\/b> The EHR module should allow authorized personnel to record, change, and access a patient's active problem list, medication list, medication allergy list, preferred drug list, and implantable device list, incorporating, where appropriate, at a minimum the SNOMED CT nomenclature standard.\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\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-19)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.4<\/b> The EHR module should incorporate configurable, role-based clinical decision support tools capable of allowing authorized personnel to trigger electronic interventions based on liked reference information standardized to Health Level 7 (HL7) Version 3 implementation guides. The reference information should be sourced.\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\/170.315\" target=\"_blank\">45 CFR Part 170.315 (a-13)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.5<\/b> The EHR module should be able to identify education resources specific to a patient's active problem and medication lists. The educational resources should be standardized to Health Level 7 (HL7) Version 3 implementation guides.\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\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-1\u2013b-2; b-4\u2013b-5)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.6<\/b> The EHR module should allow authorized personnel to create, view, send, and receive transition of care or referral summaries in such a way that the summary is properly formatted, matched to the correct patient, and reconciled according to the standards and protocols outlined in 45 CFR Part 170.315 (b-1), (b-2), (b-4), and (b-5).\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\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.7<\/b> The EHR module should allow authorized personnel to conduct electronic prescribing actions such as creating, changing, cancelling, and refilling prescriptions, incorporating at least the RxNorm and NCPDP SCRIPT standards.\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\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-6)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.8<\/b> The EHR module should allow authorized personnel to configure, create, and store data exports, incorporating at least HL7 Version 3 implementation standards, as well as SNOMED CT and ICD-9 standards.\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\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-7\u2013b-8)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.9<\/b> The EHR module should allow for the secure creation, sending, and receipt of restricted summary records, incorporating HL7 Version 3 implementation standards.\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\/170.315\" target=\"_blank\">45 CFR Part 170.315 (b-9)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.10<\/b> The EHR module should allow authorized personnel to create, record, change, access, and receive care plan information, incorporating HL7 Version 3 implementation standards.\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\/170.315\" target=\"_blank\">45 CFR Part 170.315 (c)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.11<\/b> The EHR module should provide a means to record, calculate, import, export, filter, and report on clinical quality measures according to the standards outlined in 45 CFR Part 170.315 (c).\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\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.12<\/b> The EHR module 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.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.13<\/b> The EHR module 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\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-7)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.14<\/b> The EHR module shall either encrypt electronic health information on end-user devices after use of the technology on the device stops or prevent electronic health information from being stored on end-user devices after use of the technology on the device stops.\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\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-8)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.15<\/b> The EHR module shall ensure that electronically exchanged health information has not been altered during the transfer process, using at least a hashing algorithm secured to SHA-2 or better.\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\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-11)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.16<\/b> The EHR module should be capable of recording patient disclosures made for treatment, payment, and health care operations.\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\/170.315\" target=\"_blank\">45 CFR Part 170.315 (e-1)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.17<\/b> The EHR module should provide a means for patients and their authorized representatives to view, download, and transmit their personal health information and activity history log from the EHR via an internet-based technology, using the standards outlined in 45 CFR Part 170.315 (e-1).\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\/170.315\" target=\"_blank\">45 CFR Part 170.315 (e-2\u2013e-3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.18<\/b> The EHR module should provide a means for authorized users to securely send messages to and receive messages from patients, at the same time allowing for the recording, accessing, and linking of information shared by the patient electronically (as well as directly).\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\/170.315\" target=\"_blank\">45 CFR Part 170.315 (f)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.19<\/b> The EHR module should allow vital patient information as it relates to public health to be transmitted to immunization registries, cancer registries, and public health agencies, as well as be accessed after the fact. This includes, but is not limited to, immunization history, surveillance information, laboratory test results, cancer case information, case reports, antimicrobial reporting, and health care survey information.\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\/170.315\" target=\"_blank\">45 CFR Part 170.315 (g-3\u2013g-5)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.20<\/b> The EHR developer should use user-centered and accessibility-centered design processes for creating and testing the EHR's functionality. A quality management system should be used during these 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\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (g-6)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.21<\/b> The EHR module's use of clinical document architecture (CDA) should be demonstrated and verified for conformance to the standards identified in 45 CFR Part 170.315 (g-6).\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\/170.315\" target=\"_blank\">45 CFR Part 170.315 (g-7\u2013g-9)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>25.22<\/b> The EHR module should include an application programming interface (API) that demonstrates the EHR's ability to uniquely identify a patient and corresponding ID\/token in a received records or data category request in order to accurately and securely meet the request for that patient's data. The API should be well documented.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20220125221429\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.032 seconds\nReal time usage: 0.108 seconds\nPreprocessor visited node count: 82\/1000000\nPost\u2010expand include size: 59354\/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% 86.499 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Specialty_laboratory_functions\n100.00% 86.499 1 -total\n 18.12% 15.674 1 Template:LIMSpec\/Health_information_technology\n 17.97% 15.544 1 Template:LIMSpec\/Scientific_data_management\n 16.69% 14.435 1 Template:LIMSpec\/Veterinary_data_management\n 16.33% 14.128 1 Template:LIMSpec\/Forensic_case_and_data_management\n 9.83% 8.507 1 Template:LIMSpec\/Statistical_trending_and_control_charts\n 9.75% 8.434 1 Template:LIMSpec\/Public_health_data_management\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12961-0!canonical and timestamp 20220125221429 and revision id 45858. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Specialty_laboratory_functions\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_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>","99a472907793b0329005214e41a83a39_images":[],"99a472907793b0329005214e41a83a39_timestamp":1643149336,"6b8e5e54109334857e57a1222e4af042_type":"article","6b8e5e54109334857e57a1222e4af042_title":"A3. Maintaining laboratory workflow and operations","6b8e5e54109334857e57a1222e4af042_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Maintaining_laboratory_workflow_and_operations","6b8e5e54109334857e57a1222e4af042_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Taking the next step\/Blank LIMSpec template for medical diagnostics and research 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 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\n21 CFR Part 7 (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\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\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\nCJIS Security Policy (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\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\nNew York Department of Health ELAP Microbiology Protocol\r\n\nNIST 800-53, Rev. 4 (throughout)\r\n\nOECD GLP Principles 8\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, #986, Annex 2 (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 7 (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 (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\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\n42 CFR Part 493.1773 (c\u2013d)\r\n\n45 CFR Part 160.310\r\n\n45 CFR Part 164 (throughout)\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories (throughout)\r\n\nAAVLD Requirements for an AVMDL (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-1-2\r\n\nCJIS Security Policy (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\nISO 15189:2012 (throughout)\r\n\nISO\/IEC 17025:2017 (throughout)\r\n\nNew York Department of Health ELAP Microbiology Protocol\r\n\nNIST 800-53, Rev. 4 (throughout)\r\n\nOECD GLP Principles 8\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, #986, Annex 2 (throughout)\n\n\n7.2 The system shall have the ability to readily provide access to electronic documents such as standard operating procedures, quality manuals, instrument manuals, information exchange agreements, and other applicable documents to designated personnel and officials.\n\n\n\n21 CFR Part 820.40 (a)\r\n\n42 CFR Part 493.1251 (e)\r\n\nAAVLD Requirements for an AVMDL Sec. 4.3\r\n\nASTM E1578-18 D-1-3\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 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\nASTM E1578-18 D-1-5\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 5\r\n\nISO\/IEC 17025:2017 6.5\r\n\nISO\/IEC 17025:2017 7.2.1.3\r\n\nNew York Department of Health ELAP Microbiology Protocol\r\n\nUSDA Administrative Procedures for the PDP 8.4\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 212.20 (c)\r\n\n21 CFR Part 212.70 (b)\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\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4\r\n\nEPA QA\/G-5 2.2.4\r\n\nISO\/IEC 17025:2017 7.2.2.1\r\n\nNew York Department of Health ELAP Microbiology Protocol\r\n\nUSDA Administrative Procedures for the PDP 8.4\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 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 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\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\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 2018 (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\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\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\nNew York Department of Health ELAP Microbiology Protocol\r\n\nOECD GLP Principles 1.1.2\r\n\nUSDA Administrative Procedures for the PDP 6.1\r\n\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\n\n7.10 The system shall be capable of uniquely identifying documents created in and added to 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\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\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\nNIST 800-53, Rev. 4, AT-4\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\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\nE.U. Commission Directive 2003\/94\/EC Article 13\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 211.25\r\n\n29 CFR Part 1910.1450 (f)\r\n\n42 CFR Part 73.15\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\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\nNIST 800-53, Rev. 4, AT-2 and AT-3\r\n\nNIST 800-53, Rev. 4, CP-3\r\n\nNIST 800-53, Rev. 4, IR-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 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\nFDA Hazard Analysis Critical Control Point Guidelines\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\n29 CFR Part 1910.1450 (f)\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\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\nISO 15189:2012 5.1.9\r\n\nNIST 800-53, Rev. 4, AT-2\u2013AT-4\r\n\nNIST 800-53, Rev. 4, CP-3\r\n\nNIST 800-53, Rev. 4, IR-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\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\nABFT Accreditation Manual Sec. B\r\nASTM E1578-18 E-1-4\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\nASTM E1578-18 E-1-5\r\n\nNIST 800-53, Rev. 4, AT-2 and AT-3\r\n\nNIST 800-53, Rev. 4, CP-3\r\n\nNIST 800-53, Rev. 4, IR-2\r\n\n\n\n8.7 The system should be able to produce a training matrix of personnel.\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 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\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 2018 (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\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\nASTM E1578-18 C-4-7\r\n\nASTM E1578-18 E-2-1\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\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. 4, AC-2(4) and AC-6(9)\r\n\nNIST 800-53, Rev. 4, AU-2 and AU-3\r\n\nNIST 800-53, Rev. 4, CM-5(1)\r\n\nOECD GLP Principles 8.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n9.2 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\nCJIS Security Policy 5.4.1.1\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. 4, 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\nNIST 800-53, Rev. 4, 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. 4, 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 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\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\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1\r\n\nAIHA-LAP Policies 2018 2C.3.7\u20132C.3.10\r\n\nASTM E1578-18 E-3-7\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\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\nNIST 800-53, Rev. 4, MA-2 and MA-2(2)\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\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 be 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\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\nABFT Accreditation Manual Sec. E-21\r\n\nASTM E1578-18 E-3-9\r\n\nISO 15189:2012 5.3.1.5\r\n\nISO\/IEC 17025:2017 6.4.9\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 820.72 (b-2)\r\n\nASTM E1578-18 E-3-10\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. 4, 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\nAAVLD Requirements for an AVMDL Sec. 5.6.1\u20132\r\n\nAIHA-LAP Policies 2018 2C.3.7\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nISO\/IEC 17025:2017 6.5\r\n\nOECD GLP Principles 4.2\nUSDA Data and Instrumentation for PDP 6.1\r\n\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 211.105 (b)\r\n\n42 CFR Part 493.1255\r\n\nAAVLD Requirements for an AVMDL Sec. 5.5.4\u20135\r\n\nASTM E1578-18 E-3-12\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 7\r\n\nEPA QA\/G-5 2.2.6\u20137\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. 4, CM-8\r\n\nUSDA Administrative Procedures for the PDP 7.2\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\n21 CFR Part 58.63\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\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 2018 2C.3.7\u20132C.3.10\r\n\nASTM E1578-18 E-3-14\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\nISO 15189:2012 5.3.1.4\r\n\nISO\/IEC 17025:2017 6.4.4\r\n\nNIST 800-53, Rev. 4, MA-2, MA-2(2), and MA-4\r\n\nOECD GLP Principles 4.2\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nUSDA Data and Instrumentation for PDP 5.4\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\nASTM E1578-18 E-5-1\r\nUSDA Sampling Procedures for PDP 5.6\u20137\r\n\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\n\n15.1 The system should be capable of accurately tracking the specific quantities of received and consumed test samples.\n\n\n21 CFR Part 212.60 (d)\r\nASTM E1578-18 E-8-2\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\nASTM E1578-18 E-8-3\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 212.40 (c)\r\n\n21 CFR Part 820.50\r\n\nASTM E1578-18 E-8-4\r\n\nUSDA Administrative Procedures for the PDP 7.1\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\nASTM E1578-18 E-8-5\n\n\n15.5 The system should provide a means for accurately recording the receipt, issue, 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 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\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\nEPA ERLN Laboratory Requirements 3.3\r\n\nEPA QA\/G-5 2.2.4\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 8.7.1\r\n\nOECD GLP Principles 7.3\r\n\nUSDA Administrative Procedures for the PDP 8.2.2\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\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\nEPA QA\/G-5 2.2.10\r\n\nWHO Technical Report Series, #986, Annex 2, 17.12\n\n\n16.5 The system should trigger an alert or notification when an OOS\/OOT status is found, prompting a documented investigation to identify the root cause.\n\n\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\nASTM E1578-18 E-9-4\r\n\nE.U. Commission Directive 2003\/94\/EC Article 13\r\n\nFDA Hazard Analysis Critical Control Point Principle 5\r\n\nNew York Department of Health ELAP Microbiology Protocol\r\n\nNIST 800-53, Rev. 4, IR-5\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\n16.6 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\nASTM E1578-18 E-9-5\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\nNew York Department of Health ELAP Microbiology Protocol\r\n\nNIST 800-53, Rev. 4, AU-6(1)\r\n\nNIST 800-53, Rev. 4, IR-4(1) and IR-5\r\n\nNIST 800-53, Rev. 4, SI-2 and SI-4\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\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Maintaining_laboratory_workflow_and_operations\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Maintaining_laboratory_workflow_and_operations<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:18.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 44 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","6b8e5e54109334857e57a1222e4af042_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Taking_the_next_step_Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs_Maintaining_laboratory_workflow_and_operations rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Taking_the_next_step_Blank_LIMSpec_template_for_medical_diagnostics_and_research_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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Taking the next step\/Blank LIMSpec template for medical diagnostics and research 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">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_management\">7. Document 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\/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-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\/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.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=\"http:\/\/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\/Standards\/E1188.htm\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1492.htm\" 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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 D-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 (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\/LexUriServ\/LexUriServ.do?uri=OJ:L:2003:262:0022:0026:en:PDF\" 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:\/\/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.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">New York Department of Health ELAP Microbiology Protocol<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/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.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:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (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-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-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\/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\/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.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.astm.org\/Standards\/E1188.htm\" target=\"_blank\">ASTM E1188-11 3.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1492.htm\" 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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 D-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 (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\/LexUriServ\/LexUriServ.do?uri=OJ:L:2003:262:0022:0026:en:PDF\" 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:\/\/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.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">New York Department of Health ELAP Microbiology Protocol<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/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.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:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2 (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 access to electronic documents such as standard operating procedures, quality manuals, instrument manuals, information exchange 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\/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.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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 D-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. 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:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" 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\/Standards\/E1578.htm\" 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\/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.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 D-1-5<\/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. IV, Sec. 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 6.5<\/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\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">New York Department of Health ELAP Microbiology Protocol<\/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.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" 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\/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.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=\"http:\/\/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=\"http:\/\/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.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:\/\/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.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">New York Department of Health ELAP Microbiology Protocol<\/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.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 4.11<\/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, 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\/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\/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\/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.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=\"http:\/\/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 2018 (various parts)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/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=\"http:\/\/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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-1-6<\/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 11-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/LexUriServ\/LexUriServ.do?uri=OJ:L:2003:262:0022:0026:en:PDF\" 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:\/\/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\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">New York Department of Health ELAP Microbiology Protocol<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/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>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\/Standards\/E1578.htm\" 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>\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<\/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\/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.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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AT-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 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>\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:\/\/eur-lex.europa.eu\/LexUriServ\/LexUriServ.do?uri=OJ:L:2003:262:0022:0026:en:PDF\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 13<\/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, 2.1 (j)<\/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, 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\/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=\"http:\/\/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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-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 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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AT-2 and AT-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, CP-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IR-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:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" 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 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=\"http:\/\/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=\"http:\/\/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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-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 Guidelines<\/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\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/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=\"http:\/\/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=\"http:\/\/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=\"http:\/\/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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-1-3<\/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\/LexUriServ\/LexUriServ.do?uri=OJ:L:2003:262:0022:0026:en:PDF\" 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.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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AT-2\u2013AT-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, CP-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IR-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.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 2.1 (e)<\/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, 9.4<\/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, 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;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. B<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-1-4<\/a>\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;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-1-5<\/a><br \/>\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AT-2 and AT-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, CP-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IR-2<\/a><br \/>\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;\"><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<p><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\/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.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=\"http:\/\/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 2018 (various parts)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/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=\"http:\/\/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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-3-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 D-1-6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-1-6<\/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 11-2<\/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=\"http:\/\/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.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-4-7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-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 4.9.1 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=\"http:\/\/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\/Standards\/E1578.htm\" 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.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\/LexUriServ\/LexUriServ.do?uri=OJ:L:2003:262:0022:0026:en:PDF\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AC-2(4) and AC-6(9)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AU-2 and AU-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, CM-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/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.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" 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>9.2<\/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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-2-3<\/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:\/\/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\/LexUriServ\/LexUriServ.do?uri=OJ:L:2003:262:0022:0026:en:PDF\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AU-3 and AU-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/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\/Standards\/E1578.htm\" 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\/LexUriServ\/LexUriServ.do?uri=OJ:L:2003:262:0022:0026:en:PDF\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AU-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/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\/Standards\/E1578.htm\" 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=\"http:\/\/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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AU-6 and AU-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/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.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=\"http:\/\/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=\"http:\/\/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 2018 2C.3.7\u20132C.3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-3-7<\/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:\/\/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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, MA-2 and MA-2(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 5.2.4<\/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.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 13.5<\/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, 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 be 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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-3-8<\/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, 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=\"http:\/\/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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-3-9<\/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 6.4.9<\/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, 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\/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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-3-10<\/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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, MA-2, MA-2(2), and MA-6(1)<\/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, 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.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 2018 2C.3.7<\/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.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 6.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.2<\/a>\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><br \/>\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\/Standards\/E1578.htm\" 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\/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.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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-3-12<\/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. 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:\/\/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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, CM-8<\/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>\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\/Standards\/E1578.htm\" 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\/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\/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.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=\"http:\/\/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=\"http:\/\/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 2018 2C.3.7\u20132C.3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-3-14<\/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. 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:\/\/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<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, MA-2, MA-2(2), and MA-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/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.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.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.46<\/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, 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\/Standards\/E1578.htm\" 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=\"http:\/\/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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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.astm.org\/Standards\/E1578.htm\" 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><br \/>\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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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=\"http:\/\/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\/Standards\/E1578.htm\" 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=\"http:\/\/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\/Standards\/E1578.htm\" 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:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-8-1<\/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.\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\/212.60\" target=\"_blank\">21 CFR Part 212.60 (d)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-8-2<\/a>\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.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-8-3<\/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, 14.13, 14.35, and 14.41<\/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, 15.10\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\/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.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-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 Administrative Procedures for the PDP 7.1<\/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, 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.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-8-5<\/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, issue, 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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-8-6<\/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, 12.18<\/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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/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=\"http:\/\/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=\"http:\/\/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=\"http:\/\/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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-9-1<\/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\/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:\/\/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 8.7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/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.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.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" 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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-9-2<\/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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-9-3<\/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:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.12<\/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, 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\/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.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-9-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/LexUriServ\/LexUriServ.do?uri=OJ:L:2003:262:0022:0026:en:PDF\" 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:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">New York Department of Health ELAP Microbiology Protocol<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IR-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, 2.1 (f, j)<\/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, 5.0<\/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.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 E-9-5<\/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\/LexUriServ\/LexUriServ.do?uri=OJ:L:2003:262:0022:0026:en:PDF\" 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:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">New York Department of Health ELAP Microbiology Protocol<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, AU-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IR-4(1) and IR-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, SI-2 and SI-4<\/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, 2.1 (f, j)<\/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, 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\/Standards\/E1578.htm\" 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<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20220125221428\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.094 seconds\nReal time usage: 0.240 seconds\nPreprocessor visited node count: 602\/1000000\nPost\u2010expand include size: 173565\/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% 169.282 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Maintaining_laboratory_workflow_and_operations\n100.00% 169.282 1 -total\n 13.18% 22.311 1 Template:LIMSpec\/Resource_management\n 10.27% 17.393 1 Template:LIMSpec\/Compliance_management\n 9.98% 16.900 1 Template:LIMSpec\/Standard_and_reagent_management\n 9.62% 16.278 1 Template:LIMSpec\/Document_management\n 8.96% 15.161 1 Template:LIMSpec\/Instrument_and_equipment_management\n 8.88% 15.031 1 Template:LIMSpec\/Instrument_data_capture_and_control\n 8.80% 14.897 1 Template:LIMSpec\/Batch_and_lot_management\n 8.16% 13.815 1 Template:LIMSpec\/Scheduled_event_management\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12960-0!canonical and timestamp 20220125221428 and revision id 45857. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Maintaining_laboratory_workflow_and_operations\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_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>","6b8e5e54109334857e57a1222e4af042_images":[],"6b8e5e54109334857e57a1222e4af042_timestamp":1643149336,"9b6ad57a8ca0b3a06fa0952f6b4cefc3_type":"article","9b6ad57a8ca0b3a06fa0952f6b4cefc3_title":"A2. Primary laboratory workflow","9b6ad57a8ca0b3a06fa0952f6b4cefc3_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Primary_laboratory_workflow","9b6ad57a8ca0b3a06fa0952f6b4cefc3_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Taking the next step\/Blank LIMSpec template for medical diagnostics and research 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\n42 CFR Part 493.1241\r\nASTM E1578-18 C-1-1\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\nASTM E1492-11 4.1.1.6\r\n\nASTM E1578-18 C-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\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\nASTM E1578-18 C-1-4\r\nUSDA Sampling Procedures for PDP 6.4.1.1.3\n\n1.5 The system should permit metadata like lot number, client demographics, sampling point, random selection process used, and industry-specific items 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 331.17\r\n\n9 CFR Part 121.17\r\n\n21 CFR Part 58.105 (c)\r\n\n21 CFR Part 58.195\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\nASTM E1578-18 C-1-8\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 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\nOECD GLP Principles 6.1\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 sample collection details for registered samples, including container size and type, number of containers, collection date and time, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.\n\n\nASTM E1578-18 C-1-9\r\nEPA ERLN Laboratory Requirements 3.2.1\r\nEPA ERLN Laboratory Requirements 4.4.5\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\nASTM E1578-18 C-1-11\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 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\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\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\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\nEPA ERLN Laboratory Requirements 4.4.7\r\n\nEPA QA\/G-5 2.2.3\r\n\nOECD GLP Principles 6.1\n\n\n1.14 The system shall provide a user-friendly means for acknowledging the physical reception of sample material in the laboratory, including date and time of reception.\n\n\nASTM E1578-18 C-1-14\r\nEPA ERLN Laboratory Requirements 4.4.6\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\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\nEPA ERLN Laboratory Requirements 4.4.13\r\n\nEPA ERLN Laboratory Requirements 4.11.8\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\n\n\n1.16 The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.\n\n\nASTM E1578-18 C-1-16\r\nEPA QA\/G-5 2.2.2 and 2.2.3\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\n42 CFR Part 73.11\r\n\n42 CFR Part 73.17\r\n\n42 CFR Part 493.1274\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\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\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\n\n2. Sample management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 C-2-1\r\nEPA ERLN Laboratory Requirements 4.11.14\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 to be grouped together based on associated metadata such as sample 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 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\n\n\n2.9 The system should provide a means to manually or automatically track sample inventory amounts and status.\n\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1\r\nASTM E1578-18 C-2-10\n\n2.10 The system shall be able to link test methods and specifications to standards and reagents.\n\n\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\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\nNew York Department of Health ELAP Microbiology Protocol\r\n\nUSDA Administrative Procedures for the PDP 8.5\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 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, 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 211.84 (d)\r\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.1.3.1\r\nASTM E1578-18 C-3-1\r\nISO 15189:2012 5.3.2.7\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\n21 CFR Part 211.84 (e)\r\n42 CFR Part 493.1252 (d)\r\nASTM E1578-18 C-3-2\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 2018 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 211.194\r\n\n21 CFR Part 212.60 (g)\r\n\n21 CFR Part 606.160\r\n\nASTM E1578-18 C-3-14\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\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\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\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\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\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\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\nCJIS Security Policy 5.4.1.1\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\nWHO Technical Report Series, #986, Annex 2, 15.7 and 15.9\n\n\n4.3 The system shall accurately maintain a full audit trail for modified results.\n\n\n\n21 CFR Part 211.68 (b)\r\n\nABFT Accreditation Manual Sec. E-28\u201329\r\n\nAIHA-LAP Policies 2018 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\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\nISO 15189:2012 5.7.1\r\n\nISO\/IEC 17025:2017 7.8.1.1\r\n\nUSDA Data and Instrumentation for PDP 10\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\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\nISO 15189:2012 5.9.2\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\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\nASTM E1578-18 C-5-1\r\nUSDA Sample Processing and Analysis Procedures for PDP 5.9\u201310\n\n5.1 The system shall accurately record details of a sample's final disposition.\n\n\nAIHA-LAP Policies 2018 2A.7.7.2\r\nASTM E1578-18 C-5-2\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\n42 CFR Part 493.1291 (g) and (h)\r\nASTM E1578-18 C-6-2\r\nEPA ERLN Laboratory Requirements 4.11.4\r\nEPA QA\/G-5 2.4.2\n\n6.3 The system shall alert users in advance to cases when the 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\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 2018 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\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\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\nASTM E1578-18 C-6-5\r\nISO 15189:2012 5.8.1\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, 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 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\nASTM E1578-18 C-6-7\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\nNIST 800-53, Rev. 4, IR-6 and IR-6(1)\r\n\nOECD GLP Principles 9.1\r\n\nUSDA Administrative Procedures for the PDP (throughout)\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, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator\/sponsor reports.\n\n\n\n21 CFR Part 58 Sec. 58.185 (c)\r\n\nAAVLD Requirements for an AVMDL Sec. 5.10.9\u201310\r\n\nISO\/IEC 17025:2017 7.8.8\r\n\nOECD GLP Principles 9.1\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\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Primary_laboratory_workflow\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Primary_laboratory_workflow<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:17.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 32 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","9b6ad57a8ca0b3a06fa0952f6b4cefc3_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Taking_the_next_step_Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs_Primary_laboratory_workflow rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Taking_the_next_step_Blank_LIMSpec_template_for_medical_diagnostics_and_research_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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Taking the next step\/Blank LIMSpec template for medical diagnostics and research 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">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;\"><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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-1-1<\/a>\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=\"http:\/\/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.astm.org\/Standards\/E1492.htm\" target=\"_blank\">ASTM E1492-11 4.1.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-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\/LexUriServ\/LexUriServ.do?uri=OJ:L:2003:262:0022:0026:en:PDF\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 15<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/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.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\/Standards\/E1578.htm\" 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;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-1-4<\/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 6.4.1.1.3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>1.5<\/b> The system should permit metadata like lot number, client demographics, sampling point, random selection process used, and industry-specific items 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/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\/58.105\" 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\/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=\"http:\/\/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.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-1-8<\/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. 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:\/\/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\/LexUriServ\/LexUriServ.do?uri=OJ:L:2003:262:0022:0026:en:PDF\" 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=\"http:\/\/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.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 sample collection details for registered samples, including container size and type, number of containers, collection date and time, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-1-9<\/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 3.2.1<\/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 4.4.5<\/a>\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\/Standards\/E1578.htm\" 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;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-1-11<\/a>\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\/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=\"http:\/\/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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-1-12<\/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\/LexUriServ\/LexUriServ.do?uri=OJ:L:2003:262:0022:0026:en:PDF\" 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=\"http:\/\/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.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:\/\/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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-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 4.4.7<\/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=\"http:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 6.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>1.14<\/b> The system shall provide a user-friendly means for acknowledging the physical reception of sample material in the laboratory, including date and time of reception.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-1-14<\/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 4.4.6<\/a>\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.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\/Standards\/E1492.htm\" target=\"_blank\">ASTM E1492-11 4.1.1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1492.htm\" target=\"_blank\">ASTM E1492-11 4.1.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1492.htm\" target=\"_blank\">ASTM E1492-11 4.3.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-1-15<\/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.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>\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;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-1-16<\/a><br \/><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<\/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\/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=\"http:\/\/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=\"http:\/\/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\/Standards\/E1492.htm\" target=\"_blank\">ASTM E1492-11 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-1-17<\/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. 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>\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<\/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;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-2-1<\/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>2.1<\/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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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 to be grouped together based on associated metadata such as sample 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\/Standards\/E1578.htm\" 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 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\/Standards\/E1492.htm\" target=\"_blank\">ASTM E1492-11 4.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-2-9<\/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 inventory amounts and status.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-2-10<\/a>\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\/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:\/\/www.astm.org\/Standards\/E1578.htm\" 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.wadsworth.org\/sites\/default\/files\/WebDoc\/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf\" target=\"_blank\">New York Department of Health ELAP Microbiology Protocol<\/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.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 17.7<\/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, 17.22\u201325<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>2.11<\/b> The system shall allow samples 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, 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\/211.84\" target=\"_blank\">21 CFR Part 211.84 (d)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/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 \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-3-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.3.2.7<\/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;\"><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 \/><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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-3-2<\/a>\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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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 2018 2A.7.8.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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\/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\/606.160\" target=\"_blank\">21 CFR Part 606.160<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-3-14<\/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 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:\/\/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:\/\/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<\/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<\/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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-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 4.9.11<\/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>\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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-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 4.9.2<\/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>\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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-4-3<\/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.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\/LexUriServ\/LexUriServ.do?uri=OJ:L:2003:262:0022:0026:en:PDF\" 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.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" 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>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\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/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.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2018 2A.7.7.2 and 7.7.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/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=\"http:\/\/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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-4-4<\/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 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.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 7.8.1.1<\/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 Data and Instrumentation for PDP 10<\/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\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-4-5<\/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.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.9.2<\/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\/Standards\/E1578.htm\" 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<\/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;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-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 Sample Processing and Analysis Procedures for PDP 5.9\u201310<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>5.1<\/b> The system shall accurately record details of a sample's final disposition.\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 2018 2A.7.7.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-5-2<\/a>\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\/Standards\/E1578.htm\" 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\/Standards\/E1578.htm\" 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;\"><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 \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-6-2<\/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 4.11.4<\/a><br \/><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>\n<\/td>\n<td style=\"background-color:white;\"><b>6.3<\/b> The system shall alert users in advance to cases when the 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=\"http:\/\/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\/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 2018 2A.7.8.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/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\/Standards\/E1578.htm\" 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.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" 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.astm.org\/Standards\/E1578.htm\" 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;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-6-5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.8.1<\/a>\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, 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\/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=\"http:\/\/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.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18 C-6-7<\/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 5.3.1<\/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:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4, IR-6 and IR-6(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/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.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP (throughout)<\/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, 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\/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.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:\/\/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=\"http:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 9.1<\/a>\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<!-- \nNewPP limit report\nCached time: 20220125221427\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.067 seconds\nReal time usage: 0.153 seconds\nPreprocessor visited node count: 273\/1000000\nPost\u2010expand include size: 97717\/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% 101.805 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Primary_laboratory_workflow\n100.00% 101.805 1 -total\n 18.25% 18.584 1 Template:LIMSpec\/Sample,_experiment,_and_study_approval_and_verification\n 17.89% 18.215 1 Template:LIMSpec\/Core_laboratory_testing_and_experiments\n 17.22% 17.526 1 Template:LIMSpec\/Sample_and_experiment_registration\n 17.09% 17.394 1 Template:LIMSpec\/Sample_management\n 13.55% 13.793 1 Template:LIMSpec\/Reporting\n 8.94% 9.106 1 Template:LIMSpec\/Results_review_and_verification\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12959-0!canonical and timestamp 20220125221427 and revision id 45856. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Primary_laboratory_workflow\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_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>","9b6ad57a8ca0b3a06fa0952f6b4cefc3_images":[],"9b6ad57a8ca0b3a06fa0952f6b4cefc3_timestamp":1643149336,"362e9c62dacc255c1076806a8cefae5f_type":"article","362e9c62dacc255c1076806a8cefae5f_title":"A1. Introduction and methodology","362e9c62dacc255c1076806a8cefae5f_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Introduction_and_methodology","362e9c62dacc255c1076806a8cefae5f_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Taking the next step\/Blank LIMSpec template for medical diagnostics and research 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 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. 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 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. With the latest version released in 2018, an updated Laboratory Informatics Functional Requirements checklist is included in the appendix, 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.\"\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 second revision taps into the following sources:\n\n5 CFR Part 930.301\n7 CFR Part 331\n9 CFR Part 121\n21 CFR Part 7\n21 CFR Part 11\n21 CFR Part 58\n21 CFR Part 211\n21 CFR Part 212\n21 CFR Part 225\n21 CFR Part 226\n21 CFR Part 312\n21 CFR Part 606\n21 CFR Part 810\n21 CFR Part 812\n21 CFR Part 820\n29 CFR Part 1910.120\n29 CFR Part 1910.134\n29 CFR Part 1910.1030\n29 CFR Part 1910.1096\n29 CFR Part 1910.1200\n29 CFR Part 1910.1450\n40 CFR Part 3\n40 CFR Part 60\n40 CFR Part 62\n40 CFR Part 63\n40 CFR Part 141\n40 CFR Part 370\n40 CFR Part 372\n40 CFR Part 704\n40 CFR Part 717\n40 CFR Part 720\n42 CFR Part 73\n42 CFR Part 493\n45 CFR Part 160\n45 CFR Part 162\n45 CFR Part 164\n45 CFR Part 170\nAAFCO QA\/QC Guidelines for Feed Laboratories\nAAVLD Requirements for an AVMDL\nABFT Accreditation Manual\nAIHA-LAP Policies 2018\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories\nASTM E1188-11\nASTM E1459-13\nASTM E1492-11\nASTM E1578-18\nCDC PHIN Messaging System\nCJIS Security Policy\nE.U. Annex 11\nE.U. Commission Directive 2003\/94\/EC\nEPA 815-R-05-004\nEPA ERLN Laboratory Requirements v1.6\nEPA Metadata Technical Specification\nEPA QA\/G-5\nEPA SEDD Specification and Data Element Dictionary v5.2\nFDA eLEXNET Data Exchange Program\nFDA Hazard Analysis Critical Control Point (HACCP)\nICAR 15 Data Exchange\nISO 15189:2012\nISO\/IEC 17025:2017\nNAHLN HL7 Messaging Quick User Guide\nNAHLN Information Technology System\nNew York Department of Health ELAP Microbiology Protocol\r\n\nNIST 800-53, Rev. 4\nOECD GLP Principles\nUSDA Administrative Procedures for the Pesticide Data Program (PDP)\nUSDA Data and Instrumentation for PDP\nUSDA Sample Processing and Analysis Procedures for PDP\nUSDA Sampling Procedures for PDP\nVeNom Coding Group terminology\nVeterinary Terminology Services Laboratory terminology\nVICH GL53\nWHO Technical Report Series, #986, Annex 2 \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 are both proprietary and more or less prohibitively expensive. In other cases such as the U.S. Food Emergency Response Network and Laboratory Response Network, they simply don't make their standardized procedures open to the public.\n\nReferences \n\n\n\u2191 \"specification\". Merriam-Webster. Merriam-Webster, Inc. https:\/\/www.merriam-webster.com\/dictionary\/specification . Retrieved 20 September 2019 .   \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 20 September 2019 .   \n \n\n\u2191 \"ISO\/IEC\/IEEE 29148:2018\". International Organization for Standardization. November 2018. https:\/\/www.iso.org\/standard\/72089.html . Retrieved 20 September 2019 .   \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 20 September 2019 .   \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 20 September 2019 .   \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 20 September 2019 .   \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 02 February 2020 .   \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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Introduction_and_methodology\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Introduction_and_methodology<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:17.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 38 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","362e9c62dacc255c1076806a8cefae5f_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Taking_the_next_step_Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs_Introduction_and_methodology rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Taking_the_next_step_Blank_LIMSpec_template_for_medical_diagnostics_and_research_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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Taking the next step\/Blank LIMSpec template for medical diagnostics and research 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">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 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. 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 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>. With the latest version released in 2018, an updated Laboratory Informatics Functional Requirements checklist is included in the appendix, 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>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 second revision taps into the following sources:\n<\/p>\n<ul><li><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><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2018<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/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><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1188.htm\" target=\"_blank\">ASTM E1188-11<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1459.htm\" target=\"_blank\">ASTM E1459-13<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1492.htm\" target=\"_blank\">ASTM E1492-11<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">ASTM E1578-18<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/phin\/tools\/phinms\/index.html\" target=\"_blank\">CDC PHIN Messaging System<\/a><\/li>\n<li><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><\/li>\n<li><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><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-1\/dir_2003_94\/dir_2003_94_en.pdf\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC<\/a><\/li>\n<li><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<\/a><\/li>\n<li><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 v1.6<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/geospatial\/epa-metadata-technical-specification\" target=\"_blank\">EPA Metadata Technical Specification<\/a><\/li>\n<li><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><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/2015-07\/documents\/sedd52_specification.pdf\" target=\"_blank\">EPA SEDD Specification and Data Element Dictionary v5.2<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elexnet.fda.gov\/elex\/documents\/eLEXNET_DX_Brochure_Aug_2011.pdf\" target=\"_blank\">FDA eLEXNET Data Exchange Program<\/a><\/li>\n<li><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><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.icar.org\/Guidelines\/15-Data-Exchange.pdf\" target=\"_blank\">ICAR 15 Data Exchange<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017<\/a><\/li>\n<li><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><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphis.usda.gov\/aphis\/ourfocus\/animalhealth\/lab-info-services\/nahln\/ct_nahln_it\" target=\"_blank\">NAHLN Information Technology System<\/a><\/li>\n<li><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\">New York Department of Health ELAP Microbiology Protocol<\/a><br \/><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles<\/a><\/li>\n<li><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><\/li>\n<li><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<\/a><\/li>\n<li><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<\/a><\/li>\n<li><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<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/venomcoding.org\/\" target=\"_blank\">VeNom Coding Group terminology<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/vtsl.vetmed.vt.edu\/\" target=\"_blank\">Veterinary Terminology Services Laboratory terminology<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/vichsec.org\/en\/guidelines\/general\" target=\"_blank\">VICH GL53<\/a><\/li>\n<li><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 <\/a><\/li><\/ul>\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 Official Methods of Analysis are both proprietary and more or less prohibitively expensive. In other cases such as the U.S. Food Emergency Response Network and Laboratory Response Network, they simply don't make their standardized procedures open to the public.\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 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=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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Introduction_and_methodology\"><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 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=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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Introduction_and_methodology\"><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 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=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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Introduction_and_methodology\"><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 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=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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Introduction_and_methodology\"><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 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=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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Introduction_and_methodology\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-AasemAnalysis10-6\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-AasemAnalysis10_6-0\">\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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_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 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=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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_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 02 February 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=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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Introduction_and_methodology\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20220125221427\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.134 seconds\nReal time usage: 2.183 seconds\nPreprocessor visited node count: 6297\/1000000\nPost\u2010expand include size: 71890\/2097152 bytes\nTemplate argument size: 17077\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 15267\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 110.427 1 -total\n 85.63% 94.554 1 Template:Reflist\n 62.60% 69.126 9 Template:Citation\/core\n 50.21% 55.444 7 Template:Cite_web\n 23.23% 25.650 2 Template:Cite_journal\n 14.32% 15.814 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Introduction_and_methodology\n 10.97% 12.117 6 Template:Date\n 10.32% 11.399 1 Template:LIMSpec\/Introduction_and_methodology\n 9.94% 10.980 2 Template:Citation\/identifier\n 4.84% 5.340 14 Template:Citation\/make_link\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12958-0!canonical and timestamp 20220125221425 and revision id 45855. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Introduction_and_methodology\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_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>","362e9c62dacc255c1076806a8cefae5f_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/9\/9b\/Systems_Requirement_Analysis.jpg"],"362e9c62dacc255c1076806a8cefae5f_timestamp":1643149336,"f56dfc21dd4796864f8737a0566b64cd_type":"article","f56dfc21dd4796864f8737a0566b64cd_title":"7.1 Recap and closing","f56dfc21dd4796864f8737a0566b64cd_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Closing_remarks","f56dfc21dd4796864f8737a0566b64cd_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Closing remarksFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n7. Closing remarks \nSelecting and implementing a solution such as a laboratory information system (LIS) or laboratory information management system (LIMS) for your medical diagnostic or research laboratory can be an intimidating task, whether its the laboratory's first solution or a follow-up solution. Additional concerns about the functionality and ease-of-use of such systems also persist. According to a 2016 survey by technology specialist Astrix, the most common complaints were that \"LIMS were perceived to be difficult to use and lacked integration with other systems,\" with respondents indicating the primary reason for purchasing a new solution being their overall dissatisfaction with an existing system.[1] \nA case can be made that some vendors aren't clear or honest about the functionality of their system, contributing to this end-user unhappiness. However, a more common reality is that poor requirements management is also at least partially responsible for project failure.[2] This guide has attempted to not only provide practical advice towards system selection and implementation, but it has also emphasized the real value your organization can gain from taking a methodical approach to choosing the best system for your needs via proper requirements management. In fact, according to the Project Management Institute, \"for every dollar spent on projects and programs, 5.1 percent is wasted due to poor requirements management.\"[2] It's tough to deny that system acquisition and implementation is definitively a project, so why waste dollars by not being prepared?\nThis guide has looked at the various laboratories in the medical diagnostic and research fields, their technology requirements, the functionality required in the systems they implement, and how best to go about acquiring those systems, particularly ones that are flexible in their configurability. The guide also notes the value of considering cybersecurity during decision making, a concern that will only continue to grow for the laboratory industry. You've also been given many tools to apply to your selection and implementation processes, including vendor lists and information sources. The LIMSpec, a pre-developed user requirements specification document is also discussed, including how it can be best applied to ensure your laboratory's success. Don't forget that in Appendix 1 you'll also find a blank version of LIMSpec for clinical diagnostic and research labs, including a downloadable Microsoft Word version. \nIn the end, your medical lab wants to succeed in its mission of providing the best analytical and research services towards improving overall human and animal health. It's increasingly clear that one or more laboratory informatics solutions can help with achieving that goal. Be reminded that such software is still just a tool, granted, one with which your lab can better manage testing, more closely follow regulations and standards, improve operational efficiency, and guarantee better patient outcomes. However, like any tool, picking the most suitable one for the job, and implementing it effectively and securely, is vital. We hope this guide will help you in picking the solution that best helps your organization meet its short- and long-term goals.\n\nReferences \n\n\n\u2191 \"2016 LIMS Market Research Survey Report\" (PDF). Astrix Technology Group, Inc. 2017. http:\/\/vertassets.blob.core.windows.net\/download\/a43a4bdc\/a43a4bdc-bfed-4d4b-b8b9-b0ba6d42f786\/lims_market_research_survey_summary.pdf . Retrieved 04 December 2021 .   \n \n\n\u2191 2.0 2.1 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 04 December 2021 .   \n \n\n\n\r\n\n\n-----Go to the next chapter of this guide-----\nCitation information for this chapter \nChapter: 7. Closing remarks\nTitle: Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\nEdition: 2022 Edition\nAuthor for citation: Shawn E. Douglas\nLicense for content: Creative Commons Attribution-ShareAlike 4.0 International\nPublication date: January 2022\n\r\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Closing_remarks\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Closing_remarks<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:17.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 49 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","f56dfc21dd4796864f8737a0566b64cd_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Closing_remarks rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">the beginning<\/a> of this guide-----<\/div>\n<h2><span class=\"mw-headline\" id=\"7._Closing_remarks\">7. Closing remarks<\/span><\/h2>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:CSIRO_ScienceImage_11169_CSIRO_scientist.jpg\" class=\"image wiki-link\" data-key=\"145cced84f7861ab05e2b478b3990ee7\"><img alt=\"CSIRO ScienceImage 11169 CSIRO scientist.jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/2\/2e\/CSIRO_ScienceImage_11169_CSIRO_scientist.jpg\" decoding=\"async\" width=\"220\" height=\"330\" \/><\/a><\/div><p>Selecting and implementing a solution such as a <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) or <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) for your <a href=\"https:\/\/www.limswiki.org\/index.php\/Clinical_laboratory\" title=\"Clinical laboratory\" class=\"wiki-link\" data-key=\"307bcdf1bdbcd1bb167cee435b7a5463\">medical diagnostic<\/a> or research laboratory can be an intimidating task, whether its the <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory\" title=\"Laboratory\" class=\"wiki-link\" data-key=\"c57fc5aac9e4abf31dccae81df664c33\">laboratory<\/a>'s first solution or a follow-up solution. Additional concerns about the functionality and ease-of-use of such systems also persist. According to a 2016 survey by technology specialist Astrix, the most common complaints were that \"LIMS were perceived to be difficult to use and lacked integration with other systems,\" with respondents indicating the primary reason for purchasing a new solution being their overall dissatisfaction with an existing system.<sup id=\"rdp-ebb-cite_ref-Astrix2016LIMS17_1-0\" class=\"reference\"><a href=\"#cite_note-Astrix2016LIMS17-1\">[1]<\/a><\/sup> \n<\/p><p>A case can be made that some vendors aren't clear or honest about the functionality of their system, contributing to this end-user unhappiness. However, a more common reality is that poor requirements management is also at least partially responsible for project failure.<sup id=\"rdp-ebb-cite_ref-BiegRequire14_2-0\" class=\"reference\"><a href=\"#cite_note-BiegRequire14-2\">[2]<\/a><\/sup> This guide has attempted to not only provide practical advice towards system selection and implementation, but it has also emphasized the real value your organization can gain from taking a methodical approach to choosing the best system for your needs via proper requirements management. In fact, according to the Project Management Institute, \"for every dollar spent on projects and programs, 5.1 percent is wasted due to poor requirements management.\"<sup id=\"rdp-ebb-cite_ref-BiegRequire14_2-1\" class=\"reference\"><a href=\"#cite_note-BiegRequire14-2\">[2]<\/a><\/sup> It's tough to deny that system acquisition and implementation is definitively a project, so why waste dollars by not being prepared?\n<\/p><p>This guide has looked at the various laboratories in the medical diagnostic and research fields, their technology requirements, the functionality required in the systems they implement, and how best to go about acquiring those systems, particularly ones that are flexible in their configurability. The guide also notes the value of considering cybersecurity during decision making, a concern that will only continue to grow for the laboratory industry. You've also been given many tools to apply to your selection and implementation processes, including vendor lists and information sources. The LIMSpec, a pre-developed user requirements specification document is also discussed, including how it can be best applied to ensure your laboratory's success. Don't forget that in Appendix 1 you'll also find a blank version of LIMSpec for clinical diagnostic and research labs, including a downloadable Microsoft Word version. \n<\/p><p>In the end, your medical lab wants to succeed in its mission of providing the best analytical and research services towards improving overall human and animal health. It's increasingly clear that one or more <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_informatics\" title=\"Laboratory informatics\" class=\"wiki-link\" data-key=\"00edfa43edcde538a695f6d429280301\">laboratory informatics<\/a> solutions can help with achieving that goal. Be reminded that such software is still just a tool, granted, one with which your lab can better manage testing, more closely follow regulations and standards, improve operational efficiency, and guarantee better patient outcomes. However, like any tool, picking the most suitable one for the job, and implementing it effectively and securely, is vital. We hope this guide will help you in picking the solution that best helps your organization meet its short- and long-term goals.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist\" style=\"list-style-type: decimal;\">\n<div class=\"mw-references-wrap\"><ol class=\"references\">\n<li id=\"cite_note-Astrix2016LIMS17-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-Astrix2016LIMS17_1-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/vertassets.blob.core.windows.net\/download\/a43a4bdc\/a43a4bdc-bfed-4d4b-b8b9-b0ba6d42f786\/lims_market_research_survey_summary.pdf\" target=\"_blank\">\"2016 LIMS Market Research Survey Report\"<\/a> (PDF). Astrix Technology Group, Inc. 2017<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/vertassets.blob.core.windows.net\/download\/a43a4bdc\/a43a4bdc-bfed-4d4b-b8b9-b0ba6d42f786\/lims_market_research_survey_summary.pdf\" target=\"_blank\">http:\/\/vertassets.blob.core.windows.net\/download\/a43a4bdc\/a43a4bdc-bfed-4d4b-b8b9-b0ba6d42f786\/lims_market_research_survey_summary.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 04 December 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=2016+LIMS+Market+Research+Survey+Report&rft.atitle=&rft.date=2017&rft.pub=Astrix+Technology+Group%2C+Inc&rft_id=http%3A%2F%2Fvertassets.blob.core.windows.net%2Fdownload%2Fa43a4bdc%2Fa43a4bdc-bfed-4d4b-b8b9-b0ba6d42f786%2Flims_market_research_survey_summary.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Closing_remarks\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BiegRequire14-2\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-BiegRequire14_2-0\">2.0<\/a><\/sup> <sup><a href=\"#cite_ref-BiegRequire14_2-1\">2.1<\/a><\/sup><\/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 04 December 2021<\/span>.<\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Closing_remarks\"><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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Introduction_and_methodology\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Taking the next step\/Blank LIMSpec template for medical diagnostics and research labs\/Introduction and methodology\" class=\"wiki-link\" data-key=\"362e9c62dacc255c1076806a8cefae5f\">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>: 7. Closing remarks\n<\/p><p><b>Title<\/b>: <i>Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research<\/i>\n<\/p><p><b>Edition<\/b>: 2022 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 2022\n<\/p><p><br \/>\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20220125221424\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.069 seconds\nReal time usage: 0.684 seconds\nPreprocessor visited node count: 1442\/1000000\nPost\u2010expand include size: 14303\/2097152 bytes\nTemplate argument size: 4344\/2097152 bytes\nHighest expansion depth: 19\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 3725\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 45.172 1 -total\n100.00% 45.172 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Closing_remarks\n 73.30% 33.112 1 Template:Reflist\n 60.37% 27.269 2 Template:Cite_web\n 50.86% 22.974 2 Template:Citation\/core\n 12.98% 5.862 2 Template:Date\n 7.32% 3.305 3 Template:Citation\/make_link\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12957-0!canonical and timestamp 20220125221424 and revision id 45854. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Closing_remarks\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/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>","f56dfc21dd4796864f8737a0566b64cd_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/2\/2e\/CSIRO_ScienceImage_11169_CSIRO_scientist.jpg"],"f56dfc21dd4796864f8737a0566b64cd_timestamp":1643149336,"bd3ccdce50729a1112a4e12b8de2459a_type":"article","bd3ccdce50729a1112a4e12b8de2459a_title":"6.4 Finalize the requirements specification and choose a vendor","bd3ccdce50729a1112a4e12b8de2459a_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Finalize_the_requirements_specification_and_choose_a_vendor","bd3ccdce50729a1112a4e12b8de2459a_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Taking the next step\/Finalize the requirements specification and choose a vendorFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n6.4 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 medical diagnostics and research 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\r\n\n\n-----Go to the next chapter of this guide-----\nCitation information for this chapter \nChapter: 6. Taking the next step\nTitle: Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\nEdition: 2022 Edition\nAuthor for citation: Shawn E. Douglas and Alan Vaughan\nLicense for content: Creative Commons Attribution-ShareAlike 4.0 International\nPublication date: January 2022\n\r\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Finalize_the_requirements_specification_and_choose_a_vendor\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Finalize_the_requirements_specification_and_choose_a_vendor<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:17.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 33 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","bd3ccdce50729a1112a4e12b8de2459a_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Taking_the_next_step_Finalize_the_requirements_specification_and_choose_a_vendor rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">the beginning<\/a> of this guide-----<\/div>\n<h3><span class=\"mw-headline\" id=\"6.4_Finalize_the_requirements_specification_and_choose_a_vendor\">6.4 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 medical diagnostics and research 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><p><br \/>\n<\/p>\n<div align=\"center\">-----Go to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Closing_remarks\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Closing remarks\" class=\"wiki-link\" data-key=\"f56dfc21dd4796864f8737a0566b64cd\">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. Taking the next step\n<\/p><p><b>Title<\/b>: <i>Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research<\/i>\n<\/p><p><b>Edition<\/b>: 2022 Edition\n<\/p><p><b>Author for citation<\/b>: Shawn E. Douglas and Alan Vaughan\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 2022\n<\/p><p><br \/>\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20220125221424\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.004 seconds\nReal time usage: 0.008 seconds\nPreprocessor visited node count: 12\/1000000\nPost\u2010expand include size: 3099\/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% 3.013 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Finalize_the_requirements_specification_and_choose_a_vendor\n100.00% 3.013 1 -total\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12956-0!canonical and timestamp 20220125221424 and revision id 45853. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Finalize_the_requirements_specification_and_choose_a_vendor\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/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>","bd3ccdce50729a1112a4e12b8de2459a_images":[],"bd3ccdce50729a1112a4e12b8de2459a_timestamp":1643149335,"83ad93fd6881331dbec5b7b4996b064d_type":"article","83ad93fd6881331dbec5b7b4996b064d_title":"6.3 Respond to or open dialogue with vendors","83ad93fd6881331dbec5b7b4996b064d_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Respond_to_or_open_dialogue_with_vendors","83ad93fd6881331dbec5b7b4996b064d_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Taking the next step\/Respond to or open dialogue with vendorsFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n6.3 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 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 clinical diagnostics or research laboratory. These expected benefits should tie in with your overall business mission and goals. Using a laboratory information management system (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 2.1.6; this discussion will add a few more points.) The fact that laboratory informatics systems like the LIMS or the laboratory information system (LIS) 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 or LIS 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\n6.3.1 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 medical diagnostic and research 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 01 December 2021 .   \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 01 December 2021 .   \n \n\n\u2191 \"Saving Costs with LIMS\". CSols, Inc. 25 October 2018. https:\/\/www.csolsinc.com\/blog\/saving-costs-with-lims\/ . Retrieved 01 December 2021 .   \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 July 2021 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Respond_to_or_open_dialogue_with_vendors\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Respond_to_or_open_dialogue_with_vendors<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:16.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 30 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","83ad93fd6881331dbec5b7b4996b064d_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Taking_the_next_step_Respond_to_or_open_dialogue_with_vendors rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">the beginning<\/a> of this guide-----<\/div>\n<h3><span class=\"mw-headline\" id=\"6.3_Respond_to_or_open_dialogue_with_vendors\">6.3 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 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 clinical diagnostics or research laboratory. These expected benefits should tie in with your overall business mission and goals. Using 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) 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 2.1.6; this discussion will add a few more points.) The fact that laboratory informatics systems like the LIMS or the <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) 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 or LIS 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=\"6.3.1_The_value_of_demonstrations\">6.3.1 The value of demonstrations<\/span><\/h4>\n<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 medical diagnostic and research 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 01 December 2021<\/span>.<\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/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 01 December 2021<\/span>.<\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/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 01 December 2021<\/span>.<\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/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 July 2021<\/span>.<\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/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: 20220125221423\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.050 seconds\nReal time usage: 0.073 seconds\nPreprocessor visited node count: 3539\/1000000\nPost\u2010expand include size: 32368\/2097152 bytes\nTemplate argument size: 8260\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 7465\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 66.312 1 -total\n 89.94% 59.641 1 Template:Reflist\n 54.79% 36.331 4 Template:Cite_web\n 52.82% 35.028 5 Template:Citation\/core\n 13.30% 8.817 4 Template:Date\n 12.86% 8.528 1 Template:Cite_journal\n 9.95% 6.598 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Respond_to_or_open_dialogue_with_vendors\n 5.79% 3.837 8 Template:Citation\/make_link\n 3.79% 2.515 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12955-0!canonical and timestamp 20220125221423 and revision id 45852. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Respond_to_or_open_dialogue_with_vendors\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/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>","83ad93fd6881331dbec5b7b4996b064d_images":[],"83ad93fd6881331dbec5b7b4996b064d_timestamp":1643149335,"f0675b84a3edd1d16f1940ff77061197_type":"article","f0675b84a3edd1d16f1940ff77061197_title":"6.2 Issue some of the specification as part of a request for information (RFI)","f0675b84a3edd1d16f1940ff77061197_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Issue_some_of_the_specification_as_part_of_a_request_for_information_(RFI)","f0675b84a3edd1d16f1940ff77061197_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/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 6.2 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 clinical and research 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, it's 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 30 November 2021 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Issue_some_of_the_specification_as_part_of_a_request_for_information_(RFI)\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/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 pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:16.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 25 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","f0675b84a3edd1d16f1940ff77061197_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Taking_the_next_step_Issue_some_of_the_specification_as_part_of_a_request_for_information_RFI rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">the beginning<\/a> of this guide-----<\/div>\n<h3><span id=\"rdp-ebb-6.2_Issue_some_of_the_specification_as_part_of_a_request_for_information_(RFI)\"><\/span><span class=\"mw-headline\" id=\"6.2_Issue_some_of_the_specification_as_part_of_a_request_for_information_.28RFI.29\">6.2 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 clinical and research 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, it's 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 30 November 2021<\/span>.<\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/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: 20220125221423\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.020 seconds\nReal time usage: 0.036 seconds\nPreprocessor visited node count: 677\/1000000\nPost\u2010expand include size: 11089\/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: 1957\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 28.937 1 -total\n 79.35% 22.961 1 Template:Reflist\n 54.10% 15.655 1 Template:Cite_web\n 39.88% 11.539 1 Template:Citation\/core\n 20.39% 5.900 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Issue_some_of_the_specification_as_part_of_a_request_for_information_(RFI)\n 10.15% 2.938 2 Template:Citation\/make_link\n 9.31% 2.695 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12954-0!canonical and timestamp 20220125221423 and revision id 45851. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Issue_some_of_the_specification_as_part_of_a_request_for_information_(RFI)\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/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>","f0675b84a3edd1d16f1940ff77061197_images":[],"f0675b84a3edd1d16f1940ff77061197_timestamp":1643149335,"a81f595d27ceee9f009e979f2f949ead_type":"article","a81f595d27ceee9f009e979f2f949ead_title":"6.1 Conduct initial research into a specification document","a81f595d27ceee9f009e979f2f949ead_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document","a81f595d27ceee9f009e979f2f949ead_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Taking the next step\/Conduct initial research into a specification documentFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n6. Taking the next step \nIn section 2.4 of this guide, we briefly discussed how a user requirements specification (URS) fits into the process of purchasing laboratory informatics solutions for your clinical or research 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 in 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 clinical and research 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\n6.1 Conduct initial research into a specification document \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 2019 document, omitting a few of the specialty laboratory functions that aren't applicable to clinical diagnostic and research 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 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)\n18. Statistical trending and control charts\n21. Forensic case and data management\n22. Public health data management\n23. Veterinary data management\n24. Scientific data management\n25. Health information technology\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 6.3.1.) 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 18 November 2021 .   \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 18 November 2021 .   \n \n\n\u2191 \"specification\". Merriam-Webster. Merriam-Webster, Inc. https:\/\/www.merriam-webster.com\/dictionary\/specification . Retrieved 18 November 2021 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:16.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 37 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","a81f595d27ceee9f009e979f2f949ead_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Taking_the_next_step_Conduct_initial_research_into_a_specification_document rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Taking_the_next_step_Conduct_initial_research_into_a_specification_document 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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Taking the next step\/Conduct initial research into a specification document<\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">the beginning<\/a> of this guide-----<\/div>\n<h2><span class=\"mw-headline\" id=\"6._Taking_the_next_step\">6. Taking the next step<\/span><\/h2>\n<p>In section 2.4 of this guide, we briefly discussed how a user requirements specification (URS) fits into the process of purchasing laboratory informatics solutions for your clinical or research 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 in 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, 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 <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 clinical and research 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 class=\"mw-headline\" id=\"6.1_Conduct_initial_research_into_a_specification_document\">6.1 Conduct initial research into a specification document<\/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_2019_R1\" title=\"Book:LIMSpec 2019 R1\" class=\"wiki-link\" data-key=\"be4a6879593cf6b89768cf1d794af185\">LIMSpec 2019<\/a> document, omitting a few of the specialty laboratory functions that aren't applicable to clinical diagnostic and research 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 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>18. Statistical trending and control charts<\/li>\n<li>21. Forensic case and data management<\/li>\n<li>22. Public health data management<\/li>\n<li>23. Veterinary data management<\/li>\n<li>24. Scientific data management<\/li>\n<li>25. Health information technology<\/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 6.3.1.) 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document\"><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 18 November 2021<\/span>.<\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document\"><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 18 November 2021<\/span>.<\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document\"><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 18 November 2021<\/span>.<\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20220125174905\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.057 seconds\nReal time usage: 0.119 seconds\nPreprocessor visited node count: 2784\/1000000\nPost\u2010expand include size: 25662\/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: 6573\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 92.284 1 -total\n 71.08% 65.596 1 Template:Reflist\n 48.20% 44.478 4 Template:Citation\/core\n 31.55% 29.115 1 Template:Cite_journal\n 28.84% 26.613 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document\n 28.52% 26.318 3 Template:Cite_web\n 10.66% 9.841 1 Template:Citation\/identifier\n 7.56% 6.980 2 Template:Date\n 4.22% 3.892 7 Template:Citation\/make_link\n 3.53% 3.257 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12953-0!canonical and timestamp 20220125174905 and revision id 45850. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document<\/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>","a81f595d27ceee9f009e979f2f949ead_images":[],"a81f595d27ceee9f009e979f2f949ead_timestamp":1643149335,"644cc5c11e93b1af5a2b02d40240bf94_type":"article","644cc5c11e93b1af5a2b02d40240bf94_title":"5.7 LIMSpec","644cc5c11e93b1af5a2b02d40240bf94_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/LIMSpec","644cc5c11e93b1af5a2b02d40240bf94_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 3: Industry and community resources\/LIMSpecFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n5.7 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 23 November 2021 .   \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 23 November 2021 .   \n \n\n\u2191 \"specification\". Merriam-Webster. Merriam-Webster, Inc. https:\/\/www.merriam-webster.com\/dictionary\/specification . Retrieved 23 November 2021 .   \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 23 November 2021 .   \n \n\n\n\r\n\n\n-----Go to the next chapter of this guide-----\nCitation information for this chapter \nChapter: 5. Resources for selecting and implementing informatics solutions: Part 3: Industry and community resources\nTitle: Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\nEdition: 2022 Edition\nAuthor for citation: Shawn E. Douglas\nLicense for content: Creative Commons Attribution-ShareAlike 4.0 International\nPublication date: January 2022\n\r\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/LIMSpec\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/LIMSpec<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:16.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 29 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","644cc5c11e93b1af5a2b02d40240bf94_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Resources_for_selecting_and_implementing_informatics_solutions_Part_3_Industry_and_community_resources_LIMSpec rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Resources_for_selecting_and_implementing_informatics_solutions_Part_3_Industry_and_community_resources_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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 3: Industry and community resources\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">the beginning<\/a> of this guide-----<\/div>\n<h3><span class=\"mw-headline\" id=\"5.7_LIMSpec\">5.7 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_2019_R1\" title=\"Book:LIMSpec 2019 R1\" class=\"wiki-link\" data-key=\"be4a6879593cf6b89768cf1d794af185\">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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/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 23 November 2021<\/span>.<\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/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 23 November 2021<\/span>.<\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/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 23 November 2021<\/span>.<\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/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 23 November 2021<\/span>.<\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Taking the next step\/Conduct initial research into a specification document\" class=\"wiki-link\" data-key=\"a81f595d27ceee9f009e979f2f949ead\">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. Resources for selecting and implementing informatics solutions: Part 3: Industry and community resources\n<\/p><p><b>Title<\/b>: <i>Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research<\/i>\n<\/p><p><b>Edition<\/b>: 2022 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 2022\n<\/p><p><br \/>\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20220125221423\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.068 seconds\nReal time usage: 0.173 seconds\nPreprocessor visited node count: 3457\/1000000\nPost\u2010expand include size: 28693\/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: 8276\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 80.989 1 -total\n 88.74% 71.872 1 Template:Reflist\n 62.08% 50.275 5 Template:Citation\/core\n 37.38% 30.277 1 Template:Cite_journal\n 37.36% 30.255 4 Template:Cite_web\n 15.18% 12.294 1 Template:Citation\/identifier\n 11.17% 9.048 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/LIMSpec\n 10.37% 8.396 3 Template:Date\n 5.09% 4.126 1 Template:Column-width\n 5.09% 4.126 8 Template:Citation\/make_link\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12952-0!canonical and timestamp 20220125221422 and revision id 45849. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/LIMSpec\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/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>","644cc5c11e93b1af5a2b02d40240bf94_images":["https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/9\/97\/LIMSpec.png"],"644cc5c11e93b1af5a2b02d40240bf94_timestamp":1643149335,"df7a5eb4b2a9d9dc9dc9a30ae1ad4e49_type":"article","df7a5eb4b2a9d9dc9dc9a30ae1ad4e49_title":"5.6 Further reading","df7a5eb4b2a9d9dc9dc9a30ae1ad4e49_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Further_reading","df7a5eb4b2a9d9dc9dc9a30ae1ad4e49_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 3: Industry and community resources\/Further readingFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n5.6 Further reading \nAlotaibi, Y.K.; Federico, F. (2017). \"The impact of health information technology on patient safety\". Saudi Medical Journal 38 (12): 1173\u201380. doi:10.15537\/smj.2017.12.20631. PMC PMC5787626. PMID 29209664. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC5787626 .   \nAssociation of Public Health Laboratories (May 2019). \"Laboratory Information Systems Project Management: A Guidebook for International Implementations\" (PDF). APHL. https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf .   \nBakken, S. (2021). \"The maturation of clinical research informatics as a subdomain of biomedical informatics\". JAMIA 28 (1): 1\u20132. PMC PMC7810454. PMID 33450764. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7810454 .   \nBetmouni, S. (2021). \"Diagnostic digital pathology implementation: Learning from the digital health experience\". Digital Health 7: 20552076211020240. doi:10.1177\/20552076211020240. PMC PMC8216403. PMID 34211723. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC8216403 .   \nDaniel, C.; Ballamine, A.; Kalra, D. (2021). \"Key contributions in clinical research informatics\". Yearbook of Medical Informatics 30 (1): 233\u201338. doi:10.1055\/s-0041-1726514. PMC PMC8416193. PMID 34479395. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC8416193 .   \nFraggetta, F.; L'Imperio, V.; Ameisen, D. et al. (2021). \"Best practice recommendations for the implementation of a digital pathology workflow in the anatomic pathology laboratory by the European Society of Digital and Integrative Pathology (ESDIP)\". Diagnostics 11 (11): 2167. doi:10.3390\/diagnostics11112167. PMC PMC8623219. PMID 34829514. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC8623219 .   \nJones, R.G.; Johnson, O.A.; Batstone, G. (2014). \"Informatics and the Clinical Laboratory\". The Clinical Biochemist Reviews 35 (3): 177\u201392. PMC PMC4204239. PMID 25336763. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC4204239 .   \nSilva, B. (19 December 2019). \"IT solutions in the clinical lab\". Medical Laboratory Observer. https:\/\/www.mlo-online.com\/information-technology\/article\/21117759\/it-solutions-in-the-clinical-lab .   \n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Further_reading\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Further_reading<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:16.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 42 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","df7a5eb4b2a9d9dc9dc9a30ae1ad4e49_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Resources_for_selecting_and_implementing_informatics_solutions_Part_3_Industry_and_community_resources_Further_reading rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Resources_for_selecting_and_implementing_informatics_solutions_Part_3_Industry_and_community_resources_Further_reading 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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 3: Industry and community resources\/Further reading<\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">the beginning<\/a> of this guide-----<\/div>\n<h3><span class=\"mw-headline\" id=\"5.6_Further_reading\">5.6 Further reading<\/span><\/h3>\n<ul><li><span class=\"citation Journal\">Alotaibi, Y.K.; Federico, F. (2017). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC5787626\" target=\"_blank\">\"The impact of health information technology on patient safety\"<\/a>. <i>Saudi Medical Journal<\/i> <b>38<\/b> (12): 1173\u201380. <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\/10.15537%2Fsmj.2017.12.20631\" target=\"_blank\">10.15537\/smj.2017.12.20631<\/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\/PMC5787626\/\" target=\"_blank\">PMC5787626<\/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\/29209664\" target=\"_blank\">29209664<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC5787626\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC5787626<\/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+impact+of+health+information+technology+on+patient+safety&rft.jtitle=Saudi+Medical+Journal&rft.aulast=Alotaibi%2C+Y.K.%3B+Federico%2C+F.&rft.au=Alotaibi%2C+Y.K.%3B+Federico%2C+F.&rft.date=2017&rft.volume=38&rft.issue=12&rft.pages=1173%E2%80%9380&rft_id=info:doi\/10.15537%2Fsmj.2017.12.20631&rft_id=info:pmc\/PMC5787626&rft_id=info:pmid\/29209664&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC5787626&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Further_reading\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation web\">Association of Public Health Laboratories (May 2019). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">\"Laboratory Information Systems Project Management: A Guidebook for International Implementations\"<\/a> (PDF). APHL<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Laboratory+Information+Systems+Project+Management%3A+A+Guidebook+for+International+Implementations&rft.atitle=&rft.aulast=Association+of+Public+Health+Laboratories&rft.au=Association+of+Public+Health+Laboratories&rft.date=May+2019&rft.pub=APHL&rft_id=https%3A%2F%2Fwww.aphl.org%2FaboutAPHL%2Fpublications%2FDocuments%2FGH-2019May-LIS-Guidebook-web.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Further_reading\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation Journal\">Bakken, S. (2021). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7810454\" target=\"_blank\">\"The maturation of clinical research informatics as a subdomain of biomedical informatics\"<\/a>. <i>JAMIA<\/i> <b>28<\/b> (1): 1\u20132. <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\/PMC7810454\/\" target=\"_blank\">PMC7810454<\/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\/33450764\" target=\"_blank\">33450764<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7810454\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7810454<\/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+maturation+of+clinical+research+informatics+as+a+subdomain+of+biomedical+informatics&rft.jtitle=JAMIA&rft.aulast=Bakken%2C+S.&rft.au=Bakken%2C+S.&rft.date=2021&rft.volume=28&rft.issue=1&rft.pages=1%E2%80%932&rft_id=info:pmc\/PMC7810454&rft_id=info:pmid\/33450764&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC7810454&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Further_reading\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation Journal\">Betmouni, S. (2021). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC8216403\" target=\"_blank\">\"Diagnostic digital pathology implementation: Learning from the digital health experience\"<\/a>. <i>Digital Health<\/i> <b>7<\/b>: 20552076211020240. <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\/10.1177%2F20552076211020240\" target=\"_blank\">10.1177\/20552076211020240<\/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\/PMC8216403\/\" target=\"_blank\">PMC8216403<\/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\/34211723\" target=\"_blank\">34211723<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC8216403\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC8216403<\/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=Diagnostic+digital+pathology+implementation%3A+Learning+from+the+digital+health+experience&rft.jtitle=Digital+Health&rft.aulast=Betmouni%2C+S.&rft.au=Betmouni%2C+S.&rft.date=2021&rft.volume=7&rft.pages=20552076211020240&rft_id=info:doi\/10.1177%2F20552076211020240&rft_id=info:pmc\/PMC8216403&rft_id=info:pmid\/34211723&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC8216403&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Further_reading\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation Journal\">Daniel, C.; Ballamine, A.; Kalra, D. (2021). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC8416193\" target=\"_blank\">\"Key contributions in clinical research informatics\"<\/a>. <i>Yearbook of Medical Informatics<\/i> <b>30<\/b> (1): 233\u201338. <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\/10.1055%2Fs-0041-1726514\" target=\"_blank\">10.1055\/s-0041-1726514<\/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\/PMC8416193\/\" target=\"_blank\">PMC8416193<\/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\/34479395\" target=\"_blank\">34479395<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC8416193\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC8416193<\/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=Key+contributions+in+clinical+research+informatics&rft.jtitle=Yearbook+of+Medical+Informatics&rft.aulast=Daniel%2C+C.%3B+Ballamine%2C+A.%3B+Kalra%2C+D.&rft.au=Daniel%2C+C.%3B+Ballamine%2C+A.%3B+Kalra%2C+D.&rft.date=2021&rft.volume=30&rft.issue=1&rft.pages=233%E2%80%9338&rft_id=info:doi\/10.1055%2Fs-0041-1726514&rft_id=info:pmc\/PMC8416193&rft_id=info:pmid\/34479395&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC8416193&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Further_reading\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation Journal\">Fraggetta, F.; L'Imperio, V.; Ameisen, D. et al. (2021). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC8623219\" target=\"_blank\">\"Best practice recommendations for the implementation of a digital pathology workflow in the anatomic pathology laboratory by the European Society of Digital and Integrative Pathology (ESDIP)\"<\/a>. <i>Diagnostics<\/i> <b>11<\/b> (11): 2167. <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%2Fdiagnostics11112167\" target=\"_blank\">10.3390\/diagnostics11112167<\/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\/PMC8623219\/\" target=\"_blank\">PMC8623219<\/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\/34829514\" target=\"_blank\">34829514<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC8623219\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC8623219<\/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=Best+practice+recommendations+for+the+implementation+of+a+digital+pathology+workflow+in+the+anatomic+pathology+laboratory+by+the+European+Society+of+Digital+and+Integrative+Pathology+%28ESDIP%29&rft.jtitle=Diagnostics&rft.aulast=Fraggetta%2C+F.%3B+L%27Imperio%2C+V.%3B+Ameisen%2C+D.+et+al.&rft.au=Fraggetta%2C+F.%3B+L%27Imperio%2C+V.%3B+Ameisen%2C+D.+et+al.&rft.date=2021&rft.volume=11&rft.issue=11&rft.pages=2167&rft_id=info:doi\/10.3390%2Fdiagnostics11112167&rft_id=info:pmc\/PMC8623219&rft_id=info:pmid\/34829514&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC8623219&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Further_reading\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Further_reading\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation web\">Silva, B. (19 December 2019). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.mlo-online.com\/information-technology\/article\/21117759\/it-solutions-in-the-clinical-lab\" target=\"_blank\">\"IT solutions in the clinical lab\"<\/a>. <i>Medical Laboratory Observer<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.mlo-online.com\/information-technology\/article\/21117759\/it-solutions-in-the-clinical-lab\" target=\"_blank\">https:\/\/www.mlo-online.com\/information-technology\/article\/21117759\/it-solutions-in-the-clinical-lab<\/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=IT+solutions+in+the+clinical+lab&rft.atitle=Medical+Laboratory+Observer&rft.aulast=Silva%2C+B.&rft.au=Silva%2C+B.&rft.date=19+December+2019&rft_id=https%3A%2F%2Fwww.mlo-online.com%2Finformation-technology%2Farticle%2F21117759%2Fit-solutions-in-the-clinical-lab&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Further_reading\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n\n<!-- \nNewPP limit report\nCached time: 20220125221422\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.069 seconds\nReal time usage: 0.113 seconds\nPreprocessor visited node count: 6195\/1000000\nPost\u2010expand include size: 76740\/2097152 bytes\nTemplate argument size: 19528\/2097152 bytes\nHighest expansion depth: 19\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 220\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 84.950 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Further_reading\n100.00% 84.950 1 -total\n 78.62% 66.790 8 Template:Citation\/core\n 69.92% 59.400 6 Template:Cite_journal\n 24.07% 20.444 2 Template:Cite_web\n 14.78% 12.557 16 Template:Citation\/identifier\n 10.47% 8.893 9 Template:Citation\/make_link\n 8.72% 7.410 2 Template:Date\n 5.75% 4.884 38 Template:Hide_in_print\n 4.72% 4.008 16 Template:Only_in_print\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12951-0!canonical and timestamp 20220125221422 and revision id 45848. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Further_reading\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Further_reading<\/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>","df7a5eb4b2a9d9dc9dc9a30ae1ad4e49_images":[],"df7a5eb4b2a9d9dc9dc9a30ae1ad4e49_timestamp":1643149334,"4224406d16f2e95eee34cf47467ccd7d_type":"article","4224406d16f2e95eee34cf47467ccd7d_title":"5.5 Standards, regulations, and guidance","4224406d16f2e95eee34cf47467ccd7d_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Standards,_regulations,_and_guidance","4224406d16f2e95eee34cf47467ccd7d_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 3: Industry and community resources\/Standards, regulations, and guidanceFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\nContents \n\n1 5.5 Standards, regulations, and guidance \n\n1.1 Accreditation requirements \n1.2 Guidelines and recommendations \n1.3 Regulations and legal requirements \n1.4 Standards and specifications \n\n\n\n\n\n 5.5 Standards, regulations, and guidance \nThe following represent some of the major instances of standards, regulations, and guidance documents affecting how medical diagnostic and research laboratories should operate. This collection doesn't represent every possibility but covers most of the significant options. In a few cases (e.g., the CLSI), there were too many items to list, and a link to the associated items was included instead.\n\nAccreditation requirements \n\n\n\n\n\n\n\n\n\nAccreditation requirement\n\nDescription\n\nRelevant medical or research field(s)\n\n\nAAVLD Requirements for an AVMDL\n\nthe laboratory accreditation requirements for the American Association of Veterinary Laboratory Diagnosticians\n\nVeterinary medicine\n\n\nABFT Accreditation Manual\n\nthe laboratory accreditation requirements for the American Board of Forensic Toxicology\n\nForensic medicine - toxicology\n\n\nAIHA-LAP Policies 2021\n\nthe laboratory accreditation requirements for the American Industrial Hygiene Association\n\nMicrobiology - environmental\n\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories\n\nthe laboratory accreditation requirements for the American Society of Crime Laboratory Directors \/ Laboratory Accreditation Board; NOTE: ASCLD\/LAB has since merged with the ANSI National Accreditation Board (ANAB)\n\nForensic medicine\n\n\nCOLA Laboratory Accreditation Standards\n\nthe laboratory accreditation requirements of the Commission on Office Laboratory Accreditation\n\nSee description\n\n\nJCI Laboratory Accreditation Standards\n\nthe laboratory accreditation requirements for the Joint Commission International; applicable to microbiology, clinical chemistry, hematology, blood banking and transfusion, cytogentics, and immunology\/serology labs\n\nSee description\n\n\nNYS Department of Health - Clinical Laboratory Evaluation Program\n\nthe laboratory accreditation requirements for New York State's \"clinical laboratories and blood banks, including out-of-state facilities that accept clinical specimens collected in New York State\"\n\nSee description\n\n\n\nGuidelines and recommendations \n\n\n\n\n\n\n\n\n\nGuideline\/Recommendation\n\nDescription\n\nRelevant medical or research field(s)\n\n\nACMG Standards and Guidelines for Clinical Genetics Laboratories\n\nguidelines from the American College of Medical Genetics on the laboratory \"use of molecular techniques to examine heritable changes in the human genome\"; a more recent version (2014) exists but may only be available to ACMG members\n\nGenetic diagnostics\n\n\nAPHL Clinical Laboratory Preparedness and Response Guide\n\nguidelines from the Association of Public Health Laboratories and the American Society for Microbiology on clinical (and any other) laboratories handling microorganisms and toxins of elevated risk to human health and public safety\n\nAny\n\n\nASM Sentinel Level Clinical Laboratory Guidelines for Suspected Agents of Bioterrorism and Emerging Infectious Diseases\n\nguidelines from the American Society for Microbiology on clinical (and any other) laboratories handling microorganisms and toxins of elevated risk to human health and public safety\n\nAny\n\n\nCDC Guidelines for Safe Work Practices in Human and Animal Medical Diagnostic Laboratories\n\nguidelines from the Centers for Disease Control and Prevention on biosafety practices in clinical diagnostic laboratories working with human and animal specimens\n\nAny\n\n\nCDC PHIN Messaging System\n\nguidelines from the Centers for Disease Control and Prevention on using the Public Health Information Network Messaging System\n\nPublic health\n\n\nDAIDS Guidelines for Good Clinical Laboratory Practice Standards\n\nGLP guidelines from the NIH's Division of AIDS (DAIDS) for clinical research laboratories conducting testing that supports a clinical trial sponsored by DAIDS\n\nClinical research\n\n\nICAR 15 Data Exchange\n\nguidelines from the International Committee for Animal Recording for data management and transfer of animal data; though rare, may apply to the occasional veterinary laboratory\n\nVeterinary medicine\n\n\nNIST 800-53, Rev. 4\n\nrecommendations in the form of information security and privacy controls from the National Institute of Standards and Technology; these cybersecurity controls apply to federal systems, though they can be applied to non-federal systems just as readily\n\nAny\n\n\nWHO Good Clinical Laboratory Practice\n\nguidelines from the World Health Organization (WHO) for organizations performing testing for clinical trials as part of good clinical practice\n\nClinical research\n\n\n\nRegulations and legal requirements \n\n\n\n\n\n\n\n\n\nRegulation or legal requirement\n\nDescription\n\nRelevant medical or research field(s)\n\n\n5 CFR Part 930.301\n\nU.S. Code of Federal Regulation 5 CFR \u00a7 930.301 Information systems security awareness training program; this would affect medical diagnostic and research laboratories housed in executive agencies of the U.S. government, e.g., National Institutes of Health and Federal Bureau of Investigation\n\nSee description\n\n\n9 CFR Part 121\n\nU.S. Code of Federal Regulation 9 CFR \u00a7 121 Possession, Use, and Transfer of Select Agents and Toxins; this would affect medical diagnostic and research laboratories interacting with specific biological agents and toxins that pose a threat to public and animal health and safety\n\nSee description\n\n\n18 U.S. Code Part 220 aka EKRA\n\n18 U.S. Code \u00a7 220 Illegal remunerations for referrals to recovery homes, clinical treatment facilities, and laboratories; aka EKRA, this affects all laboratories and their sales and contracting activities, prohibiting kickbacks and payments based on number of referrals or tests, or the amount billed (and yes, this is getting prosecuted)\n\nAny\n\n\n21 CFR Part 11\n\nU.S. Code of Federal Regulation 21 CFR \u00a7 11 Electronic Records and Signatures; this would affect medical diagnostic and research laboratories of all types interacting with electronic records\n\nAny\n\n\n21 CFR Part 606\n\nU.S. Code of Federal Regulation 21 CFR \u00a7 606 Current Good Manufacturing Practice for Blood and Blood Components; this would affect medical laboratories collecting, processing, testing, storing, and distributing blood and blood components\n\nBlood banking and transfusion medicine\n\n\n21 CFR Part 812\n\nU.S. Code of Federal Regulation 21 CFR \u00a7 812 Investigational Device Exemptions; this would affect central and contract research laboratories conducting clinical investigations of medical devices\n\nClinical research\n\n\n29 CFR Part 1910.1030\n\nU.S. Code of Federal Regulation 29 CFR \u00a7 1910.1030 Bloodborne pathogens; this would affect medical diagnostic and research laboratories of all types that have occupational exposure risk to blood or other potentially infectious materials\n\nSee description\n\n\n29 CFR Part 1910.1096\n\nU.S. Code of Federal Regulation 29 CFR \u00a7 1910.1096 Ionizing radiation; this would affect medical diagnostic and research laboratories of all types that have occupational exposure risk to ionizing radiation sources such as x-rays, CT or CAT scans, PET scans, fluoroscopy, or any nuclear medicine procedures\n\nSee description\n\n\n29 CFR Part 1910.1200\n\nU.S. Code of Federal Regulation 29 CFR \u00a7 1910.1200 Hazard communication; this would affect medical diagnostic and research laboratories of all types that have occupational exposure risk to hazardous chemicals, requiring proper notification of the hazards the chemicals pose\n\nSee description\n\n\n29 CFR Part 1910.1450\n\nU.S. Code of Federal Regulation 29 CFR \u00a7 1910.1450 Occupational exposure to hazardous chemicals in laboratories; this would affect medical diagnostic and research laboratories of all types that have occupational exposure risk to hazardous chemicals, requiring proper procedures and record-keeping related to workplace chemicals\n\nSee description\n\n\n42 CFR Part 73\n\nU.S. Code of Federal Regulation 42 CFR \u00a7 73 Select Agents and Toxins; this would affect medical diagnostic and research laboratories \"that possess SARS-CoV, Lujo virus, or Chapare virus\"\n\nSee description\n\n\n42 CFR Part 493 aka CLIA Regulations\n\nU.S. Code of Federal Regulation 42 CFR \u00a7 493 Laboratory Requirements aka CLIA Regulations; this would affect all medical diagnostic laboratories and apply to select medical research laboratories\n\nSee description\n\n\n45 CFR Part 160 aka HIPAA Regulations\n\nU.S. Code of Federal Regulation 45 CFR \u00a7 160 General Administrative Requirements aka HIPAA Regulations; this would affect any medical diagnostic and research laboratory \"who transmits any health information in electronic form\"\n\nSee description\n\n\n45 CFR Part 164 aka HIPAA Regulations\n\nU.S. Code of Federal Regulation 45 CFR \u00a7 164 Security and Privacy aka HIPAA Regulations; this would affect any medical diagnostic and research laboratory \"who transmits any health information in electronic form\"\n\nSee description\n\n\nCJIS Security Policy\n\nU.S. Department of Justice's Criminal Justice Information Services Security Policy; this mandates the provision of \"appropriate controls to protect the full life cycle of Criminal Justice Information\" for \"all entities with access to, or who operate in support of, FBI CJIS Division\u2019s services and information\"\n\nForensic medicine (see description)\n\n\nU.S. state-specific laboratory licensing regulations\n\nan online U.S. state licensing map by Lighthouse Lab Services which links to state-specific licensing requirements and laws\n\nAny\n\n\n\nStandards and specifications \nThough not listed below, the Clinical and Laboratory Standards Institute (CLSI) has a mountain of standards for laboratories (though pricey). There are too many to list here, so see their standards repository on their website. Similarly, ASTM International has many other informatics standards that may apply to laboratories. See their Committee E13 on Molecular Spectroscopy and Separation Science and Committee E31 on Healthcare Informatics for more standards.\n\n\n\n\n\n\n\n\n\n\nStandard or specification\n\nDescription\n\nRelevant medical or research field(s)\n\n\nASTM E1188-11\n\nASTM International's ASTM E1188-11 Standard Practice for Collection and Preservation of Information and Physical Items by a Technical Investigator; describes best practices for the \"collection and preservation of evidence for further analysis\"\n\nForensic medicine\n\n\nASTM E1459-13\n\nASTM International's ASTM E1459-13 Standard Guide for Physical Evidence Labeling and Related Documentation; describes best practices for managing chain of custody for physical evidence\n\nForensic medicine\n\n\nASTM E1492-11\n\nASTM International's ASTM E1492-11 Standard Practice for Receiving, Documenting, Storing, and Retrieving Evidence in a Forensic Science Laboratory; describes best practices for physical evidence management in order to protect the chain of custody for the evidence\n\nForensic medicine\n\n\nASTM E1578-18\n\nASTM International's ASTM E1578-18 Standard Guide for Laboratory Informatics; provides educational guidance on the many aspects of laboratory informatics, including \"issues commonly encountered at all stages in the life cycle\" of such systems\n\nAny\n\n\nDICOM Standard\n\nthe National Electrical Manufacturers Association's (NEMA) Digital Imaging and Communications in Medicine (DICOM) standard \"to transmit, store, retrieve, print, process, and display medical imaging information\"\n\nVarious\n\n\nICD-10 and 11 Standard\n\nthe World Health Organization's (WHO) International Statistical Classification of Diseases and Related Health Problems (ICD) standard for reporting diseases and health conditions; ICD-11 goes into effect 01 January 2022\n\nVarious\n\n\nISO 15189:2012\n\nInternational Organization for Standardization's ISO 15189:2012 Medical laboratories \u2014 Requirements for quality and competence; this standard \"specifies requirements for quality and competence in medical laboratories\" and is used for developing quality management systems and confirming laboratory competency\n\nAny\n\n\nISO\/IEC 17025:2017\n\nInternational Organization for Standardization's ISO 17025:2017 General requirements for the competence of testing and calibration laboratories; this standard \"specifies the general requirements for the competence, impartiality and consistent operation of laboratories\" and is used for assuaging others to the competence of the lab\n\nAny\n\n\nLOINC Standard\n\nthe Regenstrief Institute's Logical Observation Identifiers Names and Codes (LOINC) standard, \"a common language (a set of identifiers, names, and codes) for identifying health measurements, observations, and documents\"\n\nVarious\n\n\nNAHLN HL7 Messaging Quick User Guide\n\nThe Veterinary Terminology Services Laboratory, part of the Virginia-Maryland Regional College of Veterinary Medicine, and its National Animal Health Laboratory Network (NAHLN) HL7 Messaging standards; this user guide provides the participating veterinary laboratory assistance on using the HL7 messaging protocol and NAHLN standards in order to transmit data\n\nVeterinary medicine\n\n\nNYS Department of Health Clinical Laboratory Standards of Practice\n\nThe New York State Department of Health, Wadsworth Center's Clinical Laboratory Standards of Practice; this is a two-part collection of laboratory standards for NYS labs and those non-NYS labs that handle specimens originating in NYS, though these standards could effectively be applied by any medical laboratory; includes standards for specialty laboratories\n\nAny\n\n\nSNOMED CT\n\nSNOMED International's Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) standard, for standardized medical terminology\n\nVarious\n\n\nU.S. National Library of Medicine UMLS\n\nthe Unified Medical Language System (UMLS), which \"integrates and distributes key terminology, classification and coding standards, and associated resources to promote creation of more effective and interoperable biomedical information systems and services\"\n\nVarious\n\n\nVeNom Coding Group terminology\n\nVeNom Coding Group's VeNom Veterinary Nomenclature; this is a standardized veterinary terminology \"for use in referral veterinary hospital electronic patient records and first opinion veterinary practice management systems\"\n\nVeterinary medicine\n\n\nVeterinary Terminology Services Laboratory terminology options\n\nThe Veterinary Terminology Services Laboratory (VTSL), part of the Virginia-Maryland Regional College of Veterinary Medicine, and its standardized terminology resources; the VTSL maintains a variety of standardized veterinary terminologies, including \"the Veterinary Extension to SNOMED CT as well as subsets for the National Animal Health Laboratory Network, AAHA Diagnostic Terms and AAEP Diagnostic Terms\"\n\nVeterinary medicine\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Standards,_regulations,_and_guidance\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Standards,_regulations,_and_guidance<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:15.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 41 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","4224406d16f2e95eee34cf47467ccd7d_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Resources_for_selecting_and_implementing_informatics_solutions_Part_3_Industry_and_community_resources_Standards_regulations_and_guidance rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Resources_for_selecting_and_implementing_informatics_solutions_Part_3_Industry_and_community_resources_Standards_regulations_and_guidance 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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 3: Industry and community resources\/Standards, regulations, and guidance<\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">the beginning<\/a> of this guide-----<\/div>\n\n\n<h3><span id=\"rdp-ebb-5.5_Standards,_regulations,_and_guidance\"><\/span><span class=\"mw-headline\" id=\"5.5_Standards.2C_regulations.2C_and_guidance\">5.5 Standards, regulations, and guidance<\/span><\/h3>\n<p>The following represent some of the major instances of standards, regulations, and guidance documents affecting how medical diagnostic and research laboratories should operate. This collection doesn't represent every possibility but covers most of the significant options. In a few cases (e.g., the CLSI), there were too many items to list, and a link to the associated items was included instead.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"Accreditation_requirements\">Accreditation requirements<\/span><\/h4>\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=\"3\" 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;\">Accreditation requirement\n<\/th>\n<th style=\"color:brown; background-color:#ffffee;\">Description\n<\/th>\n<th style=\"color:brown; background-color:#ffffee;\">Relevant medical or research field(s)\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; 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;\">the laboratory accreditation requirements for the American Association of Veterinary Laboratory Diagnosticians\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Veterinary medicine\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/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;\">the laboratory accreditation requirements for the American Board of Forensic Toxicology\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Forensic medicine - toxicology\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/Policies\/Pages\/default.aspx\" target=\"_blank\">AIHA-LAP Policies 2021<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">the laboratory accreditation requirements for the American Industrial Hygiene Association\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Microbiology - environmental\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; 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;\">the laboratory accreditation requirements for the American Society of Crime Laboratory Directors \/ Laboratory Accreditation Board; NOTE: ASCLD\/LAB has since merged with the ANSI National Accreditation Board (<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/anab.ansi.org\/\" target=\"_blank\">ANAB<\/a>)\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Forensic medicine\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.scribd.com\/document\/324645876\/COLA-Laboratory-Accreditation-Manual\" target=\"_blank\">COLA Laboratory Accreditation Standards<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">the laboratory accreditation requirements of the <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.cola.org\/lab-testing-accreditation-quality\/what-is-cola\/\" target=\"_blank\">Commission on Office Laboratory Accreditation<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">See description\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.jointcommissioninternational.org\/en\/accreditation\/accreditation-programs\/laboratory\/\" target=\"_blank\">JCI Laboratory Accreditation Standards<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">the laboratory accreditation requirements for the Joint Commission International; applicable to microbiology, clinical chemistry, hematology, blood banking and transfusion, cytogentics, and immunology\/serology labs\n<\/td>\n<td style=\"padding:10px; background-color:white;\">See description\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/sites\/default\/files\/WebDoc\/CLEPGUIDE_July2021.pdf\" target=\"_blank\">NYS Department of Health - Clinical Laboratory Evaluation Program<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">the laboratory accreditation requirements for New York State's \"clinical laboratories and blood banks, including out-of-state facilities that accept clinical specimens collected in New York State\"\n<\/td>\n<td style=\"padding:10px; background-color:white;\">See description\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h4><span class=\"mw-headline\" id=\"Guidelines_and_recommendations\">Guidelines and recommendations<\/span><\/h4>\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=\"3\" 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;\">Guideline\/Recommendation\n<\/th>\n<th style=\"color:brown; background-color:#ffffee;\">Description\n<\/th>\n<th style=\"color:brown; background-color:#ffffee;\">Relevant medical or research field(s)\n<\/th><\/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\/Technical_Standards_and_Guidelines.aspx\" target=\"_blank\">ACMG Standards and Guidelines for Clinical Genetics Laboratories<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">guidelines from the American College of Medical Genetics on the laboratory \"use of molecular techniques to examine heritable changes in the human genome\"; a more recent version (2014) exists but may only be available to ACMG members\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Genetic diagnostics\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/WORK_BlueBook.pdf\" target=\"_blank\">APHL Clinical Laboratory Preparedness and Response Guide<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">guidelines from the Association of Public Health Laboratories and the American Society for Microbiology on clinical (and any other) laboratories handling microorganisms and toxins of elevated risk to human health and public safety\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Any\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.asm.org\/ASM\/media\/Policy-and-Advocacy\/Biosafety_Sentinel_Guideline_October_2018_FINAL.pdf\" target=\"_blank\">ASM Sentinel Level Clinical Laboratory Guidelines for Suspected Agents of Bioterrorism and Emerging Infectious Diseases<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">guidelines from the American Society for Microbiology on clinical (and any other) laboratories handling microorganisms and toxins of elevated risk to human health and public safety\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Any\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/mmwr\/pdf\/other\/su6101.pdf\" target=\"_blank\">CDC Guidelines for Safe Work Practices in Human and Animal Medical Diagnostic Laboratories<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">guidelines from the Centers for Disease Control and Prevention on biosafety practices in clinical diagnostic laboratories working with human and animal specimens\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Any\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; 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;\">guidelines from the Centers for Disease Control and Prevention on using the Public Health Information Network Messaging System\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Public health\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.niaid.nih.gov\/sites\/default\/files\/gclpstandards.pdf\" target=\"_blank\">DAIDS Guidelines for Good Clinical Laboratory Practice Standards<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">GLP guidelines from the NIH's Division of AIDS (DAIDS) for clinical research laboratories conducting testing that supports a clinical trial sponsored by DAIDS\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Clinical research\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; 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;\">guidelines from the International Committee for Animal Recording for data management and transfer of animal data; though rare, may apply to the occasional veterinary laboratory\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Veterinary medicine\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.800-53r4.pdf\" target=\"_blank\">NIST 800-53, Rev. 4<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">recommendations in the form of information security and privacy controls from the National Institute of Standards and Technology; these cybersecurity controls apply to federal systems, though they can be applied to non-federal systems just as readily\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Any\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/tdr\/publications\/documents\/gclp-web.pdf?ua=1\" target=\"_blank\">WHO Good Clinical Laboratory Practice<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">guidelines from the World Health Organization (WHO) for organizations performing testing for clinical trials as part of good clinical practice\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Clinical research\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h4><span class=\"mw-headline\" id=\"Regulations_and_legal_requirements\">Regulations and legal requirements<\/span><\/h4>\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=\"3\" 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;\">Regulation or legal requirement\n<\/th>\n<th style=\"color:brown; background-color:#ffffee;\">Description\n<\/th>\n<th style=\"color:brown; background-color:#ffffee;\">Relevant medical or research field(s)\n<\/th><\/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\/5\/930.301\" target=\"_blank\">5 CFR Part 930.301<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Code of Federal Regulation 5 CFR \u00a7 930.301 Information systems security awareness training program; this would affect medical diagnostic and research laboratories housed in executive agencies of the U.S. government, e.g., National Institutes of Health and Federal Bureau of Investigation\n<\/td>\n<td style=\"padding:10px; background-color:white;\">See description\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\/9\/part-121\" target=\"_blank\">9 CFR Part 121<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Code of Federal Regulation 9 CFR \u00a7 121 Possession, Use, and Transfer of Select Agents and Toxins; this would affect medical diagnostic and research laboratories interacting with specific biological agents and toxins that pose a threat to public and animal health and safety\n<\/td>\n<td style=\"padding:10px; background-color:white;\">See description\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\/uscode\/text\/18\/220\" target=\"_blank\">18 U.S. Code Part 220<\/a> aka EKRA\n<\/td>\n<td style=\"padding:10px; background-color:white;\">18 U.S. Code \u00a7 220 Illegal remunerations for referrals to recovery homes, clinical treatment facilities, and laboratories; aka EKRA, this affects all laboratories and their sales and contracting activities, prohibiting kickbacks and payments based on number of referrals or tests, or the amount billed (and yes, this is <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mcdonaldhopkins.com\/Insights\/Alerts\/2020\/01\/27\/EKRA-enforcement-after-a-year-of-uncertainty\" target=\"_blank\">getting prosecuted<\/a>)\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Any\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\/21\/part-11\" target=\"_blank\">21 CFR Part 11<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Code of Federal Regulation 21 CFR \u00a7 11 Electronic Records and Signatures; this would affect medical diagnostic and research laboratories of all types interacting with electronic records\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Any\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\/21\/part-606\" target=\"_blank\">21 CFR Part 606<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Code of Federal Regulation 21 CFR \u00a7 606 Current Good Manufacturing Practice for Blood and Blood Components; this would affect medical laboratories collecting, processing, testing, storing, and distributing blood and blood components\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Blood banking and transfusion medicine\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\/21\/part-812\" target=\"_blank\">21 CFR Part 812<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Code of Federal Regulation 21 CFR \u00a7 812 Investigational Device Exemptions; this would affect central and contract research laboratories conducting clinical investigations of medical devices\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Clinical research\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\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Code of Federal Regulation 29 CFR \u00a7 1910.1030 Bloodborne pathogens; this would affect medical diagnostic and research laboratories of all types that have occupational exposure risk to blood or other potentially infectious materials\n<\/td>\n<td style=\"padding:10px; background-color:white;\">See description\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\/29\/1910.1096\" target=\"_blank\">29 CFR Part 1910.1096<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Code of Federal Regulation 29 CFR \u00a7 1910.1096 Ionizing radiation; this would affect medical diagnostic and research laboratories of all types that have occupational exposure risk to ionizing radiation sources such as x-rays, CT or CAT scans, PET scans, fluoroscopy, or any nuclear medicine procedures\n<\/td>\n<td style=\"padding:10px; background-color:white;\">See description\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\/29\/1910.1200\" target=\"_blank\">29 CFR Part 1910.1200<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Code of Federal Regulation 29 CFR \u00a7 1910.1200 Hazard communication; this would affect medical diagnostic and research laboratories of all types that have occupational exposure risk to hazardous chemicals, requiring proper notification of the hazards the chemicals pose\n<\/td>\n<td style=\"padding:10px; background-color:white;\">See description\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\/29\/1910.1450\" target=\"_blank\">29 CFR Part 1910.1450<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Code of Federal Regulation 29 CFR \u00a7 1910.1450 Occupational exposure to hazardous chemicals in laboratories; this would affect medical diagnostic and research laboratories of all types that have occupational exposure risk to hazardous chemicals, requiring proper procedures and record-keeping related to workplace chemicals\n<\/td>\n<td style=\"padding:10px; background-color:white;\">See description\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\/part-73\" target=\"_blank\">42 CFR Part 73<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Code of Federal Regulation 42 CFR \u00a7 73 Select Agents and Toxins; this would affect medical diagnostic and research laboratories \"that possess SARS-CoV, Lujo virus, or Chapare virus\"\n<\/td>\n<td style=\"padding:10px; background-color:white;\">See description\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\/part-493\" target=\"_blank\">42 CFR Part 493<\/a> aka CLIA Regulations\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Code of Federal Regulation 42 CFR \u00a7 493 Laboratory Requirements aka CLIA Regulations; this would affect all medical diagnostic laboratories and apply to <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.dfhcc.harvard.edu\/crs-resources\/OHRS_Documents\/02_-_Investigator_Resources\/IS_-_Guidance_-_CLIA_Requirements.pdf\" target=\"_blank\">select medical research laboratories<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">See description\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\/part-160\" target=\"_blank\">45 CFR Part 160<\/a> aka HIPAA Regulations\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Code of Federal Regulation 45 CFR \u00a7 160 General Administrative Requirements aka HIPAA Regulations; this would affect any medical diagnostic and research laboratory \"who transmits any health information in electronic form\"\n<\/td>\n<td style=\"padding:10px; background-color:white;\">See description\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\/part-164\" target=\"_blank\">45 CFR Part 164<\/a> aka HIPAA Regulations\n<\/td>\n<td style=\"padding:10px; background-color:white;\">U.S. Code of Federal Regulation 45 CFR \u00a7 164 Security and Privacy aka HIPAA Regulations; this would affect any medical diagnostic and research laboratory \"who transmits any health information in electronic form\"\n<\/td>\n<td style=\"padding:10px; background-color:white;\">See description\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; 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;\">U.S. Department of Justice's Criminal Justice Information Services Security Policy; this mandates the provision of \"appropriate controls to protect the full life cycle of Criminal Justice Information\" for \"all entities with access to, or who operate in support of, FBI CJIS Division\u2019s services and information\"\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Forensic medicine (see description)\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.lighthouselabservices.com\/state-license\/\" target=\"_blank\">U.S. state-specific laboratory licensing regulations<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an online U.S. state licensing map by Lighthouse Lab Services which links to state-specific licensing requirements and laws\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Any\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h4><span class=\"mw-headline\" id=\"Standards_and_specifications\">Standards and specifications<\/span><\/h4>\n<p>Though not listed below, the Clinical and Laboratory Standards Institute (CLSI) has a mountain of standards for laboratories (though pricey). There are too many to list here, so see their standards repository <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/\" target=\"_blank\">on their website<\/a>. Similarly, ASTM International has many other informatics standards that may apply to laboratories. See their <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/COMMIT\/SUBCOMMIT\/E13.htm\" target=\"_blank\">Committee E13 on Molecular Spectroscopy and Separation Science<\/a> and <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/COMMIT\/SUBCOMMIT\/E31.htm\" target=\"_blank\">Committee E31 on Healthcare Informatics<\/a> for more standards.\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<th colspan=\"3\" 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;\">Standard or specification\n<\/th>\n<th style=\"color:brown; background-color:#ffffee;\">Description\n<\/th>\n<th style=\"color:brown; background-color:#ffffee;\">Relevant medical or research field(s)\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; 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 International's ASTM E1188-11 <i>Standard Practice for Collection and Preservation of Information and Physical Items by a Technical Investigator<\/i>; describes best practices for the \"collection and preservation of evidence for further analysis\"\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Forensic medicine\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; 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 International's ASTM E1459-13 <i>Standard Guide for Physical Evidence Labeling and Related Documentation<\/i>; describes best practices for managing chain of custody for physical evidence\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Forensic medicine\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; 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 International's ASTM E1492-11 <i>Standard Practice for Receiving, Documenting, Storing, and Retrieving Evidence in a Forensic Science Laboratory<\/i>; describes best practices for physical evidence management in order to protect the chain of custody for the evidence\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Forensic medicine\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<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">ASTM International's ASTM E1578-18 <i>Standard Guide for Laboratory Informatics<\/i>; provides educational guidance on the many aspects of laboratory informatics, including \"issues commonly encountered at all stages in the life cycle\" of such systems\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Any\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.dicomstandard.org\/current\/\" target=\"_blank\">DICOM Standard<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">the National Electrical Manufacturers Association's (NEMA) Digital Imaging and Communications in Medicine (DICOM) standard \"to transmit, store, retrieve, print, process, and display medical imaging information\"\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Various\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/classifications\/classification-of-diseases\" target=\"_blank\">ICD-10 and 11 Standard<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">the World Health Organization's (WHO) International Statistical Classification of Diseases and Related Health Problems (ICD) standard for reporting diseases and health conditions; ICD-11 goes into effect 01 January 2022\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Various\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; 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;\">International Organization for Standardization's ISO 15189:2012 <i>Medical laboratories \u2014 Requirements for quality and competence<\/i>; this standard \"specifies requirements for quality and competence in medical laboratories\" and is used for developing quality management systems and confirming laboratory competency\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Any\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; 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;\">International Organization for Standardization's ISO 17025:2017 <i>General requirements for the competence of testing and calibration laboratories<\/i>; this standard \"specifies the general requirements for the competence, impartiality and consistent operation of laboratories\" and is used for assuaging others to the competence of the lab\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Any\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/loinc.org\/\" target=\"_blank\">LOINC Standard<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">the Regenstrief Institute's Logical Observation Identifiers Names and Codes (LOINC) standard, \"a common language (a set of identifiers, names, and codes) for identifying health measurements, observations, and documents\"\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Various\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; 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;\">The Veterinary Terminology Services Laboratory, part of the Virginia-Maryland Regional College of Veterinary Medicine, and its <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphis.usda.gov\/aphis\/ourfocus\/animalhealth\/lab-info-services\/nahln\/ct_nahln_it\" target=\"_blank\">National Animal Health Laboratory Network<\/a> (NAHLN) HL7 Messaging standards; this user guide provides the participating veterinary laboratory assistance on using the HL7 messaging protocol and NAHLN standards in order to transmit data\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Veterinary medicine\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYS Department of Health Clinical Laboratory Standards of Practice<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">The New York State Department of Health, Wadsworth Center's Clinical Laboratory Standards of Practice; this is a two-part collection of laboratory standards for NYS labs and those non-NYS labs that handle specimens originating in NYS, though these standards could effectively be applied by any medical laboratory; includes standards for specialty laboratories\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Any\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.snomed.org\/\" target=\"_blank\">SNOMED CT<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">SNOMED International's Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) standard, for standardized medical terminology\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Various\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.nlm.nih.gov\/research\/umls\/index.html\" target=\"_blank\">U.S. National Library of Medicine UMLS<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">the Unified Medical Language System (UMLS), which \"integrates and distributes key terminology, classification and coding standards, and associated resources to promote creation of more effective and interoperable biomedical information systems and services\"\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Various\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/venomcoding.org\/\" target=\"_blank\">VeNom Coding Group terminology<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">VeNom Coding Group's VeNom Veterinary Nomenclature; this is a standardized veterinary terminology \"for use in referral veterinary hospital electronic patient records and first opinion veterinary practice management systems\"\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Veterinary medicine\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/vtsl.vetmed.vt.edu\/\" target=\"_blank\">Veterinary Terminology Services Laboratory terminology options<\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">The Veterinary Terminology Services Laboratory (VTSL), part of the Virginia-Maryland Regional College of Veterinary Medicine, and its standardized terminology resources; the VTSL maintains a variety of standardized veterinary terminologies, including \"the Veterinary Extension to SNOMED CT as well as subsets for the National Animal Health Laboratory Network, AAHA Diagnostic Terms and AAEP Diagnostic Terms\"\n<\/td>\n<td style=\"padding:10px; background-color:white;\">Veterinary medicine\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20220125221421\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.017 seconds\nReal time usage: 0.021 seconds\nPreprocessor visited node count: 9\/1000000\nPost\u2010expand include size: 26073\/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% 4.137 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Standards,_regulations,_and_guidance\n100.00% 4.137 1 -total\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12950-0!canonical and timestamp 20220125221421 and revision id 45847. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Standards,_regulations,_and_guidance\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Standards,_regulations,_and_guidance<\/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>","4224406d16f2e95eee34cf47467ccd7d_images":[],"4224406d16f2e95eee34cf47467ccd7d_timestamp":1643149334,"c66d9b96add95cb4cc2d112e2f143e6c_type":"article","c66d9b96add95cb4cc2d112e2f143e6c_title":"5.4 Books and journals","c66d9b96add95cb4cc2d112e2f143e6c_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Books_and_journals","c66d9b96add95cb4cc2d112e2f143e6c_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 3: Industry and community resources\/Books and journalsFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n5.4 Books and journals \nBooks \nHundred of books concerning medical- and research-based laboratory science\u2014as well as laboratory informatics\u2014have been published over the past several decades. As such, it's difficult to make specific recommendations, at least without context. However, professional organizations are quite proficient in making such recommendations through their reading libraries and accreditation programs. For example, the Canadian Society for Medical Laboratory Science maintains a -page list of reference textbooks that are useful for their Medical Laboratory Technologist examination. The American Society for Clinical Pathology has its own publication division, with more than 60 in-house books published on various elements of pathology and laboratory science. The American Public Health Association has a similar library, as does the American Society for Microbiology, and the American College of Physicians.\nFor medical informatics books, the Amazon-associated BookAuthority has a section for medical informatics, though it's not clear how rigorous their ratings system is. Universities such as the University of Illinois-Chicago also may offer book recommendations.\n\nJournals \n\n\n\n\n\n\n\n\n\nJournal\n\nJournal description\n\n\nACIMED\n\na Spanish language journal of medical informatics published by the National Center of Information on Medical Sciences in Cuba\n\n\nACM Transactions on Database Systems\n\na database management journal released by the Association for Computing Machinery\n\n\nAdvanced Engineering Informatics\n\nan Elsevier journal on advanced computing methods and \"knowledge-intensive tasks in engineering\"\n\n\nAnnals of Clinical & Laboratory Science\n\na journal covering research in clinical science released by the Association of Clinical Scientists\n\n\nApplied Clinical Informatics\n\na biomedical and health informatics journal produced by the International Medical Informatics Association (IMIA) and the Association of Medical Directors of Information Systems (AMDIS)\n\n\nApplied Medical Informatics\n\na medical informatics journal overseen by the Department of Medical Informatics and Biostatistics at Iuliu Ha\u021bieganu University of Medicine and Pharmacy\n\n\nArtificial Intelligence in Medicine\n\nan Elsevier journal covering \"interdisciplinary perspectives concerning the theory and practice of artificial intelligence (AI) in medicine, human biology, and health care\"\n\n\nBiodiversity Informatics\n\na University of Kansas Libraries-hosted electronic journal that \"focuses on the emerging field of biodiversity informatics\"\n\n\nBioinformatics\n\nan Oxford Journals release that focuses \"on new developments in genome bioinformatics and computational biology\"\n\n\nBiomedical Signal Processing and Control\n\nan Elsevier journal covering \"research in the measurement and analysis of signals and images in clinical medicine and the biological sciences\"\n\n\nBMC Bioinformatics\n\nan open-access journal focusing on \"the development, testing and novel application of computational and statistical methods for the modeling and analysis of all kinds of biological data\"\n\n\nBMC Medical Informatics & Decision Making\n\nan open-access journal focusing on \"the design, development, implementation, use, and evaluation of health information technologies and decision-making within the healthcare setting\"\n\n\nBriefings in Bioinformatics\n\nan Oxford Journals release that covers \"databases and analytical tools of contemporary genetics, molecular and systems biology\"\n\n\nCancer Informatics\n\nan open-access journal focusing on \"bioinformatic analysis of molecular genetic and\/or clinical data pertaining to human cancer risk, prevention, outcome or treatment response\"\n\n\nChinese Journal of Health Informatics and Management\n\na Chinese journal reporting on trends in health informatics and the management of related systems\n\n\nClinical Informatics and Telemedicine\n\nthe official journal of the Ukrainian Association for Computer Medicine, this publication focuses on \"the newest technologies in clinical informatics\"\n\n\nClinics in Laboratory Medicine\n\nan Elsevier publication, each issue focusing on a pathology topic as it relates to laboratory management and technologies (alternate URL)\n\n\nComputational Statistics & Data Analysis\n\nthe Elsevier-published official journal of the International Association of Statistical Computing (IASC) \"dedicated to the dissemination of methodological research and applications in the areas of computational statistics and data analysis\"\n\n\nComputer Communication Review\n\nthe official publication of the Association for Computing Machinery's (ACM's) Special Interest Group on Data Communication (SIGCOMM); a publication containing both peer-reviewed and non-peer-reviewed content concerning the topic of computer communication\n\n\nComputer Methods and Programs in Biomedicine\n\nan Elsevier journal covering \"computing methodology and software systems derived from computing science for implementation in all aspects of biomedical research and medical practice\"\n\n\nComputers & Geosciences\n\nan Elsevier journal covering the use of \"modern computer science paradigms, whether computational or informatics-based, to address problems in the geosciences\"\n\n\nComputers in Biology and Medicine\n\nan Elsevier journal focused on the \"advances being made in the application of the computer to the fields of bioscience and medicine\"\n\n\nComputers Informatics Nursing\n\na monthly online \/ bimonthly print journal covering \"the latest developments in nursing informatics, research, and educational technology\"\n\n\nComputing and Informatics\n\na bimonthly journal on computer architectures, distributed computing, software engineering, and information management\n\n\nCurrent Bioinformatics\n\na Betham Science journal which \"focuses on reviews on advances in computational molecular\/structural biology\"\n\n\nCurrent Protocols in Bioinformatics\n\na trimonthly Wiley publication \"designed for research biologists\" concerning the how-to of \"hundreds of applications and databases from research groups around the globe\"\n\n\nData and Knowledge Engineering\n\nan Elsevier journal focused on the \"the underlying principles in the design and effective use\" database and knowledgebase systems\n\n\nEarth Science Informatics\n\na Springer journal focused on \"geoinformatics, computational Earth science, and all aspects of computer applications dealing with the earth systems science (ESS) and planetary and space science\"\n\n\nEgyptian Informatics Journal\n\nan Elsevier journal from the Faculty of Computers and Information, Cairo University which acts as a \"forum for the state-of-the-art research and development in the fields of computing, including computer sciences, information technologies, information systems, operations research and decision support\"\n\n\nEMBnet.journal\n\nan international open-access journal for biomedical scientists covering data analysis, IT architecture, and data-driven research\n\n\nEURASIP Journal on Bioinformatics and Systems Biology\n\na SpringerOpen journal (sponsored by the European Association for Signal Processing [EURASIP]) covering \"signal processing and bioinformatics theories and techniques relevant to a wide area of applications into the core new disciplines of genomics, proteomics, and systems biology\"\n\n\nEURASIP Journal on Information Security\n\na SpringerOpen journal (sponsored by the European Association for Signal Processing [EURASIP]) covering \"information security, with a particular emphasis on the use of signal processing tools in adversarial environments\"\n\n\nEuropean Journal for Biomedical Informatics\n\nthe official multi-lingual journal of the European Federation of Medical Informatics (EFMI), targeted at \"biomedical researchers, physicians, other health personnel and citizens\"\n\n\nEvolutionary Bioinformatics\n\nan international open-access journal covering evolutionary bioinformatics\n\n\nFoundations and Trends in Information Retrieval\n\na now publishers online journal that covers numerous aspect of information retrieval, from architecture and applications to theory and usability\n\n\nFundamenta Informaticae\n\nan IOS Press journal covering \"all areas of mathematical foundations of computer science and their applications\"\n\n\nGeoInformatica\n\na Springer journal focused on \"disseminating original and fundamental research and experience in the expanding uses of computer science for spatial studies\"\n\n\nHealth Affairs\n\na journal on \"health policy thought and research,\" sponsored by Project HOPE, a non-profit international health education organization\n\n\nHealth Care and Informatics Review Online\n\nthe official journal of the not-for-profit Health Informatics New Zealand (HINZ), \"dedicated to reviewing and interpreting significant developments in healthcare delivery with a particular focus on health informatics\"\n\n\nHealth Informatics Journal\n\na SAGE journal which covers \"the fields of informatics and telematics, the health professions, computer science, engineering and management\"\n\n\nHealth Information & Libraries Journal\n\nthe Wiley-published official journal of the Health Libraries Group of the U.K. Chartered Institute of Library and Information Professionals, dedicated to health library and information workers\n\n\nHealth Information Management Interchange\n\nthe official research journal of the Health Information Management Association of Australia (HIMAA), covering healthcare informatics\n\n\nHealth Information Science and Systems\n\na multidisciplinary open-access journal \"that aims to integrate computer science\/information technology with health science and services\"\n\n\nHuman-centric Computing and Information Sciences\n\nthe SpringerOpen journal for the Future Technology Research Association International (FTRA), covering \"various theories and practical applications related to human-centric computing and information sciences\"\n\n\nIEEE Transactions on Information Technology in Biomedicine\n\nan Institute of Electrical and Electronics Engineers (IEEE) publication on \"information technology applications in health, healthcare and biomedicine\"\n\n\nIEEE Transactions on Information Theory\n\nan Institute of Electrical and Electronics Engineers (IEEE) publication on \"the transmission, processing, and utilization of information\"\n\n\nInformatica\n\na quarterly IO Press journal \"on mathematical simulation and optimization, recognition and control, programming theory and systems, automation systems and elements\"\n\n\nInformatics for Health and Social Care\n\na quarterly journal dedicated \"to show how informatics contributes to the better delivery of care through the presentation of high-quality [research or practice] material\"\n\n\nInformation and Management\n\nan Elsevier journal which \"serves managers, professionals, database administrators and senior executives of organizations which design, implement and manage information systems applications\"\n\n\nInformation and Organization\n\nan Elsevier journal focused on \"the relationships between information technologies and social organization\"\n\n\nInformation and Software Technology\n\nan Elsevier journal dedicated to \"focusing on research and experience that contributes to the improvement of software development practices\"\n\n\nInformation Knowledge Systems Management\n\nan IO Press journal focused on the \"understanding and enhancing use of information management, knowledge management, and systems management for organizational and enterprise improvement\"\n\n\nInformation Sciences\n\nan Elsevier journal focused on \"research activities in information, knowledge engineering and intelligent systems\"\n\n\nInformation Services & Use\n\nan IOS Press journal that \"aims at leaders in information management and applications in an attempt to keep them fully informed of fast-moving developments in fields such as: online systems, offline systems, electronic publishing, library automation, education and training, word processing and telecommunications\"\n\n\nInformation Systems\n\nan Elsevier journal publishing information \"concerning the design and implementation of languages, data models, process models, algorithms, software and hardware for information systems\"\n\n\nInformation Systems Journal\n\na Wiley journal \"promoting the study of, and interest in, information systems\"\n\n\nIntelligent Data Analysis\n\nan IOS Press journal that covers \"research and applications of artificial intelligence techniques in data analysis across a variety of disciplines\"\n\n\nInternational Journal of Bioinformatics Research and Applications\n\nan Inderscience journal focused \"on basic bioinformatics research methods, tool development, performance evaluation and their applications in biology\"\n\n\nInternational Journal of Data Mining & Knowledge Management Process\n\na journal of non-profit Academy & Industry Research Collaboration Center (AIRCC) that focuses on \"computational theories and tools to assist researchers in extracting useful information from the rapidly growing volumes of digital data\"\n\n\nInternational Journal of Electronic Healthcare\n\nan Inderscience journal \"which presents current practice and research in the area of e-healthcare\"\n\n\nInternational Journal of Functional Informatics and Personalised Medicine\n\na quarterly Interscience journal \"dedicated to promoting the research, education and awareness of functional informatics and personalised medicine\"\n\n\nInternational Journal of Healthcare Technology and Management\n\na quarterly Interscience journal that \"provides an international forum and refereed authoritative sources of information in the fields of the economics and management of technology in healthcare\"\n\n\nInternational Journal of Health Information Management Research\n\na University of Sheffield-hosted open-access journal covering clinical informatics, e-Health, and health information management\n\n\nInternational Journal of Information Management\n\nan Elsevier journal \"that address contemporary issues for all those involved in information management\"\n\n\nInternational Journal of Medical Engineering and Informatics\n\nan Inderscience journal that covers \"the structural\/functional aspects of disease mechanisms and the application of technology towards the treatment\/management of such diseases\"\n\n\nInternational Journal of Medical Informatics\n\nthe Elsevier-published official journal of the European Federation of Medical Informatics (EFMI)\n\n\nInternational Journal of Technology Assessment in Health Care\n\nthe official digital journal of Health Technology Assessment International (HTAI) covering \"the economic, social, ethical, medical and public health implications of health technology\"\n\n\nJapan Journal of Medical Informatics\n\na medical informatics journal from the Japan Association for Medical Informatics\n\n\nJournal of Biomedical Informatics\n\nn Elsevier journal that \"emphasizes reports of new methodologies and techniques that have general applicability and that form the basis for the evolving science of biomedical informatics\"\n\n\nJournal of Biomedical Semantics\n\nan open-access journal that \"addresses issues of semantic enrichment and semantic processing in the biomedical domain\"\n\n\nJournal of Chemical Information and Modeling\n\nan ACS journal \"reporting new methodology and\/or important applications in the fields of chemical informatics and molecular modeling\"\n\n\nJournal of Cheminformatics\n\n\"an open-access journal publishing original peer-reviewed research in all aspects of cheminformatics and molecular modelling\"\n\n\nJournal of Clinical Bioinformatics\n\n\"an open-access, peer-reviewed online journal publishing original research on all aspects of the development of bioinformatics approaches\"\n\n\nJournal of Clinical Laboratory Analysis\n\na Wiley journal focused on \"newly developing modes of technology and laboratory assays, with emphasis on their application in current and future clinical laboratory testing\"\n\n\nJournal of Clinical Monitoring and Computing\n\na Springer journal focused on \"the exchange of knowledge and clinical information through the rapid, accurate publication of empirical clinical studies, case reports,\" and other types of documents and data in the clinical sphere\n\n\nJournal of Cloud Computing: Advances, Systems and Applications\n\na SpringerOpen journal focused on \"topics that are core to cloud computing, focusing on the cloud applications, the cloud systems, and the advances that will lead to the clouds of the future\"\n\n\nJournal of Community Informatics\n\na publication of the Centre for Community Informatics Research, Development and Training which focuses on \"the study and practice of enabling communities with information and communications technologies\"\n\n\nJournal of Computer Security\n\nan IOS Press journal that \"presents research and development results of lasting significance in the theory, design, implementation, analysis, and application of secure computer systems\"\n\n\nJournal of Digital Information\n\nan online journal \"on the management, presentation and uses of information in digital environments,\" supported by the University of Texas Libraries; not accepting submissions\n\n\nJournal of Electronic Resources in Medical Libraries\n\na quarterly Routledge journal \"devoted to the access, evaluation, and management of electronic resources in the medical library environment\"\n\n\nJournal of Health Informatics in Developing Countries\n\nan open-access biannual journal focused \"on health informatics that relate to developing countries\"\n\n\nJournal of Hospital Librarianship\n\na quarterly Routledge journal that \"addresses a wide variety of subjects that are vital to the field, including administrative, technical and program issues that may challenge hospital librarians\"\n\n\nJournal of Hydroinformatics\n\nthe official journal of the IAHR-IWA-IAHS Joint Committee on Hydroinformatics, \"devoted to the application of information technology in the widest sense to problems of the aquatic environment\"\n\n\nJournal of Information Science\n\na bimonthly SAGE journal \"covering topics of interest to all those researching and working in information science and knowledge management\"\n\n\nJournal of Innovation in Health Informatics\n\nformerly known as Informatics in Primary Care, the journal is specific to \"promoting excellence and professionalism in health informatics and improving public awareness and confidence that informatics can enhance health\"\n\n\nJournal of Management Information Systems\n\na quarterly journal focused on \"research that advances the practice and understanding of organizational information systems\"\n\n\nJournal of Medical Engineering & Technology\n\nthe official journal of the Institute of Physics and Engineering in Medicine (IPEM), \"promoting an understanding of the physiological processes underlying disease processes and the appropriate application of technology\"\n\n\nJournal of Medical Informatics\n\na CNKI Chinese journal covering the field of medical informatics\n\n\nJournal of Medical Internet Research\n\nan open-access journal on the topic of health and healthcare in the Internet age\n\n\nJournal of Medical Systems\n\na Springer journal covering \"applications of new systems techniques and methods in hospital, clinic, and physician's office administration; pathology, radiology, and pharmaceutical delivery systems\"\n\n\nJournal of Radiation Oncology Informatics\n\nan open-access journal that \"deals with the use of methods of informatics within the medical discipline of radiation oncology\"\n\n\nJournal of Strategic Information Systems\n\nan Elsevier journal \"focuses on the management, business and organizational issues associated with the introduction and utilization of information systems as a strategic tool\"\n\n\nJournal of Telemedicine and Telecare\n\na SAGE journal that \"provide[s] a unique perspective on how different countries and health systems are using new technology in healthcare\"\n\n\nJournal of the American Medical Informatics Association\n\nthe official journal of the American Medical Informatics Association (AMIA), covering a wide array of biomedical and health informatics topics\n\n\nJournal of the Medical Library Association\n\nthe official quarterly journal of the Medical Library Association (MLA) \"that aims to advance the practice and research knowledgebase of health sciences librarianship\"\n\n\nKnowledge and Information Systems\n\na Springer journal that covers \"new advances on all topics related to knowledge systems and advanced information systems\"\n\n\nMedical & Biological Engineering & Computing\n\na Springer journal that presents \"experimental and theoretical developments in biomedical science and technology, and reports on advances in computer-based methodologies in these multidisciplinary subjects\"\n\n\nMedical Care\n\nthe official journal of the Medical Care Section of the American Public Health Association, \"devoted to all aspects of the administration and delivery of healthcare\"\n\n\nMedical Decision Making\n\na bimonthly SAGE journal \"offering rigorous and systematic approaches to decision making that are designed to improve the health and clinical care of individuals and to assist with health policy development\"\n\n\nMethods of Information in Medicine\n\na Thieme journal that concentrates on \"the methodology and scientific fundamentals of organizing, representing and analyzing data, information and knowledge in biomedicine and health care\"\n\n\nMicrobial Informatics and Experimentation\n\n\"an open access, peer-reviewed online journal ... which publishes high-quality research related to the application of computational methods to data from microbial organisms and systems\"\n\n\nMilbank Quarterly\n\na Wiley journal \"devoted to scholarly analysis of significant issues in health and health care policy\"\n\n\nMIS Quarterly\n\na University of Minnesota-affiliated quarterly journal focused on \"the enhancement and communication of knowledge concerning the development of IT-based services, the management of IT resources, and the use, impact, and economics of IT with managerial, organizational, and societal implications\"\n\n\nMobile Information Systems\n\nan IOS Press journal \"providing a forum for state-of-the-art development and research, as well as current innovative activities in mobile information systems\"\n\n\nNeuroinformatics\n\na Springer journal focused on \"data structure and software tools related to analysis, modeling, integration, and sharing in all areas of neuroscience research\"\n\n\nOnline Journal of Nursing Informatics\n\nan open-access journal \"that focuses on nursing informatics in all practice settings\"\n\n\nOnline Journal of Public Health Informatics\n\nan open-access journal \"dedicated to the dissemination of information about best [public health informatics] practices among public health practitioners, researchers, and educators\"\n\n\nOpen Applied Informatics Journal\n\na discontinued Bentham Science open-access journal covering \"all areas of informatics and applied computer science of relevance to major scientific disciplines\"\n\n\nOpen Medical Informatics Journal\n\na discontinued Bentham Science open-access journal covering \"all areas of medical informatics\"\n\n\nPerspectives in Health Information Management\n\nan American Health Information Management Association- (AHIMA-) supported journal dedicated \"to advance health information management practice and to encourage interdisciplinary collaboration between HIM professionals and others in disciplines supporting the advancement of the management of health information\"\n\n\nPLOS Computational Biology\n\na journal of the not-for-profit PLOS (Public Library of Science) and an official journal of the International Society for Computational Biology (ISCB), focused on \"works of exceptional significance that further our understanding of living systems at all scales\"\n\n\nProceedings of the ACM SIGKDD International Conference on Knowledge Discovery and Data Mining\n\na yearly compendium of information collected during the ACM SIGKDD International Conference on Knowledge Discovery and Data Mining\n\n\nRAIRO - Theoretical Informatics and Applications\n\na Cambridge Journals and EDP Sciences journal covering \"the area of theoretical computer science and its applications\"\n\n\nSLAS Technology: Translating Life Sciences Innovation\n\nformerly the Journal of Laboratory Automation, this is the official bimonthly SAGE journal for the Society for Laboratory Automation and Screening (SLAS) \"devoted to the advancement of technology in the laboratory\"\n\n\nSource Code for Biology and Medicine\n\nan open-access journal covering \"all aspects of workflow for information systems, decision support systems, client user networks, database management, and data mining\"\n\n\nTechnology and Health Care\n\nan IOS Press journal covering the development and significance of medical and informatics technology in health care\n\n\nTelematics and Informatics\n\nan Elsevier \"interdisciplinary journal examining the social, economic, political and cultural impacts and challenges of information and communication technologies\"\n\n\nTelemedicine and e-Health\n\na Liebert journal \"covering the full spectrum of advances and clinical applications of telemedicine and management of electronic health records\"\n\n\nTheoretical and Applied Informatics\n\nan inactive open-access journal analyzing informatics as it applies to networking, algorithms, engineering, as well as quantum and bioinformatics\n\n\nWiley Interdisciplinary Reviews: Data Mining and Knowledge Discovery\n\na Wiley journal covering data mining and knowledge discovery as they apply to business, government, and the sciences\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Books_and_journals\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Books_and_journals<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:15.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 97 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","c66d9b96add95cb4cc2d112e2f143e6c_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Resources_for_selecting_and_implementing_informatics_solutions_Part_3_Industry_and_community_resources_Books_and_journals rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Resources_for_selecting_and_implementing_informatics_solutions_Part_3_Industry_and_community_resources_Books_and_journals 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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 3: Industry and community resources\/Books and journals<\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">the beginning<\/a> of this guide-----<\/div>\n<h3><span class=\"mw-headline\" id=\"5.4_Books_and_journals\">5.4 Books and journals<\/span><\/h3>\n<h4><span class=\"mw-headline\" id=\"Books\">Books<\/span><\/h4>\n<p>Hundred of books concerning medical- and research-based laboratory science\u2014as well as laboratory informatics\u2014have been published over the past several decades. As such, it's difficult to make specific recommendations, at least without context. However, professional organizations are quite proficient in making such recommendations through their reading libraries and accreditation programs. For example, the Canadian Society for Medical Laboratory Science maintains a <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.csmls.org\/csmls\/media\/documents\/certification\/CEXM-359-F2-Textbook-Reference-List-General-Medical-Laboratory-Technology.pdf\" target=\"_blank\">-page list<\/a> of reference textbooks that are useful for their Medical Laboratory Technologist examination. The American Society for Clinical Pathology has its own <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/store.ascp.org\/\" target=\"_blank\">publication division<\/a>, with more than 60 in-house books published on various elements of pathology and laboratory science. The American Public Health Association has <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/apha.org\/Publications\/Published-Books\" target=\"_blank\">a similar library<\/a>, as does the <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wiley.com\/en-us\/ASM+Books-c-5165?order=date\" target=\"_blank\">American Society for Microbiology<\/a>, and the <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acponline.org\/clinical-information\/journals-publications\/books-from-acp\" target=\"_blank\">American College of Physicians<\/a>.\n<\/p><p>For medical informatics books, the Amazon-associated BookAuthority has a <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/bookauthority.org\/books\/best-health-informatics-books\" target=\"_blank\">section for medical informatics<\/a>, though it's not clear how rigorous their ratings system is. Universities such as the <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/researchguides.uic.edu\/c.php?g=252330&p=1683330\" target=\"_blank\">University of Illinois-Chicago<\/a> also may offer book recommendations.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"Journals\">Journals<\/span><\/h4>\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;\">Journal\n<\/th>\n<th style=\"color:brown; background-color:#ffffee;\">Journal description\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/scielo.sld.cu\/scielo.php?script=sci_serial&pid=1024-9435&lng=en&nrm=iso\" target=\"_blank\"><i>ACIMED<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a Spanish language journal of medical informatics published by the National Center of Information on Medical Sciences in Cuba\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/dl.acm.org\/journal\/tods\" target=\"_blank\"><i>ACM Transactions on Database Systems<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a database management journal released by the Association for Computing Machinery\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.journals.elsevier.com\/advanced-engineering-informatics\/\" target=\"_blank\"><i>Advanced Engineering Informatics<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an Elsevier journal on advanced computing methods and \"knowledge-intensive tasks in engineering\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.annclinlabsci.org\/\" target=\"_blank\"><i>Annals of Clinical & Laboratory Science<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a journal covering research in clinical science released by the Association of Clinical Scientists\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.thieme.com\/books-main\/clinical-informatics\/product\/4433-aci-applied-clinical-informatics\" target=\"_blank\"><i>Applied Clinical Informatics<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a biomedical and health informatics journal produced by the International Medical Informatics Association (IMIA) and the Association of Medical Directors of Information Systems (AMDIS)\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ami.info.umfcluj.ro\/index.php\/AMI\" target=\"_blank\"><i>Applied Medical Informatics<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a medical informatics journal overseen by the Department of Medical Informatics and Biostatistics at Iuliu Ha\u021bieganu University of Medicine and Pharmacy\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sciencedirect.com\/journal\/artificial-intelligence-in-medicine\" target=\"_blank\"><i>Artificial Intelligence in Medicine<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an Elsevier journal covering \"interdisciplinary perspectives concerning the theory and practice of artificial intelligence (AI) in medicine, human biology, and health care\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/journals.ku.edu\/index.php\/jbi\/index\" target=\"_blank\"><i>Biodiversity Informatics<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a University of Kansas Libraries-hosted electronic journal that \"focuses on the emerging field of biodiversity informatics\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/academic.oup.com\/bioinformatics\" target=\"_blank\"><i>Bioinformatics<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an Oxford Journals release that focuses \"on new developments in genome bioinformatics and computational biology\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.journals.elsevier.com\/biomedical-signal-processing-and-control\/\" target=\"_blank\"><i>Biomedical Signal Processing and Control<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an Elsevier journal covering \"research in the measurement and analysis of signals and images in clinical medicine and the biological sciences\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/bmcbioinformatics.biomedcentral.com\/\" target=\"_blank\"><i>BMC Bioinformatics<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an open-access journal focusing on \"the development, testing and novel application of computational and statistical methods for the modeling and analysis of all kinds of biological data\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/bmcmedinformdecismak.biomedcentral.com\/\" target=\"_blank\"><i>BMC Medical Informatics & Decision Making<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an open-access journal focusing on \"the design, development, implementation, use, and evaluation of health information technologies and decision-making within the healthcare setting\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/academic.oup.com\/bib\" target=\"_blank\"><i>Briefings in Bioinformatics<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an Oxford Journals release that covers \"databases and analytical tools of contemporary genetics, molecular and systems biology\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/journals.sagepub.com\/home\/cix\" target=\"_blank\"><i>Cancer Informatics<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an open-access journal focusing on \"bioinformatic analysis of molecular genetic and\/or clinical data pertaining to human cancer risk, prevention, outcome or treatment response\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.cnki.com.cn\/Journal_en\/E-E053-WSGL.htm\" target=\"_blank\"><i>Chinese Journal of Health Informatics and Management<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a Chinese journal reporting on trends in health informatics and the management of related systems\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.uacm.kharkov.ua\/eng\/index.shtml?e-klininfo-ujornal.htm\" target=\"_blank\"><i>Clinical Informatics and Telemedicine<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">the official journal of the Ukrainian Association for Computer Medicine, this publication focuses on \"the newest technologies in clinical informatics\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.journals.elsevier.com\/clinics-in-laboratory-medicine\/\" target=\"_blank\"><i>Clinics in Laboratory Medicine<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an Elsevier publication, each issue focusing on a pathology topic as it relates to laboratory management and technologies (<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.labmed.theclinics.com\/\" target=\"_blank\">alternate URL<\/a>)\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.journals.elsevier.com\/computational-statistics-and-data-analysis\/\" target=\"_blank\"><i>Computational Statistics & Data Analysis<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">the Elsevier-published official journal of the International Association of Statistical Computing (IASC) \"dedicated to the dissemination of methodological research and applications in the areas of computational statistics and data analysis\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.sigcomm.org\/publications\/computer-communication-review\" target=\"_blank\"><i>Computer Communication Review<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">the official publication of the Association for Computing Machinery's (ACM's) Special Interest Group on Data Communication (SIGCOMM); a publication containing both peer-reviewed and non-peer-reviewed content concerning the topic of computer communication\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.journals.elsevier.com\/computer-methods-and-programs-in-biomedicine\/\" target=\"_blank\"><i>Computer Methods and Programs in Biomedicine<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an Elsevier journal covering \"computing methodology and software systems derived from computing science for implementation in all aspects of biomedical research and medical practice\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.journals.elsevier.com\/computers-and-geosciences\/\" target=\"_blank\"><i>Computers & Geosciences<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an Elsevier journal covering the use of \"modern computer science paradigms, whether computational or informatics-based, to address problems in the geosciences\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.journals.elsevier.com\/computers-in-biology-and-medicine\/\" target=\"_blank\"><i>Computers in Biology and Medicine<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an Elsevier journal focused on the \"advances being made in the application of the computer to the fields of bioscience and medicine\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/journals.lww.com\/cinjournal\/pages\/default.aspx\" target=\"_blank\"><i>Computers Informatics Nursing<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a monthly online \/ bimonthly print journal covering \"the latest developments in nursing informatics, research, and educational technology\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.cai.sk\/ojs\/index.php\/cai\" target=\"_blank\"><i>Computing and Informatics<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a bimonthly journal on computer architectures, distributed computing, software engineering, and information management\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/benthamscience.com\/journals\/current-bioinformatics\/\" target=\"_blank\"><i>Current Bioinformatics<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a Betham Science journal which \"focuses on reviews on advances in computational molecular\/structural biology\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/currentprotocols.onlinelibrary.wiley.com\/journal\/1934340x\" target=\"_blank\"><i>Current Protocols in Bioinformatics<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a trimonthly Wiley publication \"designed for research biologists\" concerning the how-to of \"hundreds of applications and databases from research groups around the globe\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.journals.elsevier.com\/data-and-knowledge-engineering\/\" target=\"_blank\"><i>Data and Knowledge Engineering<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an Elsevier journal focused on the \"the underlying principles in the design and effective use\" database and knowledgebase systems\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.springer.com\/journal\/12145\" target=\"_blank\"><i>Earth Science Informatics<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a Springer journal focused on \"geoinformatics, computational Earth science, and all aspects of computer applications dealing with the earth systems science (ESS) and planetary and space science\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.journals.elsevier.com\/egyptian-informatics-journal\/\" target=\"_blank\"><i>Egyptian Informatics Journal<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an Elsevier journal from the Faculty of Computers and Information, Cairo University which acts as a \"forum for the state-of-the-art research and development in the fields of computing, including computer sciences, information technologies, information systems, operations research and decision support\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/journal.embnet.org\/index.php\/embnetjournal\" target=\"_blank\"><i>EMBnet.journal<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an international open-access journal for biomedical scientists covering data analysis, IT architecture, and data-driven research\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/link.springer.com\/journal\/13637\" target=\"_blank\"><i>EURASIP Journal on Bioinformatics and Systems Biology<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a SpringerOpen journal (sponsored by the European Association for Signal Processing [EURASIP]) covering \"signal processing and bioinformatics theories and techniques relevant to a wide area of applications into the core new disciplines of genomics, proteomics, and systems biology\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/jis-eurasipjournals.springeropen.com\/\" target=\"_blank\"><i>EURASIP Journal on Information Security<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a SpringerOpen journal (sponsored by the European Association for Signal Processing [EURASIP]) covering \"information security, with a particular emphasis on the use of signal processing tools in adversarial environments\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ejbi.org\/\" target=\"_blank\"><i>European Journal for Biomedical Informatics<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">the official multi-lingual journal of the European Federation of Medical Informatics (EFMI), targeted at \"biomedical researchers, physicians, other health personnel and citizens\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/journals.sagepub.com\/home\/evb\" target=\"_blank\"><i>Evolutionary Bioinformatics<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an international open-access journal covering evolutionary bioinformatics\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.nowpublishers.com\/INR\" target=\"_blank\"><i>Foundations and Trends in Information Retrieval<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a now publishers online journal that covers numerous aspect of information retrieval, from architecture and applications to theory and usability\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iospress.nl\/journal\/fundamenta-informaticae\/\" target=\"_blank\"><i>Fundamenta Informaticae<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an IOS Press journal covering \"all areas of mathematical foundations of computer science and their applications\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.springer.com\/journal\/10707\" target=\"_blank\"><i>GeoInformatica<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a Springer journal focused on \"disseminating original and fundamental research and experience in the expanding uses of computer science for spatial studies\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.healthaffairs.org\/\" target=\"_blank\"><i>Health Affairs<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a journal on \"health policy thought and research,\" sponsored by Project HOPE, a non-profit international health education organization\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.hinz.org.nz\/page\/HCIROJournal\" target=\"_blank\"><i>Health Care and Informatics Review Online<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">the official journal of the not-for-profit Health Informatics New Zealand (HINZ), \"dedicated to reviewing and interpreting significant developments in healthcare delivery with a particular focus on health informatics\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/journals.sagepub.com\/home\/jhi\" target=\"_blank\"><i>Health Informatics Journal<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a SAGE journal which covers \"the fields of informatics and telematics, the health professions, computer science, engineering and management\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/onlinelibrary.wiley.com\/journal\/14711842\" target=\"_blank\"><i>Health Information & Libraries Journal<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">the Wiley-published official journal of the Health Libraries Group of the U.K. Chartered Institute of Library and Information Professionals, dedicated to health library and information workers\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/himaa.org.au\/publications\/\" target=\"_blank\"><i>Health Information Management Interchange<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">the official research journal of the Health Information Management Association of Australia (HIMAA), covering healthcare informatics\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.springer.com\/journal\/13755\" target=\"_blank\"><i>Health Information Science and Systems<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a multidisciplinary open-access journal \"that aims to integrate computer science\/information technology with health science and services\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/hcis-journal.springeropen.com\/\" target=\"_blank\"><i>Human-centric Computing and Information Sciences<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">the SpringerOpen journal for the Future Technology Research Association International (FTRA), covering \"various theories and practical applications related to human-centric computing and information sciences\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ieeexplore.ieee.org\/xpl\/RecentIssue.jsp?punumber=4233\" target=\"_blank\"><i>IEEE Transactions on Information Technology in Biomedicine<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an Institute of Electrical and Electronics Engineers (IEEE) publication on \"information technology applications in health, healthcare and biomedicine\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ieeexplore.ieee.org\/xpl\/RecentIssue.jsp?punumber=18\" target=\"_blank\"><i>IEEE Transactions on Information Theory<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an Institute of Electrical and Electronics Engineers (IEEE) publication on \"the transmission, processing, and utilization of information\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iospress.nl\/journal\/informatica\/\" target=\"_blank\"><i>Informatica<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a quarterly IO Press journal \"on mathematical simulation and optimization, recognition and control, programming theory and systems, automation systems and elements\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.tandfonline.com\/loi\/imif20\" target=\"_blank\"><i>Informatics for Health and Social Care<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a quarterly journal dedicated \"to show how informatics contributes to the better delivery of care through the presentation of high-quality [research or practice] material\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.journals.elsevier.com\/information-and-management\/\" target=\"_blank\"><i>Information and Management<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an Elsevier journal which \"serves managers, professionals, database administrators and senior executives of organizations which design, implement and manage information systems applications\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.journals.elsevier.com\/information-and-organization\/\" target=\"_blank\"><i>Information and Organization<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an Elsevier journal focused on \"the relationships between information technologies and social organization\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.journals.elsevier.com\/information-and-software-technology\/\" target=\"_blank\"><i>Information and Software Technology<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an Elsevier journal dedicated to \"focusing on research and experience that contributes to the improvement of software development practices\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iospress.nl\/journal\/information-knowledge-systems-management\/\" target=\"_blank\"><i>Information Knowledge Systems Management<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an IO Press journal focused on the \"understanding and enhancing use of information management, knowledge management, and systems management for organizational and enterprise improvement\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.journals.elsevier.com\/information-sciences\/\" target=\"_blank\"><i>Information Sciences<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an Elsevier journal focused on \"research activities in information, knowledge engineering and intelligent systems\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iospress.nl\/journal\/information-services-use\/\" target=\"_blank\"><i>Information Services & Use<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an IOS Press journal that \"aims at leaders in information management and applications in an attempt to keep them fully informed of fast-moving developments in fields such as: online systems, offline systems, electronic publishing, library automation, education and training, word processing and telecommunications\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.journals.elsevier.com\/information-systems\/\" target=\"_blank\"><i>Information Systems<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an Elsevier journal publishing information \"concerning the design and implementation of languages, data models, process models, algorithms, software and hardware for information systems\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/onlinelibrary.wiley.com\/journal\/13652575\" target=\"_blank\"><i>Information Systems Journal<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a Wiley journal \"promoting the study of, and interest in, information systems\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iospress.nl\/journal\/intelligent-data-analysis\/\" target=\"_blank\"><i>Intelligent Data Analysis<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an IOS Press journal that covers \"research and applications of artificial intelligence techniques in data analysis across a variety of disciplines\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.inderscience.com\/jhome.php?jcode=ijbra\" target=\"_blank\"><i>International Journal of Bioinformatics Research and Applications<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an Inderscience journal focused \"on basic bioinformatics research methods, tool development, performance evaluation and their applications in biology\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/airccse.org\/journal\/ijdkp\/ijdkp.html\" target=\"_blank\"><i>International Journal of Data Mining & Knowledge Management Process<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a journal of non-profit Academy & Industry Research Collaboration Center (AIRCC) that focuses on \"computational theories and tools to assist researchers in extracting useful information from the rapidly growing volumes of digital data\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.inderscience.com\/jhome.php?jcode=ijeh\" target=\"_blank\"><i>International Journal of Electronic Healthcare<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an Inderscience journal \"which presents current practice and research in the area of e-healthcare\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.inderscience.com\/jhome.php?jcode=ijfipm\" target=\"_blank\"><i>International Journal of Functional Informatics and Personalised Medicine<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a quarterly Interscience journal \"dedicated to promoting the research, education and awareness of functional informatics and personalised medicine\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.inderscience.com\/jhome.php?jcode=ijhtm\" target=\"_blank\"><i>International Journal of Healthcare Technology and Management<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a quarterly Interscience journal that \"provides an international forum and refereed authoritative sources of information in the fields of the economics and management of technology in healthcare\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ijhimr.shef.ac.uk\/ojs\/\" target=\"_blank\"><i>International Journal of Health Information Management Research<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a University of Sheffield-hosted open-access journal covering clinical informatics, e-Health, and health information management\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.journals.elsevier.com\/international-journal-of-information-management\/\" target=\"_blank\"><i>International Journal of Information Management<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an Elsevier journal \"that address contemporary issues for all those involved in information management\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.inderscience.com\/jhome.php?jcode=ijmei\" target=\"_blank\"><i>International Journal of Medical Engineering and Informatics<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an Inderscience journal that covers \"the structural\/functional aspects of disease mechanisms and the application of technology towards the treatment\/management of such diseases\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.journals.elsevier.com\/international-journal-of-medical-informatics\/\" target=\"_blank\"><i>International Journal of Medical Informatics<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">the Elsevier-published official journal of the European Federation of Medical Informatics (EFMI)\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cambridge.org\/core\/journals\/international-journal-of-technology-assessment-in-health-care\" target=\"_blank\"><i>International Journal of Technology Assessment in Health Care<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">the official digital journal of Health Technology Assessment International (HTAI) covering \"the economic, social, ethical, medical and public health implications of health technology\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.jstage.jst.go.jp\/browse\/jami\" target=\"_blank\"><i>Japan Journal of Medical Informatics<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a medical informatics journal from the Japan Association for Medical Informatics\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.journals.elsevier.com\/journal-of-biomedical-informatics\/\" target=\"_blank\"><i>Journal of Biomedical Informatics<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">n Elsevier journal that \"emphasizes reports of new methodologies and techniques that have general applicability and that form the basis for the evolving science of biomedical informatics\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/jbiomedsem.biomedcentral.com\/\" target=\"_blank\"><i>Journal of Biomedical Semantics<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an open-access journal that \"addresses issues of semantic enrichment and semantic processing in the biomedical domain\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/pubs.acs.org\/journal\/jcisd8\" target=\"_blank\"><i>Journal of Chemical Information and Modeling<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an ACS journal \"reporting new methodology and\/or important applications in the fields of chemical informatics and molecular modeling\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/jcheminf.biomedcentral.com\/\" target=\"_blank\"><i>Journal of Cheminformatics<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">\"an open-access journal publishing original peer-reviewed research in all aspects of cheminformatics and molecular modelling\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/jclinbioinformatics.biomedcentral.com\/\" target=\"_blank\"><i>Journal of Clinical Bioinformatics<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">\"an open-access, peer-reviewed online journal publishing original research on all aspects of the development of bioinformatics approaches\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/onlinelibrary.wiley.com\/journal\/10982825\" target=\"_blank\"><i>Journal of Clinical Laboratory Analysis<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a Wiley journal focused on \"newly developing modes of technology and laboratory assays, with emphasis on their application in current and future clinical laboratory testing\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.springer.com\/journal\/10877\" target=\"_blank\"><i>Journal of Clinical Monitoring and Computing<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a Springer journal focused on \"the exchange of knowledge and clinical information through the rapid, accurate publication of empirical clinical studies, case reports,\" and other types of documents and data in the clinical sphere\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/journalofcloudcomputing.springeropen.com\/\" target=\"_blank\"><i>Journal of Cloud Computing: Advances, Systems and Applications<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a SpringerOpen journal focused on \"topics that are core to cloud computing, focusing on the cloud applications, the cloud systems, and the advances that will lead to the clouds of the future\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/openjournals.uwaterloo.ca\/index.php\/JoCI\" target=\"_blank\"><i>Journal of Community Informatics<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a publication of the Centre for Community Informatics Research, Development and Training which focuses on \"the study and practice of enabling communities with information and communications technologies\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iospress.nl\/journal\/journal-of-computer-security\/\" target=\"_blank\"><i>Journal of Computer Security<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an IOS Press journal that \"presents research and development results of lasting significance in the theory, design, implementation, analysis, and application of secure computer systems\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/journals.tdl.org\/jodi\/index.php\/jodi\" target=\"_blank\"><i>Journal of Digital Information<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an online journal \"on the management, presentation and uses of information in digital environments,\" supported by the University of Texas Libraries; not accepting submissions\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.tandfonline.com\/loi\/werm20\" target=\"_blank\"><i>Journal of Electronic Resources in Medical Libraries<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a quarterly Routledge journal \"devoted to the access, evaluation, and management of electronic resources in the medical library environment\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.jhidc.org\/\" target=\"_blank\"><i>Journal of Health Informatics in Developing Countries<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an open-access biannual journal focused \"on health informatics that relate to developing countries\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.tandfonline.com\/loi\/whos20\" target=\"_blank\"><i>Journal of Hospital Librarianship<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a quarterly Routledge journal that \"addresses a wide variety of subjects that are vital to the field, including administrative, technical and program issues that may challenge <a href=\"https:\/\/www.limswiki.org\/index.php\/Hospital\" title=\"Hospital\" class=\"wiki-link\" data-key=\"b8f070c66d8123fe91063594befebdff\">hospital<\/a> librarians\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/iwaponline.com\/jh\/\" target=\"_blank\"><i>Journal of Hydroinformatics<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">the official journal of the IAHR-IWA-IAHS Joint Committee on Hydroinformatics, \"devoted to the application of information technology in the widest sense to problems of the aquatic environment\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/journals.sagepub.com\/home\/jis\" target=\"_blank\"><i>Journal of Information Science<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a bimonthly SAGE journal \"covering topics of interest to all those researching and working in information science and knowledge management\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/hijournal.bcs.org\/index.php\/jhi\" target=\"_blank\"><i>Journal of Innovation in Health Informatics<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">formerly known as <i>Informatics in Primary Care<\/i>, the journal is specific to \"promoting excellence and professionalism in health informatics and improving public awareness and confidence that informatics can enhance health\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.jmis-web.org\/\" target=\"_blank\"><i>Journal of Management Information Systems<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a quarterly journal focused on \"research that advances the practice and understanding of organizational information systems\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.tandfonline.com\/loi\/ijmt20\" target=\"_blank\"><i>Journal of Medical Engineering & Technology<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">the official journal of the Institute of Physics and Engineering in Medicine (IPEM), \"promoting an understanding of the physiological processes underlying disease processes and the appropriate application of technology\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.cnki.com.cn\/Journal\/E-ED-YXQB-2007-06.htm\" target=\"_blank\"><i>Journal of Medical Informatics<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a CNKI Chinese journal covering the field of medical informatics\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.jmir.org\/\" target=\"_blank\"><i>Journal of Medical Internet Research<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an open-access journal on the topic of health and healthcare in the Internet age\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.springer.com\/journal\/10916\" target=\"_blank\"><i>Journal of Medical Systems<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a Springer journal covering \"applications of new systems techniques and methods in hospital, clinic, and physician's office administration; pathology, radiology, and pharmaceutical delivery systems\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/bop.unibe.ch\/jroi\/\" target=\"_blank\"><i>Journal of Radiation Oncology Informatics<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an open-access journal that \"deals with the use of methods of informatics within the medical discipline of radiation oncology\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.journals.elsevier.com\/the-journal-of-strategic-information-systems\/\" target=\"_blank\"><i>Journal of Strategic Information Systems<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an Elsevier journal \"focuses on the management, business and organizational issues associated with the introduction and utilization of information systems as a strategic tool\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/journals.sagepub.com\/home\/jtt\" target=\"_blank\"><i>Journal of Telemedicine and Telecare<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a SAGE journal that \"provide[s] a unique perspective on how different countries and health systems are using new technology in healthcare\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/academic.oup.com\/jamia\" target=\"_blank\"><i>Journal of the American Medical Informatics Association<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">the official journal of the American Medical Informatics Association (AMIA), covering a wide array of biomedical and health informatics topics\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.mlanet.org\/p\/cm\/ld\/fid=62\" target=\"_blank\"><i>Journal of the Medical Library Association<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">the official quarterly journal of the Medical Library Association (MLA) \"that aims to advance the practice and research knowledgebase of health sciences librarianship\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.springer.com\/journal\/10115\" target=\"_blank\"><i>Knowledge and Information Systems<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a Springer journal that covers \"new advances on all topics related to knowledge systems and advanced information systems\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.springer.com\/journal\/11517\" target=\"_blank\"><i>Medical & Biological Engineering & Computing<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a Springer journal that presents \"experimental and theoretical developments in biomedical science and technology, and reports on advances in computer-based methodologies in these multidisciplinary subjects\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/journals.lww.com\/lww-medicalcare\/pages\/default.aspx\" target=\"_blank\"><i>Medical Care<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">the official journal of the Medical Care Section of the American Public Health Association, \"devoted to all aspects of the administration and delivery of healthcare\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/journals.sagepub.com\/home\/mdm\" target=\"_blank\"><i>Medical Decision Making<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a bimonthly SAGE journal \"offering rigorous and systematic approaches to decision making that are designed to improve the health and clinical care of individuals and to assist with health policy development\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.thieme.com\/books-main\/clinical-informatics\/product\/4439-methods-of-information-in-medicine\" target=\"_blank\"><i>Methods of Information in Medicine<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a Thieme journal that concentrates on \"the methodology and scientific fundamentals of organizing, representing and analyzing data, information and knowledge in biomedicine and health care\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/microbialinformaticsj.biomedcentral.com\/\" target=\"_blank\"><i>Microbial Informatics and Experimentation<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">\"an open access, peer-reviewed online journal ... which publishes high-quality research related to the application of computational methods to data from microbial organisms and systems\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/onlinelibrary.wiley.com\/journal\/14680009\" target=\"_blank\"><i>Milbank Quarterly<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a Wiley journal \"devoted to scholarly analysis of significant issues in health and health care policy\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/misq.org\/\" target=\"_blank\"><i>MIS Quarterly<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a University of Minnesota-affiliated quarterly journal focused on \"the enhancement and communication of knowledge concerning the development of IT-based services, the management of IT resources, and the use, impact, and economics of IT with managerial, organizational, and societal implications\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iospress.nl\/journal\/mobile-information-systems\/\" target=\"_blank\"><i>Mobile Information Systems<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an IOS Press journal \"providing a forum for state-of-the-art development and research, as well as current innovative activities in mobile information systems\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.springer.com\/journal\/12021\" target=\"_blank\"><i>Neuroinformatics<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a Springer journal focused on \"data structure and software tools related to analysis, modeling, integration, and sharing in all areas of neuroscience research\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.himss.org\/resources\/online-journal-nursing-informatics\" target=\"_blank\"><i>Online Journal of Nursing Informatics<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an open-access journal \"that focuses on nursing informatics in all practice settings\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ojphi.org\/ojs\/index.php\/ojphi\/issue\/view\/637\" target=\"_blank\"><i>Online Journal of Public Health Informatics<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an open-access journal \"dedicated to the dissemination of information about best [public health informatics] practices among public health practitioners, researchers, and educators\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/benthamopen.com\/TOAINFOJ\/contents\/\" target=\"_blank\"><i>Open Applied Informatics Journal<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a discontinued Bentham Science open-access journal covering \"all areas of informatics and applied computer science of relevance to major scientific disciplines\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.benthamopen.com\/TOMINFOJ\/contents\/\" target=\"_blank\"><i>Open Medical Informatics Journal<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a discontinued Bentham Science open-access journal covering \"all areas of medical informatics\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/perspectives.ahima.org\/\" target=\"_blank\"><i>Perspectives in Health Information Management<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an American Health Information Management Association- (AHIMA-) supported journal dedicated \"to advance health information management practice and to encourage interdisciplinary collaboration between HIM professionals and others in disciplines supporting the advancement of the management of health information\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/journals.plos.org\/ploscompbiol\/\" target=\"_blank\"><i>PLOS Computational Biology<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a journal of the not-for-profit PLOS (Public Library of Science) and an official journal of the International Society for Computational Biology (ISCB), focused on \"works of exceptional significance that further our understanding of living systems at all scales\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/dl.acm.org\/conference\/kdd\/proceedings\" target=\"_blank\"><i>Proceedings of the ACM SIGKDD International Conference on Knowledge Discovery and Data Mining<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a yearly compendium of information collected during the ACM SIGKDD International Conference on Knowledge Discovery and Data Mining\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cambridge.org\/core\/journals\/rairo-theoretical-informatics-and-applications\" target=\"_blank\"><i>RAIRO - Theoretical Informatics and Applications<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a Cambridge Journals and EDP Sciences journal covering \"the area of theoretical computer science and its applications\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/journals.sagepub.com\/home\/jla\" target=\"_blank\"><i>SLAS Technology: Translating Life Sciences Innovation<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">formerly the <i>Journal of Laboratory Automation<\/i>, this is the official bimonthly SAGE journal for the Society for Laboratory Automation and Screening (SLAS) \"devoted to the advancement of technology in the laboratory\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/scfbm.biomedcentral.com\/\" target=\"_blank\"><i>Source Code for Biology and Medicine<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an open-access journal covering \"all aspects of workflow for information systems, decision support systems, client user networks, database management, and data mining\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iospress.nl\/journal\/technology-and-health-care\/\" target=\"_blank\"><i>Technology and Health Care<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an IOS Press journal covering the development and significance of medical and informatics technology in health care\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.journals.elsevier.com\/telematics-and-informatics\/\" target=\"_blank\"><i>Telematics and Informatics<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an Elsevier \"interdisciplinary journal examining the social, economic, political and cultural impacts and challenges of information and communication technologies\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/home.liebertpub.com\/publications\/telemedicine-and-e-health\/54\/\" target=\"_blank\"><i>Telemedicine and e-Health<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a Liebert journal \"covering the full spectrum of advances and clinical applications of telemedicine and management of electronic health records\"\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/journals.pan.pl\/tai?language=en\" target=\"_blank\"><i>Theoretical and Applied Informatics<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">an inactive open-access journal analyzing informatics as it applies to networking, algorithms, engineering, as well as quantum and bioinformatics\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:350px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/onlinelibrary.wiley.com\/journal\/19424795\" target=\"_blank\"><i>Wiley Interdisciplinary Reviews: Data Mining and Knowledge Discovery<\/i><\/a>\n<\/td>\n<td style=\"padding:10px; background-color:white;\">a Wiley journal covering data mining and knowledge discovery as they apply to business, government, and the sciences\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<!-- \nNewPP limit report\nCached time: 20220125221421\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.026 seconds\nReal time usage: 0.033 seconds\nPreprocessor visited node count: 9\/1000000\nPost\u2010expand include size: 86138\/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% 7.777 1 -total\n100.00% 7.777 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Books_and_journals\n 54.80% 4.262 1 Template:Resources\/Journals\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12949-0!canonical and timestamp 20220125221421 and revision id 45846. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Books_and_journals\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Books_and_journals<\/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>","c66d9b96add95cb4cc2d112e2f143e6c_images":[],"c66d9b96add95cb4cc2d112e2f143e6c_timestamp":1643149334,"88266dfb459e745c2f5143f10ba7dc70_type":"article","88266dfb459e745c2f5143f10ba7dc70_title":"5.3 User communities","88266dfb459e745c2f5143f10ba7dc70_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/User_communities","88266dfb459e745c2f5143f10ba7dc70_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 3: Industry and community resources\/User communitiesFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n5.3 User communities \nThe following user communities (in the form of forums, discussion boards, email discussion lists, etc.) are known to provide a space for medical diagnostic and research personnel to discuss their work:\n\nAAPC Medical Billing and Coding Forum\nAmericanEHR\nASCLS Open Forum\nBCS Health Informatics Forum, on LinkedIn\nForens-L Email Discussion List\nHealth Informatics Forum\nIAMA Email Discussion Lists\nJISCMail's industry-specific mailing lists\nLaboratory LOINC\nLaboratory Research & Innovation Group, on LinkedIn\nLabWrench\nLIMS\/Laboratory Informatics group, on LinkedIn\nLIMSforum\nPathLabTalk\nReddit-based communities \n\/r\/healthIT\n\/r\/labrats\n\/r\/MedLabProfessionals\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/User_communities\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/User_communities<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:15.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 35 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","88266dfb459e745c2f5143f10ba7dc70_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Resources_for_selecting_and_implementing_informatics_solutions_Part_3_Industry_and_community_resources_User_communities rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Resources_for_selecting_and_implementing_informatics_solutions_Part_3_Industry_and_community_resources_User_communities 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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 3: Industry and community resources\/User communities<\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">the beginning<\/a> of this guide-----<\/div>\n<h3><span class=\"mw-headline\" id=\"5.3_User_communities\">5.3 User communities<\/span><\/h3>\n<p>The following user communities (in the form of forums, discussion boards, email discussion lists, etc.) are known to provide a space for medical diagnostic and research personnel to discuss their work:\n<\/p>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aapc.com\/discuss\/\" target=\"_blank\">AAPC Medical Billing and Coding Forum<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.americanehr.com\/Home.aspx\" target=\"_blank\">AmericanEHR<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/connect.ascls.org\/communities\/redirectopenforum\" target=\"_blank\">ASCLS Open Forum<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.linkedin.com\/groups\/1058857\/\" target=\"_blank\">BCS Health Informatics Forum, on LinkedIn<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/yfsf.aafs.org\/resources\/professional-discussion-lists\/\" target=\"_blank\">Forens-L Email Discussion List<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/healthinformaticsforum.com\/\" target=\"_blank\">Health Informatics Forum<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iami.org.in\/\" target=\"_blank\">IAMA Email Discussion Lists<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.jiscmail.ac.uk\/\" target=\"_blank\">JISCMail's industry-specific mailing lists<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/loinc.org\/forums\/forum\/laboratory-loinc\/\" target=\"_blank\">Laboratory LOINC<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.linkedin.com\/groups\/705\/\" target=\"_blank\">Laboratory Research & Innovation Group, on LinkedIn<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.labwrench.com\/\" target=\"_blank\">LabWrench<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.linkedin.com\/groups\/36640\/\" target=\"_blank\">LIMS\/Laboratory Informatics group, on LinkedIn<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.limsforum.com\/\" target=\"_blank\">LIMSforum<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pathlabtalk.com\/forum\/\" target=\"_blank\">PathLabTalk<\/a><\/li><\/ul>\n<h4><span class=\"mw-headline\" id=\"Reddit-based_communities\">Reddit-based communities<\/span><\/h4>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.reddit.com\/r\/healthIT\/\" target=\"_blank\">\/r\/healthIT<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.reddit.com\/r\/labrats\/\" target=\"_blank\">\/r\/labrats<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.reddit.com\/r\/medlabprofessionals\/\" target=\"_blank\">\/r\/MedLabProfessionals<\/a><\/li><\/ul>\n<!-- \nNewPP limit report\nCached time: 20220125221421\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.005 seconds\nReal time usage: 0.009 seconds\nPreprocessor visited node count: 6\/1000000\nPost\u2010expand include size: 1452\/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% 3.780 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/User_communities\n100.00% 3.780 1 -total\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12948-0!canonical and timestamp 20220125221421 and revision id 45845. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/User_communities\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/User_communities<\/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>","88266dfb459e745c2f5143f10ba7dc70_images":[],"88266dfb459e745c2f5143f10ba7dc70_timestamp":1643149334,"2574a22b8ca0940242424fa5279a406b_type":"article","2574a22b8ca0940242424fa5279a406b_title":"5.2 Conferences and trade shows","2574a22b8ca0940242424fa5279a406b_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Conferences_and_trade_shows","2574a22b8ca0940242424fa5279a406b_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 3: Industry and community resources\/Conferences and trade showsFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n5.2 Conferences and trade shows \nIf you wish to first sort by one column, and then another column (e.g., first by year, and then by date), simply left-click the desired arrow for the first column to sort by, and then hold the Shift key and left-click the desired arrow for the second column to sort by.\nNote: These listings are updated three times a year, typically at the beginning of January, May, and September.\n\nConferences \n\n\n\nConference\n\nCountry\n\nCity (State)\n\nMonth \/ Day(s)\n\nYear\n\nOrganizer\n\nDetails\n\n\nACM-BCB 2022\n\nUnknown\n\nUnknown\n\n08 \/ Unknown\n\n2022\n\nAssociation for Computing Machinery (ACM)\n\nAn annual conference on bioinformatics, computational biology, and health informatics\n\n\n\n\nACM SIGCOMM 2022\n\nNetherlands\n\nAmsterdam\n\n08 \/ 22\u201326\n\n2022\n\nAssociation for Computing Machinery's (ACM's) Special Interest Group on Data Communication (SIGCOMM)\n\nAn annual international meeting of the ACM SIGCOMM on the topic of computer and data communication networks and their \"architecture, design, implementation, operations, analysis, measurement, and simulation\" (alternate URL)\n\n\n\n\nAIME 2022\n\nUnknown\n\nUnknown\n\n06 \/ Unknown\n\n2022\n\nEuropean Society for Artificial Intelligence in Medicine (AIME)\n\nA biennial international conference on AI techniques in medical research and care for AIME\n\n\n\n\nAMIA 2022 Annual Symposium\n\nUnknown\n\nUnknown\n\n10 \/ Unknown\n\n2022\n\nAmerican Medical Informatics Association (AMIA)\n\nAn annual biomedical and informatics symposium for the AMIA\n\n\n\n\nAMIA Clinical Informatics Conference 2022\n\nUnited States\n\nHouston (Texas)\n\n05 \/ 24\u201326\n\n2022\n\nAmerican Medical Informatics Association (AMIA)\n\nAnnual summit on bioinformatics, translational research, and other aspects of data science\n\n\n\n\nANIA 2022 Conference\n\nUnited States\n\nHollywood (Florida)\n\n04 \/ 27\u201329\n\n2022\n\nAmerican Nursing Informatics Association (ANIA)\n\nAn annual informatics conference for the ANIA\n\n\n\n\nAPHL 2022\n\nUnited States\n\nCleveland (Ohio)\n\n05 \/ 17\u201320\n\n2022\n\nAssociation of Public Health Laboratories (APHL)\n\nAn annual public health conference for the APHL\n\n \n\n\nApplied Bioinformatics and Public Health Microbiology\n\nUnknown\n\nUnknown\n\n05 \/ Unknown\n\n2022\n\nWellcome Genome Campus\n\nAn annual conference \"focusing on the implications of data-driven genomics approaches in public health settings\"\n\n \n\n\nASCLD 2022 Symposium\n\nUnited States\n\nReno (Nevada)\n\n04 \/ 24\u201328\n\n2022\n\nAmerican Society of Crime Laboratory Directors (ASCLD)\n\nAn annual symposium concerning \"the day-to-day operation of a crime laboratory\" for the ASCLD\n\n\n\n\nASIS&T 2022 Annual Meeting\n\nUnited States\n\nPittsburgh (Pennsylvania)\n\n10 \/ 29 \u2013 11 \/ 01\n\n2022\n\nAssociation for Information Science and Technology (ASIS&T)\n\nAn annual information science and technology conference for the ASIS&T\n\n\n\n\nBio-IT World Conference and Expo 2022\n\nUnited States\n\nBoston (Massachusetts)\n\n05 \/ 03\u201305\n\n2022\n\nCambridge Healthtech Institute\n\nAn annual medical and biomedical informatics conference and exhibition\n\n\n\n\nBIOSTEC 2022\n\nAustria\n\nVienna\n\n02 \/ 03\u201311\n\n2022\n\nInstitute for Systems and Technologies of Information, Control and Communication\n\nAn annual multi-conference on \"theoretical advances and applications of information systems, artificial intelligence, signal processing, electronics and other engineering tools in knowledge areas related to biology and medicine\"\n\n\n\n\nBIOTECHNO 2022\n\nItaly\n\nVenice\n\n05 \/ 22\u201326\n\n2022\n\nInternational Academy, Research and Industry Association (IARIA)\n\nAn international conference on bioinformatics, biocomputational systems, and biotechnologies\n\n\n\n\nC3DIS 2022\n\nUnknown\n\nUnknown\n\n07 \/ Unknown\n\n2022\n\nConference Design Pty. Ltd.\n\nAn Australasian conference on \"the production of breakthrough science outcomes that require large scale, complex computations and analyses to be carried out over massive data sets\"\n\n\n\n\nComputing in Cardiology\n\nFinland\n\nTampere\n\n09 \/ 04\u201307\n\n2022\n\nComputers in Cardiology, Inc.\n\nAn international conference on computing in clinical cardiology and cardiovascular physiology\n\n\n\n\nContext Sensitive Health Informatics (CSHI) 2023\n\nUnknown\n\nUnknown\n\n11 \/ Unknown\n\n2023\n\nEuropean Federation for Medical Informatics\n\nA biennial international conference on health information technologies and their environments\n\n\n\n\nDigital Health & Care Scotland 2022\n\nScotland\n\nEdinburgh\n\n02 \/ 22\u201323\n\n2022\n\nHolyrood Connect\n\nAn annual national conference for sharing digital health successes and lessons learned\n\n \n\n\nDigital Health Institute Summit 2022\n\nAustralia\n\nMelbourne (Victoria)\n\n02 \/ 21\u201322\n\n2022\n\nAustralasian Institute of Digital Health (AIDH)\n\nA national conference for the Australasian Institute of Digital Health\n\n \n\n\ne-Health 2022 (Toronto)\n\nONLINE\n\nONLINE\n\n05 \/ 01\u201302\n\n2022\n\nCanada Health Infoway (CHI); Canadian Institute for Health Information (CIHI); COACH: Canada's Health Informatics Association\n\nA national conference on eHealth and medical informatics\n\n\n\n\nEAI Healthware 2024\n\nUnknown\n\nUnknown\n\n11 \/ Unknown\n\n2024\n\nEuropean Alliance for Innovation (EAI)\n\nA triennial international conference of the \"key issues, opportunities and obstacles for personal health data research\"\n\n\n\n\nEMBC\u201922\n\nScotland\n\nGlasgow\n\n07 \/ 11\u201315\n\n2022\n\nThe IEEE Engineering in Medicine and Biology Society (IEEE EMBC)\n\nAn annual international conference of the IEEE EMBC\n\n\n\n\nEMBnet AGM 2022\n\nUnknown\n\nUnknown\n\n10 \/ Unknown\n\n2022\n\nEMBnet, The Global Bioinformatics Network\n\nAn annual conference on bioinformatics for EMBnet\n\n\n\n\nEuroIA 2022\n\nUnknown\n\nUnknown\n\n09 \/ Unknown\n\n2022\n\nEuroIA Organizing Committee\n\nAn annual European conference on information architecture and informatics\n\n\n\n\nEXPO.health 2022\n\nUnknown\n\nUnknown\n\n09 \/ Unknown\n\n2022\n\nHealthcare Scene\n\nAn annual conference \"focused on improving healthcare through technology collaboration\"\n\n\n\n\nFOIS 2023\n\nUnknown\n\nUnknown\n\n09 \/ Unknown\n\n2023\n\nThe International Association for Ontology and its Applications (IAOA)\n\nA biennial conference on formal ontology and information systems\n\n\n\n\nFuture Laboratory Informatics Forum\n\nUnknown\n\nUnknown\n\n11 \/ Unknown\n\n2022\n\nIQPC\n\nAn annual European conference on laboratory informatics\n\n\n\n\nHealth Datapalooza 2022\n\nUnited States\n\nArlington (Virginia)\n\n04 \/ 04\u201305\n\n2022\n\nAcademyHealth\n\nA conference on \"creating knowledge from data and pioneering innovations that drive health policy and practice\"\n\n\n\n\nHEALTHINF 2022\n\nAustria\n\nVienna\n\n02 \/ 09\u201311\n\n2022\n\nInstitute for Systems and Technologies of Information, Control and Communication (INSTICC)\n\nAn annual international conference on health informatics\n\n\n\n\nHIMAA 2022\n\nAustralia\n\nAdelaide (South Australia)\n\n10 \/ 26\u201328\n\n2022\n\nThe Health Information Management Association Australia (HIMAA)\n\nAn annual health informatics conference for HIMAA\n\n\n\n\nHIMSS 2022\n\nUnited States\n\nOrlando (Florida)\n\n03 \/ 14\u201318\n\n2022\n\nThe Healthcare Information Management and Systems Society (HIMSS)\n\nAn annual health informatics conference for HIMSS\n\n\n\n\nHIMSS Europe 2022\n\nFinland\n\nHelsinki\n\n06 \/ 14\u201316\n\n2022\n\nHealthcare Information Management and Systems Society (HIMSS) Europe\n\nAn annual international conference of HIMSS Europe\n\n\n\n\nHINZ 2022\n\nNew Zealand\n\nWellington\n\n03 \/ 22\u201324\n\n2022\n\nHealth Informatics New Zealand (HINZ)\n\nAn annual health informatics conference for HINZ\n\n\n\n\nHIS 2022\n\nUnknown\n\nUnknown\n\n10 \/ Unknown\n\n2022\n\nHIS (Health Information Science) Organizing Committee\n\nAn annual international conference on health informatics\n\n\n\n\nHPCS 2022\n\nUnknown\n\nUnknown\n\nUnknown\n\n2022\n\nHPCS Organizing Committee\n\nAn annual international conference on high-performance and large-scale computing systems\n\n\n\n\nICIMTH 2022\n\nONLINE\n\nONLINE\n\n07 \/ 01\u201303\n\n2022\n\nICIMTH Organizing Committee\n\nAn annual international conference on biomedical, clinical, and other types of informatics\n\n \n\n\nICMHI 2022\n\nJapan\n\nKyoto\n\n05 \/ 13\u201315\n\n2022\n\nChemical, Biological & Environmental Engineering Society\n\nAn annual international conference on technology in the medical and health sciences\n\n\n\n\nICSITech 2022\n\nUnknown\n\nUnknown\n\n11 \/ Unknown\n\n2022\n\nICSITech Organizing Committee\n\nAn annual international conference on all aspects of knowledge management\n\n\n\n\nICKM 2022\n\nGermany\n\nPotsdam\n\n03 \/ 10\u201312\n\n2022\n\nICKM Organizing Committee\n\nAn annual international conference on on scientific developments in information technology and knowledge management\n\n\n\n\nIEEE International Conference on Healthcare Informatics 2022\n\nUnited States\n\nRochester (Minnesota)\n\n06 \/ 11\u201314\n\n2022\n\nIEEE\n\nAn annual international conference on scientific developments in clinical information technology\n\n\n\n\nIFHIMA Congress 2022\n\nAustralia\n\nBrisbane (Queensland)\n\n11 \/ Unknown\n\n2022\n\nThe International Federation of Health Information Management Associations (IFHIMA) and the Canadian Health Information Management Association (CHIMA)\n\nA triennial international health information management congress for IFHIMA\n\n\n\n\nInform 2022 Waters Informatics Users Conference\n\nUnknown\n\nUnknown\n\n05 \/ Unknown\n\n2022\n\nWaters Corporation\n\nAn annual user conference of Waters' informatics products\n\n\n\n\nINFORMATIK 2022\n\nGermany\n\nHamburg\n\n09 \/ 26\u201330\n\n2022\n\nGesellschaft f\u00fcr Informatik\n\nAn annual national conference on informatics\n\n\n\n\nInformation Architecture Conference 2022\n\nUnknown\n\nUnknown\n\n04 \/ 19\u201323\n\n2022\n\nIA Institute\n\nAn annual information architecture and informatics summit\n\n\n\n\nInternational Conference on Algorithms for Computational Biology (AICoB)\n\nUnknown\n\nUnknown\n\n11 \/ Unknown\n\n2022\n\nInstitute for Research Development, Training and Advice\n\nAn annual international conference on \"research using string and graph algorithms and combinatorial optimization to deal with problems in biological sequence analysis, genome rearrangement, phylogeny reconstruction, and structure prediction\"\n\n\n\n\nInternational Conference on Biomedical and Health Informatics 2022 (ICBHI)\n\nTurkey\n\nIstanbul\n\n06 \/ 27\u201328\n\n2022\n\nInternational Federation for Medical and Biological Engineering and others\n\nAn international conference on biomedical and health informatics\n\n\n\n\nInternational Conference on Brain Informatics and Neuroinformatics 2022\n\nItaly\n\nRome\n\n11 \/ 11\u201312\n\n2022\n\nWorld Academy of Science, Engineering and Technology\n\nAn international conference that \"aims to bring together leading academic scientists, researchers and research scholars to exchange and share their experiences and research results on all aspects of brain informatics and neuroinformatics.\"\n\n\n\n\nInternational Conference on Digital Information Management (ICDIM)\n\nUnknown\n\nUnknown\n\n11 \/ Unknown\n\n2022\n\nICDIM Organizing Committee\n\nAn annual international conference on digital information management, science, and technology\n\n\n\n\nInternational Conference on Health and Medical Informatics 2022\n\nItaly\n\nVenice\n\n08 \/ 12\u201313\n\n2022\n\nWorld Academy of Science, Engineering and Technology\n\nAn annual international conference on health informatics\n\n\n\n\nInternational Conference on Informatics in Control, Automation and Robotics (ICINCO) 2022\n\nPortugal\n\nLisbon\n\n07 \/ 14\u201316\n\n2022\n\nInstitute for Systems and Technologies of Information, Control and Communication\n\nAn annual international conference on the \"application of informatics to control, automation, and robotics\"\n\n\n\n\nInternational Conference on Medical Informatics & Telemedicine\n\nUnknown\n\nUnknown\n\n07 \/ Unknown\n\n2022\n\nOMICS Group\n\nAn annual international conference on medical informatics and its applications to telemedicine\n\n\n\n\nInternational Conference on Proteomics, Genomics and Bioinformatics\n\nSingapore\n\nSingapore City\n\n08 \/ 22\u201323\n\n2022\n\nOMICS Group\n\nAn annual international conference on proteomics and bioinformatics\n\n\n\n\nISBER 2022\n\nUnited States\n\nAtlanta (Georgia)\n\n05 \/ 16\u201320\n\n2022\n\nInternational Society for Biological and Environmental Repositories (ISBER)\n\nAn annual international conference for ISBER\n\n\n\n\nISC'22\n\nGermany\n\nHamburg\n\n05 \/ 29 \u2013 06 \/ 02\n\n2022\n\nPrometeus\n\nAn annual international conference on high-performance computing\n\n\n\n\nISCB 2022\n\nUnited Kingdom\n\nNewcastle upon Tyne\n\n08 \/ 21\u201325\n\n2022\n\nInternational Society for Clinical Biostatistics (ISCB)\n\nAn annual international conference for the ISCB\n\n\n\n\nISCB Africa ASBCB 2023\n\nUnknown\n\nUnknown\n\n06 \/ Unknown\n\n2023\n\nInternational Society for Computational Biology and the African Society for Bioinformatics and Computational Biology\n\nA biennial national meeting on bioinformatics\n\n\n\n\nISMB 2022\n\nUnited States\n\nMadison (Wisconsin)\n\n07 \/ 10\u201314\n\n2022\n\nInternational Society for Computational Biology\n\nAn annual international bioinformatics and computational biology conference\n\n\n\n\nLabWare 2022 Africa Customer Education Conference\n\nUnknown\n\nUnknown\n\n09 \/ Unknown\n\n2022\n\nLabWare, Inc.\n\nAn annual LabWare customer education conference for the Africa region\n\n\n\n\nLabWare 2022 Asia Pacific Customer Education Conference\n\nUnknown\n\nUnknown\n\n08 \/ Unknown\n\n2022\n\nLabWare, Inc.\n\nAn annual LabWare customer education conference for the Asia Pacific region\n\n\n\n\nLabWare 2022 China Customer Education Conference\n\nChina\n\nUnknown\n\n09 \/ Unknown\n\n2022\n\nLabWare, Inc.\n\nAn annual LabWare customer education conference for the China region\n\n\n\n\nLabWare 2022 European Customer Education Conference\n\nCzech Republic\n\nPrague\n\n06 \/ 20\u201324\n\n2022\n\nLabWare, Inc.\n\nAn annual LabWare customer education conference for the European region\n\n\n\n\nLabWare 2022 Latin American Customer Education Conference\n\nUnknown\n\nUnknown\n\n10 \/ Unknown\n\n2022\n\nLabWare, Inc.\n\nAn annual LabWare customer education conference for the Latin American region\n\n\n\n\nLabWare 2022 North American Customer Education Conference\n\nUnited States\n\nOrlando (Florida)\n\n05 \/ 15\u201320\n\n2022\n\nLabWare, Inc.\n\nAn annual LabWare customer education conference for the North American region\n\n\n\n\nLIMS-Forum 2022\n\nGermany\n\nCologne (North Rhine-Westphalia)\n\n10 \/ 11\u201312\n\n2022\n\nInternational Quality and Productivity Center (IQPC)\n\nAn annual forum on laboratory informatics\n\n\n\n\nMedInfo 2023\n\nAustralia\n\nSydney (New South Wales)\n\n08 \/ Unknown\n\n2023\n\nInternational Medical Informatics Association\n\nA biennial international congress on medical and health informatics\n\n\n\n\nMedTech Conference, The\n\nUnited States\n\nBoston (Massachusetts)\n\n10 \/ 24\u201426\n\n2022\n\nAdvaMed\n\nAn annual conference on medical informatics and technology\n\n\n\n\nMIE 2022\n\nFrance\n\nNice\n\n05 \/ 27\u201330\n\n2022\n\nEuropean Federation for Medical Informatics (EFMI)\n\nAn annual European conference on medical informatics\n\n\n\n\nNAHDO Annual Conference\n\nUnknown\n\nUnknown\n\n09 \/ Unknown\n\n2022\n\nNational Association of Health Data Organizations (NAHDO)\n\nAn annual health informatics conference for NAHDO\n\n\n\n\nNextGen Omics Series UK\n\nUnited Kingdom\n\nLondon\n\n11 \/ Unknown\n\n2022\n\nOxford Global Conferences\n\nAn annual European congress on NGS technologies, data analysis, and clinical applications\n\n\n\n\nPaperless Lab Academy 2022\n\nItaly\n\nLake Maggiore\n\n04 \/ 26\u201327\n\n2022\n\nIndustrial Lab Automation\n\nAn annual conference on the paperless laboratory\n\n\n\n\nPathology Informatics 2022\n\nUnited States\n\nPittsburgh (Pennsylvania)\n\n05 \/ 9\u201312\n\n2022\n\nUniversity of Pittsburgh and the Association for Pathology Informatics (API)\n\nAn annual educational conference on pathology informatics\n\n\n\n\nPharmaTec Series\n\nUnited Kingdom\n\nLondon\n\n09 \/ 08\u201309\n\n2022\n\nOxford Global Conferences\n\nAn annual European congress on the role of technology on the pharmaceutical sector\n\n\n\n\nPhysician-Computer Connection Annual Symposium\n\nUnited States\n\nOjai (California)\n\n06 \/ 14\u201317\n\n2022\n\nAssociation of Medical Directors of Information Systems\n\nAn annual national symposium on physician use of healthcare information systems and technology\n\n\n\n\nPittcon\n\nUnited States\n\nAtlanta (Georgia)\n\n03 \/ 05\u201309\n\n2022\n\nThe Pittsburgh Conference on Analytical Chemistry and Applied Spectroscopy\n\nAn annual international conference and expo on laboratory science\n\n\n\n\nRDAP22\n\nONLINE\n\nONLINE\n\n03 \/ 15\u201317\n\n2022\n\nResearch Data Access & Preservation Association\n\nAn annual research data access and preservation summit\n\n\n\n\nRocky Mountain Bioinformatics Annual Conference\n\nUnited States\n\nSnowmass Village (Colorado)\n\n12 \/ Unknown\n\n2022\n\nInternational Society for Computational Biology (ISCB)\n\nAn annual conference for the ISCB\n\n\n\n\nSC22\n\nUnited States\n\nDallas (Texas)\n\n11 \/ 13\u201318\n\n2022\n\nHPC Interconnections\n\nAn annual international supercomputing conference\n\n\n\n\nSIGKDD 2022\n\nUnited Stated\n\nWashington (D.C.)\n\n08 \/ 14\u201318\n\n2022\n\nKDD 2021 Organizing Committee\n\nAn annual conference on data mining and big data\n\n\n\n\nSIIM 2022 Annual Meeting\n\nUnited States\n\nKissimmee (Florida)\n\n06 \/ 09\u201311\n\n2022\n\nSociety for Imaging Informatics in Medicine\n\nAn annual conference on imaging informatics and technology\n\n\n\n\nSLAS2022\n\nUnited States\n\nBoston (Massachusetts)\n\n02 \/ 05\u201309\n\n2022\n\nSociety for Laboratory Automation & Screening (SLAS)\n\nAn annual conference and exhibition about laboratory automation for SLAS\n\n\n\n\nSmartLab Exchange USA\n\nUnited States\n\nUnknown\n\n02 \/ Unknown\n\n2022\n\nIQPC Exchange and the International Quality and Productivity Center (IQPC)\n\nA European conference on informatics in R&D and manufacturing\n\n\n\n\nSoftware Design for Medical Devices Global Annual Summit\n\nGermany\n\nBerlin\n\n02 \/ 22\u201324\n\n2022\n\nInternational Quality and Productivity Center (IQPC)\n\nAn annual conference on software for medical device manufacturers\n\n\n\n\nState Healthcare IT Connect Summit 2022\n\nUnited States\n\nBaltimore\n\n04 \/ 18\u201320\n\n2022\n\nNational Association of State Chief Information Officers (NASCIO)\n\nAn annual summit for those managing state health IT systems\n\n\n\n\nSummer Institute in Nursing Informatics (SINI) 2022\n\nUnited States\n\nBaltimore (Maryland)\n\n07 \/ 14\u201315\n\n2022\n\nUniversity of Maryland School of Nursing\n\nAn annual national nursing informatics conference\n\n\n\nTrade shows \n\n\n\nTrade show\n\nCountry\n\nCity (State)\n\nMonth \/ Day(s)\n\nYear\n\nOrganizer\n\nDetails\n\n\nAnalitica Latin America\n\nBrazil\n\nS\u00e3o Paulo\n\n06 \/ 21\u201323\n\n2022\n\nN\u00fcrnbergMesse Brasil\n\nA biennial international exhibition for laboratory technology, analyses, biotechnology, and quality control\n\n\n\n\nanalytica\n\nGermany\n\nMunich (Bavaria)\n\n06 \/ 21\u201324\n\n2022\n\nMesse M\u00fcnchen\n\nA biennial international trade fair for laboratory technology, analysis, and biotechnology\n\n\n\n\nAnaliza\n\nIsrael\n\nTel-Aviv\n\n05 \/ 16\u201317\n\n2022\n\nSTIER\n\nA biennial international trade fair for laboratory technology, equipment, and instrumentation\n\n\n\n\nanalytica Anacon India - Hyderabad\n\nIndia\n\nHyderabad (Telangana)\n\n09 \/ 15\u201317\n\n2022\n\nMesse M\u00fcnchen\n\nA biannual international trade fair for laboratory technology, analysis, and biotechnology\n\n\n\n\nanalytica Anacon India - Mumbai\n\nIndia\n\nMumbai (Maharashtra)\n\n04 \/ 20\u201321\n\n2022\n\nMesse M\u00fcnchen\n\nAn annual international trade fair for laboratory technology, analysis, and biotechnology\n\n\n\n\nanalytica China\n\nChina\n\nShanghai\n\n11 \/ 14\u201316\n\n2022\n\nMesse M\u00fcnchen\n\nA biennial international trade fair for laboratory technology, analysis, and biotechnology\n\n\n\n\nanalytica Vietnam\n\nVietnam\n\nHo Chi Minh City\n\n05 \/ 05\u201307\n\n2022\n\nMesse M\u00fcnchen\n\nA biennial international trade fair for laboratory technology, analysis, and biotechnology\n\n\n\n\nARABLAB 2022\n\nUnited Arab Emirates\n\nDubai\n\n10 \/ 24\u201326\n\n2022\n\nThe ARABLAB Group, Scientific International Exhibitions Ltd.\n\nAn annual international laboratory and instrumentation tech trade fair\n\n\n\n\nBelarus Medica 2022\n\nBelarus\n\nMinsk\n\n04 \/ 19\u201322\n\n2022\n\nTechnics And Communications Jsc\n\nA medical exhibition featuring all major branches of medicine\n\n\n\n\nCISILE 2022\n\nChina\n\nBeijing\n\n05 \/ 11\u201313\n\n2022\n\nChina Instrument Manufacturers Association\n\nAn annual international scientific instrument and laboratory equipment exhibition\n\n\n\n\nClinical Lab Expo 2022\n\nUnited States\n\nChicago (Illinois)\n\n07 \/ 24\u201328\n\n2022\n\nAACC\n\nAn annual exhibition of clinical laboratory products and services\n\n\n\n\nDMEA 2022\n\nGermany\n\nBerlin (Berlin)\n\n04 \/ 26\u201328\n\n2022\n\nMesse Berlin\n\nAn annual European exhibition on healthcare IT (formerly Connecting Healthcare IT)\n\n\n\n\nExpomed Eurasia 2022\n\nTurkey\n\nIstanbul\n\n03 \/ 17\u201319\n\n2022\n\nReed T\u00fcyap Exhibitions Inc.\n\nAn annual international trade fair for the healthcare industry (formerly LabtechMED Eurasia)\n\n\n\n\nForensics Europe Expo 2022\n\nEngland\n\nLondon\n\n06 \/ 08\u201309\n\n2022\n\nClarion Defence and Security Limited\n\nAn annual trade fair and conference for anything related to forensic science\n\n\n\n\nForum LABO Lyon 2022\n\nFrance\n\nLyon\n\n09 \/ 19\u201320\n\n2022\n\nComit\u00e9 Interprofessionnel des Fournisseurs du Laboratoire (CIFL)\n\nA biennial European exhibition focused on laboratory professionals from multiple sectors\n\n\n\n\nForum LABO Paris 2023\n\nFrance\n\nParis\n\n03 \/ 28\u201330\n\n2023\n\nComit\u00e9 Interprofessionnel des Fournisseurs du Laboratoire (CIFL)\n\nA biennial European exhibition focused on laboratory professionals from multiple sectors\n\n\n\n\nHospital Expo - Indonesia 2022\n\nIndonesia\n\nJakarta\n\n01 \/ 26\u201329\n\n2022\n\nPT. Okta Sejahtera Insani\n\nAn annual international exhibition on hospital, medical, clinical, and pharmaceutical equipment and technologies\n\n\n\n\nHospital Expo - Medan 2022\n\nIndonesia\n\nMedan\n\nUnknown\n\n2022\n\nPT. Okta Sejahtera Insani\n\nAn annual international exhibition on hospital, medical, clinical, and pharmaceutical equipment and technologies\n\n\n\n\nHospital Expo - Surabaya 2022\n\nIndonesia\n\nSurabaya\n\nUnknown\n\n2022\n\nPT. Okta Sejahtera Insani\n\nAn annual international exhibition on hospital, medical, clinical, and pharmaceutical equipment and technologies\n\n\n\n\nILMAC Basel 2023\n\nSwitzerland\n\nBasel\n\n09 \/ 26\u201328\n\n2023\n\nMCH Group AG\n\nA biennial trade fair for process and laboratory technology\n\n\n\n\nILMAC Luasanne 2022\n\nSwitzerland\n\nLuasanne\n\n09 \/ 28\u201329\n\n2022\n\nMCH Group AG\n\nA biennial trade fair for process and laboratory technology\n\n\n\n\nIndia Lab Expo 2022 - Hyderabad\n\nIndia\n\nHyderabad (Telangana)\n\n09 \/ 15\u201317\n\n2022\n\nMesse M\u00fcnchen\n\nAn annual trade show on laboratory and bioinformatics\n\n\n\n\nIndia Lab Expo 2022 - Mumbai\n\nIndia\n\nMumbai (Maharashtra)\n\n04 \/ 20\u201321\n\n2022\n\nMesse M\u00fcnchen\n\nAn annual trade show on laboratory and bioinformatics\n\n\n\n\nInfosecurity Europe 2022\n\nEngland\n\nLondon\n\n06 \/ 21\u201323\n\n2022\n\nReed Exhibitions Limited\n\nAn annual European information security exhibition\n\n\n\n\nInterlab Africa 2022\n\nAlgeria\n\nAlger\n\n12 \/ Unknown\n\n2022\n\nATEX International Exhibitions\n\nAn annual African exhibition for laboratory technology\n\n\n\n\nINTERPHEX 2022\n\nUnited States\n\nNew York City (New York)\n\n05 \/ 24\u201326\n\n2022\n\nReed Exhibitions\n\nAn annual pharmaceutical and biopharmaceutical trade show\n\n\n\n\nJASIS 2022\n\nJapan\n\nChiba\n\n11 \/ Unknown\n\n2022\n\nJapan Analytical Instruments Manufacturers' Association\n\nAn annual national trade show on analytical and scientific systems and solutions\n\n\n\n\nKorea Lab 2022\n\nSouth Korea\n\nSeoul\n\n06 \/ 14\u201317\n\n2022\n\nKyungyon Exhibition Corp.\n\nAn annual national trade show on laboratory and biotechnology\n\n\n\n\n\nLab Indonesia 2022\n\nIndonesia\n\nJakarta\n\n10 \/ 07\u201309\n\n2022\n\nInforma PLC\n\nAn annual national trade fair for the laboratory sector\n\n\n\n\nLab Innovations 2022\n\nUnited Kingdom\n\nBirmingham\n\n11 \/ 02\u201303\n\n2022\n\nEasyFairs UK Ltd.\n\nAn annual European trade fair for the laboratory sector\n\n\n\n\nLAB-SUPPLY 2022 Regional Fair - Berlin\n\nGermany\n\nBerlin (Berlin)\n\n05 \/ 17\n\n2022\n\nVogel Communications Group GmbH & Co. KG\n\nAn annual regional trade fair for instrumental analytics, laboratory technology, laboratory chemicals, and biotechnology\n\n\n\n\nLAB-SUPPLY 2022 Regional Fair - Dresden\n\nGermany\n\nDresden (Saxony)\n\n09 \/ 21\n\n2022\n\nVogel Communications Group GmbH & Co. KG\n\nAn annual regional trade fair for instrumental analytics, laboratory technology, laboratory chemicals, and biotechnology\n\n\n\n\nLAB-SUPPLY 2022 Regional Fair - Hamburg\n\nGermany\n\nHamburg (Hamburg)\n\n08 \/ 17\n\n2022\n\nVogel Communications Group GmbH & Co. KG\n\nAn annual regional trade fair for instrumental analytics, laboratory technology, laboratory chemicals, and biotechnology\n\n \n\n\nLAB-SUPPLY 2023 Regional Fair - Hannover\n\nGermany\n\nHannover (Lower Saxony)\n\n09 \/ 06\n\n2023\n\nVogel Communications Group GmbH & Co. KG\n\nAn annual regional trade fair for instrumental analytics, laboratory technology, laboratory chemicals, and biotechnology\n\n\n\n\nLAB-SUPPLY 2022 Regional Fair - Main in Frankfurt\n\nGermany\n\nFrankfurt (Hesse)\n\n03 \/ 09\n\n2022\n\nVogel Communications Group GmbH & Co. KG\n\nAn annual regional trade fair for instrumental analytics, laboratory technology, laboratory chemicals, and biotechnology\n\n\n\n\nLAB-SUPPLY 2022 Regional Fair - M\u00fcnster\n\nGermany\n\nM\u00fcnster (North Rhine-Westphalia)\n\n11 \/ 09\n\n2022\n\nVogel Communications Group GmbH & Co. KG\n\nAn annual regional trade fair for instrumental analytics, laboratory technology, laboratory chemicals, and biotechnology\n\n\n\nLAB-SUPPLY 2022 Regional Fair - Sindelfingen\n\nGermany\n\nSindelfingen (Baden-W\u00fcrttemberg)\n\n10 \/ 19\n\n2022\n\nVogel Communications Group GmbH & Co. KG\n\nAn annual regional trade fair for instrumental analytics, laboratory technology, laboratory chemicals, and biotechnology\n\n\n\n\nLAB-SUPPLY 2022 Regional Fair - Wien\n\nAustria\n\nVienna\n\n04 \/ 27\n\n2022\n\nVogel Communications Group GmbH & Co. KG\n\nAn annual regional trade fair for instrumental analytics, laboratory technology, laboratory chemicals, and biotechnology\n\n\n\n\nLabAsia 2023\n\nMalaysia\n\nKuala Lampur\n\n10 \/ 10\u201312\n\n2023\n\nInforma PLC\n\nA biennial regional trade fair and conference for the laboratory sector\n\n\n\n\nLabComplEX 2022\n\nUkraine\n\nKyiv\n\n09 \/ 27\u201329\n\n2022\n\nExpoForum, LLC\n\nAn annual national trade show on laboratory and biotechnology\n\n \n\n\nLaborama 2022\n\nBelgium\n\nBruxelles\n\n03 \/ 17\u201318\n\n2022\n\nLaborama vzw-asbl\n\nAn annual European trade fair for the laboratory sector\n\n\n\n\nLABVOLUTION 2023\n\nGermany\n\nHannover (Lower Saxony)\n\n05 \/ 09\u201311\n\n2023\n\nDeutsche Messe\n\nA biennial international trade fair for the biotechnology, life sciences, and laboratory tech communities\n\n\n\n\nMEDIDENT 2022\n\nSerbia\n\nBelgrade\n\n10 \/ Unknown\n\n2022\n\nBelgrade Fair\n\nAn annual international exhibition of medical, laboratory, pharmaceutical, dental, and veterinary equipment, instruments, and services\n\n\n\n\nMEDLAB Asia Pacific 2022\n\nThailand\n\nBangkok\n\n10 \/ 19\u201321\n\n2022\n\nInforma Life Sciences Exhibitions\n\nAn annual international laboratory exhibition and congress\n\n\n\n\nPhilippines Lab Expo 2022\n\nPhilippines\n\nManila\n\n08 \/ 24\u201326\n\n2022\n\nFireworks Exhibitions and Conferences\n\nAn annual national laboratory exhibition\n\n\nRommedica 2022\n\nRomania\n\nBucharest\n\nUnknown\n\n2022\n\nROMEXPO\n\nAn annual international trade fair for medical instruments and equipment\n\n\n\n\nSri Lanka Lab Expo 2022\n\nSri Lanka\n\nColombo\n\nUnknown\n\n2022\n\nS D Promo Media Pvt. Ltd.\n\nAn annual national trade fair for laboratory and biotechnology\n\n\n\n\nThailand Lab International 2022\n\nThailand\n\nBangkok\n\n09 \/ 14\u201316\n\n2022\n\nVNU Exhibitions Asia Pacific Co., Ltd.\n\nAn annual international trade fair for analytical laboratory equipment & technology, biotechnology & life sciences, and chemicals & safety\n\n\n\n\nTbilisi Health Forum 2022\n\nGeorgia\n\nTbilisi\n\n11 \/ Unknown\n\n2022\n\nExpoGeorgia Co\n\nAn annual international trade fair for medical technology, laboratory equipment, dentistry, pharmaceuticals, optics, and hospital equipment (formerly Caucasus Healthcare)\n\n\n\n\nWorld of Technology & Science 2022\n\nThe Netherlands\n\nUtrecht\n\n09 \/ 27\u201330\n\n2022\n\nFHI Federation of Technology Branches\n\nA biennial international trade fair for industrial electronics, industrial automation, and laboratory technology\n\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Conferences_and_trade_shows\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Conferences_and_trade_shows<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:15.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 43 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","2574a22b8ca0940242424fa5279a406b_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Resources_for_selecting_and_implementing_informatics_solutions_Part_3_Industry_and_community_resources_Conferences_and_trade_shows rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Resources_for_selecting_and_implementing_informatics_solutions_Part_3_Industry_and_community_resources_Conferences_and_trade_shows 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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 3: Industry and community resources\/Conferences and trade shows<\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">the beginning<\/a> of this guide-----<\/div>\n<h3><span class=\"mw-headline\" id=\"5.2_Conferences_and_trade_shows\">5.2 Conferences and trade shows<\/span><\/h3>\n<p>If you wish to first sort by one column, and then another column (e.g., first by year, and then by date), simply left-click the desired arrow for the first column to sort by, and then hold the <i>Shift<\/i> key and left-click the desired arrow for the second column to sort by.\n<\/p><p><b>Note<\/b>: These listings are updated three times a year, typically at the beginning of January, May, and September.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"Conferences\">Conferences<\/span><\/h4>\n<div style=\"text-align: left;\">\n<table class=\"sortable\" id=\"rdp-ebb-HigherEd\" border=\"1\" cellpadding=\"5\" cellspacing=\"0\" align=\"center\" style=\"width: 75%;\">\n<tbody><tr>\n<th>Conference\n<\/th>\n<th>Country\n<\/th>\n<th>City (State)\n<\/th>\n<th>Month \/ Day(s)\n<\/th>\n<th>Year\n<\/th>\n<th>Organizer\n<\/th>\n<th>Details\n<\/th><\/tr>\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/acm-bcb.org\/\" target=\"_blank\">ACM-BCB 2022<\/a>\n<\/td>\n<td>Unknown\n<\/td>\n<td>Unknown\n<\/td>\n<td>08 \/ Unknown\n<\/td>\n<td>2022\n<\/td>\n<td>Association for Computing Machinery (ACM)\n<\/td>\n<td>An annual conference on bioinformatics, computational biology, and health informatics\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.sigcomm.org\/events\/sigcomm-conference\" target=\"_blank\">ACM SIGCOMM 2022<\/a>\n<\/td>\n<td>Netherlands\n<\/td>\n<td>Amsterdam\n<\/td>\n<td>08 \/ 22\u201326\n<\/td>\n<td>2022\n<\/td>\n<td>Association for Computing Machinery's (ACM's) Special Interest Group on Data Communication (SIGCOMM)\n<\/td>\n<td>An annual international meeting of the ACM SIGCOMM on the topic of computer and data communication networks and their \"architecture, design, implementation, operations, analysis, measurement, and simulation\" (<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.sigcomm.org\/events\/sigcomm-conference\" target=\"_blank\">alternate URL)<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/aimedicine.info\/aime\/index.php\/aime-conferences\" target=\"_blank\">AIME 2022<\/a>\n<\/td>\n<td>Unknown\n<\/td>\n<td>Unknown\n<\/td>\n<td>06 \/ Unknown\n<\/td>\n<td>2022\n<\/td>\n<td>European Society for Artificial Intelligence in Medicine (AIME)\n<\/td>\n<td>A biennial international conference on AI techniques in medical research and care for AIME\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/amia.org\/education-events\/annual-symposium\" target=\"_blank\">AMIA 2022 Annual Symposium<\/a>\n<\/td>\n<td>Unknown\n<\/td>\n<td>Unknown\n<\/td>\n<td>10 \/ Unknown\n<\/td>\n<td>2022\n<\/td>\n<td>American Medical Informatics Association (AMIA)\n<\/td>\n<td>An annual biomedical and informatics symposium for the AMIA\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.amia.org\/summit2022\" target=\"_blank\">AMIA Clinical Informatics Conference 2022<\/a>\n<\/td>\n<td>United States\n<\/td>\n<td>Houston (Texas)\n<\/td>\n<td>05 \/ 24\u201326\n<\/td>\n<td>2022\n<\/td>\n<td>American Medical Informatics Association (AMIA)\n<\/td>\n<td>Annual summit on bioinformatics, translational research, and other aspects of data science\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ania.org\/annual-conference\" target=\"_blank\">ANIA 2022 Conference<\/a>\n<\/td>\n<td>United States\n<\/td>\n<td>Hollywood (Florida)\n<\/td>\n<td>04 \/ 27\u201329\n<\/td>\n<td>2022\n<\/td>\n<td>American Nursing Informatics Association (ANIA)\n<\/td>\n<td>An annual informatics conference for the ANIA\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/conferences\/annualmeeting\/Pages\/default.aspx\" target=\"_blank\">APHL 2022<\/a>\n<\/td>\n<td>United States\n<\/td>\n<td>Cleveland (Ohio)\n<\/td>\n<td>05 \/ 17\u201320\n<\/td>\n<td>2022\n<\/td>\n<td>Association of Public Health Laboratories (APHL)\n<\/td>\n<td>An annual public health conference for the APHL\n<\/td><\/tr>\n \n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/coursesandconferences.wellcomeconnectingscience.org\/event\/applied-bioinformatics-and-public-health-microbiology-virtual-conference-20210505\/\" target=\"_blank\">Applied Bioinformatics and Public Health Microbiology<\/a>\n<\/td>\n<td>Unknown\n<\/td>\n<td>Unknown\n<\/td>\n<td>05 \/ Unknown\n<\/td>\n<td>2022\n<\/td>\n<td>Wellcome Genome Campus\n<\/td>\n<td>An annual conference \"focusing on the implications of data-driven genomics approaches in public health settings\"\n<\/td><\/tr>\n \n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ascld.org\/ascld-annual-symposium\/\" target=\"_blank\">ASCLD 2022 Symposium<\/a>\n<\/td>\n<td>United States\n<\/td>\n<td>Reno (Nevada)\n<\/td>\n<td>04 \/ 24\u201328\n<\/td>\n<td>2022\n<\/td>\n<td>American Society of Crime Laboratory Directors (ASCLD)\n<\/td>\n<td>An annual symposium concerning \"the day-to-day operation of a crime laboratory\" for the ASCLD\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.asist.org\/am22\/\" target=\"_blank\">ASIS&T 2022 Annual Meeting<\/a>\n<\/td>\n<td>United States\n<\/td>\n<td>Pittsburgh (Pennsylvania)\n<\/td>\n<td>10 \/ 29 \u2013 11 \/ 01\n<\/td>\n<td>2022\n<\/td>\n<td>Association for Information Science and Technology (ASIS&T)\n<\/td>\n<td>An annual information science and technology conference for the ASIS&T\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.bio-itworldexpo.com\/\" target=\"_blank\">Bio-IT World Conference and Expo 2022<\/a>\n<\/td>\n<td>United States\n<\/td>\n<td>Boston (Massachusetts)\n<\/td>\n<td>05 \/ 03\u201305\n<\/td>\n<td>2022\n<\/td>\n<td>Cambridge Healthtech Institute\n<\/td>\n<td>An annual medical and biomedical informatics conference and exhibition\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.biostec.org\/\" target=\"_blank\">BIOSTEC 2022<\/a>\n<\/td>\n<td>Austria\n<\/td>\n<td>Vienna\n<\/td>\n<td>02 \/ 03\u201311\n<\/td>\n<td>2022\n<\/td>\n<td>Institute for Systems and Technologies of Information, Control and Communication\n<\/td>\n<td>An annual multi-conference on \"theoretical advances and applications of information systems, artificial intelligence, signal processing, electronics and other engineering tools in knowledge areas related to biology and medicine\"\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iaria.org\/conferences.html\" target=\"_blank\">BIOTECHNO 2022<\/a>\n<\/td>\n<td>Italy\n<\/td>\n<td>Venice\n<\/td>\n<td>05 \/ 22\u201326\n<\/td>\n<td>2022\n<\/td>\n<td>International Academy, Research and Industry Association (IARIA)\n<\/td>\n<td>An international conference on bioinformatics, biocomputational systems, and biotechnologies\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.c3dis.com\/\" target=\"_blank\">C3DIS 2022<\/a>\n<\/td>\n<td>Unknown\n<\/td>\n<td>Unknown\n<\/td>\n<td>07 \/ Unknown\n<\/td>\n<td>2022\n<\/td>\n<td>Conference Design Pty. Ltd.\n<\/td>\n<td>An Australasian conference on \"the production of breakthrough science outcomes that require large scale, complex computations and analyses to be carried out over massive data sets\"\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/events.tuni.fi\/cinc2022\/\" target=\"_blank\">Computing in Cardiology<\/a>\n<\/td>\n<td>Finland\n<\/td>\n<td>Tampere\n<\/td>\n<td>09 \/ 04\u201307\n<\/td>\n<td>2022\n<\/td>\n<td>Computers in Cardiology, Inc.\n<\/td>\n<td>An international conference on computing in clinical cardiology and cardiovascular physiology\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cshi2021.sciencesconf.org\/\" target=\"_blank\">Context Sensitive Health Informatics (CSHI) 2023<\/a>\n<\/td>\n<td>Unknown\n<\/td>\n<td>Unknown\n<\/td>\n<td>11 \/ Unknown\n<\/td>\n<td>2023\n<\/td>\n<td>European Federation for Medical Informatics\n<\/td>\n<td>A biennial international conference on health information technologies and their environments\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/events.holyrood.com\/event\/digital-health-care-2022\/\" target=\"_blank\">Digital Health & Care Scotland 2022<\/a>\n<\/td>\n<td>Scotland\n<\/td>\n<td>Edinburgh\n<\/td>\n<td>02 \/ 22\u201323\n<\/td>\n<td>2022\n<\/td>\n<td>Holyrood Connect\n<\/td>\n<td>An annual national conference for sharing digital health successes and lessons learned\n<\/td><\/tr>\n \n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/digitalhealth.org.au\/institute-summit\/\" target=\"_blank\">Digital Health Institute Summit 2022<\/a>\n<\/td>\n<td>Australia\n<\/td>\n<td>Melbourne (Victoria)\n<\/td>\n<td>02 \/ 21\u201322\n<\/td>\n<td>2022\n<\/td>\n<td>Australasian Institute of Digital Health (AIDH)\n<\/td>\n<td>A national conference for the Australasian Institute of Digital Health\n<\/td><\/tr>\n \n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.e-healthconference.com\/\" target=\"_blank\">e-Health 2022 (Toronto)<\/a>\n<\/td>\n<td>ONLINE\n<\/td>\n<td>ONLINE\n<\/td>\n<td>05 \/ 01\u201302\n<\/td>\n<td>2022\n<\/td>\n<td>Canada Health Infoway (CHI); Canadian Institute for Health Information (CIHI); COACH: Canada's Health Informatics Association\n<\/td>\n<td>A national conference on eHealth and medical informatics\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/healthwear-conference.org\/\" target=\"_blank\">EAI Healthware 2024<\/a>\n<\/td>\n<td>Unknown\n<\/td>\n<td>Unknown\n<\/td>\n<td>11 \/ Unknown\n<\/td>\n<td>2024\n<\/td>\n<td>European Alliance for Innovation (EAI)\n<\/td>\n<td>A triennial international conference of the \"key issues, opportunities and obstacles for personal health data research\"\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/embc.embs.org\/2022\/\" target=\"_blank\">EMBC\u201922<\/a>\n<\/td>\n<td>Scotland\n<\/td>\n<td>Glasgow\n<\/td>\n<td>07 \/ 11\u201315\n<\/td>\n<td>2022\n<\/td>\n<td>The IEEE Engineering in Medicine and Biology Society (IEEE EMBC)\n<\/td>\n<td>An annual international conference of the IEEE EMBC\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.embnet.eu\/\" target=\"_blank\">EMBnet AGM 2022<\/a>\n<\/td>\n<td>Unknown\n<\/td>\n<td>Unknown\n<\/td>\n<td>10 \/ Unknown\n<\/td>\n<td>2022\n<\/td>\n<td>EMBnet, The Global Bioinformatics Network\n<\/td>\n<td>An annual conference on bioinformatics for EMBnet\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.euroia.eu\/\" target=\"_blank\">EuroIA 2022<\/a>\n<\/td>\n<td>Unknown\n<\/td>\n<td>Unknown\n<\/td>\n<td>09 \/ Unknown\n<\/td>\n<td>2022\n<\/td>\n<td>EuroIA Organizing Committee\n<\/td>\n<td>An annual European conference on information architecture and informatics\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.expo.health\/\" target=\"_blank\">EXPO.health 2022<\/a>\n<\/td>\n<td>Unknown\n<\/td>\n<td>Unknown\n<\/td>\n<td>09 \/ Unknown\n<\/td>\n<td>2022\n<\/td>\n<td>Healthcare Scene\n<\/td>\n<td>An annual conference \"focused on improving healthcare through technology collaboration\"\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/fois2020.inf.unibz.it\/\" target=\"_blank\">FOIS 2023<\/a>\n<\/td>\n<td>Unknown\n<\/td>\n<td>Unknown\n<\/td>\n<td>09 \/ Unknown\n<\/td>\n<td>2023\n<\/td>\n<td>The International Association for Ontology and its Applications (IAOA)\n<\/td>\n<td>A biennial conference on formal ontology and information systems\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pharma-iq.com\/events-pharma-live-future-lab-informatics\" target=\"_blank\">Future Laboratory Informatics Forum<\/a>\n<\/td>\n<td>Unknown\n<\/td>\n<td>Unknown\n<\/td>\n<td>11 \/ Unknown\n<\/td>\n<td>2022\n<\/td>\n<td>IQPC\n<\/td>\n<td>An annual European conference on laboratory informatics\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/academyhealth.org\/events\/site\/2022-health-datapalooza-and-national-health-policy-conference\" target=\"_blank\">Health Datapalooza 2022<\/a>\n<\/td>\n<td>United States\n<\/td>\n<td>Arlington (Virginia)\n<\/td>\n<td>04 \/ 04\u201305\n<\/td>\n<td>2022\n<\/td>\n<td>AcademyHealth\n<\/td>\n<td>A conference on \"creating knowledge from data and pioneering innovations that drive health policy and practice\"\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.healthinf.biostec.org\/\" target=\"_blank\">HEALTHINF 2022<\/a>\n<\/td>\n<td>Austria\n<\/td>\n<td>Vienna\n<\/td>\n<td>02 \/ 09\u201311\n<\/td>\n<td>2022\n<\/td>\n<td>Institute for Systems and Technologies of Information, Control and Communication (INSTICC)\n<\/td>\n<td>An annual international conference on health informatics\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/himaa.org.au\/annual-national-conference\/\" target=\"_blank\">HIMAA 2022<\/a>\n<\/td>\n<td>Australia\n<\/td>\n<td>Adelaide (South Australia)\n<\/td>\n<td>10 \/ 26\u201328\n<\/td>\n<td>2022\n<\/td>\n<td>The Health Information Management Association Australia (HIMAA)\n<\/td>\n<td>An annual health informatics conference for HIMAA\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.himssconference.org\/\" target=\"_blank\">HIMSS 2022<\/a>\n<\/td>\n<td>United States\n<\/td>\n<td>Orlando (Florida)\n<\/td>\n<td>03 \/ 14\u201318\n<\/td>\n<td>2022\n<\/td>\n<td>The Healthcare Information Management and Systems Society (HIMSS)\n<\/td>\n<td>An annual health informatics conference for HIMSS\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.himss.org\/event-himss-europe-digital\" target=\"_blank\">HIMSS Europe 2022<\/a>\n<\/td>\n<td>Finland\n<\/td>\n<td>Helsinki\n<\/td>\n<td>06 \/ 14\u201316\n<\/td>\n<td>2022\n<\/td>\n<td>Healthcare Information Management and Systems Society (HIMSS) Europe\n<\/td>\n<td>An annual international conference of HIMSS Europe\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.hinz.org.nz\/page\/homeDHM22\" target=\"_blank\">HINZ 2022<\/a>\n<\/td>\n<td>New Zealand\n<\/td>\n<td>Wellington\n<\/td>\n<td>03 \/ 22\u201324\n<\/td>\n<td>2022\n<\/td>\n<td>Health Informatics New Zealand (HINZ)\n<\/td>\n<td>An annual health informatics conference for HINZ\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.his-conferences.org\/\" target=\"_blank\">HIS 2022<\/a>\n<\/td>\n<td>Unknown\n<\/td>\n<td>Unknown\n<\/td>\n<td>10 \/ Unknown\n<\/td>\n<td>2022\n<\/td>\n<td>HIS (Health Information Science) Organizing Committee\n<\/td>\n<td>An annual international conference on health informatics\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/hpcs2021.cisedu.info\/\" target=\"_blank\">HPCS 2022<\/a>\n<\/td>\n<td>Unknown\n<\/td>\n<td>Unknown\n<\/td>\n<td>Unknown\n<\/td>\n<td>2022\n<\/td>\n<td>HPCS Organizing Committee\n<\/td>\n<td>An annual international conference on high-performance and large-scale computing systems\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.icimth.com\/\" target=\"_blank\">ICIMTH 2022<\/a>\n<\/td>\n<td>ONLINE\n<\/td>\n<td>ONLINE\n<\/td>\n<td>07 \/ 01\u201303\n<\/td>\n<td>2022\n<\/td>\n<td>ICIMTH Organizing Committee\n<\/td>\n<td>An annual international conference on biomedical, clinical, and other types of informatics\n<\/td><\/tr>\n \n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.icmhi.org\/\" target=\"_blank\">ICMHI 2022<\/a>\n<\/td>\n<td>Japan\n<\/td>\n<td>Kyoto\n<\/td>\n<td>05 \/ 13\u201315\n<\/td>\n<td>2022\n<\/td>\n<td>Chemical, Biological & Environmental Engineering Society\n<\/td>\n<td>An annual international conference on technology in the medical and health sciences\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/icsitech.org\/2021\/\" target=\"_blank\">ICSITech 2022<\/a>\n<\/td>\n<td>Unknown\n<\/td>\n<td>Unknown\n<\/td>\n<td>11 \/ Unknown\n<\/td>\n<td>2022\n<\/td>\n<td>ICSITech Organizing Committee\n<\/td>\n<td>An annual international conference on all aspects of knowledge management\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ickm.net\/\" target=\"_blank\">ICKM 2022<\/a>\n<\/td>\n<td>Germany\n<\/td>\n<td>Potsdam\n<\/td>\n<td>03 \/ 10\u201312\n<\/td>\n<td>2022\n<\/td>\n<td>ICKM Organizing Committee\n<\/td>\n<td>An annual international conference on on scientific developments in information technology and knowledge management\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ohnlp.github.io\/IEEEICHI2022\/\" target=\"_blank\">IEEE International Conference on Healthcare Informatics 2022<\/a>\n<\/td>\n<td>United States\n<\/td>\n<td>Rochester (Minnesota)\n<\/td>\n<td>06 \/ 11\u201314\n<\/td>\n<td>2022\n<\/td>\n<td>IEEE\n<\/td>\n<td>An annual international conference on scientific developments in clinical information technology\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/ifhima.org\/ifhima-congress\/\" target=\"_blank\">IFHIMA Congress 2022<\/a>\n<\/td>\n<td>Australia\n<\/td>\n<td>Brisbane (Queensland)\n<\/td>\n<td>11 \/ Unknown\n<\/td>\n<td>2022\n<\/td>\n<td>The International Federation of Health Information Management Associations (IFHIMA) and the Canadian Health Information Management Association (CHIMA)\n<\/td>\n<td>A triennial international health information management congress for IFHIMA\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/wvmc.waters.com\/inform\/\" target=\"_blank\">Inform 2022 Waters Informatics Users Conference<\/a>\n<\/td>\n<td>Unknown\n<\/td>\n<td>Unknown\n<\/td>\n<td>05 \/ Unknown\n<\/td>\n<td>2022\n<\/td>\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>An annual user conference of Waters' informatics products\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/informatik2022.gi.de\" target=\"_blank\">INFORMATIK 2022<\/a>\n<\/td>\n<td>Germany\n<\/td>\n<td>Hamburg\n<\/td>\n<td>09 \/ 26\u201330\n<\/td>\n<td>2022\n<\/td>\n<td>Gesellschaft f\u00fcr Informatik\n<\/td>\n<td>An annual national conference on informatics\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.theiaconference.com\/\" target=\"_blank\">Information Architecture Conference 2022<\/a>\n<\/td>\n<td>Unknown\n<\/td>\n<td>Unknown\n<\/td>\n<td>04 \/ 19\u201323\n<\/td>\n<td>2022\n<\/td>\n<td>IA Institute\n<\/td>\n<td>An annual information architecture and informatics summit\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/irdta.eu\/events\/\" target=\"_blank\">International Conference on Algorithms for Computational Biology (AICoB)<\/a>\n<\/td>\n<td>Unknown\n<\/td>\n<td>Unknown\n<\/td>\n<td>11 \/ Unknown\n<\/td>\n<td>2022\n<\/td>\n<td>Institute for Research Development, Training and Advice\n<\/td>\n<td>An annual international conference on \"research using string and graph algorithms and combinatorial optimization to deal with problems in biological sequence analysis, genome rearrangement, phylogeny reconstruction, and structure prediction\"\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/waset.org\/health-and-biomedical-informatics-conference-in-june-2022-in-istanbul\" target=\"_blank\">International Conference on Biomedical and Health Informatics 2022 (ICBHI)<\/a>\n<\/td>\n<td>Turkey\n<\/td>\n<td>Istanbul\n<\/td>\n<td>06 \/ 27\u201328\n<\/td>\n<td>2022\n<\/td>\n<td>International Federation for Medical and Biological Engineering and others\n<\/td>\n<td>An international conference on biomedical and health informatics\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/waset.org\/brain-informatics-and-neuroinformatics-conference-in-november-2022-in-rome\" target=\"_blank\">International Conference on Brain Informatics and Neuroinformatics 2022<\/a>\n<\/td>\n<td>Italy\n<\/td>\n<td>Rome\n<\/td>\n<td>11 \/ 11\u201312\n<\/td>\n<td>2022\n<\/td>\n<td>World Academy of Science, Engineering and Technology\n<\/td>\n<td>An international conference that \"aims to bring together leading academic scientists, researchers and research scholars to exchange and share their experiences and research results on all aspects of brain informatics and neuroinformatics.\"\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.icdim.org\/\" target=\"_blank\">International Conference on Digital Information Management (ICDIM)<\/a>\n<\/td>\n<td>Unknown\n<\/td>\n<td>Unknown\n<\/td>\n<td>11 \/ Unknown\n<\/td>\n<td>2022\n<\/td>\n<td>ICDIM Organizing Committee\n<\/td>\n<td>An annual international conference on digital information management, science, and technology\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/waset.org\/health-and-medical-informatics-conference-in-august-2022-in-venice\" target=\"_blank\">International Conference on Health and Medical Informatics 2022<\/a>\n<\/td>\n<td>Italy\n<\/td>\n<td>Venice\n<\/td>\n<td>08 \/ 12\u201313\n<\/td>\n<td>2022\n<\/td>\n<td>World Academy of Science, Engineering and Technology\n<\/td>\n<td>An annual international conference on health informatics\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.icinco.org\/\" target=\"_blank\">International Conference on Informatics in Control, Automation and Robotics (ICINCO) 2022<\/a>\n<\/td>\n<td>Portugal\n<\/td>\n<td>Lisbon\n<\/td>\n<td>07 \/ 14\u201316\n<\/td>\n<td>2022\n<\/td>\n<td>Institute for Systems and Technologies of Information, Control and Communication\n<\/td>\n<td>An annual international conference on the \"application of informatics to control, automation, and robotics\"\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/medicalinformatics.healthconferences.org\/\" target=\"_blank\">International Conference on Medical Informatics & Telemedicine<\/a>\n<\/td>\n<td>Unknown\n<\/td>\n<td>Unknown\n<\/td>\n<td>07 \/ Unknown\n<\/td>\n<td>2022\n<\/td>\n<td>OMICS Group\n<\/td>\n<td>An annual international conference on medical informatics and its applications to telemedicine\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/proteomics.metabolomicsconference.com\/\" target=\"_blank\">International Conference on Proteomics, Genomics and Bioinformatics<\/a>\n<\/td>\n<td>Singapore\n<\/td>\n<td>Singapore City\n<\/td>\n<td>08 \/ 22\u201323\n<\/td>\n<td>2022\n<\/td>\n<td>OMICS Group\n<\/td>\n<td>An annual international conference on proteomics and bioinformatics\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.isber.org\/page\/events\" target=\"_blank\">ISBER 2022<\/a>\n<\/td>\n<td>United States\n<\/td>\n<td>Atlanta (Georgia)\n<\/td>\n<td>05 \/ 16\u201320\n<\/td>\n<td>2022\n<\/td>\n<td>International Society for Biological and Environmental Repositories (ISBER)\n<\/td>\n<td>An annual international conference for ISBER\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.isc-hpc.com\/\" target=\"_blank\">ISC'22<\/a>\n<\/td>\n<td>Germany\n<\/td>\n<td>Hamburg\n<\/td>\n<td>05 \/ 29 \u2013 06 \/ 02\n<\/td>\n<td>2022\n<\/td>\n<td>Prometeus\n<\/td>\n<td>An annual international conference on high-performance computing\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iscb2022.info\" target=\"_blank\">ISCB 2022<\/a>\n<\/td>\n<td>United Kingdom\n<\/td>\n<td>Newcastle upon Tyne\n<\/td>\n<td>08 \/ 21\u201325\n<\/td>\n<td>2022\n<\/td>\n<td>International Society for Clinical Biostatistics (ISCB)\n<\/td>\n<td>An annual international conference for the ISCB\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iscb.org\/iscbafrica2021\" target=\"_blank\">ISCB Africa ASBCB 2023<\/a>\n<\/td>\n<td>Unknown\n<\/td>\n<td>Unknown\n<\/td>\n<td>06 \/ Unknown\n<\/td>\n<td>2023\n<\/td>\n<td>International Society for Computational Biology and the African Society for Bioinformatics and Computational Biology\n<\/td>\n<td>A biennial national meeting on bioinformatics\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iscb.org\/ismb2022\" target=\"_blank\">ISMB 2022<\/a>\n<\/td>\n<td>United States\n<\/td>\n<td>Madison (Wisconsin)\n<\/td>\n<td>07 \/ 10\u201314\n<\/td>\n<td>2022\n<\/td>\n<td>International Society for Computational Biology\n<\/td>\n<td>An annual international bioinformatics and computational biology conference\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.labware.com\/events\/cec\" target=\"_blank\">LabWare 2022 Africa Customer Education Conference<\/a>\n<\/td>\n<td>Unknown\n<\/td>\n<td>Unknown\n<\/td>\n<td>09 \/ Unknown\n<\/td>\n<td>2022\n<\/td>\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>An annual LabWare customer education conference for the Africa region\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.labware.com\/events\/cec\" target=\"_blank\">LabWare 2022 Asia Pacific Customer Education Conference<\/a>\n<\/td>\n<td>Unknown\n<\/td>\n<td>Unknown\n<\/td>\n<td>08 \/ Unknown\n<\/td>\n<td>2022\n<\/td>\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>An annual LabWare customer education conference for the Asia Pacific region\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.labware.com\/events\/cec\" target=\"_blank\">LabWare 2022 China Customer Education Conference<\/a>\n<\/td>\n<td>China\n<\/td>\n<td>Unknown\n<\/td>\n<td>09 \/ Unknown\n<\/td>\n<td>2022\n<\/td>\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>An annual LabWare customer education conference for the China region\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.labware.com\/events\/cec\" target=\"_blank\">LabWare 2022 European Customer Education Conference<\/a>\n<\/td>\n<td>Czech Republic\n<\/td>\n<td>Prague\n<\/td>\n<td>06 \/ 20\u201324\n<\/td>\n<td>2022\n<\/td>\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>An annual LabWare customer education conference for the European region\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.labware.com\/events\/cec\" target=\"_blank\">LabWare 2022 Latin American Customer Education Conference<\/a>\n<\/td>\n<td>Unknown\n<\/td>\n<td>Unknown\n<\/td>\n<td>10 \/ Unknown\n<\/td>\n<td>2022\n<\/td>\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>An annual LabWare customer education conference for the Latin American region\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.labware.com\/events\/cec\" target=\"_blank\">LabWare 2022 North American Customer Education Conference<\/a>\n<\/td>\n<td>United States\n<\/td>\n<td>Orlando (Florida)\n<\/td>\n<td>05 \/ 15\u201320\n<\/td>\n<td>2022\n<\/td>\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>An annual LabWare customer education conference for the North American region\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.lims-forum.de\/\" target=\"_blank\">LIMS-Forum 2022<\/a>\n<\/td>\n<td>Germany\n<\/td>\n<td>Cologne (North Rhine-Westphalia)\n<\/td>\n<td>10 \/ 11\u201312\n<\/td>\n<td>2022\n<\/td>\n<td>International Quality and Productivity Center (IQPC)\n<\/td>\n<td>An annual forum on laboratory informatics\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/medinfo2023.org\/\" target=\"_blank\">MedInfo 2023<\/a>\n<\/td>\n<td>Australia\n<\/td>\n<td>Sydney (New South Wales)\n<\/td>\n<td>08 \/ Unknown\n<\/td>\n<td>2023\n<\/td>\n<td>International Medical Informatics Association\n<\/td>\n<td>A biennial international congress on medical and health informatics\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/themedtechconference.com\/\" target=\"_blank\">MedTech Conference, The<\/a>\n<\/td>\n<td>United States\n<\/td>\n<td>Boston (Massachusetts)\n<\/td>\n<td>10 \/ 24\u201426\n<\/td>\n<td>2022\n<\/td>\n<td>AdvaMed\n<\/td>\n<td>An annual conference on medical informatics and technology\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mie2022.org\/en\/\" target=\"_blank\">MIE 2022<\/a>\n<\/td>\n<td>France\n<\/td>\n<td>Nice\n<\/td>\n<td>05 \/ 27\u201330\n<\/td>\n<td>2022\n<\/td>\n<td>European Federation for Medical Informatics (EFMI)\n<\/td>\n<td>An annual European conference on medical informatics\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.nahdo.org\/annual_meeting\" target=\"_blank\">NAHDO Annual Conference<\/a>\n<\/td>\n<td>Unknown\n<\/td>\n<td>Unknown\n<\/td>\n<td>09 \/ Unknown\n<\/td>\n<td>2022\n<\/td>\n<td>National Association of Health Data Organizations (NAHDO)\n<\/td>\n<td>An annual health informatics conference for NAHDO\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oxfordglobal.co.uk\/nextgen-omics-series-uk\/\" target=\"_blank\">NextGen Omics Series UK<\/a>\n<\/td>\n<td>United Kingdom\n<\/td>\n<td>London\n<\/td>\n<td>11 \/ Unknown\n<\/td>\n<td>2022\n<\/td>\n<td>Oxford Global Conferences\n<\/td>\n<td>An annual European congress on NGS technologies, data analysis, and clinical applications\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.paperlesslabacademy.com\/\" target=\"_blank\">Paperless Lab Academy 2022<\/a>\n<\/td>\n<td>Italy\n<\/td>\n<td>Lake Maggiore\n<\/td>\n<td>04 \/ 26\u201327\n<\/td>\n<td>2022\n<\/td>\n<td>Industrial Lab Automation\n<\/td>\n<td>An annual conference on the paperless laboratory\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pathologyinformatics.org\/pathology-informatics-summit\" target=\"_blank\">Pathology Informatics 2022<\/a>\n<\/td>\n<td>United States\n<\/td>\n<td>Pittsburgh (Pennsylvania)\n<\/td>\n<td>05 \/ 9\u201312\n<\/td>\n<td>2022\n<\/td>\n<td>University of Pittsburgh and the Association for Pathology Informatics (API)\n<\/td>\n<td>An annual educational conference on pathology informatics\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oxfordglobal.co.uk\/pharmatec-series\/\" target=\"_blank\">PharmaTec Series<\/a>\n<\/td>\n<td>United Kingdom\n<\/td>\n<td>London\n<\/td>\n<td>09 \/ 08\u201309\n<\/td>\n<td>2022\n<\/td>\n<td>Oxford Global Conferences\n<\/td>\n<td>An annual European congress on the role of technology on the pharmaceutical sector\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/amdis.org\/pcc-symposium\/\" target=\"_blank\">Physician-Computer Connection Annual Symposium<\/a>\n<\/td>\n<td>United States\n<\/td>\n<td>Ojai (California)\n<\/td>\n<td>06 \/ 14\u201317\n<\/td>\n<td>2022\n<\/td>\n<td>Association of Medical Directors of Information Systems\n<\/td>\n<td>An annual national symposium on physician use of healthcare information systems and technology\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/pittcon.org\/\" target=\"_blank\">Pittcon<\/a>\n<\/td>\n<td>United States\n<\/td>\n<td>Atlanta (Georgia)\n<\/td>\n<td>03 \/ 05\u201309\n<\/td>\n<td>2022\n<\/td>\n<td>The Pittsburgh Conference on Analytical Chemistry and Applied Spectroscopy\n<\/td>\n<td>An annual international conference and expo on laboratory science\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/rdapassociation.org\/summit\" target=\"_blank\">RDAP22<\/a>\n<\/td>\n<td>ONLINE\n<\/td>\n<td>ONLINE\n<\/td>\n<td>03 \/ 15\u201317\n<\/td>\n<td>2022\n<\/td>\n<td>Research Data Access & Preservation Association\n<\/td>\n<td>An annual research data access and preservation summit\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iscb.org\/iscb-conference-events\" target=\"_blank\">Rocky Mountain Bioinformatics Annual Conference<\/a>\n<\/td>\n<td>United States\n<\/td>\n<td>Snowmass Village (Colorado)\n<\/td>\n<td>12 \/ Unknown\n<\/td>\n<td>2022\n<\/td>\n<td>International Society for Computational Biology (ISCB)\n<\/td>\n<td>An annual conference for the ISCB\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/sc22.supercomputing.org\" target=\"_blank\">SC22<\/a>\n<\/td>\n<td>United States\n<\/td>\n<td>Dallas (Texas)\n<\/td>\n<td>11 \/ 13\u201318\n<\/td>\n<td>2022\n<\/td>\n<td>HPC Interconnections\n<\/td>\n<td>An annual international supercomputing conference\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.kdd.org\/kdd2022\/\" target=\"_blank\">SIGKDD 2022<\/a>\n<\/td>\n<td>United Stated\n<\/td>\n<td>Washington (D.C.)\n<\/td>\n<td>08 \/ 14\u201318\n<\/td>\n<td>2022\n<\/td>\n<td>KDD 2021 Organizing Committee\n<\/td>\n<td>An annual conference on data mining and big data\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/siim.org\/page\/22m_cfa_session\" target=\"_blank\">SIIM 2022 Annual Meeting<\/a>\n<\/td>\n<td>United States\n<\/td>\n<td>Kissimmee (Florida)\n<\/td>\n<td>06 \/ 09\u201311\n<\/td>\n<td>2022\n<\/td>\n<td>Society for Imaging Informatics in Medicine\n<\/td>\n<td>An annual conference on imaging informatics and technology\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.slas.org\/2022\" target=\"_blank\">SLAS2022<\/a>\n<\/td>\n<td>United States\n<\/td>\n<td>Boston (Massachusetts)\n<\/td>\n<td>02 \/ 05\u201309\n<\/td>\n<td>2022\n<\/td>\n<td>Society for Laboratory Automation & Screening (SLAS)\n<\/td>\n<td>An annual conference and exhibition about laboratory automation for SLAS\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pharma-iq.com\/events-smartlab-exchange-usa\" target=\"_blank\">SmartLab Exchange USA<\/a>\n<\/td>\n<td>United States\n<\/td>\n<td>Unknown\n<\/td>\n<td>02 \/ Unknown\n<\/td>\n<td>2022\n<\/td>\n<td>IQPC Exchange and the International Quality and Productivity Center (IQPC)\n<\/td>\n<td>A European conference on informatics in R&D and manufacturing\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pharma-iq.com\/events-sdmdglobal\" target=\"_blank\">Software Design for Medical Devices Global Annual Summit<\/a>\n<\/td>\n<td>Germany\n<\/td>\n<td>Berlin\n<\/td>\n<td>02 \/ 22\u201324\n<\/td>\n<td>2022\n<\/td>\n<td>International Quality and Productivity Center (IQPC)\n<\/td>\n<td>An annual conference on software for medical device manufacturers\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/healthcareitconnect.com\" target=\"_blank\">State Healthcare IT Connect Summit 2022<\/a>\n<\/td>\n<td>United States\n<\/td>\n<td>Baltimore\n<\/td>\n<td>04 \/ 18\u201320\n<\/td>\n<td>2022\n<\/td>\n<td>National Association of State Chief Information Officers (NASCIO)\n<\/td>\n<td>An annual summit for those managing state health IT systems\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.nursing.umaryland.edu\/academics\/pe\/events\/sini\/\" target=\"_blank\">Summer Institute in Nursing Informatics (SINI) 2022<\/a>\n<\/td>\n<td>United States\n<\/td>\n<td>Baltimore (Maryland)\n<\/td>\n<td>07 \/ 14\u201315\n<\/td>\n<td>2022\n<\/td>\n<td>University of Maryland School of Nursing\n<\/td>\n<td>An annual national nursing informatics conference\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/div>\n<h4><span class=\"mw-headline\" id=\"Trade_shows\">Trade shows<\/span><\/h4>\n<div style=\"text-align: left;\">\n<table class=\"sortable\" id=\"rdp-ebb-HigherEd\" border=\"1\" cellpadding=\"5\" cellspacing=\"0\" align=\"center\" style=\"width: 75%;\">\n<tbody><tr>\n<th>Trade show\n<\/th>\n<th>Country\n<\/th>\n<th>City (State)\n<\/th>\n<th>Month \/ Day(s)\n<\/th>\n<th>Year\n<\/th>\n<th>Organizer\n<\/th>\n<th>Details\n<\/th><\/tr>\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.analiticanet.com.br\/en\" target=\"_blank\">Analitica Latin America<\/a>\n<\/td>\n<td>Brazil\n<\/td>\n<td>S\u00e3o Paulo\n<\/td>\n<td>06 \/ 21\u201323\n<\/td>\n<td>2022\n<\/td>\n<td>N\u00fcrnbergMesse Brasil\n<\/td>\n<td>A biennial international exhibition for laboratory technology, analyses, biotechnology, and quality control\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.analytica.de\/en\/\" target=\"_blank\">analytica<\/a>\n<\/td>\n<td>Germany\n<\/td>\n<td>Munich (Bavaria)\n<\/td>\n<td>06 \/ 21\u201324\n<\/td>\n<td>2022\n<\/td>\n<td>Messe M\u00fcnchen\n<\/td>\n<td>A biennial international trade fair for laboratory technology, analysis, and biotechnology\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.stier.co.il\/analiza\/en\/\" target=\"_blank\">Analiza<\/a>\n<\/td>\n<td>Israel\n<\/td>\n<td>Tel-Aviv\n<\/td>\n<td>05 \/ 16\u201317\n<\/td>\n<td>2022\n<\/td>\n<td>STIER\n<\/td>\n<td>A biennial international trade fair for laboratory technology, equipment, and instrumentation\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.analyticaindia.com\/\" target=\"_blank\">analytica Anacon India - Hyderabad<\/a>\n<\/td>\n<td>India\n<\/td>\n<td>Hyderabad (Telangana)\n<\/td>\n<td>09 \/ 15\u201317\n<\/td>\n<td>2022\n<\/td>\n<td>Messe M\u00fcnchen\n<\/td>\n<td>A biannual international trade fair for laboratory technology, analysis, and biotechnology\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.analyticaindia.com\/\" target=\"_blank\">analytica Anacon India - Mumbai<\/a>\n<\/td>\n<td>India\n<\/td>\n<td>Mumbai (Maharashtra)\n<\/td>\n<td>04 \/ 20\u201321\n<\/td>\n<td>2022\n<\/td>\n<td>Messe M\u00fcnchen\n<\/td>\n<td>An annual international trade fair for laboratory technology, analysis, and biotechnology\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.analyticachina.com\/\" target=\"_blank\">analytica China<\/a>\n<\/td>\n<td>China\n<\/td>\n<td>Shanghai\n<\/td>\n<td>11 \/ 14\u201316\n<\/td>\n<td>2022\n<\/td>\n<td>Messe M\u00fcnchen\n<\/td>\n<td>A biennial international trade fair for laboratory technology, analysis, and biotechnology\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.analyticavietnam.com\/\" target=\"_blank\">analytica Vietnam<\/a>\n<\/td>\n<td>Vietnam\n<\/td>\n<td>Ho Chi Minh City\n<\/td>\n<td>05 \/ 05\u201307\n<\/td>\n<td>2022\n<\/td>\n<td>Messe M\u00fcnchen\n<\/td>\n<td>A biennial international trade fair for laboratory technology, analysis, and biotechnology\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.arablab.com\" target=\"_blank\">ARABLAB 2022<\/a>\n<\/td>\n<td>United Arab Emirates\n<\/td>\n<td>Dubai\n<\/td>\n<td>10 \/ 24\u201326\n<\/td>\n<td>2022\n<\/td>\n<td>The ARABLAB Group, Scientific International Exhibitions Ltd.\n<\/td>\n<td>An annual international laboratory and instrumentation tech trade fair\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.tc.by\/english\/events\/\" target=\"_blank\">Belarus Medica 2022<\/a>\n<\/td>\n<td>Belarus\n<\/td>\n<td>Minsk\n<\/td>\n<td>04 \/ 19\u201322\n<\/td>\n<td>2022\n<\/td>\n<td>Technics And Communications Jsc\n<\/td>\n<td>A medical exhibition featuring all major branches of medicine\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.cisile.com.cn\/\" target=\"_blank\">CISILE 2022<\/a>\n<\/td>\n<td>China\n<\/td>\n<td>Beijing\n<\/td>\n<td>05 \/ 11\u201313\n<\/td>\n<td>2022\n<\/td>\n<td>China Instrument Manufacturers Association\n<\/td>\n<td>An annual international scientific instrument and laboratory equipment exhibition\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/events.jspargo.com\/AACC22\/Public\/Enter.aspx\" target=\"_blank\">Clinical Lab Expo 2022<\/a>\n<\/td>\n<td>United States\n<\/td>\n<td>Chicago (Illinois)\n<\/td>\n<td>07 \/ 24\u201328\n<\/td>\n<td>2022\n<\/td>\n<td>AACC\n<\/td>\n<td>An annual exhibition of clinical laboratory products and services\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.dmea.de\/en\/\" target=\"_blank\">DMEA 2022<\/a>\n<\/td>\n<td>Germany\n<\/td>\n<td>Berlin (Berlin)\n<\/td>\n<td>04 \/ 26\u201328\n<\/td>\n<td>2022\n<\/td>\n<td>Messe Berlin\n<\/td>\n<td>An annual European exhibition on healthcare IT (formerly Connecting Healthcare IT)\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/expomedistanbul.com\/en\/\" target=\"_blank\">Expomed Eurasia 2022<\/a>\n<\/td>\n<td>Turkey\n<\/td>\n<td>Istanbul\n<\/td>\n<td>03 \/ 17\u201319\n<\/td>\n<td>2022\n<\/td>\n<td>Reed T\u00fcyap Exhibitions Inc.\n<\/td>\n<td>An annual international trade fair for the healthcare industry (formerly LabtechMED Eurasia)\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.forensicseuropeexpo.com\/\" target=\"_blank\">Forensics Europe Expo 2022<\/a>\n<\/td>\n<td>England\n<\/td>\n<td>London\n<\/td>\n<td>06 \/ 08\u201309\n<\/td>\n<td>2022\n<\/td>\n<td>Clarion Defence and Security Limited\n<\/td>\n<td>An annual trade fair and conference for anything related to forensic science\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.forumlabo.com\/lyon\/en-gb.html\" target=\"_blank\">Forum LABO Lyon 2022<\/a>\n<\/td>\n<td>France\n<\/td>\n<td>Lyon\n<\/td>\n<td>09 \/ 19\u201320\n<\/td>\n<td>2022\n<\/td>\n<td>Comit\u00e9 Interprofessionnel des Fournisseurs du Laboratoire (CIFL)\n<\/td>\n<td>A biennial European exhibition focused on laboratory professionals from multiple sectors\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.forumlabo.com\/paris\/en-gb.html\" target=\"_blank\">Forum LABO Paris 2023<\/a>\n<\/td>\n<td>France\n<\/td>\n<td>Paris\n<\/td>\n<td>03 \/ 28\u201330\n<\/td>\n<td>2023\n<\/td>\n<td>Comit\u00e9 Interprofessionnel des Fournisseurs du Laboratoire (CIFL)\n<\/td>\n<td>A biennial European exhibition focused on laboratory professionals from multiple sectors\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.hospital-expo.com\/\" target=\"_blank\">Hospital Expo - Indonesia 2022<\/a>\n<\/td>\n<td>Indonesia\n<\/td>\n<td>Jakarta\n<\/td>\n<td>01 \/ 26\u201329\n<\/td>\n<td>2022\n<\/td>\n<td>PT. Okta Sejahtera Insani\n<\/td>\n<td>An annual international exhibition on hospital, medical, clinical, and pharmaceutical equipment and technologies\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.hospital-expo.com\/\" target=\"_blank\">Hospital Expo - Medan 2022<\/a>\n<\/td>\n<td>Indonesia\n<\/td>\n<td>Medan\n<\/td>\n<td>Unknown\n<\/td>\n<td>2022\n<\/td>\n<td>PT. Okta Sejahtera Insani\n<\/td>\n<td>An annual international exhibition on hospital, medical, clinical, and pharmaceutical equipment and technologies\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.hospital-expo.com\/\" target=\"_blank\">Hospital Expo - Surabaya 2022<\/a>\n<\/td>\n<td>Indonesia\n<\/td>\n<td>Surabaya\n<\/td>\n<td>Unknown\n<\/td>\n<td>2022\n<\/td>\n<td>PT. Okta Sejahtera Insani\n<\/td>\n<td>An annual international exhibition on hospital, medical, clinical, and pharmaceutical equipment and technologies\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ilmac.ch\/\" target=\"_blank\">ILMAC Basel 2023<\/a>\n<\/td>\n<td>Switzerland\n<\/td>\n<td>Basel\n<\/td>\n<td>09 \/ 26\u201328\n<\/td>\n<td>2023\n<\/td>\n<td>MCH Group AG\n<\/td>\n<td>A biennial trade fair for process and laboratory technology\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ilmac.ch\/\" target=\"_blank\">ILMAC Luasanne 2022<\/a>\n<\/td>\n<td>Switzerland\n<\/td>\n<td>Luasanne\n<\/td>\n<td>09 \/ 28\u201329\n<\/td>\n<td>2022\n<\/td>\n<td>MCH Group AG\n<\/td>\n<td>A biennial trade fair for process and laboratory technology\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.indialabexpo.com\/\" target=\"_blank\">India Lab Expo 2022 - Hyderabad<\/a>\n<\/td>\n<td>India\n<\/td>\n<td>Hyderabad (Telangana)\n<\/td>\n<td>09 \/ 15\u201317\n<\/td>\n<td>2022\n<\/td>\n<td>Messe M\u00fcnchen\n<\/td>\n<td>An annual trade show on laboratory and bioinformatics\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.indialabexpo.com\/\" target=\"_blank\">India Lab Expo 2022 - Mumbai<\/a>\n<\/td>\n<td>India\n<\/td>\n<td>Mumbai (Maharashtra)\n<\/td>\n<td>04 \/ 20\u201321\n<\/td>\n<td>2022\n<\/td>\n<td>Messe M\u00fcnchen\n<\/td>\n<td>An annual trade show on laboratory and bioinformatics\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.infosecurityeurope.com\/\" target=\"_blank\">Infosecurity Europe 2022<\/a>\n<\/td>\n<td>England\n<\/td>\n<td>London\n<\/td>\n<td>06 \/ 21\u201323\n<\/td>\n<td>2022\n<\/td>\n<td>Reed Exhibitions Limited\n<\/td>\n<td>An annual European information security exhibition\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.interlabexhibition.com\/\" target=\"_blank\">Interlab Africa 2022<\/a>\n<\/td>\n<td>Algeria\n<\/td>\n<td>Alger\n<\/td>\n<td>12 \/ Unknown\n<\/td>\n<td>2022\n<\/td>\n<td>ATEX International Exhibitions\n<\/td>\n<td>An annual African exhibition for laboratory technology\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.interphex.com\/\" target=\"_blank\">INTERPHEX 2022<\/a>\n<\/td>\n<td>United States\n<\/td>\n<td>New York City (New York)\n<\/td>\n<td>05 \/ 24\u201326\n<\/td>\n<td>2022\n<\/td>\n<td>Reed Exhibitions\n<\/td>\n<td>An annual pharmaceutical and biopharmaceutical trade show\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.jasis.jp\/en\/\" target=\"_blank\">JASIS 2022<\/a>\n<\/td>\n<td>Japan\n<\/td>\n<td>Chiba\n<\/td>\n<td>11 \/ Unknown\n<\/td>\n<td>2022\n<\/td>\n<td>Japan Analytical Instruments Manufacturers' Association\n<\/td>\n<td>An annual national trade show on analytical and scientific systems and solutions\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.korealab.org\/eng\/main.asp\" target=\"_blank\">Korea Lab 2022<\/a>\n<\/td>\n<td>South Korea\n<\/td>\n<td>Seoul\n<\/td>\n<td>06 \/ 14\u201317\n<\/td>\n<td>2022\n<\/td>\n<td>Kyungyon Exhibition Corp.\n<\/td>\n<td>An annual national trade show on laboratory and biotechnology\n<\/td><\/tr>\n\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.lab-indo.com\/\" target=\"_blank\">Lab Indonesia 2022<\/a>\n<\/td>\n<td>Indonesia\n<\/td>\n<td>Jakarta\n<\/td>\n<td>10 \/ 07\u201309\n<\/td>\n<td>2022\n<\/td>\n<td>Informa PLC\n<\/td>\n<td>An annual national trade fair for the laboratory sector\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.lab-innovations.com\/\" target=\"_blank\">Lab Innovations 2022<\/a>\n<\/td>\n<td>United Kingdom\n<\/td>\n<td>Birmingham\n<\/td>\n<td>11 \/ 02\u201303\n<\/td>\n<td>2022\n<\/td>\n<td>EasyFairs UK Ltd.\n<\/td>\n<td>An annual European trade fair for the laboratory sector\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.lab-supply.info\/\" target=\"_blank\">LAB-SUPPLY 2022 Regional Fair - Berlin<\/a>\n<\/td>\n<td>Germany\n<\/td>\n<td>Berlin (Berlin)\n<\/td>\n<td>05 \/ 17\n<\/td>\n<td>2022\n<\/td>\n<td>Vogel Communications Group GmbH & Co. KG\n<\/td>\n<td>An annual regional trade fair for instrumental analytics, laboratory technology, laboratory chemicals, and biotechnology\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.lab-supply.info\/\" target=\"_blank\">LAB-SUPPLY 2022 Regional Fair - Dresden<\/a>\n<\/td>\n<td>Germany\n<\/td>\n<td>Dresden (Saxony)\n<\/td>\n<td>09 \/ 21\n<\/td>\n<td>2022\n<\/td>\n<td>Vogel Communications Group GmbH & Co. KG\n<\/td>\n<td>An annual regional trade fair for instrumental analytics, laboratory technology, laboratory chemicals, and biotechnology\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.lab-supply.info\/\" target=\"_blank\">LAB-SUPPLY 2022 Regional Fair - Hamburg<\/a>\n<\/td>\n<td>Germany\n<\/td>\n<td>Hamburg (Hamburg)\n<\/td>\n<td>08 \/ 17\n<\/td>\n<td>2022\n<\/td>\n<td>Vogel Communications Group GmbH & Co. KG\n<\/td>\n<td>An annual regional trade fair for instrumental analytics, laboratory technology, laboratory chemicals, and biotechnology\n<\/td><\/tr>\n \n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.lab-supply.info\/\" target=\"_blank\">LAB-SUPPLY 2023 Regional Fair - Hannover<\/a>\n<\/td>\n<td>Germany\n<\/td>\n<td>Hannover (Lower Saxony)\n<\/td>\n<td>09 \/ 06\n<\/td>\n<td>2023\n<\/td>\n<td>Vogel Communications Group GmbH & Co. KG\n<\/td>\n<td>An annual regional trade fair for instrumental analytics, laboratory technology, laboratory chemicals, and biotechnology\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.lab-supply.info\/\" target=\"_blank\">LAB-SUPPLY 2022 Regional Fair - Main in Frankfurt<\/a>\n<\/td>\n<td>Germany\n<\/td>\n<td>Frankfurt (Hesse)\n<\/td>\n<td>03 \/ 09\n<\/td>\n<td>2022\n<\/td>\n<td>Vogel Communications Group GmbH & Co. KG\n<\/td>\n<td>An annual regional trade fair for instrumental analytics, laboratory technology, laboratory chemicals, and biotechnology\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.lab-supply.info\/\" target=\"_blank\">LAB-SUPPLY 2022 Regional Fair - M\u00fcnster<\/a>\n<\/td>\n<td>Germany\n<\/td>\n<td>M\u00fcnster (North Rhine-Westphalia)\n<\/td>\n<td>11 \/ 09\n<\/td>\n<td>2022\n<\/td>\n<td>Vogel Communications Group GmbH & Co. KG\n<\/td>\n<td>An annual regional trade fair for instrumental analytics, laboratory technology, laboratory chemicals, and biotechnology\n<\/td><\/tr>\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.lab-supply.info\/\" target=\"_blank\">LAB-SUPPLY 2022 Regional Fair - Sindelfingen<\/a>\n<\/td>\n<td>Germany\n<\/td>\n<td>Sindelfingen (Baden-W\u00fcrttemberg)\n<\/td>\n<td>10 \/ 19\n<\/td>\n<td>2022\n<\/td>\n<td>Vogel Communications Group GmbH & Co. KG\n<\/td>\n<td>An annual regional trade fair for instrumental analytics, laboratory technology, laboratory chemicals, and biotechnology\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.lab-supply.info\/\" target=\"_blank\">LAB-SUPPLY 2022 Regional Fair - Wien<\/a>\n<\/td>\n<td>Austria\n<\/td>\n<td>Vienna\n<\/td>\n<td>04 \/ 27\n<\/td>\n<td>2022\n<\/td>\n<td>Vogel Communications Group GmbH & Co. KG\n<\/td>\n<td>An annual regional trade fair for instrumental analytics, laboratory technology, laboratory chemicals, and biotechnology\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.lab-asia.com\/\" target=\"_blank\">LabAsia 2023<\/a>\n<\/td>\n<td>Malaysia\n<\/td>\n<td>Kuala Lampur\n<\/td>\n<td>10 \/ 10\u201312\n<\/td>\n<td>2023\n<\/td>\n<td>Informa PLC\n<\/td>\n<td>A biennial regional trade fair and conference for the laboratory sector\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/labcomplex.com\/?lang=en\" target=\"_blank\">LabComplEX 2022<\/a>\n<\/td>\n<td>Ukraine\n<\/td>\n<td>Kyiv\n<\/td>\n<td>09 \/ 27\u201329\n<\/td>\n<td>2022\n<\/td>\n<td>ExpoForum, LLC\n<\/td>\n<td>An annual national trade show on laboratory and biotechnology\n<\/td><\/tr>\n \n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/expo.laborama.be\/en\" target=\"_blank\">Laborama 2022<\/a>\n<\/td>\n<td>Belgium\n<\/td>\n<td>Bruxelles\n<\/td>\n<td>03 \/ 17\u201318\n<\/td>\n<td>2022\n<\/td>\n<td>Laborama vzw-asbl\n<\/td>\n<td>An annual European trade fair for the laboratory sector\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.labvolution.de\/home\" target=\"_blank\">LABVOLUTION 2023<\/a>\n<\/td>\n<td>Germany\n<\/td>\n<td>Hannover (Lower Saxony)\n<\/td>\n<td>05 \/ 09\u201311\n<\/td>\n<td>2023\n<\/td>\n<td>Deutsche Messe\n<\/td>\n<td>A biennial international trade fair for the biotechnology, life sciences, and laboratory tech communities\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/sajam.rs\/en\/calendar-2022\/\" target=\"_blank\">MEDIDENT 2022<\/a>\n<\/td>\n<td>Serbia\n<\/td>\n<td>Belgrade\n<\/td>\n<td>10 \/ Unknown\n<\/td>\n<td>2022\n<\/td>\n<td>Belgrade Fair\n<\/td>\n<td>An annual international exhibition of medical, laboratory, pharmaceutical, dental, and veterinary equipment, instruments, and services\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.medlabasia.com\/\" target=\"_blank\">MEDLAB Asia Pacific 2022<\/a>\n<\/td>\n<td>Thailand\n<\/td>\n<td>Bangkok\n<\/td>\n<td>10 \/ 19\u201321\n<\/td>\n<td>2022\n<\/td>\n<td>Informa Life Sciences Exhibitions\n<\/td>\n<td>An annual international laboratory exhibition and congress\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.philmedical.com\/\" target=\"_blank\">Philippines Lab Expo 2022<\/a>\n<\/td>\n<td>Philippines\n<\/td>\n<td>Manila\n<\/td>\n<td>08 \/ 24\u201326\n<\/td>\n<td>2022\n<\/td>\n<td>Fireworks Exhibitions and Conferences\n<\/td>\n<td>An annual national laboratory exhibition\n<\/td><\/tr>\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.rommedica.ro\/en\/\" target=\"_blank\">Rommedica 2022<\/a>\n<\/td>\n<td>Romania\n<\/td>\n<td>Bucharest\n<\/td>\n<td>Unknown\n<\/td>\n<td>2022\n<\/td>\n<td>ROMEXPO\n<\/td>\n<td>An annual international trade fair for medical instruments and equipment\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.srilankalabexpo.com\/\" target=\"_blank\">Sri Lanka Lab Expo 2022<\/a>\n<\/td>\n<td>Sri Lanka\n<\/td>\n<td>Colombo\n<\/td>\n<td>Unknown\n<\/td>\n<td>2022\n<\/td>\n<td>S D Promo Media Pvt. Ltd.\n<\/td>\n<td>An annual national trade fair for laboratory and biotechnology\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.thailandlab.com\/\" target=\"_blank\">Thailand Lab International 2022<\/a>\n<\/td>\n<td>Thailand\n<\/td>\n<td>Bangkok\n<\/td>\n<td>09 \/ 14\u201316\n<\/td>\n<td>2022\n<\/td>\n<td>VNU Exhibitions Asia Pacific Co., Ltd.\n<\/td>\n<td>An annual international trade fair for analytical laboratory equipment & technology, biotechnology & life sciences, and chemicals & safety\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/tbilisihealthforum.ge\/\" target=\"_blank\">Tbilisi Health Forum 2022<\/a>\n<\/td>\n<td>Georgia\n<\/td>\n<td>Tbilisi\n<\/td>\n<td>11 \/ Unknown\n<\/td>\n<td>2022\n<\/td>\n<td>ExpoGeorgia Co\n<\/td>\n<td>An annual international trade fair for medical technology, laboratory equipment, dentistry, pharmaceuticals, optics, and hospital equipment (formerly Caucasus Healthcare)\n<\/td><\/tr>\n\n\n<tr>\n<td><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/wots.nl\/\" target=\"_blank\">World of Technology & Science 2022<\/a>\n<\/td>\n<td>The Netherlands\n<\/td>\n<td>Utrecht\n<\/td>\n<td>09 \/ 27\u201330\n<\/td>\n<td>2022\n<\/td>\n<td>FHI Federation of Technology Branches\n<\/td>\n<td>A biennial international trade fair for industrial electronics, industrial automation, and laboratory technology\n<\/td><\/tr>\n\n<\/tbody><\/table>\n<\/div>\n<!-- \nNewPP limit report\nCached time: 20220125124347\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.046 seconds\nReal time usage: 0.084 seconds\nPreprocessor visited node count: 13\/1000000\nPost\u2010expand include size: 71932\/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% 16.932 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Conferences_and_trade_shows\n100.00% 16.932 1 -total\n 22.77% 3.855 1 Template:Resources\/Conferences\n 21.66% 3.668 1 Template:Resources\/Trade_shows\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12947-0!canonical and timestamp 20220125124347 and revision id 45844. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Conferences_and_trade_shows\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Conferences_and_trade_shows<\/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>","2574a22b8ca0940242424fa5279a406b_images":[],"2574a22b8ca0940242424fa5279a406b_timestamp":1643149334,"1dca96282078cc576add1d583de19527_type":"article","1dca96282078cc576add1d583de19527_title":"5.1 Trade organizations","1dca96282078cc576add1d583de19527_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Trade_organizations","1dca96282078cc576add1d583de19527_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 3: Industry and community resources\/Trade organizationsFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\nContents \n\n1 5. Resources for selecting and implementing informatics solutions: Part 3: Industry and community resources \n\n1.1 5.1 Trade organizations \n\n1.1.1 A through D \n1.1.2 E through J \n1.1.3 K through Z \n\n\n\n\n\n\n\n5. Resources for selecting and implementing informatics solutions: Part 3: Industry and community resources \nPart 3 of this guide's resources chapters provides a variety of industry and community resources that may prove helpful to clinical diagnostic and research laboratories. This includes trade organizations, conferences, trade shows, user communities, books, journals, regulations, standards, and guidance documents, as well as discussion about LIMSpec, an ever-evolving set of software user requirements specifications for laboratory informatics systems.\n\r\n\n\n5.1 Trade organizations \nTrade organizations and associations help bring people in similar industries or with similar goals together to learn and share ideas, improve their industry, and gain insights into the newest technologies and procedures. The following represent organizations, associations, and other groups dedicated to not only medical fields but also the application of technology and informatics in medicine.\n\nA through D \nAHIMA Foundation: \"improves health information management by supporting the people, research and resources that advance the HIM profession;\" 501 (c)(3) charitable child organization of the American Health Information Management Association (AHIMA)\nAlliance for Nursing Informatics: ANI; a collection of organizations which aims to \"advance nursing informatics practice, education, policy and research\"\nAmerican Association of Integrated Healthcare Delivery Systems: AAIHDS; \"a non-profit organization dedicated to the educational advancement of provider-based managed care professionals responsible for accountable and integrated healthcare delivery\"\nAmerican Health Information Management Association: AHIMA; a collaboration of other associations and individuals involved in health information management\nAmerican Medical Informatics Association: AMIA; a professional scientific association which \"aims to lead the way in transforming health care through trusted science, education, and the practice of informatics\"\nAmerican Nursing Informatics Association: ANIA; a professional organization which aims \"to advance the field of nursing informatics through communication, education, research and professional activities\"\nAmerican Society of Crime Laboratory Directors: ASCLD; a volunteer not-for-profit organization \"dedicated to providing excellence in forensic science through leadership and innovation\"\nAmerican Society of Health Informatics Managers: ASHIM; \"a non-governmental organization that acts in public interest by fostering professional standards in health IT professionals through its setting and enforcement of the education, examination, experience, ethics, and other requirements for CHISP certification\"\nAmerican Telemedicine Association: ATA; a non-profit organization dedicated to \"promoting the deployment of telemedicine throughout the world\"\nANSI National Accreditation Board: ANAB; \"a non-governmental organization that provides accreditation services and training to public- and private-sector organizations, serving the global marketplace,\" including laboratories. The ASCLD Laboratory Accreditation Board was merged into ANAB.\nArmenian Association of Telemedicine: AATM; a non-governmental, non-profit professional organization \"interested in exploring and developing the field of telemedicine and eHealth in Armenia as well as worldwide\"\nArtificial Intelligence in Medicine: AIME; attempts to \"foster fundamental and applied research in the application of artificial intelligence (AI) techniques to medical care and medical research\"\nAsia Pacific Association for Medical Informatics: APAMI; the official Asia-Pacific chapter of the International Medical Informatics Association\nAssociation for Clinical Data Management: ACDM; \"represents professionals working in the management of clinical data ... through training, conferences, discussions and information provision\"\nAssociation for Health Information and Libraries in Africa: AHILA; an organization with a vision \"to become a leader in promoting access and use of health information in Africa\"\nAssociation for Information Science and Technology: ASIS&T; a professional association which aims to discover \"new and better theories, techniques, and technologies to improve access to information\"\nAssociation for Information Systems: AIS; a non-profit organization and \"professional association for individuals and organizations who lead the research, teaching, practice, and study of information systems worldwide\"\nAssociation for Pathology Informatics: API; seeks \"to promote the field of pathology informatics as an academic and a clinical subspecialty of pathology\"\nAssociation for Veterinary Informatics: AVI; \"a non-profit international and interdisciplinary organization comprised of individuals involved in biomedical informatics research, design, implementation, education and advocacy within the domain of veterinary medicine\"\nAssociation of Clinical Scientists: a non-profit scientific and educational corporation \"dedicated to the advancement of research and learning in laboratory science\"\nAssociation of Medical Directors of Information Systems: AMDIS; a \"professional organization for physicians interested in and responsible for healthcare information technology\"\nAssociation of Public Health Laboratories: APHL; a non-profit 501(c)(3) organization promoting public health laboratories\nAustralasian College of Health Informatics: ACHI; a \"professional body for health informatics in the Asia-Pacific region\"\nAustralasian Telehealth Society: ATHS; an incorporated association that acts as \"a forum for all of those involved in telehealth in Australia\"\nAutomation and Analytical Management Group of the Royal Society of Chemistry: AAMG; a special interest group of the analytical division of the Royal Society of Chemistry (RSC)\n\r\n\n\nBelgian Medical Informatics Association: MIM; a not-for-profit association which aims \"to promote and develop medical information science and technology in Belgium\"\nBioInfoBank Institute: a non-for-profit research and development organization which aims \"to generate, incubate and inspire innovative ideas\" and \"productive research conducted by highly motivated excellent young scientists in Poland\"\nBioinformatics Institute of India: BII; registered under the Confrere Educational Society, aims \"to promote excellence in biotech, life sciences and pharma education\"\nBioinformatics Organization: an incorporated non-profit organization which aims to \"develop and maintain computational resources to facilitate world-wide communications and collaborations between people of all educational and professional levels\"\nBritish Computer Society Health: BCS; an international organization actings as \"the chartered institute for IT;\" aims \"to promote new thinking, education and knowledge sharing\" in the industry\nBritish Computer Society Health Scotland : the Scottish branch of the BCS\n\r\n\n\nCanadian Health Information Management Association : CHIMA; a national membership-based organization which aims to act as a \"change leader in health information management\"\nCanadian Nursing Informatics Association: CNIA; a national membership-based organization which aims \"to be the voice for nursing informatics in Canada\"\nChild Health Informatics Center: CHIC; an American Academy of Pediatrics (AAP) effort \"to support and prepare pediatricians for the many changes that will be occurring over the next few years in regard to health information technology\"\nCollege of Healthcare Information Management Executives: CHIME; a non-profit \"professional organization for chief information officers and other senior healthcare IT leaders\"\nCommission on Accreditation for Health Informatics and Information Management Education: CAHIIM; a 501(c)3 not for profit organization that provides \"quality monitoring of academic programs in health information management and health informatics through maintenance of accreditation policies and processes\"\nCommission on Office Laboratory Accreditation: COLA; \"an independent, non-profit accreditor whose education program and standards enable clinical laboratories and staff to meet U.S. CLIA and other regulatory requirements\"\nComputing in Cardiology: an incorporated non-profit and international society of scientists and professionals focused on examining the \"methods and results of computation\" in the study and application of cardiology and cardiovascular physiology\nCouncil on Clinical Information Technology: COCIT; an American Academy of Pediatrics (AAP) sub-group dedicated \"to support the development of health information technology\"\nCzech Society for Biomedical Engineering and Medical Informatics: \u010cLS; a voluntary independent association of \"physicians, pharmacists and other personnel in healthcare and affiliated fields\" and other entities\nSociety for Cybernetics and Informatics: CSKI; a society focused on the \"support and promotion of cybernetics, informatics and related fields\"\n\r\n\n\nDigital Health Canada: DHC; a professional association dedicated to advancing the field of health informatics (formerly known as COACH: Canada's Health Informatics Association)\nE through J \nEar-Nose-Throat Informatics Society: ENTIS-J; a Japanese society dedicated to information management in the ENT field\neHealth Initiative: eHI; a national organization attempting \"to drive improvement in the quality of healthcare by promoting the use of technology and information\"\nEMBnet - The Global Bioinformatics Network: EMBnet; an initiative of the European Molecular Biology Laboratory (EMBL) that acts as \"a pioneer and a provider of bioinformatics services, expertise and training, across Europe and beyond\"\nEmergency Informatics Association: EIA; \"to propose, track, publish, and promote projects in the emergency informatics domain in support of the EIA vision\"\nEuropean Federation for Medical Informatics: EFMI; \"a nonprofit organisation concerned with the theory and practice of information science and technology within health and health science in a European context\"\nEuropean Health Telematics Association: EHTEL; \"a pan European multi-stakeholder forum providing a leadership and networking platform for European corporate, institutional and individual actors dedicated to the betterment of healthcare delivery through eHealth\"\nEuropean Research Consortium for Informatics and Mathematics: ERCIM; a consortium that \"aims to foster collaborative work within the European research community and to increase co-operation with European industry\"\nEUROREC Institute: \"an independent not-for-profit organisation, promoting in Europe the use of high quality electronic health record systems (EHRs)\"\n\r\n\n\nFederation for Informatics Professionals: FEDIP; continuing on in spirit of the work the UK Council for Health Informatics Professions was doing, FEDIP \"is the only public register for all informatics professionals in the UK dedicated to delivering better health and care through the advanced use of technology\"\nFoundation of Healthcare Technologies Society: FHTS; an Indian association of \"professionals from diverse backgrounds\" attempting \"to work in collaboration and to utilize accessible technologies as a medium to facilitate improvement in overall population health\"\n\r\n\n\nGlobal Observatory for eHealth: GOE; a WHO-backed initiative \"dedicated to the study of eHealth [and] its evolution and impact on health in countries\"\nGlobal Organisation for Bioinformatics Learning, Education & Training: GOBLET; a European coalition of individuals and organizations dedicated \"to coordinate world-wide bioinformatics training activities\" in a shared and mutually respectful way\n\r\n\n\nHealth Informatics in Africa: HELINA; a pan-African health informatics association dedicated to developing education, research, and strategic plans related to health informatics in Africa\nHealth Informatics New Zealand: HINZ; a professional association that \"seeks to facilitate improved health care outcomes through the dissemination and utilisation of information, knowledge and technology\"\nHealth Informatics Society of Australia: HISA; \"a not-for-profit membership organisation for health informaticians and those with an interest in health informatics\"\nHealth Informatics Society of Ireland: HISI; this organization \"bridges between computer professionals interested in health care, and health care professionals interested in computing \u2013 while supporting and embracing the new professionals of healthcare informatics\"\nHealth Informatics Society of Nigeria: HISN; \"a professional membership driven association, developed to serve the growing community of clinical science, information science, computer science and management science professionals who are tasked with managing the dynamic health information technology life cycle\"\nHealth Information Management Association of Australia: HIMAA; an association turned national company that \"seeks to promote and support [its] members as the universally recognised specialists in information management at all levels of the healthcare system\"\nHealth Level Seven International: HL7; \"a not-for-profit, ANSI-accredited standards developing organization dedicated to providing a comprehensive framework and related standards for the exchange, integration, sharing, and retrieval of electronic health information that supports clinical practice and the management, delivery, and evaluation of health services\"\nHealth On the Net Foundation: HON; a non-governmental organization that \"promotes and guides the deployment of useful and reliable online health information, and its appropriate and efficient use\"\nHealthcare Informatics Society of Ireland: HISI; incorporates the Healthcare Informatics sections of the Royal Academy of Medicine in Ireland and of the Irish Computer Society; strives to develop knowledge and promote research in healthcare informatics\nHealthcare Information and Management Systems Society: HIMSS; a \"not-for-profit organization exclusively focused on providing global leadership for the optimal use of information technology (IT) and management systems for the betterment of healthcare\"\nHIMSS EHR Association: HIMSS EHRA; \"a trade association of electronic health record (EHR) companies, addressing national efforts to create interoperable EHRs in hospital and ambulatory care settings\"\n\r\n\n\nIEEE Engineering in Medicine and Biology Society: IEEE EMBS; an international society of biomedical engineers \"focused on the development and application of engineering concepts and methods to provide new solutions to biological, medical and healthcare problems\"\nIEEE Technology Management Council: IEEE TMC; an international organization that \"provides information and services to IEEE members and the worldwide audience of practitioners and researchers engaged in the profession of engineering, technology, and innovation management\"\nIHE International: IHE; \"an initiative by healthcare professionals and industry to improve the way computer systems in healthcare share information\"\nIndian Association for Medical Informatics: IAMI; an Indian association dedicated to medical specialists using informatics \"into a common thread for the benefit of the patients and provoking an interdisciplinary research\"\nInformation Institute: a non-profit policy research and educational organization comprised of academics and industry representatives dedicated \"to further[ing] understanding of intricate relationships between information science and technology\"\nInitiative for Parallel Bioinformatics: IPAB; a Japanese initiative to accelerate the use of technology for performing information processing in the field of bioinformatics\nInstitute of Electrical and Electronics Engineers: IEEE; a \"professional association dedicated to advancing technological innovation and excellence for the benefit of humanity\"\nInstitute of Health Records & Information Management: IHRIM; an educational body dedicated \"to provide qualifications at different levels as well as career and professional assistance for members\" from \"the fields of health records, information management, clinical coding and information governance\"\nInternational Council on Archives: ICA; a non-governmental, member-funded organization \"dedicated to the effective management of records and the preservation, care and use of the world's archival heritage\"\nInternational Federation for Information Processing: IFIP; \"a non-governmental, non-profit umbrella organization for national societies working in the field of information processing\"\nInternational Federation of Health Information Management Associations: IFHIMA; a non-profit organization affiliated with the World Health Organization (WHO) as a non-governmental organization that \"supports national associations and health record professionals to implement and improve health records and the systems which support them\"\nInternational Medical Informatics Association: IMIA; an \"association of associations\" which acts as a bridge between constituent organizations and their members to better \"enable the transformation of healthcare in accord with the world-wide vision of improving the health of the world population\"\nInternational Society for Biological and Environmental Repositories: ISBER; a division of the American Society for Investigative Pathology, \"promoting harmonized high quality standards, ethical principles and innovation in the science and management of biospecimen collection, processing, storage, distribution and use\"\nInternational Society for Clinical Biostatistics: ISCB; a professional organization dedicated \"to [stimulating] research into the principles and methodology used in the design and analysis of clinical research and to increase the relevance of statistical theory to the real world of clinical medicine\"\nInternational Society for Computational Biology: ISCB; a non-profit corporation \"addressing scientific policies, providing access to high quality publications, organizing meetings, and serving as a portal to information about training, education, employment and news\" for those in the field of bioinformatics and computational biology\nInternational Society for Pharmaceutical Engineering: ISPE; an international society of scientific and technical personnel in the pharmaceutical manufacturing industry, \"committed to the advancement of the educational and technical efficiency of its members through forums for the exchange of ideas and practical experience\"\nIQVIA Institute for Human Data Science: an outgrowth of the IMS Institute for Healthcare Informatics\u2014which was part of IMS Health, which merged with Quintiles to form IQVIA\u2014the institute \"contributes to the advancement of human health globally through timely research, insightful analysis and scientific expertise applied to granular non-identified patient-level data\"\n\r\n\n\nJapan Association for Medical Informatics: JAMI; a Japanese professional association dedicated to sharing academic research related to medical informatics\nJapan Association for Medical Informatics - Nursing Informatics: JAMI-NI; the JAMI subcommittee on nursing informatics\nJapan Association for Clinical Laboratory Science: formerly the Japan Society for Clinical Laboratory Automation, this association attempts to \"contribute to precise diagnosis, appropriate treatment, and better health care by applying the latest technologies to clinical laboratories\"\nJapan Society of Health Information Management: JHIM; a Japanese scientific organization dedicated to \"establishing, implementing, and promoting the science of health information (record) management in Japan\"\nJapanese Society for Bioinformatics: JSBi; a Japanese professional association dedicated \"to develop[ing] the discipline of bioinformatics in Japan\" as well as \"the promotion of the technology and related business\" aspects of bioinformatics\nJapanese Society of Drug Informatics: JASDI; a Japanese professional association dedicated to \"contributing to the improvement and advancement [of] pharmaceutical medicine ... as well as the improvement of science education and research on drug information\"\nJISC: a registered U.K. charity dedicated to promoting \"the innovative use of information and communication technology to support education, research and institutional effectiveness\"\nK through Z \nKenya Health Informatics Association: KeHIA; a professional association dedicated \"to further[ing] the health and biomedical agenda in Kenya to support the government's initiatives to improve and sustain quality health services for all Kenyans\"\nKDD: a sub-group of the Association for Computing Machinery, promoting the \"advancement and adoption of the 'science' of knowledge discovery and data mining\"\n\r\n\n\nLaboratory Research & Innovation Group LRIG; formerly the Laboratory Robotics Interest Group, this is a \"special interest group focused on laboratory automation\"\n\r\n\n\nMarkle Foundation: a private foundation with the goal of helping others \"realize the potential of information technology to address previously intractable public problems, for the health and security of all Americans\"\nMedical Computer Society of India: MCSI; a professional society dedicated to promoting the use of computer technology to better patient outcomes\nMedical Informatics and Technology Applications Consortium: MedITAC; \"a unique NASA Research Partnership Center (RPC), established to develop, evaluate, and promote information and medical technologies for space flight and ground applications\"\nMedical Library Association: MLA; a nonprofit, educational organization \"committed to educating health information professionals, supporting health information research, [and] promoting access to the world's health sciences information\"\nMedical Software Industry Association: MSIA; a membership-based professional association representing \"the interests of the Australian commercial software industry which develops, supplies and services information management products and services for healthcare practitioners, healthcare service providers and healthcare organisations\"\nMedTech Europe: formerly the European Diagnostic Manufacturer\u2019s Association and Eucomed, the two combined to form MedTech Europe, a \"trade association for the medical technology industry including diagnostics, medical devices and digital health\"\nMiddle East Association for Health Informatics: MEAHI; a not-for-profit organization \"trying to use regional as well as global potentials to provide a collaborative environment, in which requirements are discussed, solutions are provided, and resources are allocated to tackle healthcare issues of this vulnerable part of the world\"\n\r\n\n\nNational Academies: a collection of U.S. \"private, nonprofit institutions that provide expert advice on some of the most pressing challenges facing the nation and the world,\" including sciences, engineering, medicine, and research\nNational Association of Health Data Organizations: NAHDO; a U.S. \"non-profit membership and educational association dedicated to improving health care data collection and use\"\nNational Institutes of Health Informatics: NIHI; a Canadian not-for-profit corporation \"dedicated to fostering health informatics (HI) innovation, research and education\"\nThe NELAC Institute: TNI; a \"non-profit organization whose mission is to foster the generation of environmental data of known and documented quality through an open, inclusive, and transparent process that is responsive to the needs of the community\"\nNetworked Digital Library of Theses and Dissertations: NDLTD; \"an international organization dedicated to promoting the adoption, creation, use, dissemination, and preservation of electronic theses and dissertations\"\nNew England Nursing Informatics Consortium: NENIC; \"a dynamic regional organization of nurses, allied healthcare professionals, and HIT solution providers\"\nNursing Specialist Group: NSG; a British Computer Society-related \"U.K. organisation for nurses and therapists interested in the management and use of information and communications technology to improve the quality, delivery and recording of care\"\n\r\n\n\nOntario Nursing Informatics Group: ONIG; a professional group attempting \"to provide a forum for nursing professionals to communicate and disseminate current developments in health care information systems\"\nopenEHR Foundation: a not-for-profit company that develops specification, clinical model, and other medical programs and also supports health informatics education\nOSCAR Canada Users' Society: OCUS; a not-for-profit society dedicated to promoting the education and use of OSCAR, \"a suite of open-source applications including an electronic medical record\"\n\r\n\n\nPublic Health Informatics Institute: PHII; a non-profit organization acting \"as a neutral convener of public health professionals and their stakeholders, transforming health practitioners' ability to apply information effectively in order to improve health outcomes worldwide\"\nPublic Library of Science: PLOS; a not-for-profit \"publisher, membership, and advocacy organization with a mission to accelerate progress in science and medicine by leading a transformation in research communication\"\n\r\n\n\nRegenstrief Institute: RI; an informatics and healthcare research organization dedicated to \"improving quality of care, increasing efficiency of healthcare delivery, preventing medical errors and enhancing patient safety\"\n\r\n\n\nScholarly Publishing & Academic Resources Coalition: SPARC; \"an international alliance of academic and research libraries working to correct imbalances in the scholarly publishing system\"\nSIGCOMM: a special interest group of the Association for Computing Machinery (ACM) dedicated to finding answers to \"systems engineering and architectural questions surrounding computer communication\"\nSNOMED International: SNOMED; the not-for-profit association that owns and maintains SNOMED CT, a comprehensive and multilingual set of clinical terminology\nSociety for Imaging Informatics in Medicine: SIIM; a \"leading healthcare professional organization for those interested in the current and future use of informatics in medical imaging\"\nSociety for Laboratory Automation and Screening: SLAS; \"a global organization that exists to provide forums for education and information exchange to encourage the study of, and improve the science and practice of, laboratory automation and screening\"\nSwedish Association of Medical Informatics: SFMI; a professional association that strives \"to promote the development of informatics in health care, in particular through the organization of meetings with scientific lectures and discussions\"\nSwiss Institute of Bioinformatics: SIB; an academic, non-profit foundation that \"coordinates research and education in bioinformatics throughout Switzerland and provides high quality bioinformatics services to the national and international research community\"\n\r\n\n\nUkrainian Association for Computer Medicine: UACM; an independent non-governmental non-commercial organization dedicated to furthering the use of computers and other technology in medicine\nUniversity hospital Medical Information Network: UMIN; \"a cooperative organization for national medical schools in Japan\"\nURAC: an independent, nonprofit organization \"promoting health care quality through its accreditation, education and measurement programs\"\n\r\n\n\nVancouver Bioinformatics Users Group: VanBUG; \"an association of researchers, other professionals and students in the B.C. Lower Mainland who have an interest in the field of bioinformatics\"\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Trade_organizations\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Trade_organizations<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:14.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 60 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","1dca96282078cc576add1d583de19527_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Resources_for_selecting_and_implementing_informatics_solutions_Part_3_Industry_and_community_resources_Trade_organizations rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Resources_for_selecting_and_implementing_informatics_solutions_Part_3_Industry_and_community_resources_Trade_organizations 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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 3: Industry and community resources\/Trade organizations<\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">the beginning<\/a> of this guide-----<\/div>\n\n\n<h2><span class=\"mw-headline\" id=\"5._Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\">5. Resources for selecting and implementing informatics solutions: Part 3: Industry and community resources<\/span><\/h2>\n<p>Part 3 of this guide's resources chapters provides a variety of industry and community resources that may prove helpful to clinical diagnostic and research laboratories. This includes trade organizations, conferences, trade shows, user communities, books, journals, regulations, standards, and guidance documents, as well as discussion about LIMSpec, an ever-evolving set of software user requirements specifications for laboratory informatics systems.\n<\/p><p><br \/>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"5.1_Trade_organizations\">5.1 Trade organizations<\/span><\/h3>\n<p>Trade organizations and associations help bring people in similar industries or with similar goals together to learn and share ideas, improve their industry, and gain insights into the newest technologies and procedures. The following represent organizations, associations, and other groups dedicated to not only medical fields but also the application of technology and informatics in medicine.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"A_through_D\">A through D<\/span><\/h4>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ahimafoundation.org\/\" target=\"_blank\">AHIMA Foundation<\/a>: \"improves health information management by supporting the people, research and resources that advance the HIM profession;\" 501 (c)(3) charitable child organization of the American Health Information Management Association (AHIMA)<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.allianceni.org\/\" target=\"_blank\">Alliance for Nursing Informatics<\/a>: ANI; a collection of organizations which aims to \"advance nursing informatics practice, education, policy and research\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.aaihds.org\/\" target=\"_blank\">American Association of Integrated Healthcare Delivery Systems<\/a>: AAIHDS; \"a non-profit organization dedicated to the educational advancement of provider-based managed care professionals responsible for accountable and integrated healthcare delivery\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ahima.org\/\" target=\"_blank\">American Health Information Management Association<\/a>: AHIMA; a collaboration of other associations and individuals involved in health information management<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.amia.org\/\" target=\"_blank\">American Medical Informatics Association<\/a>: AMIA; a professional scientific association which \"aims to lead the way in transforming health care through trusted science, education, and the practice of informatics\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ania.org\/\" target=\"_blank\">American Nursing Informatics Association<\/a>: ANIA; a professional organization which aims \"to advance the field of nursing informatics through communication, education, research and professional activities\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ascld.org\/\" target=\"_blank\">American Society of Crime Laboratory Directors<\/a>: ASCLD; a volunteer not-for-profit organization \"dedicated to providing excellence in forensic science through leadership and innovation\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ashim.com\/\" target=\"_blank\">American Society of Health Informatics Managers<\/a>: ASHIM; \"a non-governmental organization that acts in public interest by fostering professional standards in health IT professionals through its setting and enforcement of the education, examination, experience, ethics, and other requirements for CHISP certification\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.americantelemed.org\/\" target=\"_blank\">American Telemedicine Association<\/a>: ATA; a non-profit organization dedicated to \"promoting the deployment of telemedicine throughout the world\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/anab.ansi.org\/laboratory-accreditation\" target=\"_blank\">ANSI National Accreditation Board<\/a>: ANAB; \"a non-governmental organization that provides accreditation services and training to public- and private-sector organizations, serving the global marketplace,\" including laboratories. The ASCLD Laboratory Accreditation Board was merged into ANAB.<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/armtelemed.org\/\" target=\"_blank\">Armenian Association of Telemedicine<\/a>: AATM; a non-governmental, non-profit professional organization \"interested in exploring and developing the field of telemedicine and eHealth in Armenia as well as worldwide\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/aimedicine.info\/aime\/\" target=\"_blank\">Artificial Intelligence in Medicine<\/a>: AIME; attempts to \"foster fundamental and applied research in the application of artificial intelligence (AI) techniques to medical care and medical research\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.apami.org\/\" target=\"_blank\">Asia Pacific Association for Medical Informatics<\/a>: APAMI; the official Asia-Pacific chapter of the International Medical Informatics Association<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/acdmglobal.org\/\" target=\"_blank\">Association for Clinical Data Management<\/a>: ACDM; \"represents professionals working in the management of clinical data ... through training, conferences, discussions and information provision\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ahila.org\/\" target=\"_blank\">Association for Health Information and Libraries in Africa<\/a>: AHILA; an organization with a vision \"to become a leader in promoting access and use of health information in Africa\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.asist.org\/\" target=\"_blank\">Association for Information Science and Technology<\/a>: ASIS&T; a professional association which aims to discover \"new and better theories, techniques, and technologies to improve access to information\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/aisnet.org\/\" target=\"_blank\">Association for Information Systems<\/a>: AIS; a non-profit organization and \"professional association for individuals and organizations who lead the research, teaching, practice, and study of information systems worldwide\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pathologyinformatics.org\/\" target=\"_blank\">Association for Pathology Informatics<\/a>: API; seeks \"to promote the field of pathology informatics as an academic and a clinical subspecialty of pathology\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.avinformatics.org\/\" target=\"_blank\">Association for Veterinary Informatics<\/a>: AVI; \"a non-profit international and interdisciplinary organization comprised of individuals involved in biomedical informatics research, design, implementation, education and advocacy within the domain of veterinary medicine\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.clinicalscience.org\/\" target=\"_blank\">Association of Clinical Scientists<\/a>: a non-profit scientific and educational corporation \"dedicated to the advancement of research and learning in laboratory science\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/amdis.org\/\" target=\"_blank\">Association of Medical Directors of Information Systems<\/a>: AMDIS; a \"professional organization for physicians interested in and responsible for healthcare information technology\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/\" target=\"_blank\">Association of Public Health Laboratories<\/a>: APHL; a non-profit 501(c)(3) organization promoting public health laboratories<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.achi.org.au\/\" target=\"_blank\">Australasian College of Health Informatics<\/a>: ACHI; a \"professional body for health informatics in the Asia-Pacific region\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/aths.org.au\/\" target=\"_blank\">Australasian Telehealth Society<\/a>: ATHS; an incorporated association that acts as \"a forum for all of those involved in telehealth in Australia\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/my.rsc.org\/groups\/home\/47\" target=\"_blank\">Automation and Analytical Management Group of the Royal Society of Chemistry<\/a>: AAMG; a special interest group of the analytical division of the Royal Society of Chemistry (RSC)<\/li><\/ul>\n<p><br \/>\n<\/p>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.bmia.be\/\" target=\"_blank\">Belgian Medical Informatics Association<\/a>: MIM; a not-for-profit association which aims \"to promote and develop medical information science and technology in Belgium\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/bioinfo.pl\/\" target=\"_blank\">BioInfoBank Institute<\/a>: a non-for-profit research and development organization which aims \"to generate, incubate and inspire innovative ideas\" and \"productive research conducted by highly motivated excellent young scientists in Poland\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/bii.in\/\" target=\"_blank\">Bioinformatics Institute of India<\/a>: BII; registered under the Confrere Educational Society, aims \"to promote excellence in biotech, life sciences and pharma education\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.bioinformatics.org\/\" target=\"_blank\">Bioinformatics Organization<\/a>: an incorporated non-profit organization which aims to \"develop and maintain computational resources to facilitate world-wide communications and collaborations between people of all educational and professional levels\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.bcs.org\/\" target=\"_blank\">British Computer Society Health<\/a>: BCS; an international organization actings as \"the chartered institute for IT;\" aims \"to promote new thinking, education and knowledge sharing\" in the industry<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/scotshi.bcs.org\/\" target=\"_blank\">British Computer Society Health Scotland <\/a>: the Scottish branch of the BCS<\/li><\/ul>\n<p><br \/>\n<\/p>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.echima.ca\/\" target=\"_blank\">Canadian Health Information Management Association <\/a>: CHIMA; a national membership-based organization which aims to act as a \"change leader in health information management\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cnia.ca\/\" target=\"_blank\">Canadian Nursing Informatics Association<\/a>: CNIA; a national membership-based organization which aims \"to be the voice for nursing informatics in Canada\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aap.org\/en-us\/advocacy-and-policy\/aap-health-initiatives\/Informatics\/Pages\/Child-Health-Informatics-Center.aspx\" target=\"_blank\">Child Health Informatics Center<\/a>: CHIC; an American Academy of Pediatrics (AAP) effort \"to support and prepare pediatricians for the many changes that will be occurring over the next few years in regard to health information technology\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/chimecentral.org\/\" target=\"_blank\">College of Healthcare Information Management Executives<\/a>: CHIME; a non-profit \"professional organization for chief information officers and other senior healthcare IT leaders\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cahiim.org\/\" target=\"_blank\">Commission on Accreditation for Health Informatics and Information Management Education<\/a>: CAHIIM; a 501(c)3 not for profit organization that provides \"quality monitoring of academic programs in health information management and health informatics through maintenance of accreditation policies and processes\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cola.org\/\" target=\"_blank\">Commission on Office Laboratory Accreditation<\/a>: COLA; \"an independent, non-profit accreditor whose education program and standards enable clinical laboratories and staff to meet U.S. <a href=\"https:\/\/www.limswiki.org\/index.php\/CLIA\" class=\"mw-redirect wiki-link\" title=\"CLIA\" data-key=\"9c0b9bbf5c8d2310833a79d137ac621e\">CLIA<\/a> and other regulatory requirements\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cinc.org\/\" target=\"_blank\">Computing in Cardiology<\/a>: an incorporated non-profit and international society of scientists and professionals focused on examining the \"methods and results of computation\" in the study and application of cardiology and cardiovascular physiology<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/services.aap.org\/en\/community\/aap-councils\/clinical-information-technology\/\" target=\"_blank\">Council on Clinical Information Technology<\/a>: COCIT; an American Academy of Pediatrics (AAP) sub-group dedicated \"to support the development of health information technology\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.csbmili.cz\/en\" target=\"_blank\">Czech Society for Biomedical Engineering and Medical Informatics<\/a>: \u010cLS; a voluntary independent association of \"physicians, pharmacists and other personnel in healthcare and affiliated fields\" and other entities<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.cski.cz\/main.php?id=02.01.01.00Czech\" target=\"_blank\">Society for Cybernetics and Informatics<\/a>: CSKI; a society focused on the \"support and promotion of cybernetics, informatics and related fields\"<\/li><\/ul>\n<p><br \/>\n<\/p>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/digitalhealthcanada.com\/\" target=\"_blank\">Digital Health Canada<\/a>: DHC; a professional association dedicated to advancing the field of health informatics (formerly known as COACH: Canada's Health Informatics Association)<\/li><\/ul>\n<h4><span class=\"mw-headline\" id=\"E_through_J\">E through J<\/span><\/h4>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.entnet.jp\/index-j.html\" target=\"_blank\">Ear-Nose-Throat Informatics Society<\/a>: ENTIS-J; a Japanese society dedicated to information management in the ENT field<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ehealthinitiative.org\/\" target=\"_blank\">eHealth Initiative<\/a>: eHI; a national organization attempting \"to drive improvement in the quality of healthcare by promoting the use of technology and information\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.embnet.org\/\" target=\"_blank\">EMBnet - The Global Bioinformatics Network<\/a>: EMBnet; an initiative of the European Molecular Biology Laboratory (EMBL) that acts as \"a pioneer and a provider of bioinformatics services, expertise and training, across Europe and beyond\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/emergencyinformatics.org\/\" target=\"_blank\">Emergency Informatics Association<\/a>: EIA; \"to propose, track, publish, and promote projects in the emergency informatics domain in support of the EIA vision\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/efmi.org\/\" target=\"_blank\">European Federation for Medical Informatics<\/a>: EFMI; \"a nonprofit organisation concerned with the theory and practice of information science and technology within health and health science in a European context\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ehtel.eu\/\" target=\"_blank\">European Health Telematics Association<\/a>: EHTEL; \"a pan European multi-stakeholder forum providing a leadership and networking platform for European corporate, institutional and individual actors dedicated to the betterment of healthcare delivery through eHealth\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ercim.eu\/\" target=\"_blank\">European Research Consortium for Informatics and Mathematics<\/a>: ERCIM; a consortium that \"aims to foster collaborative work within the European research community and to increase co-operation with European industry\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.eurorec.org\/\" target=\"_blank\">EUROREC Institute<\/a>: \"an independent not-for-profit organisation, promoting in Europe the use of high quality <a href=\"https:\/\/www.limswiki.org\/index.php\/Electronic_health_record\" title=\"Electronic health record\" class=\"wiki-link\" data-key=\"f2e31a73217185bb01389404c1fd5255\">electronic health record<\/a> systems (EHRs)\"<\/li><\/ul>\n<p><br \/>\n<\/p>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fedip.org\/\" target=\"_blank\">Federation for Informatics Professionals<\/a>: FEDIP; continuing on in spirit of the work the UK Council for Health Informatics Professions was doing, FEDIP \"is the only public register for all informatics professionals in the UK dedicated to delivering better health and care through the advanced use of technology\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/fhts.ac.in\/\" target=\"_blank\">Foundation of Healthcare Technologies Society<\/a>: FHTS; an Indian association of \"professionals from diverse backgrounds\" attempting \"to work in collaboration and to utilize accessible technologies as a medium to facilitate improvement in overall population health\"<\/li><\/ul>\n<p><br \/>\n<\/p>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/observatories\/global-observatory-for-ehealth\" target=\"_blank\">Global Observatory for eHealth<\/a>: GOE; a WHO-backed initiative \"dedicated to the study of eHealth [and] its evolution and impact on health in countries\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.mygoblet.org\/\" target=\"_blank\">Global Organisation for Bioinformatics Learning, Education & Training<\/a>: GOBLET; a European coalition of individuals and organizations dedicated \"to coordinate world-wide bioinformatics training activities\" in a shared and mutually respectful way<\/li><\/ul>\n<p><br \/>\n<\/p>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.helina-online.org\/\" target=\"_blank\">Health Informatics in Africa<\/a>: HELINA; a pan-African health informatics association dedicated to developing education, research, and strategic plans related to health informatics in Africa<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.hinz.org.nz\/\" target=\"_blank\">Health Informatics New Zealand<\/a>: HINZ; a professional association that \"seeks to facilitate improved health care outcomes through the dissemination and utilisation of information, knowledge and technology\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.hisa.org.au\/\" target=\"_blank\">Health Informatics Society of Australia<\/a>: HISA; \"a not-for-profit membership organisation for health informaticians and those with an interest in health informatics\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.hisi.ie\/\" target=\"_blank\">Health Informatics Society of Ireland<\/a>: HISI; this organization \"bridges between computer professionals interested in health care, and health care professionals interested in computing \u2013 while supporting and embracing the new professionals of healthcare informatics\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.his.org.ng\/\" target=\"_blank\">Health Informatics Society of Nigeria<\/a>: HISN; \"a professional membership driven association, developed to serve the growing community of clinical science, information science, computer science and management science professionals who are tasked with managing the dynamic health information technology life cycle\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/himaa.org.au\/\" target=\"_blank\">Health Information Management Association of Australia<\/a>: HIMAA; an association turned national company that \"seeks to promote and support [its] members as the universally recognised specialists in information management at all levels of the healthcare system\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.hl7.org\/\" target=\"_blank\">Health Level Seven International<\/a>: HL7; \"a not-for-profit, ANSI-accredited standards developing organization dedicated to providing a comprehensive framework and related standards for the exchange, integration, sharing, and retrieval of electronic health information that supports clinical practice and the management, delivery, and evaluation of health services\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.hon.ch\/en\/\" target=\"_blank\">Health On the Net Foundation<\/a>: HON; a non-governmental organization that \"promotes and guides the deployment of useful and reliable online health information, and its appropriate and efficient use\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.hisi.ie\/\" target=\"_blank\">Healthcare Informatics Society of Ireland<\/a>: HISI; incorporates the Healthcare Informatics sections of the Royal Academy of Medicine in Ireland and of the Irish Computer Society; strives to develop knowledge and promote research in healthcare informatics<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.himss.org\/\" target=\"_blank\">Healthcare Information and Management Systems Society<\/a>: HIMSS; a \"not-for-profit organization exclusively focused on providing global leadership for the optimal use of information technology (IT) and management systems for the betterment of healthcare\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ehra.org\/\" target=\"_blank\">HIMSS EHR Association<\/a>: HIMSS EHRA; \"a trade association of electronic health record (EHR) companies, addressing national efforts to create interoperable EHRs in hospital and ambulatory care settings\"<\/li><\/ul>\n<p><br \/>\n<\/p>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.embs.org\/\" target=\"_blank\">IEEE Engineering in Medicine and Biology Society<\/a>: IEEE EMBS; an international society of biomedical engineers \"focused on the development and application of engineering concepts and methods to provide new solutions to biological, medical and healthcare problems\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ieee-tems.org\/\" target=\"_blank\">IEEE Technology Management Council<\/a>: IEEE TMC; an international organization that \"provides information and services to IEEE members and the worldwide audience of practitioners and researchers engaged in the profession of engineering, technology, and innovation management\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ihe.net\/\" target=\"_blank\">IHE International<\/a>: IHE; \"an initiative by healthcare professionals and industry to improve the way computer systems in healthcare share information\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iami.org.in\/\" target=\"_blank\">Indian Association for Medical Informatics<\/a>: IAMI; an Indian association dedicated to medical specialists using informatics \"into a common thread for the benefit of the patients and provoking an interdisciplinary research\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.information-institute.org\/\" target=\"_blank\">Information Institute<\/a>: a non-profit policy research and educational organization comprised of academics and industry representatives dedicated \"to further[ing] understanding of intricate relationships between information science and technology\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ipab.org\/\" target=\"_blank\">Initiative for Parallel Bioinformatics<\/a>: IPAB; a Japanese initiative to accelerate the use of technology for performing information processing in the field of bioinformatics<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ieee.org\/\" target=\"_blank\">Institute of Electrical and Electronics Engineers<\/a>: IEEE; a \"professional association dedicated to advancing technological innovation and excellence for the benefit of humanity\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ihrim.co.uk\/\" target=\"_blank\">Institute of Health Records & Information Management<\/a>: IHRIM; an educational body dedicated \"to provide qualifications at different levels as well as career and professional assistance for members\" from \"the fields of health records, information management, clinical coding and information governance\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ica.org\/en\" target=\"_blank\">International Council on Archives<\/a>: ICA; a non-governmental, member-funded organization \"dedicated to the effective management of records and the preservation, care and use of the world's archival heritage\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifip.org\/\" target=\"_blank\">International Federation for Information Processing<\/a>: IFIP; \"a non-governmental, non-profit umbrella organization for national societies working in the field of information processing\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ifhima.org\/\" target=\"_blank\">International Federation of Health Information Management Associations<\/a>: IFHIMA; a non-profit organization affiliated with the World Health Organization (WHO) as a non-governmental organization that \"supports national associations and health record professionals to implement and improve health records and the systems which support them\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/imia-medinfo.org\/\" target=\"_blank\">International Medical Informatics Association<\/a>: IMIA; an \"association of associations\" which acts as a bridge between constituent organizations and their members to better \"enable the transformation of healthcare in accord with the world-wide vision of improving the health of the world population\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.isber.org\/\" target=\"_blank\">International Society for Biological and Environmental Repositories<\/a>: ISBER; a division of the American Society for Investigative Pathology, \"promoting harmonized high quality standards, ethical principles and innovation in the science and management of biospecimen collection, processing, storage, distribution and use\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iscb.info\/\" target=\"_blank\">International Society for Clinical Biostatistics<\/a>: ISCB; a professional organization dedicated \"to [stimulating] research into the principles and methodology used in the design and analysis of clinical research and to increase the relevance of statistical theory to the real world of clinical medicine\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iscb.org\/\" target=\"_blank\">International Society for Computational Biology<\/a>: ISCB; a non-profit corporation \"addressing scientific policies, providing access to high quality publications, organizing meetings, and serving as a portal to information about training, education, employment and news\" for those in the field of bioinformatics and computational biology<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ispe.org\/\" target=\"_blank\">International Society for Pharmaceutical Engineering<\/a>: ISPE; an international society of scientific and technical personnel in the pharmaceutical manufacturing industry, \"committed to the advancement of the educational and technical efficiency of its members through forums for the exchange of ideas and practical experience\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iqvia.com\/insights\/the-iqvia-institute\" target=\"_blank\">IQVIA Institute for Human Data Science<\/a>: an outgrowth of the IMS Institute for Healthcare Informatics\u2014which was part of IMS Health, which merged with Quintiles to form IQVIA\u2014the institute \"contributes to the advancement of human health globally through timely research, insightful analysis and scientific expertise applied to granular non-identified patient-level data\"<\/li><\/ul>\n<p><br \/>\n<\/p>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.jami.jp\/english\/\" target=\"_blank\">Japan Association for Medical Informatics<\/a>: JAMI; a Japanese professional association dedicated to sharing academic research related to medical informatics<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.jami-ni.jp\/\" target=\"_blank\">Japan Association for Medical Informatics - Nursing Informatics<\/a>: JAMI-NI; the JAMI subcommittee on nursing informatics<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/jcls.or.jp\/\" target=\"_blank\">Japan Association for Clinical Laboratory Science<\/a>: formerly the Japan Society for Clinical Laboratory Automation, this association attempts to \"contribute to precise diagnosis, appropriate treatment, and better health care by applying the latest technologies to clinical laboratories\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/jhim-e.com\/\" target=\"_blank\">Japan Society of Health Information Management<\/a>: JHIM; a Japanese scientific organization dedicated to \"establishing, implementing, and promoting the science of health information (record) management in Japan\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.jsbi.org\/\" target=\"_blank\">Japanese Society for Bioinformatics<\/a>: JSBi; a Japanese professional association dedicated \"to develop[ing] the discipline of bioinformatics in Japan\" as well as \"the promotion of the technology and related business\" aspects of bioinformatics<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.jasdi.jp\/\" target=\"_blank\">Japanese Society of Drug Informatics<\/a>: JASDI; a Japanese professional association dedicated to \"contributing to the improvement and advancement [of] pharmaceutical medicine ... as well as the improvement of science education and research on drug information\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.jisc.ac.uk\/\" target=\"_blank\">JISC<\/a>: a registered U.K. charity dedicated to promoting \"the innovative use of information and communication technology to support education, research and institutional effectiveness\"<\/li><\/ul>\n<h4><span class=\"mw-headline\" id=\"K_through_Z\">K through Z<\/span><\/h4>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/kehia.org\/\" target=\"_blank\">Kenya Health Informatics Association<\/a>: KeHIA; a professional association dedicated \"to further[ing] the health and biomedical agenda in Kenya to support the government's initiatives to improve and sustain quality health services for all Kenyans\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.kdd.org\/\" target=\"_blank\">KDD<\/a>: a sub-group of the Association for Computing Machinery, promoting the \"advancement and adoption of the 'science' of knowledge discovery and data mining\"<\/li><\/ul>\n<p><br \/>\n<\/p>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.lrig.org\/\" target=\"_blank\">Laboratory Research & Innovation Group<\/a> LRIG; formerly the Laboratory Robotics Interest Group, this is a \"special interest group focused on laboratory automation\"<\/li><\/ul>\n<p><br \/>\n<\/p>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.markle.org\/\" target=\"_blank\">Markle Foundation<\/a>: a private foundation with the goal of helping others \"realize the potential of information technology to address previously intractable public problems, for the health and security of all Americans\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.mcsiindia.com\/\" target=\"_blank\">Medical Computer Society of India<\/a>: MCSI; a professional society dedicated to promoting the use of computer technology to better patient outcomes<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.meditac.com\/\" target=\"_blank\">Medical Informatics and Technology Applications Consortium<\/a>: MedITAC; \"a unique NASA Research Partnership Center (RPC), established to develop, evaluate, and promote information and medical technologies for space flight and ground applications\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.mlanet.org\/\" target=\"_blank\">Medical Library Association<\/a>: MLA; a nonprofit, educational organization \"committed to educating health information professionals, supporting health information research, [and] promoting access to the world's health sciences information\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.msia.com.au\/\" target=\"_blank\">Medical Software Industry Association<\/a>: MSIA; a membership-based professional association representing \"the interests of the Australian commercial software industry which develops, supplies and services information management products and services for healthcare practitioners, healthcare service providers and healthcare organisations\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.medtecheurope.org\/\" target=\"_blank\">MedTech Europe<\/a>: formerly the European Diagnostic Manufacturer\u2019s Association and Eucomed, the two combined to form MedTech Europe, a \"trade association for the medical technology industry including diagnostics, medical devices and digital health\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.meahi.org\/\" target=\"_blank\">Middle East Association for Health Informatics<\/a>: MEAHI; a not-for-profit organization \"trying to use regional as well as global potentials to provide a collaborative environment, in which requirements are discussed, solutions are provided, and resources are allocated to tackle healthcare issues of this vulnerable part of the world\"<\/li><\/ul>\n<p><br \/>\n<\/p>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nationalacademies.org\/\" target=\"_blank\">National Academies<\/a>: a collection of U.S. \"private, nonprofit institutions that provide expert advice on some of the most pressing challenges facing the nation and the world,\" including sciences, engineering, medicine, and research<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.nahdo.org\/\" target=\"_blank\">National Association of Health Data Organizations<\/a>: NAHDO; a U.S. \"non-profit membership and educational association dedicated to improving health care data collection and use\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.nihi.ca\/\" target=\"_blank\">National Institutes of Health Informatics<\/a>: NIHI; a Canadian not-for-profit corporation \"dedicated to fostering health informatics (HI) innovation, research and education\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nelac-institute.org\/index.php\" target=\"_blank\">The NELAC Institute<\/a>: TNI; a \"non-profit organization whose mission is to foster the generation of environmental data of known and documented quality through an open, inclusive, and transparent process that is responsive to the needs of the community\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ndltd.org\/\" target=\"_blank\">Networked Digital Library of Theses and Dissertations<\/a>: NDLTD; \"an international organization dedicated to promoting the adoption, creation, use, dissemination, and preservation of electronic theses and dissertations\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.nenic.org\/\" target=\"_blank\">New England Nursing Informatics Consortium<\/a>: NENIC; \"a dynamic regional organization of nurses, allied healthcare professionals, and HIT solution providers\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.bcs.org\/membership\/member-communities\/nursing-specialist-group\/\" target=\"_blank\">Nursing Specialist Group<\/a>: NSG; a British Computer Society-related \"U.K. organisation for nurses and therapists interested in the management and use of information and communications technology to improve the quality, delivery and recording of care\"<\/li><\/ul>\n<p><br \/>\n<\/p>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/onig.on.ca\/\" target=\"_blank\">Ontario Nursing Informatics Group<\/a>: ONIG; a professional group attempting \"to provide a forum for nursing professionals to communicate and disseminate current developments in health care information systems\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.openehr.org\/about\/vision_and_mission\" target=\"_blank\">openEHR Foundation<\/a>: a not-for-profit company that develops specification, clinical model, and other medical programs and also supports health informatics education<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/oscarcanada.org\/usersgroups\/oscarcanada-users-society\" target=\"_blank\">OSCAR Canada Users' Society<\/a>: OCUS; a not-for-profit society dedicated to promoting the education and use of OSCAR, \"a suite of open-source applications including an electronic medical record\"<\/li><\/ul>\n<p><br \/>\n<\/p>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/phii.org\/\" target=\"_blank\">Public Health Informatics Institute<\/a>: PHII; a non-profit organization acting \"as a neutral convener of public health professionals and their stakeholders, transforming health practitioners' ability to apply information effectively in order to improve health outcomes worldwide\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.plos.org\/\" target=\"_blank\">Public Library of Science<\/a>: PLOS; a not-for-profit \"publisher, membership, and advocacy organization with a mission to accelerate progress in science and medicine by leading a transformation in research communication\"<\/li><\/ul>\n<p><br \/>\n<\/p>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.regenstrief.org\/\" target=\"_blank\">Regenstrief Institute<\/a>: RI; an informatics and healthcare research organization dedicated to \"improving quality of care, increasing efficiency of healthcare delivery, preventing medical errors and enhancing patient safety\"<\/li><\/ul>\n<p><br \/>\n<\/p>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/sparcopen.org\/\" target=\"_blank\">Scholarly Publishing & Academic Resources Coalition<\/a>: SPARC; \"an international alliance of academic and research libraries working to correct imbalances in the scholarly publishing system\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.sigcomm.org\/\" target=\"_blank\">SIGCOMM<\/a>: a special interest group of the Association for Computing Machinery (ACM) dedicated to finding answers to \"systems engineering and architectural questions surrounding computer communication\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.snomed.org\/\" target=\"_blank\">SNOMED International<\/a>: SNOMED; the not-for-profit association that owns and maintains SNOMED CT, a comprehensive and multilingual set of clinical terminology<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/siim.org\/\" target=\"_blank\">Society for Imaging Informatics in Medicine<\/a>: SIIM; a \"leading healthcare professional organization for those interested in the current and future use of informatics in medical imaging\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/slas.org\/\" target=\"_blank\">Society for Laboratory Automation and Screening<\/a>: SLAS; \"a global organization that exists to provide forums for education and information exchange to encourage the study of, and improve the science and practice of, laboratory automation and screening\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sfmi.se\/\" target=\"_blank\">Swedish Association of Medical Informatics<\/a>: SFMI; a professional association that strives \"to promote the development of informatics in health care, in particular through the organization of meetings with scientific lectures and discussions\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sib.swiss\/\" target=\"_blank\">Swiss Institute of Bioinformatics<\/a>: SIB; an academic, non-profit foundation that \"coordinates research and education in bioinformatics throughout Switzerland and provides high quality bioinformatics services to the national and international research community\"<\/li><\/ul>\n<p><br \/>\n<\/p>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/uacm.kharkov.ua\/eng\/index.html\" target=\"_blank\">Ukrainian Association for Computer Medicine<\/a>: UACM; an independent non-governmental non-commercial organization dedicated to furthering the use of computers and other technology in medicine<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.umin.ac.jp\/english\/\" target=\"_blank\">University hospital Medical Information Network<\/a>: UMIN; \"a cooperative organization for national medical schools in Japan\"<\/li><\/ul>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.urac.org\/\" target=\"_blank\">URAC<\/a>: an independent, nonprofit organization \"promoting health care quality through its accreditation, education and measurement programs\"<\/li><\/ul>\n<p><br \/>\n<\/p>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.vanbug.org\/\" target=\"_blank\">Vancouver Bioinformatics Users Group<\/a>: VanBUG; \"an association of researchers, other professionals and students in the B.C. Lower Mainland who have an interest in the field of bioinformatics\"<\/li><\/ul>\n<!-- \nNewPP limit report\nCached time: 20220125221421\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.019 seconds\nReal time usage: 0.028 seconds\nPreprocessor visited node count: 28\/1000000\nPost\u2010expand include size: 62232\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 4\/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% 7.628 1 -total\n100.00% 7.628 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Trade_organizations\n 51.77% 3.949 1 Template:Resources\/Organizations\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12946-0!canonical and timestamp 20220125221421 and revision id 45843. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Trade_organizations\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Trade_organizations<\/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>","1dca96282078cc576add1d583de19527_images":[],"1dca96282078cc576add1d583de19527_timestamp":1643149334,"b89eb59ef012aafa0f5cde1de5ac497a_type":"article","b89eb59ef012aafa0f5cde1de5ac497a_title":"4.5 Consultants","b89eb59ef012aafa0f5cde1de5ac497a_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/Consultants","b89eb59ef012aafa0f5cde1de5ac497a_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 2: Other vendors and service providers\/ConsultantsFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n4.5 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\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\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\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\nup to data professional services GmbH\n\nW\u00f6rrstadt, Germany\n\nLaboratory informatics, LIMS, custom development, Thermo Scientific products, 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\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: Part 2: Other vendors and service providers\nTitle: Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\nEdition: 2022 Edition\nAuthor for citation: Shawn E. Douglas\nLicense for content: Creative Commons Attribution-ShareAlike 4.0 International\nPublication date: January 2022\n\r\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/Consultants\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/Consultants<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:14.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 54 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","b89eb59ef012aafa0f5cde1de5ac497a_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Resources_for_selecting_and_implementing_informatics_solutions_Part_2_Other_vendors_and_service_providers_Consultants rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Resources_for_selecting_and_implementing_informatics_solutions_Part_2_Other_vendors_and_service_providers_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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 2: Other vendors and service providers\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">the beginning<\/a> of this guide-----<\/div>\n<h2><span class=\"mw-headline\" id=\"4.5_Consultants\">4.5 Consultants<\/span><\/h2>\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 style=\"line-height: 50px; vertical-align: middle;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/astrixinc.com\/\" target=\"_blank\">Astrix, Inc.<\/a> <div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Astrix_145.jpg\" class=\"image wiki-link\" data-key=\"1bad1f08a76c6872ac53925adbe87863\"><img alt=\"Astrix 145.jpg\" src=\"https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/e\/e2\/Astrix_145.jpg\" decoding=\"async\" width=\"120\" height=\"52\" \/><\/a><\/div>\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\/services\/\" 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:\/\/brevitas.us\/lab-informatics\/\" 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 style=\"line-height: 60px; vertical-align: middle;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/CSols,_Inc.\" title=\"CSols, Inc.\" class=\"wiki-link\" data-key=\"d2fdccdc0381a8bfdfaa0f256f28c3ee\">CSols, Inc.<\/a> <div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Vendor449.jpg\" class=\"image wiki-link\" data-key=\"b58b63cd05e9d805c6033990956d3ae5\"><img alt=\"Vendor449.jpg\" src=\"https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/c\/cf\/Vendor449.jpg\" decoding=\"async\" width=\"120\" height=\"76\" \/><\/a><\/div>\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:\/\/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 style=\"line-height: 50px; vertical-align: middle;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/Kalleid,_Inc.\" title=\"Kalleid, Inc.\" class=\"wiki-link\" data-key=\"12f59459a3ea995dc9684890ab6a46c7\">Kalleid, Inc.<\/a> <div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Kalleid_145.jpg\" class=\"image wiki-link\" data-key=\"cdca5d32cf035d86aebeeb7d98f834f0\"><img alt=\"Kalleid 145.jpg\" src=\"https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/f\/fe\/Kalleid_145.jpg\" decoding=\"async\" width=\"120\" height=\"29\" \/><\/a><\/div>\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\/index.html\" 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\/laboratory-lims-consultant.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-informatics\/\" 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=\"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:\/\/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:\/\/uptodata.de\/home-en.html\" target=\"_blank\">up to data professional services GmbH<\/a>\n<\/td>\n<td>W\u00f6rrstadt, Germany\n<\/td>\n<td>Laboratory informatics, LIMS, 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, etc.\n<\/td>\n<td><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/uptodata.de\/it-services-en.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.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<p><br \/>\n<\/p>\n<div align=\"center\">-----Go to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Trade_organizations\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 3: Industry and community resources\/Trade organizations\" class=\"wiki-link\" data-key=\"1dca96282078cc576add1d583de19527\">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: Part 2: Other vendors and service providers\n<\/p><p><b>Title<\/b>: <i>Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research<\/i>\n<\/p><p><b>Edition<\/b>: 2022 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 2022\n<\/p><p><br \/>\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20220125221420\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.034 seconds\nReal time usage: 0.095 seconds\nPreprocessor visited node count: 40\/1000000\nPost\u2010expand include size: 33184\/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% 7.178 1 -total\n100.00% 7.178 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/Consultants\n 53.94% 3.872 1 Template:LIMS,_LIS,_and_laboratory\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12945-0!canonical and timestamp 20220125221420 and revision id 45842. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/Consultants\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/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>","b89eb59ef012aafa0f5cde1de5ac497a_images":["https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/e\/e2\/Astrix_145.jpg","https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/c\/cf\/Vendor449.jpg","https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/f\/fe\/Kalleid_145.jpg"],"b89eb59ef012aafa0f5cde1de5ac497a_timestamp":1643149333,"e05bbc55003d6664467a36acf6d8a411_type":"article","e05bbc55003d6664467a36acf6d8a411_title":"4.4 Laboratory billing service providers","e05bbc55003d6664467a36acf6d8a411_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/Laboratory_billing_service_providers","e05bbc55003d6664467a36acf6d8a411_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 2: Other vendors and service providers\/Laboratory billing service providersFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n4.4 Laboratory billing service providers \nThese businesses are known to provide revenue management and improvement services to laboratories. Additionally, a handful of these businesses may also offer their own laboratory billing software solutions in addition to providing billing services.\n\nAdvanced Data Systems Corporation\nAdvantEdge Healthcare Solutions\nAffinity Billing, Inc.\nAMC Billing Services, LLC\nAPS Medical Billing, Inc.\nBikham Information Technology Corporation\nChange Healthcare, Inc.\nClaimCare, Inc.\nCollaborateMD, Inc.\nCoronis Health\nHealthteq Services, LLC\nMedcare MSO, LLC\nMedConverge, LLC\nMedsphere Systems Corporation\nMPM, Inc.\nThe Negotiators, LLC\nPhoenix Healthcare Services, Inc.\nPhysicians Group Management, LLC\nPractiSource, LLC\nQuadax, Inc.\nQuest National Services, LLC\nRPM Billing, LLC\nSoftactics, Inc.\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/Laboratory_billing_service_providers\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/Laboratory_billing_service_providers<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:14.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 33 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","e05bbc55003d6664467a36acf6d8a411_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Resources_for_selecting_and_implementing_informatics_solutions_Part_2_Other_vendors_and_service_providers_Laboratory_billing_service_providers rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Resources_for_selecting_and_implementing_informatics_solutions_Part_2_Other_vendors_and_service_providers_Laboratory_billing_service_providers 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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 2: Other vendors and service providers\/Laboratory billing service providers<\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">the beginning<\/a> of this guide-----<\/div>\n<h3><span class=\"mw-headline\" id=\"4.4_Laboratory_billing_service_providers\">4.4 Laboratory billing service providers<\/span><\/h3>\n<p>These businesses are known to provide revenue management and improvement services to laboratories. Additionally, a handful of these businesses may also offer their own laboratory billing software solutions in addition to providing billing services.\n<\/p>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.adsc.com\/laboratory-billing-services\" target=\"_blank\">Advanced Data Systems Corporation<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ahsrcm.com\/solutions\/billing\/\" target=\"_blank\">AdvantEdge Healthcare Solutions<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.affinitybilling.com\/\" target=\"_blank\">Affinity Billing, Inc.<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/amcbillingservices.com\/\" target=\"_blank\">AMC Billing Services, LLC<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/apsmedbill.com\/\" target=\"_blank\">APS Medical Billing, Inc.<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.bikham.com\/medical-laboratory-billing-services\" target=\"_blank\">Bikham Information Technology Corporation<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.changehealthcare.com\/revenue-cycle-management\/reimbursement-management\/physician-revenue-cycle-services\/clinical-labs\" target=\"_blank\">Change Healthcare, Inc.<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/claimcare.com\/\" target=\"_blank\">ClaimCare, Inc.<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.collaboratemd.com\/collaboratemd-pricing\/medical-billing-and-labs\/\" target=\"_blank\">CollaborateMD, Inc.<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.coronishealth.com\/about\/companies\/lab-billing\/\" target=\"_blank\">Coronis Health<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/healthteqservices.com\/\" target=\"_blank\">Healthteq Services, LLC<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/medcaremso.com\/\" target=\"_blank\">Medcare MSO, LLC<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.medconverge.com\/\" target=\"_blank\">MedConverge, LLC<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.medsphere.com\/who-we-serve\/labs\/\" target=\"_blank\">Medsphere Systems Corporation<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/metropm.com\/\" target=\"_blank\">MPM, Inc.<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sunshinebilling.com\/\" target=\"_blank\">The Negotiators, LLC<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/phoenixhcs.com\/laboratory-billing\/\" target=\"_blank\">Phoenix Healthcare Services, Inc.<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pgmbilling.com\/\" target=\"_blank\">Physicians Group Management, LLC<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.practisource.com\/medical-and-lab-billing\/\" target=\"_blank\">PractiSource, LLC<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.quadax.com\/laboratory-revenue-cycle-management-software-solutions-billing-services\/\" target=\"_blank\">Quadax, Inc.<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/questns.com\/\" target=\"_blank\">Quest National Services, LLC<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/rpmbilling.com\/\" target=\"_blank\">RPM Billing, LLC<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.softactics.com\/\" target=\"_blank\">Softactics, Inc.<\/a><\/li><\/ul>\n<!-- \nNewPP limit report\nCached time: 20220125221420\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.006 seconds\nReal time usage: 0.019 seconds\nPreprocessor visited node count: 5\/1000000\nPost\u2010expand include size: 1949\/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% 14.164 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/Laboratory_billing_service_providers\n100.00% 14.164 1 -total\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12944-0!canonical and timestamp 20220125221420 and revision id 45841. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/Laboratory_billing_service_providers\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/Laboratory_billing_service_providers<\/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>","e05bbc55003d6664467a36acf6d8a411_images":[],"e05bbc55003d6664467a36acf6d8a411_timestamp":1643149333,"4bdc6fd01d0fcfb0f617fefa536a6e60_type":"article","4bdc6fd01d0fcfb0f617fefa536a6e60_title":"4.3 Laboratory business intelligence (BI) and workflow solution vendors","4bdc6fd01d0fcfb0f617fefa536a6e60_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/Laboratory_business_intelligence_(BI)_and_workflow_solution_vendors","4bdc6fd01d0fcfb0f617fefa536a6e60_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 2: Other vendors and service providers\/Laboratory business intelligence (BI) and workflow solution vendorsFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n 4.3 Laboratory business intelligence (BI) and workflow solution vendors \nThese vendors provide software solutions that provide optimization of and insight into the business processes of a laboratory, from revenue management and client interaction to compliance management and process analysis. Some companies such as Soft Computer and Sunquest provide an entire suite of applications, while others focus on specific aspects of running a medical or research laboratory. For additional insight into selecting a BI solution for the medical laboratory, see Arezou Taheri's 2014 open-access journal article (HTML, PDF) on the subject. While dated, its list of key selection factors still largely remains relevant.\n\nAbbott Laboratories, Inc.\nAccumen, Inc.\nAdvanced Data Systems Corporation\nAdvancedMD, Inc.\nAttune Technologies Pvt. Ltd.\nCompuGroup Medical AG\nhc1, Inc.\nOrchard Software Corporation\nProscia, Inc.\nQuadax, Inc.\nSchillaci Computer Service, Inc.\nSisense, Inc.\nSoft Computer Consultants, Inc.\nSoftware Point Oy\nSunquest Information Systems, Inc.\nXIFIN, Inc\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/Laboratory_business_intelligence_(BI)_and_workflow_solution_vendors\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/Laboratory_business_intelligence_(BI)_and_workflow_solution_vendors<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:14.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 64 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","4bdc6fd01d0fcfb0f617fefa536a6e60_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Resources_for_selecting_and_implementing_informatics_solutions_Part_2_Other_vendors_and_service_providers_Laboratory_business_intelligence_BI_and_workflow_solution_vendors rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Resources_for_selecting_and_implementing_informatics_solutions_Part_2_Other_vendors_and_service_providers_Laboratory_business_intelligence_BI_and_workflow_solution_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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 2: Other vendors and service providers\/Laboratory business intelligence (BI) and workflow solution 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">the beginning<\/a> of this guide-----<\/div>\n<h3><span id=\"rdp-ebb-4.3_Laboratory_business_intelligence_(BI)_and_workflow_solution_vendors\"><\/span><span class=\"mw-headline\" id=\"4.3_Laboratory_business_intelligence_.28BI.29_and_workflow_solution_vendors\">4.3 Laboratory business intelligence (BI) and workflow solution vendors<\/span><\/h3>\n<p>These vendors provide software solutions that provide optimization of and insight into the business processes of a laboratory, from revenue management and client interaction to compliance management and process analysis. Some companies such as Soft Computer and Sunquest provide an entire suite of applications, while others focus on specific aspects of running a medical or research laboratory. For additional insight into selecting a BI solution for the medical laboratory, see Arezou Taheri's 2014 open-access journal article (<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20200211025016\/https:\/\/www.ijcttjournal.org\/archives\/ijctt-v16p127\" target=\"_blank\">HTML<\/a>, <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20200211025017\/http:\/\/www.ijcttjournal.org\/Volume16\/number-3\/IJCTT-V16P127.pdf\" target=\"_blank\">PDF<\/a>) on the subject. While dated, its list of key selection factors still largely remains relevant.\n<\/p>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.corelaboratory.abbott\/us\/en\/offerings\/brands\/aliniq\/aliniq-bis\" target=\"_blank\">Abbott Laboratories, Inc.<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/accumen.com\/\" target=\"_blank\">Accumen, Inc.<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.adsc.com\/lab-software\" target=\"_blank\">Advanced Data Systems Corporation<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.advancedmd.com\/specialties\/laboratory\/\" target=\"_blank\">AdvancedMD, Inc.<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/attunelive.com\/bi-solutions-for-labs\/\" target=\"_blank\">Attune Technologies Pvt. Ltd.<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cgm.com\/usa_en\/products\/lab-management-software\/cgm-labnexus.html\" target=\"_blank\">CompuGroup Medical AG<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.hc1.com\/solutions\/operations-management\/\" target=\"_blank\">hc1, Inc.<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.orchardsoft.com\/solutions\/orchard-outreach\/\" target=\"_blank\">Orchard Software Corporation<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/proscia.com\/\" target=\"_blank\">Proscia, Inc.<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.quadax.com\/laboratory-revenue-cycle-management-software-solutions-billing-services\/\" target=\"_blank\">Quadax, Inc.<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.armaninollp.com\/software\/microsoft-dynamics-gp\/\" target=\"_blank\">Schillaci Computer Service, Inc.<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sisense.com\/solutions\/healthcare\/\" target=\"_blank\">Sisense, Inc.<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.softcomputer.com\/products-services\/outreach\/\" target=\"_blank\">Soft Computer Consultants, Inc.<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/softwarepoint.com\/laboratories\/laboratory-intelligence\" target=\"_blank\">Software Point Oy<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sunquestinfo.com\/software-and-services\/psc-portal\/\" target=\"_blank\">Sunquest Information Systems, Inc.<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.xifin.com\/solutions\/business-intelligence\" target=\"_blank\">XIFIN, Inc<\/a><\/li><\/ul>\n<!-- \nNewPP limit report\nCached time: 20220125221420\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.007 seconds\nReal time usage: 0.036 seconds\nPreprocessor visited node count: 5\/1000000\nPost\u2010expand include size: 2232\/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% 15.356 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/Laboratory_business_intelligence_(BI)_and_workflow_solution_vendors\n100.00% 15.356 1 -total\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12943-0!canonical and timestamp 20220125221420 and revision id 45840. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/Laboratory_business_intelligence_(BI)_and_workflow_solution_vendors\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/Laboratory_business_intelligence_(BI)_and_workflow_solution_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>","4bdc6fd01d0fcfb0f617fefa536a6e60_images":[],"4bdc6fd01d0fcfb0f617fefa536a6e60_timestamp":1643149333,"ed5267dc612120980decc29d603ba1e8_type":"article","ed5267dc612120980decc29d603ba1e8_title":"4.2 EHR vendors","ed5267dc612120980decc29d603ba1e8_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/EHR_vendors","ed5267dc612120980decc29d603ba1e8_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 2: Other vendors and service providers\/EHR vendorsFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n4.2 EHR vendors \nAn electronic health record (EHR) is \"defined as a longitudinal collection of electronic health information about individual patients and populations.\"[1] It is a record in digital format that is theoretically capable of being shared across different health care settings. In some cases, this sharing can occur by way of network-connected enterprise-wide information systems and other information networks or exchanges. \nIn the United States, many EHRs have been certified by the Office of the National Coordinator's (ONC) Health IT Certification Program. Those certifications are based on \"standards, implementation specifications and certification criteria adopted by the Secretary.\"[2] The ONC's Certified Health IT Product List is an excellent resource for browsing EHR and electronic medical record (EMR) vendors. It can be found at https:\/\/chpl.healthit.gov\/. One approach is to click the \"Browse All' button, then on the new screen select \"Certification Status\" and uncheck \"Suspended by ONC\" and \"Suspended by ONC-ACB.\" That will give you a list of active results. Of course, you can apply additional filters, compare products (including certification criteria and clinical quality measures), and download results.\n\nReferences \n\n\n\u2191 Gunter, T.D.; Terry, N.P. (2005). \"The Emergence of National Electronic Health Record Architectures in the United States and Australia: Models, Costs, and Questions\". Journal of Medical Internet Research 7 (1): e3. doi:10.2196\/jmir.7.1.e3. PMC PMC1550638. PMID 15829475. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC1550638 .   \n \n\n\u2191 Office of the National Coordinator for Health Information Technology (9 November 2021). \"About The ONC Health IT Certification Program\". HealthIT.gov. https:\/\/www.healthit.gov\/topic\/certification-ehrs\/about-onc-health-it-certification-program . Retrieved 19 November 2021 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/EHR_vendors\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/EHR_vendors<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:14.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 27 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","ed5267dc612120980decc29d603ba1e8_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Resources_for_selecting_and_implementing_informatics_solutions_Part_2_Other_vendors_and_service_providers_EHR_vendors rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Resources_for_selecting_and_implementing_informatics_solutions_Part_2_Other_vendors_and_service_providers_EHR_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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 2: Other vendors and service providers\/EHR 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">the beginning<\/a> of this guide-----<\/div>\n<h3><span class=\"mw-headline\" id=\"4.2_EHR_vendors\">4.2 EHR vendors<\/span><\/h3>\n<p>An <a href=\"https:\/\/www.limswiki.org\/index.php\/Electronic_health_record\" title=\"Electronic health record\" class=\"wiki-link\" data-key=\"f2e31a73217185bb01389404c1fd5255\">electronic health record<\/a> (EHR) is \"defined as a longitudinal collection of electronic health information about individual patients and populations.\"<sup id=\"rdp-ebb-cite_ref-GunterTerryEHR_1-0\" class=\"reference\"><a href=\"#cite_note-GunterTerryEHR-1\">[1]<\/a><\/sup> It is a record in digital format that is theoretically capable of being shared across different health care settings. In some cases, this sharing can occur by way of network-connected enterprise-wide information systems and other <a href=\"https:\/\/www.limswiki.org\/index.php\/Information\" title=\"Information\" class=\"wiki-link\" data-key=\"6300a14d9c2776dcca0999b5ed940e7d\">information<\/a> networks or exchanges. \n<\/p><p>In the United States, many EHRs have been certified by the Office of the National Coordinator's (ONC) Health IT Certification Program. Those certifications are based on \"standards, implementation specifications and certification criteria adopted by the Secretary.\"<sup id=\"rdp-ebb-cite_ref-HITAbout19_2-0\" class=\"reference\"><a href=\"#cite_note-HITAbout19-2\">[2]<\/a><\/sup> The ONC's <i>Certified Health IT Product List<\/i> is an excellent resource for browsing EHR and <a href=\"https:\/\/www.limswiki.org\/index.php\/Electronic_medical_record\" title=\"Electronic medical record\" class=\"wiki-link\" data-key=\"99a695d2af23397807da0537d29d0be7\">electronic medical record<\/a> (EMR) vendors. It can be found at <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/chpl.healthit.gov\/#\/search\" target=\"_blank\">https:\/\/chpl.healthit.gov\/<\/a>. One approach is to click the \"Browse All' button, then on the new screen select \"Certification Status\" and uncheck \"Suspended by ONC\" and \"Suspended by ONC-ACB.\" That will give you a list of active results. Of course, you can apply additional filters, compare products (including certification criteria and clinical quality measures), and download results.\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-GunterTerryEHR-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-GunterTerryEHR_1-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Gunter, T.D.; Terry, N.P. (2005). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC1550638\" target=\"_blank\">\"The Emergence of National Electronic Health Record Architectures in the United States and Australia: Models, Costs, and Questions\"<\/a>. <i>Journal of Medical Internet Research<\/i> <b>7<\/b> (1): e3. <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\/10.2196%2Fjmir.7.1.e3\" target=\"_blank\">10.2196\/jmir.7.1.e3<\/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\/PMC1550638\/\" target=\"_blank\">PMC1550638<\/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\/15829475\" target=\"_blank\">15829475<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC1550638\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC1550638<\/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+Emergence+of+National+Electronic+Health+Record+Architectures+in+the+United+States+and+Australia%3A+Models%2C+Costs%2C+and+Questions&rft.jtitle=Journal+of+Medical+Internet+Research&rft.aulast=Gunter%2C+T.D.%3B+Terry%2C+N.P.&rft.au=Gunter%2C+T.D.%3B+Terry%2C+N.P.&rft.date=2005&rft.volume=7&rft.issue=1&rft.pages=e3&rft_id=info:doi\/10.2196%2Fjmir.7.1.e3&rft_id=info:pmc\/PMC1550638&rft_id=info:pmid\/15829475&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC1550638&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/EHR_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-HITAbout19-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HITAbout19_2-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Office of the National Coordinator for Health Information Technology (9 November 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.healthit.gov\/topic\/certification-ehrs\/about-onc-health-it-certification-program\" target=\"_blank\">\"About The ONC Health IT Certification Program\"<\/a>. <i>HealthIT.gov<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.healthit.gov\/topic\/certification-ehrs\/about-onc-health-it-certification-program\" target=\"_blank\">https:\/\/www.healthit.gov\/topic\/certification-ehrs\/about-onc-health-it-certification-program<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 19 November 2021<\/span>.<\/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+The+ONC+Health+IT+Certification+Program&rft.atitle=HealthIT.gov&rft.aulast=Office+of+the+National+Coordinator+for+Health+Information+Technology&rft.au=Office+of+the+National+Coordinator+for+Health+Information+Technology&rft.date=9+November+2021&rft_id=https%3A%2F%2Fwww.healthit.gov%2Ftopic%2Fcertification-ehrs%2Fabout-onc-health-it-certification-program&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/EHR_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20220125221420\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.046 seconds\nReal time usage: 0.085 seconds\nPreprocessor visited node count: 1601\/1000000\nPost\u2010expand include size: 17523\/2097152 bytes\nTemplate argument size: 5634\/2097152 bytes\nHighest expansion depth: 20\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 4792\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 77.103 1 -total\n 75.69% 58.356 1 Template:Reflist\n 48.90% 37.701 2 Template:Citation\/core\n 44.05% 33.962 1 Template:Cite_journal\n 24.17% 18.637 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/EHR_vendors\n 19.69% 15.185 1 Template:Cite_web\n 13.40% 10.335 3 Template:Citation\/identifier\n 8.74% 6.737 3 Template:Citation\/make_link\n 6.69% 5.157 1 Template:Date\n 5.25% 4.051 3 Template:Only_in_print\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12942-0!canonical and timestamp 20220125221420 and revision id 45839. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/EHR_vendors\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/EHR_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>","ed5267dc612120980decc29d603ba1e8_images":[],"ed5267dc612120980decc29d603ba1e8_timestamp":1643149333,"17733f9801557e7af6825433f338fbef_type":"article","17733f9801557e7af6825433f338fbef_title":"4.1 Medical diagnostics instrumentation and equipment vendors","17733f9801557e7af6825433f338fbef_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/Medical_diagnostics_instrumentation_and_equipment_vendors","17733f9801557e7af6825433f338fbef_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 2: Other vendors and service providers\/Medical diagnostics instrumentation and equipment vendorsFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\nContents \n\n1 4. Resources for selecting and implementing informatics solutions: Part 2: Other vendors and service providers \n\n1.1 4.1 Medical diagnostics instrumentation and equipment vendors \n\n1.1.1 4.1.1 CLIA-certified vendors \n1.1.2 4.1.2 Other vendors \n\n\n\n\n2 References \n\n\n\n4. Resources for selecting and implementing informatics solutions: Part 2: Other vendors and service providers \nPart 2 of this guide's resources chapters steps away from LIMS, LIS, and ELN and looks at more the diagnostic equipment and supplies available to laboratories, as well as some applicable EHR vendors should your clinical laboratory require one. Additionally, service providers able to help you with laboratory workflows, billing, and other aspects of clinical diagnostic and research labs are listed here.\n\r\n\n\n4.1 Medical diagnostics instrumentation and equipment vendors \n4.1.1 CLIA-certified vendors \nMedical diagnostics laboratories perform various types of testing, including point-of-care testing. At least in the United States, the Clinical Laboratory Improvement Amendments (CLIA) test complexities, as determined by the U.S. Food & Drug Administration (FDA)[1], and resulting public CLIA Database provide insight into the instrumentation and equipment vendors marketing equipment for diagnostic and research laboratories. While not a complete list of instrument and equipment vendors, the CLIA-approved vendor lists below make an excellent starting point for laboratories seeking to add to its testing inventory.\nThe following two tables list vendors verified to sell CLIA-waived instruments and\/or test kits. CLIA-waived instruments and test kits are deemed as being simple to use and as having little chance in providing wrong information or harming someone. The vendors were pulled from the FDA's downloadable CLIA file from November 2021. The file was sorted to pull out the CLIA-waived devices, and then the vendors were researched to see if they still actively marketed the listed product(s). In some cases, the vendor listed on the FDA file was acquired by another company. If the associated products were still found to be marketed by the acquiring company, that company name was used. CLIA-waived device and test kit types are given as a general guide to what CLIA-waived items the vendor offers.\nNote: Do not assume that just because a vendor is listed here all of its offerings are CLIA-waived. Some of these vendors may also sell analyzers and tests that are CLIA-certified as moderate or complex, as well as a variety of other non-CLIA-certified solutions. Additionally, this listing does not name the specific CLIA-waived item(s). It is ultimately up to the potential buyer to verify with the vendor that a specific item is CLIA-waived before purchase. \n\n\n\n\n\n\n\nVendors of CLIA-waived Instruments and Devices\n\n\nOriginal manufacturer\n\nTesting domain(s) covered\n\nDevice type(s)\n\n\nAbaxis, Inc.\n\nclinical chemistry\n\nchemistry analyzers\n\n\nAbbot Diabetes Care\n\nclinical chemistry\n\nblood glucose monitors\n\n\nAbbot Point of Care\n\nclinical chemistry, hematology\n\nblood analyzers, chemistry analyzers, hematology devices, molecular immunoassay analyzer\n\n\nACON Laboratories, Inc.\n\nclinical chemistry, hematology, urinalysis\n\nblood glucose monitors, hematology devices, urine analyzers\n\n\nAdvocate Meters, Inc.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nAgaMatrix, Inc.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nAll Medicus Co., Ltd.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nAlliance International Co., Ltd.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nAmVenturex, Inc.\n\nclinical chemistry\n\nblood ketone monitors\n\n\nAmerican Screening Corp.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nAndon Health Co., Ltd.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nApex Biotechnology Corp.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nApplied Biomedical, LLC\n\nclinical chemistry\n\nblood glucose monitors\n\n\nArkray USA, Inc.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nAscensia Diabetes Care Holdings AG\n\nclinical chemistry\n\nblood glucose monitors\n\n\nBecton Dickson and Company\n\nimmunology\n\ndigital immunoassay analyzer\n\n\nBigfoot Biomedical, Inc.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nbinx health, Inc.\n\nimmunology\n\nmolecular immunoassay analyzer\n\n\nBioLand Technology Ltd.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nBionime Corporation\n\nclinical chemistry\n\nblood glucose monitors\n\n\nBioSys Laboratories, Inc.\n\nurinalysis\n\nurine analyzers\n\n\nBioTelemetry, Inc.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nBiotron Diagnostics, Inc.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nBonraybio Co., Ltd.\n\nmiscellaneous\n\nfertility monitor (male)\n\n\nBruno Pharma Innovations, LLC\n\nclinical chemistry\n\nblood glucose monitors, blood ketone monitors\n\n\nBTNX, Inc.\n\nclinical chemistry, urinalysis\n\nblood glucose monitors, urine analyzers\n\n\nCambridge Sensors Ltd.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nCardinal Health, Inc.\n\nurinalysis\n\nurine analyzers\n\n\nCGETC, Inc.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nClarity Diagnostics, LLC\n\nclinical chemistry, hematology, urinalysis\n\nblood glucose monitors, hematology devices, urine analyzers\n\n\nCoaguSense, Inc.\n\nhematology\n\nhematology devices\n\n\nDELBio, Inc.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nDiathrive, Inc.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nEKF Diagnostics Holding Plc\n\nclinical chemistry, hematology\n\nblood glucose monitors, blood ketone monitors, hematology devices\n\n\nEmpecs Medical Co., Ltd.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nEPS Bio Technology Corp.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nFifty 50 Medical, Inc.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nFirstVitals Health and Wellness, Inc.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nForaCare, Inc.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nGeneral Life Biotechnology Co., Ltd.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nGermaine Laboratories, Inc.\n\nclinical chemistry, urinalysis\n\nblood cholesterol monitors, blood glucose monitors, urine analyzers\n\n\nGL Diabetes, LLC\n\nclinical chemistry\n\nblood glucose monitors\n\n\nGluco Perfect, Inc.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nGreenCross Medis Corp.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nHemoCue AB\n\nclinical chemistry, hematology\n\nblood glucose monitors, hematology devices\n\n\nHenry Schein, Inc.\n\nurinalysis\n\nurine analyzers\n\n\nHMD Biomedical, Inc.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nHome Aide Diagnostics, Inc.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nHummingbird Medical, Inc.\r\ndba Nurse Rosie Products\n\nclinical chemistry\n\nblood glucose monitors\n\n\ni-SENS. Inc.\n\nclinical chemistry\n\nblood glucose monitors\n\n\niHealth Labs, Inc.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nijDream Corporation\n\nclinical chemistry\n\nblood glucose monitors\n\n\niLine Microsystems SL\n\nhematology\n\nhematology devices\n\n\nInfopia Co., Ltd.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nIntuity Medical, Inc.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nJant Pharmacal Corp.\n\nhematology\n\nhematology devices\n\n\nJoinsoon Medical Technology Co., Ltd.\n\nhematology\n\nhematology devices\n\n\nKeto-Check, Inc.\n\nclinical chemistry\n\nblood glucose monitors, blood ketone monitors\n\n\nKPI Healthcare, Inc.\n\nclinical chemistry\n\nblood cholesterol monitors\n\n\nLabStyle Innovations Ltd.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nLifeScan, Inc.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nLivongo Health, Inc.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nMagellan Diagnostics, Inc.\n\nclinical chemistry\n\nblood analyzers\n\n\nMajor Biosystem Co., Ltd.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nMcKesson Medical-Surgical\r\nMcKesson Medical-Surgical, PSS site\n\nclinical chemistry, urinalysis\n\nblood glucose monitors, urine analyzers\n\n\nMediVena, LLC\n\nclinical chemistry\n\nblood glucose monitors\n\n\nMedline Industries, Inc.\n\nclinical chemistry, urinalysis\n\nblood glucose monitors, urine analyzers\n\n\nMesa Biotech, Inc.\n\nimmunology\n\ndigital immunoassay analyzer\n\n\nMetene Limited\n\nclinical chemistry\n\nblood glucose monitors\n\n\nMHC Medical Products, LLC\n\nclinical chemistry\n\nblood glucose monitors\n\n\nMiCoBioMed Co., Ltd.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nMicroTech Medical (Hangzhou) Co., Ltd.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nMidwest Trading Group, Inc.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nNova Biomedical Corp.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nOk Biotech Co., Ltd.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nOmnis Health, LLC\n\nclinical chemistry\n\nblood glucose monitors\n\n\nOptumRx, Inc.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nPhilosys Co., Ltd.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nPolymer Technology Systems, Inc.\n\nclinical chemistry\n\nblood glucose monitors, blood cholesterol monitors\n\n\nPOPS! Diabetes Care, Inc.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nProdigy Diabetes Care, LLC\n\nclinical chemistry\n\nblood glucose monitors\n\n\nPTS Diagnostics\n\nclinical chemistry, hematology\n\nblood glucose monitors, hematology devices\n\n\nRoche Diagnostics\n\nclinical chemistry, hematology, urinalysis\n\nblood glucose monitors, hematology devices, urine analyzers\n\n\nSD BioSensor, Inc.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nSeparation Technology, Inc.\n\nhematology\n\nhematology devices\n\n\nSiemens Healthcare GmbH\n\nhematology, urinalysis\n\nhematology devices, urine analyzers\n\n\nSimple Diagnostics, Inc.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nSinocare, Inc.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nSmart Meter, LLC\n\nclinical chemistry\n\nblood glucose monitors\n\n\nSMC Direct, LLC\n\nclinical chemistry, urinalysis\n\nblood glucose monitors, urine analyzers\n\n\nStanbio Laboratory L.P.\n\nhematology, urinalysis\n\nhematology devices, urine analyzers\n\n\nSwiss Precision Diagnostics GmbH\n\nurinalysis\n\nfertility monitor (female)\n\n\nTearLab Corporation\n\nclinical chemistry\n\nchemistry analyzers\n\n\nTeco Diagnostics, Inc.\n\nurinalysis\n\nurine analyzers\n\n\nTrividia Health, Inc.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nTyson Bioresearch, Inc.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nUS Diagnostics, Inc.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nVidan Diagnostics, LLC\n\nclinical chemistry\n\nblood glucose monitors, blood ketone monitors\n\n\nVisgeneer, Inc.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nVivaChek Laboratories, Inc.\n\nclinical chemistry\n\nblood glucose monitors\n\n\nYD Diagnostics Corp.\n\nurinalysis\n\nurine analyzers\n\n\nZenith Diagnostics\n\nclinical chemistry\n\nblood glucose monitors\n\n\n\n\n\n\n\n\n\nVendors of CLIA-waived Test Kits and Supplies\n\n\nOriginal manufacturer\n\nTesting domain(s) covered\n\nTest kit type(s)\n\n\n1 Step Detect Associates, LLC\n\ntoxicology\n\ndrug screen\n\n\nAbbott (formerly Alere\/Inverness\/Innovacon)\n\nimmunology, toxicology\n\ndrug screen, fecal occult, H. pylori, influenza, mono, pregnancy test, Strep A\n\n\nACON Laboratories, Inc.\n\nimmunology, toxicology, urinalysis\n\ndrug screen, H. pylori, mono, ovulation test, pregnancy test, Strep A, urine reagent strips\n\n\nAcro Biotech, Inc.\n\nimmunology\n\npregnancy test\n\n\nAdvin Biotech, Inc.\n\ntoxicology\n\ndrug screen\n\n\nAerscher Diagnostics, LLC\n\nimmunology\n\nfecal occult, gastric occult\n\n\nAi De Diagnostic Co.\n\nimmunology\n\npregnancy test\n\n\nAlfa Scientific Designs, Inc.\n\nimmunology, toxicology, urinalysis\n\ndrug screen, fecal occult, H. pylori, ovulation test, pregnancy test\n\n\nAmerican Bio Medica Corp.\n\ntoxicology\n\ndrug screen\n\n\nAmerican Screening Corp.\n\ntoxicology\n\ndrug screen\n\n\nAmeritek USA, Inc.\n\nimmunology\n\nfecal occult, ovulation test, pregnancy test, trichomonas\n\n\nAnalyticon Biotechnologies AG\n\nurinalysis\n\nurine reagent strips\n\n\nArlington Scientific, Inc.\n\nimmunology\n\npregnancy test\n\n\nArtron Laboratories, Inc.\n\nimmunology\n\npregnancy test\n\n\nAssure Tech. (Hangzhou) Co., Ltd.\n\ntoxicology\n\ndrug screen\n\n\nAtlas Medical Ltd.\n\nimmunology\n\npregnancy test\n\n\nAxium BioResearch, Inc.\n\ntoxicology\n\ndrug screen\n\n\nAzure Biotech, Inc.\n\nimmunology\n\npregnancy test\n\n\nBeckman Coulter, Inc.\n\nimmunology\n\nfecal occult, gastric occult, H. pylori, mono, pregnancy test, Strep A\n\n\nBecton Dickson and Company\n\nimmunology\n\nH. pylori, ovulation test, pregnancy test, Strep A\n\n\nBest Value Medical\n\ntoxicology\n\ndrug screen\n\n\nBhat Bio-tech India Private Limited\n\nurinalysis\n\nurine reagent strips\n\n\nBig Room Testing, LLC\n\ntoxicology\n\ndrug screen\n\n\nbioLytical Laboratories, Inc.\n\nimmunology\n\nHIV-1\n\n\nBiomerica, Inc.\n\nimmunology\n\nfecal occult, ovulation test, pregnancy test\n\n\nbioM\u00e9rieux SA\n\nimmunology\n\npregnancy test\n\n\nBiorex Labs, LLC\n\nurinalysis\n\nurine reagent strips\n\n\nBiotech Screening, LLC\n\ntoxicology\n\ndrug screen\n\n\nBiotron Diagnostics, Inc.\n\nurinalysis\n\nurine reagent strips\n\n\nBTNX, Inc.\n\nimmunology, toxicology\n\ndrug screen, fecal occult, FSH, H. pylori, pregnancy test, RSV, Strep A, TSH\n\n\nCambridge Diagnostic Products, Inc.\n\nimmunology\n\nfecal occult\n\n\nCardinal Health, Inc.\n\nimmunology, urinalysis\n\nH. pylori, mono, pregnancy test, Strep A, urine reagent strips\n\n\nCen-Med Enterprises, Inc.\n\nimmunology\n\nfecal occult, pregnancy test\n\n\nCenogenics Corp.\n\nimmunology, urinalysis\n\nfecal occult, pregnancy test, urine reagent strips\n\n\nCepheid\n\nimmunology\n\ninfluenza, Strep A\n\n\nChain Drug Marketing Association, Inc.\n\nurinalysis\n\nurine reagent strips\n\n\nChematics, Inc.\n\ntoxicology\n\ndrug screen\n\n\nChembio Diagnostic Systems, Inc.\n\nimmunology\n\nHIV-1, HIV-2\n\n\nChemtron Biotech, Inc.\n\nimmunology, toxicology\n\ndrug screen, pregnancy test\n\n\nChurch & Dwight Co., Inc.\n\nimmunology\n\npregnancy test\n\n\nClarity Diagnostics, LLC\n\nimmunology, toxicology\n\ndrug screen, fecal occult, H. pylori, mono, pregnancy test\n\n\nCLIAwaived, Inc.\n\nimmunology, toxicology, urinalysis\n\ndrug screen, fecal occult, H. pylori, pregnancy test, Strep A, TSH, urine reagent strips\n\n\nClinical Genomics Technologies Pty. Ltd.\n\nimmunology\n\nfecal occult\n\n\nClinical Reference Laboratory, Inc.\n\ntoxicology\n\ndrug screen\n\n\nCoastline Medical Management, LLC\n\ntoxicology\n\ndrug screen\n\n\nCo-innovation Biotech Co., Ltd.\n\nimmunology, toxicology\n\ndrug screen, pregnancy test\n\n\nCommon Sense Ltd.\n\nimmunology\n\nvaginal pH\n\n\nConfirm Biosciences\n\ntoxicology\n\ndrug screen\n\n\nCoretests, Inc.\n\nimmunology, toxicology\n\ndrug screen, pregnancy test\n\n\nDealmed Medical Supplies, LLC\n\nimmunology\n\nStrep A\n\n\nDevon Medical Products, Inc.\n\ntoxicology\n\ndrug screen\n\n\nDFI Co., Ltd.\n\nurinalysis\n\nurine reagent strips\n\n\nDiagnostics Direct, LLC\n\nimmunology\n\nsyphilis\n\n\nDeus Vult, LLC\n\ntoxicology\n\ndrug screen\n\n\nDrug Test City, Inc.\n\ntoxicology\n\ndrug screen\n\n\nEASY at Home Medical, LLC\n\nimmunology, toxicology, urinalysis\n\ndrug screen, pregnancy test, urine reagent strips\n\n\nEKLA Corporation\n\nimmunology, toxicology\n\ndrug screen, pregnancy test\n\n\nExpress Diagnostics International, Inc.\n\nimmunology, toxicology, urinalysis\n\ndrug screen, pregnancy test, urine reagent strips\n\n\nEZ Testing Solutions, Inc.\n\ntoxicology\n\ndrug screen\n\n\nFirst Check Diagnostics, LLC\n\ntoxicology\n\ndrug screen\n\n\nFisher Healthcare\n\nimmunology\n\ninfluenza, RSV\n\n\nGermaine Laboratories, Inc.\n\nimmunology, urinalysis\n\nfecal occult, H. pylori, mono, pregnancy test, Strep A, urine reagent strips\n\n\nGet Stix, LLC\n\nimmunology\n\npregnancy test, urine reagent strips\n\n\nGuangzhou Wondfo Co., Ltd.\n\nimmunology, toxicology\n\ndrug screen, pregnancy test\n\n\nHalyard Worldwide, Inc.\n\nimmunology\n\nH. pylori\n\n\nHangzhou AllTest Biotech Co., Ltd.\n\ntoxicology\n\ndrug screen\n\n\nHangzhou Biotest Biotech Co., Ltd.\n\ntoxicology\n\ndrug screen\n\n\nHangzhou Clongene Biotech Co. Ltd.\n\nimmunology\n\npregnancy test\n\n\nHatty, Inc.\n\nurinalysis\n\nurine reagent strips\n\n\nHealgen Scientific, LLC\n\nimmunology, toxicology, urinalysis\n\ndrug screen, fecal occult, pregnancy test, urine reagent strips\n\n\nHealthy.io Ltd.\n\nurinalysis\n\nurine reagent strips\n\n\nHelena Laboratories Corp.\n\nimmunology\n\nfecal occult\n\n\nHenry Schein, Inc.\n\nimmunology, urinalysis\n\nfecal occult, H. pylori, influenza, mono, pregnancy test, Strep A, urine reagent strips\n\n\nHeritage House '76 Inc.\n\nimmunology\n\npregnancy test\n\n\nHome Health UK, Ltd.\n\nimmunology\n\npregnancy test\n\n\nHospital Connect, Inc.\n\ntoxicology\n\ndrug screen\n\n\ni-Health, Inc.\n\nurinalysis\n\nurine reagent strips\n\n\nIMCO, Inc.\n\nimmunology\n\nmono, pregnancy test, Strep A, trichomonas\n\n\nImmunostics, Inc.\n\nimmunology, urinalysis\n\npregnancy test, Strep A, urine reagent strips\n\n\nInnovative Laboratory Solutions, LLC\n\ntoxicology\n\ndrug screen\n\n\nInnovita (Tangshan) Biological Technology Co. Ltd.\n\nimmunology\n\npregnancy test\n\n\nIndependent Medical Co-Op, Inc.\n\nimmunology, toxicology\n\ndrug screen, pregnancy test\n\n\nIntrinsic Interventions, Inc.\n\ntoxicology\n\ndrug screen\n\n\nJant Pharmacal Corp.\n\nimmunology, toxicology\n\ndrug screen, fecal occult, H. pylori, mono, pregnancy test, Strep A, TSH, urine reagent strips\n\n\nLabsystems Diagnostics Oy\n\nimmunology\n\npregnancy test\n\n\nLendas, UAB\n\ntoxicology\n\ndrug screen\n\n\nLIA Diagnostics, Inc.\n\nimmunology\n\npregnancy test\n\n\nLifeSign, LLC\n\nimmunology\n\nfecal occult, H. pylori, influenza, mono, pregnancy test, Strep A\n\n\nLumiQuick Diagnostics, Inc.\n\ntoxicology\n\ndrug screen\n\n\nMACHEREY-NAGEL GmbH & Co. KG\n\nurinalysis\n\nurine reagent strips\n\n\nMandarin Enterprises, LLC\n\nimmunology\n\npregnancy test\n\n\nMagenta Technology Partners, LLC\n\ntoxicology\n\ndrug screen\n\n\nMasena Invest BV\n\nimmunology\n\npregnancy test\n\n\nMcKesson Medical-Surgical\n\nimmunology, urinalysis\n\ndrug screen, H. pylori, mono, pregnancy test, Strep A, urine reagent strips\n\n\nMedical Disposables Corporation\n\nimmunology, toxicology\n\ndrug screen, fecal occult\n\n\nMedical Distribution Group, Inc.\n\ntoxicology\n\ndrug screen\n\n\nMedical Electronic Systems, LLC\n\nimmunology\n\nsemen\n\n\nMedimpex United, Inc.\n\nimmunology, toxicology\n\ndrug screen, pregnancy test\n\n\nMedline Industries, Inc.\n\nimmunology, urinalysis\n\ndrug screen, fecal occult, influenza, mono, pregnancy test, urine reagent strips\n\n\nMercedes Scientific, Inc.\n\ntoxicology\n\ndrug screen\n\n\nMeridian Bioscience, Inc.\n\nimmunology\n\npregnancy test\n\n\nMergers Marketing, Inc.\n\nimmunology, toxicology\n\ndrug screen, pregnancy test\n\n\nMFB Fertility, Inc.\n\nimmunology\n\nfertility test\n\n\nMicro Distributing II, Ltd.\n\ntoxicology\n\ndrug screen\n\n\nMosie, LLC\n\nimmunology\n\npregnancy test\n\n\nMossman Associates, Inc.\n\ntoxicology\n\ndrug screen\n\n\nMotilityCount ApS\n\nimmunology\n\nsemen\n\n\nMP Biomedicals, LLC\n\ntoxicology\n\ndrug screen\n\n\nMyDrugTestCups.com, LLC\n\ntoxicology\n\ndrug screen\n\n\nNantong EGENS Bio Technology Company\n\nimmunology\n\npregnancy test\n\n\nNational Diagnostic Products Pty. Ltd.\n\nclinical chemistry\n\nblood glucose test strips\n\n\nNational Distribution & Contracting, Inc.\n\nimmunology\n\nfecal occult, H. pylori, mono, pregnancy test, Strep A\n\n\nNational Test Systems, LLC\n\ntoxicology\n\ndrug screen\n\n\nNative Diagnostics, Inc.\n\ntoxicology\n\ndrug screen\n\n\nNatural Cycles Nordic AB\n\nimmunology\n\npregnancy test\n\n\nNewScen Coast Bio-Pharmaceutical Co., Ltd.\n\nimmunology\n\npregnancy test\n\n\nNexScreen, LLC\n\ntoxicology\n\ndrug screen\n\n\nNoble Medical, Inc.\n\ntoxicology\n\ndrug screen\n\n\nOmega Laboratories, Inc.\n\ntoxicology\n\ndrug screen\n\n\nOn-Site Testing Specialists, Inc.\n\ntoxicology\n\ndrug screen\n\n\nOraSure Technologies, Inc.\n\nimmunology, toxicology\n\ndrug screen, HCV, HIV-1\n\n\nOrigin, Inc.\n\ntoxicology\n\ndrug screen\n\n\nOwens & Minor, Inc.\n\nimmunology\n\npregnancy test\n\n\nPhamatech, Inc.\n\ntoxicology\n\ndrug screen\n\n\nPharmaceutical Marketing Systems, Inc.\n\nimmunology\n\nTSH\n\n\nPinnacle BioLabs, LLC\n\nurinalysis\n\nurine reagent strips\n\n\nPolymed Therapeutics, Inc.\n\nimmunology, toxicology\n\ndrug screen, pregnancy test\n\n\nPolymedco, Inc.\n\nimmunology\n\nBTA, fecal occult, H. pylori, mono, pregnancy test, Strep A\n\n\nPremier Biotech, Inc.\n\ntoxicology\n\ndrug screen\n\n\nPrestige Brands Holdings, Inc.\n\nimmunology\n\npregnancy test\n\n\nPrinceton BioMeditech Corporation\n\nimmunology, toxicology\n\ndrug screen, fecal occult, H. pylori, ovulation test, pregnancy test, Strep A\n\n\nProctor and Gamble\n\nimmunology\n\npregnancy test\n\n\nProfessional Medical, Inc.\n\nurinalysis\n\nurine reagent strips\n\n\nPropper Manufacturing Co., Inc.\n\nimmunology\n\nfecal occult\n\n\nQingdao Hightop Biotech Co. Ltd.\n\nimmunology\n\npregnancy test\n\n\nQualigen, Inc.\n\nimmunology\n\nTSH\n\n\nQuidel Corporation\n\nimmunology, urinalysis\n\nH. pylori, influenza, mono, pregnancy test, RSV, Strep A, urine reagent strips, vaginal pH\n\n\nRapid Pathogen Screening, Inc.\n\nadenovirus, MMP-9\n\npregnancy test\n\n\nRapid Self Test, Inc.\n\ntoxicology\n\ndrug screen\n\n\nRedwood Toxicology Laboratory, Inc.\n\ntoxicology\n\ndrug screen\n\n\nRhema Scientific, Inc.\n\ntoxicology\n\ndrug screen\n\n\nRightBio Metrics, Inc.\n\nimmunology\n\ngastric pH\n\n\nRunbio Biotech Co., Ltd.\n\nimmunology\n\novulation test, pregnancy test\n\n\nSA Scientific, Ltd.\n\nimmunology\n\ninfluenza, pregnancy test, RSV, Strep A\n\n\nSandstone Diagnostics, Inc.\n\nimmunology\n\nsemen\n\n\nSavyon Diagnostics Ltd.\n\nurinalysis\n\nurine reagent strips\n\n\nScanwell Health, Inc.\n\nurinalysis\n\nurine reagent strips\n\n\nSafecare Biotech (Hangzhou) Co. Ltd.\n\nimmunology, toxicology\n\ndrug screen, pregnancy test\n\n\nScanadu, Inc.\n\nurinalysis\n\nurine reagent strips\n\n\nSCI Medic, Inc.\n\nimmunology, toxicology, urinalysis\n\ndrug screen, pregnancy test, urine reagent strips\n\n\nScreening Devices Canada, Inc.\n\nclinical chemistry\n\nTSH\n\n\nSekisui Diagnostics, LLC\n\nimmunology\n\ninfluenza, mono, pregnancy test, Strep A, trichomonas\n\n\nSerim Research Corporation\n\nimmunology\n\nH. pylori\n\n\nShanghai Chemtron Biotech Co., Ltd.\n\nimmunology\n\npregnancy test\n\n\nShenzhen Bioeasy Biotechnology Co., Ltd.\n\ntoxicology\n\ndrug screen\n\n\nSiemens Healthcare GmbH\n\nurinalysis\n\nurine reagent strips\n\n\nSMC Direct, LLC\n\nimmunology, urinalysis\n\npregnancy test, Strep A, urine reagent strips\n\n\nSolCraft, Inc.\n\nimmunology\n\npregnancy test\n\n\nSpermCheck\n\nimmunology\n\nsemen\n\n\nSpeedy Solutions, LLC\n\ntoxicology\n\ndrug screen\n\n\nStanbio Laboratory L.P.\n\nimmunology, urinalysis\n\nfecal occult, H. pylori, mono, pregnancy test, Strep A, urine reagent strips\n\n\nSugentech, Inc.\n\nimmunology\n\npregnancy test\n\n\nSwiss Precision Diagnostics GmbH\n\nimmunology\n\novulation test, pregnancy test\n\n\nSyntron Bioresearch, Inc.\n\nimmunology, toxicology, urinalysis\n\ndrug screen, pregnancy test, urine reagent strips\n\n\nSZIO+, Inc.\n\nurinalysis\n\nurine reagent strips\n\n\nTanner Scientific, Inc.\n\nurinalysis\n\nurine reagent strips\n\n\nTeco Diagnostics, Inc.\n\nimmunology, toxicology, urinalysis\n\ndrug screen, fecal occult, ovulation test, pregnancy test, urine reagent strips\n\n\nThermo Fisher Scientific, Inc.\n\nimmunology, urinalysis\n\nfecal occult, H. pylori, influenza, pregnancy test, RSV, Strep A, urine reagent strips\n\n\nTianjin New Bay Bioresearch Co. Ltd. \n\nimmunology\n\npregnancy test\n\n\nTransMed Co., LLC\n\ntoxicology\n\ndrug screen\n\n\nTransmetron, Inc.\n\ntoxicology\n\ndrug screen\n\n\nTrinity Biotech Plc\n\nimmunology\n\nH. pylori, HIV-1\n\n\nTrue Diagnostics, Inc.\n\nimmunology\n\npregnancy test\n\n\nTurklab AS\n\nimmunology\n\npregnancy test\n\n\nUCP Biosciences, Inc.\n\ntoxicology\n\ndrug screen\n\n\nUltimate Analysis Cup, Inc.\n\ntoxicology\n\ndrug screen\n\n\nUniversal Meditech, Inc.\n\nimmunology, urinalysis\n\nfecal occult, pregnancy test, urine reagent strips\n\n\nUqora, Inc.\n\nurinalysis\n\nurine reagent strips\n\n\nUS Diagnostics, Inc.\n\ntoxicology\n\ndrug screen\n\n\nUTest\n\ntoxicology\n\ndrug screen\n\n\nuVera Diagnostics, Inc.\n\ntoxicology\n\ndrug screen\n\n\nVerify Diagnostics, Inc.\n\nimmunology, toxicology\n\ndrug screen, pregnancy test\n\n\nVicTorch Meditek, Inc.\n\nimmunology\n\npregnancy test\n\n\nVisby Medical, Inc.\n\nimmunology\n\nSTI test\n\n\nW.H.P.M., Inc.\n\nimmunology, toxicology\n\ndrug screen, pregnancy test\n\n\nWeihai Kangzhou Biotechnology Engineering Co., Ltd.\n\nimmunology\n\npregnancy test\n\n\nWholepower Biotech Co., Ltd.\n\nimmunology\n\npregnancy test\n\n\nWiener Laboratorios SAIC\n\nurinalysis\n\nurine reagent strips\n\n\nWOLFE, Inc.\n\ntoxicology\n\ndrug screen\n\n\nWondfo Biotech Co. Ltd.\n\nimmunology, toxicology\n\ndrug screen, ovulation test, pregnancy test\n\n\nXiamen Useful Import and Export Co., Ltd.\n\ntoxicology\n\ndrug screen\n\n\nYD Diagnostics\n\nurinalysis\n\nurine reagent strips\n\n\nZer Hitech Ltd.\n\nimmunology\n\npregnancy test\n\n\nZhejiang Orient Gene Biotech Co., Ltd.\n\nimmunology\n\nfecal occult, pregnancy test\n\n\n\nThe following is a list of additional vendors verified to offer CLIA-certified moderate or complex diagnostic instruments and\/or test kits. The same methodology was used as above for CLIA-waived, with the exception of opting to not provide specifics about instrument and test types.\nNote: Most of these vendors sell analyzers and tests that are CLIA-certified moderate or complex. However, is ultimately up to the potential buyer to verify with the vendor an item's CLIA certification status before purchase.\n\n\n\n\n\n\n\n\n\nAB Sciex Pte. Ltd.\r\n\nAbbot\r\n\nAccelerate Diagnostics, Inc.\r\n\nAccess Bio, Inc.\r\n\nAcro Biotech, LLC\r\n\nAdvin Biotech, Inc.\r\n\nAESKU.GROUP GmbH & Co. KG\r\n\nAggredyne, Inc.\r\n\nAgilent Technologies, Inc.\r\n\nAiDe Diagnostic Co., Ltd.\r\n\nAkonni Biosystems, Inc.\r\n\nAlba Bioscience Ltd.\r\n\nALCOR Scientific, Inc.\r\n\nAlfa Wassermann, Inc.\r\n\nAlifax S.r.l.\r\n\nAlpha Laboratories Ltd.\r\n\nAmerican Laboratory Products Company Ltd.\r\n\nAnsh Labs, LLC\r\n\nApplied Biocode, Inc.\r\n\nApplied Spectral Imaging, Inc.\r\n\nArlington Scientific, Inc.\r\n\nARK Diagnostics, Inc.\r\n\nAssociates of Cape Cod, Inc.\r\n\nAstute Medical, Inc.\r\n\nATAGO U.S.A., Inc.\r\n\nAthelas, Inc.\r\n\nAtlas Medical Ltd.\r\n\nAvioq, Inc.\r\n\nAwareness Technology, Inc.\r\n\nAXIM Biotechnologies, Inc.\r\n\nAzure Biotech, Inc.\r\n\nBacterioScan, Inc.\r\n\nBeckman Coulter, Inc.\r\n\nBecton, Dickinson and Company - Biosciences\r\n\nBecton, Dickinson and Company - Molecular\r\n\nBaebies, Inc.\r\n\nThe Binding Site Group Ltd.\r\n\nbinx health, Inc.\r\n\nBio-Rad Laboratories, Inc.\r\n\nBiocare Medical, LLC\r\n\nBiocartis NV\r\n\nBiofire Diagnostics, LLC\r\n\nBioGenix Laboratories, Inc.\r\n\nBiofortuna Ltd.\r\n\nbioLytical Laboratories, Inc.\r\n\nbioM\u00e9rieux SA\r\n\nBiorex Labs, LLC\r\n\nBioSystems SA\r\n\nBioTek Instruments, Inc.\r\n\nBioview Ltd.\r\n\nBoditech Med, Inc.\r\n\nBonraybio Co., Ltd.\r\n\nB\u00dcHLMANN Laboratories AG\r\n\nBRAHMS GmbH\r\n\nBruker Corporation\r\n\nCardinal Health, Inc.\r\n\nCarolina Liquid Chemistries Corp.\r\n\nCellaVision AB\r\n\nCD Diagnostics, Inc.\r\n\nCepheid\r\n\nCheck-Points Health BV\r\n\nChembio Diagnostic Systems, Inc.\r\n\nChrono-Log Corporation\r\n\nClever Culture Systems AG\r\n\nClinical Diagnostics Solutions, Inc.\r\n\nCuretis NV\r\n\nDenka Company Limited\r\n\nDiAgam SA\r\n\nDIAGAST SAS\r\n\nDiagnostic Grifols SA\r\n\nDiagnostica Stago, Inc.\r\n\nDiamond Diagnostics, Inc.\r\n\nDiaSorin S.p.A.\r\n\nDiatron Medical Instruments Ltd.\r\n\nDiazyme Laboratories, Inc.\r\n\nDIESSE Diagnostica Senese SpA\r\n\nDIRUI Industrial Co. Ltd.\r\n\nDrew Scientific, Inc.\r\n\nDrawbridge Health, Inc.\r\n\nEDAN Instruments, Inc.\r\n\nEiken Chemical Co., Ltd.\r\n\nELITech Group SAS\r\n\nErba Diagnostics Mannheim GmbH\r\n\nErba Lachema s.r.o.\r\n\nEUROIMMUN Medizinische Labordiagnostika AG\r\n\nEurospital SpA\n\n\n\n\n\n\n\n\n\nFirst Light Diagnostics, Inc.\r\n\nFocus Diagnostics, Inc.\r\n\nFoundation Medicine, Inc.\r\n\nFUJIFILM Healthcare Americas Corporation\r\n\nFujirebio Europe NV\r\n\nGenalyte, Inc.\r\n\nGenBio\r\n\nGenMark Diagnostics, Inc.\r\n\nGenPrime, Inc.\r\n\nGenzyme Corporation\r\n\nGlycoMark, Inc.\r\n\nGold Standard Diagnostics\r\n\nGreat Basin Corporation\r\n\nGuangzhou Wondfo Co., Ltd.\r\n\nGuardant Health, Inc.\r\n\nHaemonetics Corporation\r\n\nHardy Diagnostics, Inc.\r\n\nHealgen Scientific, LLC\r\n\nHealthy.io Ltd.\r\n\nHelena Laboratories Corporation\r\n\nHelix OpCo, LLC\r\n\nHemaTechnologies\r\n\nHemosonics, LLC\r\n\nHenry Schein, Inc.\r\n\nHologic, Inc.\r\n\nHORIBA, Ltd. - Main Site\r\n\nHORIBA, Ltd. - MedTestDx)\r\n\nHycor Biomedical, Inc.\r\n\nHYPHEN Biomed SAS\r\n\niCubate, Inc.\r\n\nIDS PLC\r\n\niLine Microsystems SL\r\n\nIllumina, Inc.\r\n\nImmucor, Inc.\r\n\nImmunalysis Corporation\r\n\nImmuno Concepts N.A. Ltd.\r\n\nImmuno-Mycologics, Inc.\r\n\nImmunodiagnostic Systems Holdings PLC\r\n\nImmunotech sro\r\n\nInBios International, Inc.\r\n\nIndependent Medical Co-Op, Inc.\r\n\nInDevR, Inc.\r\n\nInfrared Laboratory Systems, LLC\r\n\nInvivoscribe, Inc\r\n\nIVD Research, Inc.\r\n\niXensor Co., Ltd.\r\n\nJana Care, Inc.\r\n\nKamiya Biomedical Company, LLC\r\n\nKPS Analytics\r\n\nKRONUS, Inc.\r\n\nLaborie Medical Technologies Corp.\r\n\nLeica Biosystems Nussloch GmbH\r\n\nLifeSign, LLC\r\n\nLin-Zhi International, Inc.\r\n\nLiofilchem srl\r\n\nLite-On Technology Corporation\r\n\nLuminex Corporation\r\n\nLumiQuick Diagnostics, Inc.\r\n\nM Dialysis AB\r\n\nMACHEREY-NAGEL GmbH & Co. KG\r\n\nMagnaBioSciences, LLC\r\n\nMedica Corporation\r\n\nMedical Electronic Systems, LLC\r\n\nMedical Wire & Equipment\r\n\nMedicon Hellas SA\r\n\nMedimpex United, Inc.\r\n\nMedtronic PLC\r\n\nMELET SCHLOESING Laboratoires SA\r\n\nMeMed Diagnostics, Ltd.\r\n\nMeridian Bioscience, Inc.\r\n\nMeso Scale Diagnostics, LLC\r\n\nMetaSystems Indigo GmbH\r\n\nMicro Distributing II, Ltd.\r\n\nMinaris Medical America, Inc.\r\n\nMindray Medical International Ltd.\r\n\nMitsubishi Chemical Medience Corp.\r\n\nMonobind, Inc.\r\n\nMyriad Genetics, Inc.\r\n\nNano-Ditech Corporation\r\n\nNanoEnTek, Inc.\r\n\nNantHealth, Inc.\r\n\nNative Diagnostics International\r\n\nNeuMoDx Molecular, Inc.\r\n\nNexScreen, LLC\r\n\nNG Biotech SAS\r\n\nNova Biomedical Corporation\n\n\n\n\n\n\n\n\n\nNOVX Systems, Inc.\r\n\nNOWDiagnostics, Inc.\r\n\nOne Lambda, Inc.\r\n\nOPKO Health, Inc.\r\n\nOPTI Medical Systems\r\n\nOraSure Technologies, Inc.\r\n\nOrion Diagnostica Oy\r\n\nOrtho-Clinical Diagnostics, Inc.\r\n\nOtsuka Pharmaceutical Co., Ltd.\r\n\nOxford Gene Technology IP Limited\r\n\nOy Medix Biochemica Ab\r\n\nPall Corporation\r\n\nPanion & BF Biotech Inc.\r\n\nParsagen Diagnostics, Inc.\r\n\nPerkinElmer, Inc.\r\n\nPhamatech, Inc.\r\n\nPixcell Medical Technologies, Ltd.\r\n\nPointe Scientific, Inc.\r\n\nPolymedco CDP, LLC\r\n\nPolymer Technology Systems, Inc.\r\n\nPrecision BioLogic, Inc.\r\n\nPremier Biotech, Inc.\r\n\nProgenika Biopharma SA\r\n\nPsychemedics Corporation\r\n\nQIAGEN GmbH\r\n\nQuidel Corporation\r\n\nQuotient Ltd.\r\n\nR-Biopharm AG\r\n\nr2 Diagnostics\r\n\nRadiometer Medical ApS\r\n\nRandox Laboratories Ltd.\r\n\nRapid Detect, Inc.\r\n\nReichert, Inc.\r\n\nResponse Biomedical Corporation\r\n\nRoche Diagnostics\r\n\nSakae, Inc.\r\n\nSanguina, LLC\r\n\nScopio Labs Ltd.\r\n\nSebia SA\r\n\nSekisui Diagnostics PEI, Inc.\r\n\nSentinel CH SpA\r\n\nSerosep Ltd.\r\n\nShenzhen Bioeasy Biotechnology Co. Ltd.\r\n\nShenzhen New Industries Biomedical Engineering Co. Ltd.\r\n\nSiemens Healthcare Diagnostics\r\n\nSight Diagnostics Ltd.\r\n\nSkyla Corporation\r\n\nSpectral Medical, Inc.\r\n\nSSI Diagnostica A\/S\r\n\nStanbio Laboratory L.P.\r\n\nStratec Biomedical AG\r\n\nStreck, Inc.\r\n\nSvar Life Science AB\r\n\nSysmex America, Inc.\r\n\nT2 Biosystems, Inc.\r\n\nTaiDoc Technology Corporation\r\n\nTecan Trading AG\r\n\nTECHLAB, Inc.\r\n\nTeco Diagnostics, Inc.\r\n\nTEM Innovations GmbH\r\n\nTexas BioGene, Inc.\r\n\nThermo Fisher Scientific\r\n\nTokyo Boeki Holdings Corp.\r\n\nTosoh Corporation\r\n\nTrinity Biotech Plc\r\n\nUniversal Meditech, Inc.\r\n\nURIT Medical Electronic Group Co., Ltd.\r\n\nVela Diagnostics Pte. Ltd.\r\n\nViramed Biotech AG\r\n\nWerfen\r\n\nWiener Laboratorios SAIC\r\n\nWuxi BioHermes Biomedical Technology Co. Ltd.\r\n\nYD Diagnostics Corp.\n\n\n\n\n4.1.2 Other vendors \nAs previously mentioned, some vendors manufacturing and distributing medical diagnostic and research solutions don't get their instruments and tests CLIA certified in the U.S. It's beyond the scope of this guide to attempt to list them all, but a few representative examples include:\n\nAbacus Diagnostica Oy\nCarl Zeiss Meditec AG\nClonit SRL\nDevyser AB\nDia.Pro Diagnostic Bioprobes Srl\nDynamiker Biotechnology (Tianjin) Co., Ltd.\nDynex Technologies, Inc.\nEasyDx, Inc.\nEntroGen, Inc.\nEppendorf AG\nHitachi High-Technologies Corporation\nHTZ Ltd.\nHumasis Co., Ltd.\nInstitut Virion\\Serion GmbH\nJEOL USA, Inc.\nLaunch Diagnostics Ltd.\nMettler-Toledo International, Inc.\nMKL Diagnostics AB\nNikon Corporation\nNovaTec Immundiagnostica GmbH\nOlympus Corporation of the Americas\nORGENTEC Diagnostika GmbH\nPENTAX Europe GmbH\nSartorius AG\nShimadzu Corporation\nVircell SL\nWaters Corporation\nAlso, see BioPharmGuy's worldwide diagnostics companies, by location.\n\nReferences \n\n\n\u2191 U.S. Food & Drug Administration (25 February 2020). \"CLIA Categorizations\". https:\/\/www.fda.gov\/medical-devices\/ivd-regulatory-assistance\/clia-categorizations . Retrieved 18 November 2021 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/Medical_diagnostics_instrumentation_and_equipment_vendors\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/Medical_diagnostics_instrumentation_and_equipment_vendors<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:13.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 35 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","17733f9801557e7af6825433f338fbef_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Resources_for_selecting_and_implementing_informatics_solutions_Part_2_Other_vendors_and_service_providers_Medical_diagnostics_instrumentation_and_equipment_vendors rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Resources_for_selecting_and_implementing_informatics_solutions_Part_2_Other_vendors_and_service_providers_Medical_diagnostics_instrumentation_and_equipment_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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 2: Other vendors and service providers\/Medical diagnostics instrumentation and equipment 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">the beginning<\/a> of this guide-----<\/div>\n\n\n<h2><span class=\"mw-headline\" id=\"4._Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\">4. Resources for selecting and implementing informatics solutions: Part 2: Other vendors and service providers<\/span><\/h2>\n<p>Part 2 of this guide's resources chapters steps away from LIMS, LIS, and ELN and looks at more the diagnostic equipment and supplies available to laboratories, as well as some applicable EHR vendors should your clinical laboratory require one. Additionally, service providers able to help you with laboratory workflows, billing, and other aspects of clinical diagnostic and research labs are listed here.\n<\/p><p><br \/>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"4.1_Medical_diagnostics_instrumentation_and_equipment_vendors\">4.1 Medical diagnostics instrumentation and equipment vendors<\/span><\/h3>\n<h4><span class=\"mw-headline\" id=\"4.1.1_CLIA-certified_vendors\">4.1.1 CLIA-certified vendors<\/span><\/h4>\n<p>Medical diagnostics laboratories perform various types of testing, including point-of-care testing. At least in the United States, the <a href=\"https:\/\/www.limswiki.org\/index.php\/Clinical_Laboratory_Improvement_Amendments\" title=\"Clinical Laboratory Improvement Amendments\" class=\"wiki-link\" data-key=\"64bdae1dc17c40c28e0c560396a6ae35\">Clinical Laboratory Improvement Amendments<\/a> (CLIA) test complexities, as determined by the U.S. Food & Drug Administration (FDA)<sup id=\"rdp-ebb-cite_ref-FDA_CLIA18_1-0\" class=\"reference\"><a href=\"#cite_note-FDA_CLIA18-1\">[1]<\/a><\/sup>, and resulting public CLIA Database provide insight into the instrumentation and equipment vendors marketing equipment for diagnostic and research laboratories. While not a complete list of instrument and equipment vendors, the CLIA-approved vendor lists below make an excellent starting point for laboratories seeking to add to its testing inventory.\n<\/p><p>The following two tables list vendors verified to sell CLIA-waived instruments and\/or test kits. CLIA-waived instruments and test kits are deemed as being simple to use and as having little chance in providing wrong <a href=\"https:\/\/www.limswiki.org\/index.php\/Information\" title=\"Information\" class=\"wiki-link\" data-key=\"6300a14d9c2776dcca0999b5ed940e7d\">information<\/a> or harming someone. The vendors were pulled from the FDA's <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/medical-devices\/medical-device-databases\/clinical-laboratory-improvement-amendments-download-data\" target=\"_blank\">downloadable CLIA file<\/a> from November 2021. The file was sorted to pull out the CLIA-waived devices, and then the vendors were researched to see if they still actively marketed the listed product(s). In some cases, the vendor listed on the FDA file was acquired by another company. If the associated products were still found to be marketed by the acquiring company, that company name was used. CLIA-waived device and test kit types are given as a general guide to what CLIA-waived items the vendor offers.\n<\/p><p><b>Note<\/b>: Do not assume that just because a vendor is listed here all of its offerings are CLIA-waived. Some of these vendors may also sell analyzers and tests that are CLIA-certified as moderate or complex, as well as a variety of other non-CLIA-certified solutions. Additionally, this listing does not name the specific CLIA-waived item(s). It is ultimately up to the potential buyer to verify with the vendor that a specific item is CLIA-waived before purchase. \n<\/p>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible sortable\" border=\"1\" cellpadding=\"5\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"3\">Vendors of CLIA-waived Instruments and Devices\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee;\">Original manufacturer\n<\/th>\n<th style=\"color:brown; background-color:#ffffee;\">Testing domain(s) covered\n<\/th>\n<th style=\"color:brown; background-color:#ffffee;\">Device type(s)\n<\/th><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abaxis.com\/\" target=\"_blank\">Abaxis, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">chemistry analyzers\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.diabetescare.abbott\/\" target=\"_blank\">Abbot Diabetes Care<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.globalpointofcare.abbott\/en\/index.html\" target=\"_blank\">Abbot Point of Care<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry, hematology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood analyzers, chemistry analyzers, hematology devices, molecular immunoassay analyzer\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aconlabs.com\/\" target=\"_blank\">ACON Laboratories, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry, hematology, urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors, hematology devices, urine analyzers\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/advocatemeters.com\/\" target=\"_blank\">Advocate Meters, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/agamatrix.com\/\" target=\"_blank\">AgaMatrix, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.allmedicus.com\/\" target=\"_blank\">All Medicus Co., Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.alliance-intl.com.tw\/en\/\" target=\"_blank\">Alliance International Co., Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ketocoachx.com\/\" target=\"_blank\">AmVenturex, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood ketone monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.americanscreeningcorp.com\/\" target=\"_blank\">American Screening Corp.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.jiuan.com\/\" target=\"_blank\">Andon Health Co., Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.apexbio.com\/\" target=\"_blank\">Apex Biotechnology Corp.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/appliedbiomedical.com\/wp\/\" target=\"_blank\">Applied Biomedical, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.arkrayusa.com\/\" target=\"_blank\">Arkray USA, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ascensia.com\/\" target=\"_blank\">Ascensia Diabetes Care Holdings AG<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.bd.com\/\" target=\"_blank\">Becton Dickson and Company<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">digital immunoassay analyzer\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.bigfootbiomedical.com\/\" target=\"_blank\">Bigfoot Biomedical, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mybinxhealth.com\/\" target=\"_blank\">binx health, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">molecular immunoassay analyzer\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.bioland.com.hk\/\" target=\"_blank\">BioLand Technology Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.bionime.com\/\" target=\"_blank\">Bionime Corporation<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/biosyslabs.com\/\" target=\"_blank\">BioSys Laboratories, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urine analyzers\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gobio.com\/health-management\/\" target=\"_blank\">BioTelemetry, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.biotrondiagnostics.com\/\" target=\"_blank\">Biotron Diagnostics, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/lenshooke.com\/\" target=\"_blank\">Bonraybio Co., Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">miscellaneous\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">fertility monitor (male)\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/brunomd6.com\/\" target=\"_blank\">Bruno Pharma Innovations, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors, blood ketone monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.btnx.com\/\" target=\"_blank\">BTNX, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry, urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors, urine analyzers\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.microdotcs.com\/\" target=\"_blank\">Cambridge Sensors Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cardinalhealth.com\/\" target=\"_blank\">Cardinal Health, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urine analyzers\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/okra.care\/\" target=\"_blank\">CGETC, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/claritydiagnostics.com\/\" target=\"_blank\">Clarity Diagnostics, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry, hematology, urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors, hematology devices, urine analyzers\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/coag-sense.com\/\" target=\"_blank\">CoaguSense, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">hematology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">hematology devices\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.delbioww.com\/en\/Home\/Index\" target=\"_blank\">DELBio, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/diathrive.com\/\" target=\"_blank\">Diathrive, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ekfdiagnostics.com\/\" target=\"_blank\">EKF Diagnostics Holding Plc<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry, hematology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors, blood ketone monitors, hematology devices\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.empecs.com\/\" target=\"_blank\">Empecs Medical Co., Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/epsbio.en.ec21.com\/\" target=\"_blank\">EPS Bio Technology Corp.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fifty50pharmacy.com\/\" target=\"_blank\">Fifty 50 Medical, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.firstvitals.com\/\" target=\"_blank\">FirstVitals Health and Wellness, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/foracare.com\/\" target=\"_blank\">ForaCare, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.glbiotech.com.tw\/\" target=\"_blank\">General Life Biotechnology Co., Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.germainelabs.com\/\" target=\"_blank\">Germaine Laboratories, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry, urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood cholesterol monitors, blood glucose monitors, urine analyzers\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gl-diabetes.com\/\" target=\"_blank\">GL Diabetes, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/glucoperfect.com\/\" target=\"_blank\">Gluco Perfect, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.gcmedis.com\/src\/sub211.php\" target=\"_blank\">GreenCross Medis Corp.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.hemocue.us\/\" target=\"_blank\">HemoCue AB<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry, hematology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors, hematology devices\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.henryschein.com\/us-en\/medical\/\" target=\"_blank\">Henry Schein, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urine analyzers\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.hmdbio.com\/\" target=\"_blank\">HMD Biomedical, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.homeaide.us\/\" target=\"_blank\">Home Aide Diagnostics, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nurserosie.com\/\" target=\"_blank\">Hummingbird Medical, Inc.<br \/>dba Nurse Rosie Products<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/i-sens.com\/\" target=\"_blank\">i-SENS. Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ihealthlabs.com\/\" target=\"_blank\">iHealth Labs, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ijdream.com\/\" target=\"_blank\">ijDream Corporation<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ilinemicrosystems.com\/nw\/en\/home\/\" target=\"_blank\">iLine Microsystems SL<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">hematology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">hematology devices\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/infopia.en.ec21.com\/\" target=\"_blank\">Infopia Co., Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.presspogo.com\/\" target=\"_blank\">Intuity Medical, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.jantdx.com\/\" target=\"_blank\">Jant Pharmacal Corp.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">hematology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">hematology devices\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.joinsoon.net\/\" target=\"_blank\">Joinsoon Medical Technology Co., Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">hematology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">hematology devices\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/keto-mojo.com\/\" target=\"_blank\">Keto-Check, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors, blood ketone monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.curofit.com\/\" target=\"_blank\">KPI Healthcare, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood cholesterol monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mydario.com\/\" target=\"_blank\">LabStyle Innovations Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.onetouch.com\/\" target=\"_blank\">LifeScan, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/welcome.livongo.com\/\" target=\"_blank\">Livongo Health, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.magellandx.com\/\" target=\"_blank\">Magellan Diagnostics, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood analyzers\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.majorbio.com.tw\/\" target=\"_blank\">Major Biosystem Co., Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/eccatalogue.mckesson.com\/\" target=\"_blank\">McKesson Medical-Surgical<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/secure.mypss.com\/\" target=\"_blank\">McKesson Medical-Surgical, PSS site<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry, urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors, urine analyzers\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/medivena.squarespace.com\/\" target=\"_blank\">MediVena, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.medline.com\/\" target=\"_blank\">Medline Industries, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry, urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors, urine analyzers\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.mesabiotech.com\/\" target=\"_blank\">Mesa Biotech, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">digital immunoassay analyzer\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/metene.com\/\" target=\"_blank\">Metene Limited<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/mhcmed.com\/\" target=\"_blank\">MHC Medical Products, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.micobiomed.com\/\" target=\"_blank\">MiCoBioMed Co., Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.microtechmd.com\/en\/\" target=\"_blank\">MicroTech Medical (Hangzhou) Co., Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nuvomed.us\/\" target=\"_blank\">Midwest Trading Group, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.novabiomedical.com\/\" target=\"_blank\">Nova Biomedical Corp.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.okbiotech.com\/\" target=\"_blank\">Ok Biotech Co., Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.omnishealth.com\/\" target=\"_blank\">Omnis Health, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.optumrx.com\/\" target=\"_blank\">OptumRx, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.philosys.com\/\" target=\"_blank\">Philosys Co., Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ptsdiagnostics.com\/\" target=\"_blank\">Polymer Technology Systems, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors, blood cholesterol monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/popsdiabetes.com\/\" target=\"_blank\">POPS! Diabetes Care, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.prodigymeter.com\/\" target=\"_blank\">Prodigy Diabetes Care, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ptsdiagnostics.com\/\" target=\"_blank\">PTS Diagnostics<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry, hematology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors, hematology devices\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/usdiagnostics.roche.com\/\" target=\"_blank\">Roche Diagnostics<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry, hematology, urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors, hematology devices, urine analyzers\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/sdbiosensor.co.kr\/\" target=\"_blank\">SD BioSensor, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ekfusa.com\/separation-technology\/\" target=\"_blank\">Separation Technology, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">hematology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">hematology devices\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.siemens-healthineers.com\/\" target=\"_blank\">Siemens Healthcare GmbH<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">hematology, urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">hematology devices, urine analyzers\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/simplediagnostics.com\/\" target=\"_blank\">Simple Diagnostics, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.sinocare.com\/\" target=\"_blank\">Sinocare, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/smartmeterrpm.com\/\" target=\"_blank\">Smart Meter, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/smcdirectonline.com\/\" target=\"_blank\">SMC Direct, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry, urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors, urine analyzers\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ekfusa.com\/\" target=\"_blank\">Stanbio Laboratory L.P.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">hematology, urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">hematology devices, urine analyzers\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.swissprecisiondiagnostics.com\/\" target=\"_blank\">Swiss Precision Diagnostics GmbH<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">fertility monitor (female)\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.tearlab.com\/\" target=\"_blank\">TearLab Corporation<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">chemistry analyzers\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.tecodiagnostics.com\/\" target=\"_blank\">Teco Diagnostics, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urine analyzers\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.trividiahealth.com\/\" target=\"_blank\">Trividia Health, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.tysonbio.com\/\" target=\"_blank\">Tyson Bioresearch, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.usdiagnostics.net\/\" target=\"_blank\">US Diagnostics, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/vidandiagnostics.com\/\" target=\"_blank\">Vidan Diagnostics, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors, blood ketone monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.visgeneer.com.tw\/\" target=\"_blank\">Visgeneer, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.vivachek.com\/\" target=\"_blank\">VivaChek Laboratories, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.yd-diagnostics.com\/\" target=\"_blank\">YD Diagnostics Corp.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urine analyzers\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.zenithdiagnostics.com\/\" target=\"_blank\">Zenith Diagnostics<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose monitors\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible sortable\" border=\"1\" cellpadding=\"5\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"3\">Vendors of CLIA-waived Test Kits and Supplies\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee;\">Original manufacturer\n<\/th>\n<th style=\"color:brown; background-color:#ffffee;\">Testing domain(s) covered\n<\/th>\n<th style=\"color:brown; background-color:#ffffee;\">Test kit type(s)\n<\/th><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.1stepdtx.com\/\" target=\"_blank\">1 Step Detect Associates, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.alere.com\/en\/home.html\" target=\"_blank\">Abbott (formerly Alere\/Inverness\/Innovacon)<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen, fecal occult, H. pylori, influenza, mono, pregnancy test, Strep A\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aconlabs.com\/\" target=\"_blank\">ACON Laboratories, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, toxicology, urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen, H. pylori, mono, ovulation test, pregnancy test, Strep A, urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acrobiotech.com\/\" target=\"_blank\">Acro Biotech, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.advinbio.com\/\" target=\"_blank\">Advin Biotech, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/hemaprompt.com\/\" target=\"_blank\">Aerscher Diagnostics, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">fecal occult, gastric occult\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.qdaide.com\/\" target=\"_blank\">Ai De Diagnostic Co.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.alfascientific.com\/\" target=\"_blank\">Alfa Scientific Designs, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, toxicology, urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen, fecal occult, H. pylori, ovulation test, pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/abmc.com\/\" target=\"_blank\">American Bio Medica Corp.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.americanscreeningcorp.com\/\" target=\"_blank\">American Screening Corp.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ameritek.org\/\" target=\"_blank\">Ameritek USA, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">fecal occult, ovulation test, pregnancy test, trichomonas\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.analyticon-diagnostics.com\/en\/\" target=\"_blank\">Analyticon Biotechnologies AG<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.arlingtonscientific.com\/\" target=\"_blank\">Arlington Scientific, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.artronlab.com\/\" target=\"_blank\">Artron Laboratories, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.diareagent.com\/\" target=\"_blank\">Assure Tech. (Hangzhou) Co., Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/atlas-medical.com\/\" target=\"_blank\">Atlas Medical Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.axiumbioresearch.com\/\" target=\"_blank\">Axium BioResearch, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.azurebiotech.com\/\" target=\"_blank\">Azure Biotech, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.beckmancoulter.com\/\" target=\"_blank\">Beckman Coulter, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">fecal occult, gastric occult, H. pylori, mono, pregnancy test, Strep A\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.bd.com\/en-us\" target=\"_blank\">Becton Dickson and Company<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">H. pylori, ovulation test, pregnancy test, Strep A\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/bestvaluemedical.com\/\" target=\"_blank\">Best Value Medical<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/bhatbiotech.com\/\" target=\"_blank\">Bhat Bio-tech India Private Limited<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ntsbiz.com\/\" target=\"_blank\">Big Room Testing, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/biolytical.com\/\" target=\"_blank\">bioLytical Laboratories, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">HIV-1\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.biomerica.com\/\" target=\"_blank\">Biomerica, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">fecal occult, ovulation test, pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.biomerieux-diagnostics.com\/\" target=\"_blank\">bioM\u00e9rieux SA<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/biorexlabs.com\/\" target=\"_blank\">Biorex Labs, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.biotechscreening.com\/\" target=\"_blank\">Biotech Screening, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.biotrondiagnostics.com\/\" target=\"_blank\">Biotron Diagnostics, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.btnx.com\/\" target=\"_blank\">BTNX, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen, fecal occult, FSH, H. pylori, pregnancy test, RSV, Strep A, TSH\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ecamco.com\/\" target=\"_blank\">Cambridge Diagnostic Products, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">fecal occult\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cardinalhealth.com\/\" target=\"_blank\">Cardinal Health, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">H. pylori, mono, pregnancy test, Strep A, urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cenmedonline.com\/\" target=\"_blank\">Cen-Med Enterprises, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">fecal occult, pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.cenogenics.net\/\" target=\"_blank\">Cenogenics Corp.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">fecal occult, pregnancy test, urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cepheid.com\/\" target=\"_blank\">Cepheid<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">influenza, Strep A\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.chaindrug.com\/quality-choice-1\" target=\"_blank\">Chain Drug Marketing Association, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/chematics.com\/\" target=\"_blank\">Chematics, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/chembio.com\/\" target=\"_blank\">Chembio Diagnostic Systems, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">HIV-1, HIV-2\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.uschemtronbio.com\/\" target=\"_blank\">Chemtron Biotech, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen, pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/churchdwight.com\/\" target=\"_blank\">Church & Dwight Co., Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/claritydiagnostics.com\/\" target=\"_blank\">Clarity Diagnostics, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen, fecal occult, H. pylori, mono, pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cliawaived.com\/\" target=\"_blank\">CLIAwaived, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, toxicology, urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen, fecal occult, H. pylori, pregnancy test, Strep A, TSH, urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.clinicalgenomics.com\/\" target=\"_blank\">Clinical Genomics Technologies Pty. Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">fecal occult\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.crlcorp.com\/\" target=\"_blank\">Clinical Reference Laboratory, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.coastlinems.com\/\" target=\"_blank\">Coastline Medical Management, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.co-innovation.com.cn\/\" target=\"_blank\">Co-innovation Biotech Co., Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen, pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.cs-commonsense.com\/\" target=\"_blank\">Common Sense Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">vaginal pH\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.confirmbiosciences.com\/\" target=\"_blank\">Confirm Biosciences<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.coretests.com\/\" target=\"_blank\">Coretests, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen, pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.dealmed.com\/\" target=\"_blank\">Dealmed Medical Supplies, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">Strep A\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.devonmedicalproducts.com\/\" target=\"_blank\">Devon Medical Products, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.dficare.com\/en\/index.php\/\" target=\"_blank\">DFI Co., Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.diagnosticsdirect2u.com\/\" target=\"_blank\">Diagnostics Direct, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">syphilis\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/preferredmedsupply.com\/\" target=\"_blank\">Deus Vult, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/drugtestcity.com\/\" target=\"_blank\">Drug Test City, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/healthcare-manager.com\/\" target=\"_blank\">EASY at Home Medical, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, toxicology, urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen, pregnancy test, urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eklacorp.com\/\" target=\"_blank\">EKLA Corporation<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen, pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.drugcheck.com\/\" target=\"_blank\">Express Diagnostics International, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, toxicology, urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen, pregnancy test, urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.eztestcup.com\/\" target=\"_blank\">EZ Testing Solutions, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.firstcheckfamily.com\/\" target=\"_blank\">First Check Diagnostics, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fishersci.com\/us\/en\/healthcare-products\/selection-guides\/fisher-healthcare-sure-vue-kits.html\" target=\"_blank\">Fisher Healthcare<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">influenza, RSV\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.germainelabs.com\/\" target=\"_blank\">Germaine Laboratories, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">fecal occult, H. pylori, mono, pregnancy test, Strep A, urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/getstix.co\/\" target=\"_blank\">Get Stix, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test, urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/en.wondfo.com.cn\/\" target=\"_blank\">Guangzhou Wondfo Co., Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen, pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/products.halyardhealth.com\/\" target=\"_blank\">Halyard Worldwide, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">H. pylori\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.alltests.com.cn\/\" target=\"_blank\">Hangzhou AllTest Biotech Co., Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.biotests.com.cn\/\" target=\"_blank\">Hangzhou Biotest Biotech Co., Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/en.clongene.com\/\" target=\"_blank\">Hangzhou Clongene Biotech Co. Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nursehatty.com\/\" target=\"_blank\">Hatty, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.healgen.com\/\" target=\"_blank\">Healgen Scientific, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, toxicology, urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen, fecal occult, pregnancy test, urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/healthy.io\/\" target=\"_blank\">Healthy.io Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.helena.com\/\" target=\"_blank\">Helena Laboratories Corp.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">fecal occult\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.henryschein.com\/us-en\/medical\/\" target=\"_blank\">Henry Schein, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">fecal occult, H. pylori, influenza, mono, pregnancy test, Strep A, urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.heritagehouse76.com\/\" target=\"_blank\">Heritage House '76 Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/homehealth-uk.com\/\" target=\"_blank\">Home Health UK, Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/12panelnow.com\/\" target=\"_blank\">Hospital Connect, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.azoproducts.com\/\" target=\"_blank\">i-Health, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.imcoinc.com\/\" target=\"_blank\">IMCO, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">mono, pregnancy test, Strep A, trichomonas\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.immunostics.com\/\" target=\"_blank\">Immunostics, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test, Strep A, urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eztestcup.com\/\" target=\"_blank\">Innovative Laboratory Solutions, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.innovita.com.cn\/index.php\" target=\"_blank\">Innovita (Tangshan) Biological Technology Co. Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.imcoinc.com\/\" target=\"_blank\">Independent Medical Co-Op, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen, pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/myvistaflow.com\/\" target=\"_blank\">Intrinsic Interventions, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.jantdx.com\/\" target=\"_blank\">Jant Pharmacal Corp.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen, fecal occult, H. pylori, mono, pregnancy test, Strep A, TSH, urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/labsystemsdx.com\/\" target=\"_blank\">Labsystems Diagnostics Oy<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/exploroproducts.com\/\" target=\"_blank\">Lendas, UAB<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/meetlia.com\/\" target=\"_blank\">LIA Diagnostics, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.lifesignmed.com\/\" target=\"_blank\">LifeSign, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">fecal occult, H. pylori, influenza, mono, pregnancy test, Strep A\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/lumiquick.co\/\" target=\"_blank\">LumiQuick Diagnostics, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.mn-net.com\/\" target=\"_blank\">MACHEREY-NAGEL GmbH & Co. KG<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.clinicalguard.com\/\" target=\"_blank\">Mandarin Enterprises, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.magentadrugtest.com\/\" target=\"_blank\">Magenta Technology Partners, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/iproven.com\/\" target=\"_blank\">Masena Invest BV<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/eccatalogue.mckesson.com\/\" target=\"_blank\">McKesson Medical-Surgical<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen, H. pylori, mono, pregnancy test, Strep A, urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.medicaldisposables.us\/\" target=\"_blank\">Medical Disposables Corporation<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen, fecal occult\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.medicaldistributiongroup.com\/\" target=\"_blank\">Medical Distribution Group, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mes-global.com\/\" target=\"_blank\">Medical Electronic Systems, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">semen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.meditests.com\/\" target=\"_blank\">Medimpex United, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen, pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.medline.com\/\" target=\"_blank\">Medline Industries, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen, fecal occult, influenza, mono, pregnancy test, urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.mercedesscientific.com\/\" target=\"_blank\">Mercedes Scientific, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.meridianbioscience.com\/\" target=\"_blank\">Meridian Bioscience, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/drugtestsinbulk.com\/\" target=\"_blank\">Mergers Marketing, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen, pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/proovtest.com\/\" target=\"_blank\">MFB Fertility, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">fertility test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.micro-distributing.com\/\" target=\"_blank\">Micro Distributing II, Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mosiebaby.com\/\" target=\"_blank\">Mosie, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.mossmanassociates.com\/\" target=\"_blank\">Mossman Associates, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.swimcount.com\/\" target=\"_blank\">MotilityCount ApS<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">semen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.mpbio.com\/\" target=\"_blank\">MP Biomedicals, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mydrugtestcups.com\/\" target=\"_blank\">MyDrugTestCups.com, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.egens-bio.com\/\" target=\"_blank\">Nantong EGENS Bio Technology Company<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/betachek-europe.com\/\" target=\"_blank\">National Diagnostic Products Pty. Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">blood glucose test strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.proadvantagebyndc.com\/\" target=\"_blank\">National Distribution & Contracting, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">fecal occult, H. pylori, mono, pregnancy test, Strep A\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ntsbiz.com\/\" target=\"_blank\">National Test Systems, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/nativediagnostics.com\/\" target=\"_blank\">Native Diagnostics, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.naturalcycles.com\/about\/\" target=\"_blank\">Natural Cycles Nordic AB<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/newscen.com\/\" target=\"_blank\">NewScen Coast Bio-Pharmaceutical Co., Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.nexscreen.com\/\" target=\"_blank\">NexScreen, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.noblemedical.com\/\" target=\"_blank\">Noble Medical, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.omegalabs.net\/\" target=\"_blank\">Omega Laboratories, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ostsus.com\/\" target=\"_blank\">On-Site Testing Specialists, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.orasure.com\/\" target=\"_blank\">OraSure Technologies, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen, HCV, HIV-1\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.origindiagnostics.com\/\" target=\"_blank\">Origin, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.owens-minor.com\/\" target=\"_blank\">Owens & Minor, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.phamatech.com\/\" target=\"_blank\">Phamatech, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.tshchek.com\/\" target=\"_blank\">Pharmaceutical Marketing Systems, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">TSH\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pblabs.com\/\" target=\"_blank\">Pinnacle BioLabs, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.polymedt.com\/\" target=\"_blank\">Polymed Therapeutics, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen, pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.polymedco.com\/\" target=\"_blank\">Polymedco, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">BTA, fecal occult, H. pylori, mono, pregnancy test, Strep A\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/premierbiotech.com\/\" target=\"_blank\">Premier Biotech, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.eptfamily.com\/\" target=\"_blank\">Prestige Brands Holdings, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pbmc.com\/\" target=\"_blank\">Princeton BioMeditech Corporation<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen, fecal occult, H. pylori, ovulation test, pregnancy test, Strep A\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/us.pg.com\/\" target=\"_blank\">Proctor and Gamble<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.promedsupply.com\/\" target=\"_blank\">Professional Medical, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.proppermfg.com\/\" target=\"_blank\">Propper Manufacturing Co., Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">fecal occult\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.hightopqd.com\/en\/index.aspx\" target=\"_blank\">Qingdao Hightop Biotech Co. Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.qualigeninc.com\/\" target=\"_blank\">Qualigen, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">TSH\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.quidel.com\/\" target=\"_blank\">Quidel Corporation<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">H. pylori, influenza, mono, pregnancy test, RSV, Strep A, urine reagent strips, vaginal pH\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.rpsdetectors.com\/\" target=\"_blank\">Rapid Pathogen Screening, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">adenovirus, MMP-9\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/rapidselftest.com\/\" target=\"_blank\">Rapid Self Test, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.redwoodtoxicology.com\/\" target=\"_blank\">Redwood Toxicology Laboratory, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.rhemascientific.com\/\" target=\"_blank\">Rhema Scientific, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/rightbiometrics.com\/\" target=\"_blank\">RightBio Metrics, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">gastric pH\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.runbio-bio.com\/\" target=\"_blank\">Runbio Biotech Co., Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">ovulation test, pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sascientific.com\/\" target=\"_blank\">SA Scientific, Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">influenza, pregnancy test, RSV, Strep A\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/sandstonedx.com\/\" target=\"_blank\">Sandstone Diagnostics, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">semen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.savyondiagnostics.com\/\" target=\"_blank\">Savyon Diagnostics Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.scanwellhealth.com\/\" target=\"_blank\">Scanwell Health, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/m.safecare.com.cn\/\" target=\"_blank\">Safecare Biotech (Hangzhou) Co. Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen, pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.inuihealth.com\/inui\/home\" target=\"_blank\">Scanadu, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/scimedic.com\/\" target=\"_blank\">SCI Medic, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, toxicology, urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen, pregnancy test, urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/thyrochek.com\/\" target=\"_blank\">Screening Devices Canada, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">clinical chemistry\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">TSH\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sekisuidiagnostics.com\/\" target=\"_blank\">Sekisui Diagnostics, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">influenza, mono, pregnancy test, Strep A, trichomonas\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.serim.com\/\" target=\"_blank\">Serim Research Corporation<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">H. pylori\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.chemtronbio.com\/\" target=\"_blank\">Shanghai Chemtron Biotech Co., Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.bioeasy.com\/\" target=\"_blank\">Shenzhen Bioeasy Biotechnology Co., Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.siemens-healthineers.com\/\" target=\"_blank\">Siemens Healthcare GmbH<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/smcdirectonline.com\/\" target=\"_blank\">SMC Direct, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test, Strep A, urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/solcraftmedical.com\/\" target=\"_blank\">SolCraft, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/spermcheck.com\/\" target=\"_blank\">SpermCheck<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">semen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.drugtestsite.com\/\" target=\"_blank\">Speedy Solutions, LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ekfusa.com\/\" target=\"_blank\">Stanbio Laboratory L.P.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">fecal occult, H. pylori, mono, pregnancy test, Strep A, urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/sugentech.com\/\" target=\"_blank\">Sugentech, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.swissprecisiondiagnostics.com\/\" target=\"_blank\">Swiss Precision Diagnostics GmbH<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">ovulation test, pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.syntron.net\/\" target=\"_blank\">Syntron Bioresearch, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, toxicology, urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen, pregnancy test, urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/szioplus.com\/\" target=\"_blank\">SZIO+, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/tannerscientific.com\/\" target=\"_blank\">Tanner Scientific, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.tecodiagnostics.com\/\" target=\"_blank\">Teco Diagnostics, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, toxicology, urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen, fecal occult, ovulation test, pregnancy test, urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fishersci.com\/\" target=\"_blank\">Thermo Fisher Scientific, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">fecal occult, H. pylori, influenza, pregnancy test, RSV, Strep A, urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.femometer.com\/\" target=\"_blank\">Tianjin New Bay Bioresearch Co. Ltd. <\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.transmedco.com\/\" target=\"_blank\">TransMed Co., LLC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.transmetrondrugtest.com\/\" target=\"_blank\">Transmetron, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.trinitybiotech.com\/\" target=\"_blank\">Trinity Biotech Plc<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">H. pylori, HIV-1\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/truediag.com\/\" target=\"_blank\">True Diagnostics, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.turklab.com.tr\/\" target=\"_blank\">Turklab AS<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ucpbiosciences.com\/\" target=\"_blank\">UCP Biosciences, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uacups.com\/\" target=\"_blank\">Ultimate Analysis Cup, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.universal-meditech.com\/\" target=\"_blank\">Universal Meditech, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">fecal occult, pregnancy test, urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/uqora.com\/\" target=\"_blank\">Uqora, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.usdiagnostics.net\/\" target=\"_blank\">US Diagnostics, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/utestdrugtesting.com\/\" target=\"_blank\">UTest<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/uveradiagnostics.com\/\" target=\"_blank\">uVera Diagnostics, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/verifydiagnostics.com\/\" target=\"_blank\">Verify Diagnostics, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen, pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/victorch.com\/\" target=\"_blank\">VicTorch Meditek, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.visbymedical.com\/\" target=\"_blank\">Visby Medical, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">STI test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.whpm.com\/\" target=\"_blank\">W.H.P.M., Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen, pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.whkangzhou.com\/\" target=\"_blank\">Weihai Kangzhou Biotechnology Engineering Co., Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wholepowerbio.com\/\" target=\"_blank\">Wholepower Biotech Co., Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wiener-lab.com.ar\/EN\/\" target=\"_blank\">Wiener Laboratorios SAIC<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/wolfeinc.com\/\" target=\"_blank\">WOLFE, Inc.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/wondfousa.com\/\" target=\"_blank\">Wondfo Biotech Co. Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology, toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen, ovulation test, pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/useful.en.alibaba.com\/\" target=\"_blank\">Xiamen Useful Import and Export Co., Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">toxicology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">drug screen\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.yd-diagnostics.com\/\" target=\"_blank\">YD Diagnostics<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urinalysis\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">urine reagent strips\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.zerhitech.com\/\" target=\"_blank\">Zer Hitech Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">pregnancy test\n<\/td><\/tr>\n<tr>\n<td style=\"font-weight: bold; padding-left:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.orientgene.com\/\" target=\"_blank\">Zhejiang Orient Gene Biotech Co., Ltd.<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">immunology\n<\/td>\n<td style=\"background-color:white; padding-left:10px;\">fecal occult, pregnancy test\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<p>The following is a list of additional vendors verified to offer CLIA-certified moderate or complex diagnostic instruments and\/or test kits. The same methodology was used as above for CLIA-waived, with the exception of opting to not provide specifics about instrument and test types.\n<\/p><p><b>Note<\/b>: Most of these vendors sell analyzers and tests that are CLIA-certified moderate or complex. However, is ultimately up to the potential buyer to verify with the vendor an item's CLIA certification status before purchase.\n<\/p>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable\" style=\"\">\n\n\n<tbody><tr valign=\"top\">\n<td style=\"padding-left:10px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/sciex.com\/\" target=\"_blank\">AB Sciex Pte. Ltd.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.globalpointofcare.abbott\/en\/index.html\" target=\"_blank\">Abbot<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/acceleratediagnostics.com\/\" target=\"_blank\">Accelerate Diagnostics, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.accessbio.net\/\" target=\"_blank\">Access Bio, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acrobiotech.com\/\" target=\"_blank\">Acro Biotech, LLC<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.advinbio.com\/\" target=\"_blank\">Advin Biotech, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aesku.com\/\" target=\"_blank\">AESKU.GROUP GmbH & Co. KG<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aggredyne.com\/\" target=\"_blank\">Aggredyne, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.agilent.com\/\" target=\"_blank\">Agilent Technologies, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.qdaide.com\/english\/index.aspx\" target=\"_blank\">AiDe Diagnostic Co., Ltd.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/akonni.com\/\" target=\"_blank\">Akonni Biosystems, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/quotientbd.com\/us\/\" target=\"_blank\">Alba Bioscience Ltd.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/alcorscientific.com\/\" target=\"_blank\">ALCOR Scientific, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/awdt.us\/\" target=\"_blank\">Alfa Wassermann, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.alifax.com\/\" target=\"_blank\">Alifax S.r.l.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.alphalabs.co.uk\/\" target=\"_blank\">Alpha Laboratories Ltd.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.alpco.com\/\" target=\"_blank\">American Laboratory Products Company Ltd.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.anshlabs.com\/\" target=\"_blank\">Ansh Labs, LLC<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.apbiocode.com\/\" target=\"_blank\">Applied Biocode, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/spectral-imaging.com\/\" target=\"_blank\">Applied Spectral Imaging, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.arlingtonscientific.com\/\" target=\"_blank\">Arlington Scientific, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ark-tdm.com\/\" target=\"_blank\">ARK Diagnostics, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fungitell.com\/\" target=\"_blank\">Associates of Cape Cod, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astutemedical.com\/\" target=\"_blank\">Astute Medical, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.atago.net\/en\/index.php\" target=\"_blank\">ATAGO U.S.A., Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/athelas.com\/\" target=\"_blank\">Athelas, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/atlas-medical.com\/\" target=\"_blank\">Atlas Medical Ltd.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/avioq.com\/\" target=\"_blank\">Avioq, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.awaretech.com\/\" target=\"_blank\">Awareness Technology, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/aximbiotech.com\/\" target=\"_blank\">AXIM Biotechnologies, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.azurebiotech.com\/\" target=\"_blank\">Azure Biotech, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/bacterioscan.com\/\" target=\"_blank\">BacterioScan, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.beckmancoulter.com\/\" target=\"_blank\">Beckman Coulter, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.bdbiosciences.com\/\" target=\"_blank\">Becton, Dickinson and Company - Biosciences<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/moleculardiagnostics.bd.com\/\" target=\"_blank\">Becton, Dickinson and Company - Molecular<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/baebies.com\/\" target=\"_blank\">Baebies, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.bindingsite.com\/\" target=\"_blank\">The Binding Site Group Ltd.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mybinxhealth.com\/\" target=\"_blank\">binx health, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.bio-rad.com\/\" target=\"_blank\">Bio-Rad Laboratories, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/biocare.net\/\" target=\"_blank\">Biocare Medical, LLC<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.biocartis.com\/\" target=\"_blank\">Biocartis NV<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.biofiredx.com\/\" target=\"_blank\">Biofire Diagnostics, LLC<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.biogenex.com\/\" target=\"_blank\">BioGenix Laboratories, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.biofortuna.com\/\" target=\"_blank\">Biofortuna Ltd.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/biolytical.com\/\" target=\"_blank\">bioLytical Laboratories, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.biomerieux-diagnostics.com\/\" target=\"_blank\">bioM\u00e9rieux SA<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/biorexlabs.com\/\" target=\"_blank\">Biorex Labs, LLC<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/home.biosystems.es\/\" target=\"_blank\">BioSystems SA<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.biotek.com\/\" target=\"_blank\">BioTek Instruments, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/bioview.com\/\" target=\"_blank\">Bioview Ltd.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.boditech.co.kr\/en\" target=\"_blank\">Boditech Med, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.bonraybio.com\/en\" target=\"_blank\">Bonraybio Co., Ltd.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.buhlmannlabs.ch\/\" target=\"_blank\">B\u00dcHLMANN Laboratories AG<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.brahms.de\/\" target=\"_blank\">BRAHMS GmbH<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.bruker.com\/\" target=\"_blank\">Bruker Corporation<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cardinalhealth.com\/en.html\" target=\"_blank\">Cardinal Health, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.carolinachemistries.com\/\" target=\"_blank\">Carolina Liquid Chemistries Corp.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cellavision.com\/\" target=\"_blank\">CellaVision AB<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cddiagnostics.com\/\" target=\"_blank\">CD Diagnostics, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cepheid.com\/\" target=\"_blank\">Cepheid<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.check-points.com\/\" target=\"_blank\">Check-Points Health BV<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/chembio.com\/\" target=\"_blank\">Chembio Diagnostic Systems, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.chronolog.com\/\" target=\"_blank\">Chrono-Log Corporation<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cleverculturesystems.com\/\" target=\"_blank\">Clever Culture Systems AG<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdsolinc.com\/\" target=\"_blank\">Clinical Diagnostics Solutions, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/curetis.com\/\" target=\"_blank\">Curetis NV<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.denka.co.jp\/eng\/\" target=\"_blank\">Denka Company Limited<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.diagam.com\/en\" target=\"_blank\">DiAgam SA<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.diagast.com\/\" target=\"_blank\">DIAGAST SAS<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.diagnostic.grifols.com\/en\/\" target=\"_blank\">Diagnostic Grifols SA<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.stago-us.com\/\" target=\"_blank\">Diagnostica Stago, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.diamonddiagnostics.com\/\" target=\"_blank\">Diamond Diagnostics, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.diasorin.com\/home\/\" target=\"_blank\">DiaSorin S.p.A.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.diatron.com\/\" target=\"_blank\">Diatron Medical Instruments Ltd.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.diazyme.com\/\" target=\"_blank\">Diazyme Laboratories, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.diesse.it\/en\/\" target=\"_blank\">DIESSE Diagnostica Senese SpA<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.dirui.com.cn\/\" target=\"_blank\">DIRUI Industrial Co. Ltd.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.drewscientific.com\/\" target=\"_blank\">Drew Scientific, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.drawbridgehealth.com\/\" target=\"_blank\">Drawbridge Health, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.edan.com\/\" target=\"_blank\">EDAN Instruments, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.eiken.co.jp\/en\/index.html\" target=\"_blank\">Eiken Chemical Co., Ltd.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.elitechgroup.com\/\" target=\"_blank\">ELITech Group SAS<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.erbamannheim.com\/\" target=\"_blank\">Erba Diagnostics Mannheim GmbH<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.erbalachema.com\/en\/\" target=\"_blank\">Erba Lachema s.r.o.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.euroimmun.com\/\" target=\"_blank\">EUROIMMUN Medizinische Labordiagnostika AG<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.calprotectina.com\/en\/\" target=\"_blank\">Eurospital SpA<\/a>\n<\/p>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td>\n<td style=\"vertical-align:top; padding-right:10px;\">\n<table class=\"wikitable\" style=\"\">\n\n<tbody><tr valign=\"top\">\n<td style=\"padding-left:10px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.firstlightdx.com\/\" target=\"_blank\">First Light Diagnostics, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.focusdx.com\/\" target=\"_blank\">Focus Diagnostics, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.foundationmedicine.com\/\" target=\"_blank\">Foundation Medicine, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/healthcaresolutions-us.fujifilm.com\/\" target=\"_blank\">FUJIFILM Healthcare Americas Corporation<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fujirebio.com\/\" target=\"_blank\">Fujirebio Europe NV<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.genalyte.com\/\" target=\"_blank\">Genalyte, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.genbio.com\/\" target=\"_blank\">GenBio<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.genmarkdx.com\/\" target=\"_blank\">GenMark Diagnostics, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.genprime.com\/\" target=\"_blank\">GenPrime, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sanofi.com\/en\" target=\"_blank\">Genzyme Corporation<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/glycomark.com\/\" target=\"_blank\">GlycoMark, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/gsdx.us\/\" target=\"_blank\">Gold Standard Diagnostics<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/gbscience.com\/\" target=\"_blank\">Great Basin Corporation<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/en.wondfo.com.cn\/\" target=\"_blank\">Guangzhou Wondfo Co., Ltd.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/guardant360cdx.com\/\" target=\"_blank\">Guardant Health, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.haemonetics.com\/\" target=\"_blank\">Haemonetics Corporation<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/hardydiagnostics.com\/\" target=\"_blank\">Hardy Diagnostics, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.healgen.com\/\" target=\"_blank\">Healgen Scientific, LLC<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/healthy.io\/\" target=\"_blank\">Healthy.io Ltd.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.helena.com\/\" target=\"_blank\">Helena Laboratories Corporation<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.helix.com\/\" target=\"_blank\">Helix OpCo, LLC<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.hematek.com\/index.php\" target=\"_blank\">HemaTechnologies<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/hemosonics.com\/\" target=\"_blank\">Hemosonics, LLC<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.henryschein.com\/us-en\/medical\/\" target=\"_blank\">Henry Schein, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ffntest.com\/\" target=\"_blank\">Hologic, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.horiba.com\/en_en\/\" target=\"_blank\">HORIBA, Ltd. - Main Site<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.medtestdx.com\/\" target=\"_blank\">HORIBA, Ltd. - MedTestDx<\/a>)<br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.hycorbiomedical.com\/\" target=\"_blank\">Hycor Biomedical, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.hyphen-biomed.com\/\" target=\"_blank\">HYPHEN Biomed SAS<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/icubate.com\/\" target=\"_blank\">iCubate, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.idsplc.com\/\" target=\"_blank\">IDS PLC<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ilinemicrosystems.com\/nw\/en\/home\/\" target=\"_blank\">iLine Microsystems SL<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.illumina.com\/\" target=\"_blank\">Illumina, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.immucor.com\/en-us\/\" target=\"_blank\">Immucor, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/immunalysis.com\/\" target=\"_blank\">Immunalysis Corporation<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/immunoconcepts.com\/\" target=\"_blank\">Immuno Concepts N.A. Ltd.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.immy.com\/\" target=\"_blank\">Immuno-Mycologics, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.idsplc.com\/\" target=\"_blank\">Immunodiagnostic Systems Holdings PLC<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/immunotech.cz\/immunotech-s.r.o\" target=\"_blank\">Immunotech sro<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/inbios.com\/\" target=\"_blank\">InBios International, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.imcoinc.com\/\" target=\"_blank\">Independent Medical Co-Op, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/indevr.com\/\" target=\"_blank\">InDevR, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.irlabsystems.com\/\" target=\"_blank\">Infrared Laboratory Systems, LLC<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/invivoscribe.com\/\" target=\"_blank\">Invivoscribe, Inc<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ivdresearch.com\/\" target=\"_blank\">IVD Research, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ixensor.com\/\" target=\"_blank\">iXensor Co., Ltd.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.janacare.com\/\" target=\"_blank\">Jana Care, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.kamiyabiomedical.com\/\" target=\"_blank\">Kamiya Biomedical Company, LLC<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.kpmanalytics.com\/\" target=\"_blank\">KPS Analytics<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/kronus.com\/index.php\" target=\"_blank\">KRONUS, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.laborie.com\/\" target=\"_blank\">Laborie Medical Technologies Corp.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.leicabiosystems.com\/\" target=\"_blank\">Leica Biosystems Nussloch GmbH<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.lifesignmed.com\/\" target=\"_blank\">LifeSign, LLC<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/lin-zhi.com\/\" target=\"_blank\">Lin-Zhi International, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.liofilchem.com\/\" target=\"_blank\">Liofilchem srl<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.skyla.com\/\" target=\"_blank\">Lite-On Technology Corporation<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.luminexcorp.com\/\" target=\"_blank\">Luminex Corporation<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/lumiquick.co\/\" target=\"_blank\">LumiQuick Diagnostics, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.mdialysis.com\/\" target=\"_blank\">M Dialysis AB<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.mn-net.com\/\" target=\"_blank\">MACHEREY-NAGEL GmbH & Co. KG<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.magnabiosciences.com\/\" target=\"_blank\">MagnaBioSciences, LLC<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.medicacorp.com\/\" target=\"_blank\">Medica Corporation<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mes-global.com\/\" target=\"_blank\">Medical Electronic Systems, LLC<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.amnicator.com\/\" target=\"_blank\">Medical Wire & Equipment<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.mediconsa.com\/en\/\" target=\"_blank\">Medicon Hellas SA<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.meditests.com\/\" target=\"_blank\">Medimpex United, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.medtronic.com\/\" target=\"_blank\">Medtronic PLC<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mslabos.eu\/hum\/en\/\" target=\"_blank\">MELET SCHLOESING Laboratoires SA<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.me-med.com\/\" target=\"_blank\">MeMed Diagnostics, Ltd.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.meridianbioscience.com\/\" target=\"_blank\">Meridian Bioscience, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.mesoscale.com\/\" target=\"_blank\">Meso Scale Diagnostics, LLC<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/metasystems-indigo.com\/\" target=\"_blank\">MetaSystems Indigo GmbH<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.micro-distributing.com\/\" target=\"_blank\">Micro Distributing II, Ltd.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/minarismedical.com\/\" target=\"_blank\">Minaris Medical America, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.mindray.com\/en\/\" target=\"_blank\">Mindray Medical International Ltd.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pathfast.com\/\" target=\"_blank\">Mitsubishi Chemical Medience Corp.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.monobind.com\/\" target=\"_blank\">Monobind, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/myriad.com\/\" target=\"_blank\">Myriad Genetics, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.nanoditech.com\/\" target=\"_blank\">Nano-Ditech Corporation<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.nanoentek.com\/\" target=\"_blank\">NanoEnTek, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nanthealth.com\/\" target=\"_blank\">NantHealth, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/nativediagnostics.com\/\" target=\"_blank\">Native Diagnostics International<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.neumodx.com\/\" target=\"_blank\">NeuMoDx Molecular, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nexscreen.com\/\" target=\"_blank\">NexScreen, LLC<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ngbiotech.com\/\" target=\"_blank\">NG Biotech SAS<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.novabiomedical.com\/\" target=\"_blank\">Nova Biomedical Corporation<\/a>\n<\/p>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td>\n<td style=\"vertical-align:top; padding-right:10px;\">\n<table class=\"wikitable\" style=\"\">\n\n<tbody><tr valign=\"top\">\n<td style=\"padding-left:10px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.novxsystems.com\/\" target=\"_blank\">NOVX Systems, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nowdx.com\/\" target=\"_blank\">NOWDiagnostics, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.thermofisher.com\/onelambda\/us\/en\/home.html\" target=\"_blank\">One Lambda, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.opko.com\/\" target=\"_blank\">OPKO Health, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.optimedical.com\/\" target=\"_blank\">OPTI Medical Systems<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.orasure.com\/\" target=\"_blank\">OraSure Technologies, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aidian.eu\/\" target=\"_blank\">Orion Diagnostica Oy<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.orthoclinicaldiagnostics.com\/\" target=\"_blank\">Ortho-Clinical Diagnostics, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.otsuka.co.jp\/en\/\" target=\"_blank\">Otsuka Pharmaceutical Co., Ltd.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ogt.com\/\" target=\"_blank\">Oxford Gene Technology IP Limited<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.medixbiochemica.com\/en\/\" target=\"_blank\">Oy Medix Biochemica Ab<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pall.com\/\" target=\"_blank\">Pall Corporation<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pbf.com.tw\/\" target=\"_blank\">Panion & BF Biotech Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/partosure.com\/\" target=\"_blank\">Parsagen Diagnostics, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.perkinelmer.com\/\" target=\"_blank\">PerkinElmer, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.phamatech.com\/\" target=\"_blank\">Phamatech, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pixcell-medical.com\/\" target=\"_blank\">Pixcell Medical Technologies, Ltd.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pointescientific.com\/\" target=\"_blank\">Pointe Scientific, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.polymedco.com\/\" target=\"_blank\">Polymedco CDP, LLC<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ptsdiagnostics.com\/\" target=\"_blank\">Polymer Technology Systems, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/precisionbiologic.com\/\" target=\"_blank\">Precision BioLogic, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.premierbiotech.com\/\" target=\"_blank\">Premier Biotech, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.progenika.com\/\" target=\"_blank\">Progenika Biopharma SA<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.psychemedics.com\/\" target=\"_blank\">Psychemedics Corporation<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.qiagen.com\/\" target=\"_blank\">QIAGEN GmbH<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.quidel.com\/\" target=\"_blank\">Quidel Corporation<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/quotientbd.com\/\" target=\"_blank\">Quotient Ltd.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clinical.r-biopharm.com\/\" target=\"_blank\">R-Biopharm AG<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/r2diagnostics.com\/\" target=\"_blank\">r<sup>2<\/sup> Diagnostics<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.radiometer.com\/en\/\" target=\"_blank\">Radiometer Medical ApS<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.randox.com\/\" target=\"_blank\">Randox Laboratories Ltd.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.rapiddetect.com\/\" target=\"_blank\">Rapid Detect, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.reichertai.com\/\" target=\"_blank\">Reichert, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/responsebio.com\/\" target=\"_blank\">Response Biomedical Corporation<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/diagnostics.roche.com\/global\/en\/products\/product-category\/molecular-diagnostics.html\" target=\"_blank\">Roche Diagnostics<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.sakaecorp.com\/\" target=\"_blank\">Sakae, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sanguina.com\/\" target=\"_blank\">Sanguina, LLC<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/scopiolabs.com\/\" target=\"_blank\">Scopio Labs Ltd.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sebia.com\/en-UK\/\" target=\"_blank\">Sebia SA<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sekisuidiagnostics.com\/\" target=\"_blank\">Sekisui Diagnostics PEI, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sentineldiagnostics.com\/\" target=\"_blank\">Sentinel CH SpA<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.serosep.com\/\" target=\"_blank\">Serosep Ltd.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.bioeasy.com\/\" target=\"_blank\">Shenzhen Bioeasy Biotechnology Co. Ltd.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.snibe.com\/zh_en\/en_index.aspx\" target=\"_blank\">Shenzhen New Industries Biomedical Engineering Co. Ltd.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.siemens-healthineers.com\/\" target=\"_blank\">Siemens Healthcare Diagnostics<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sightdx.com\/\" target=\"_blank\">Sight Diagnostics Ltd.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.skyla.com\/\" target=\"_blank\">Skyla Corporation<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/spectraldx.com\/\" target=\"_blank\">Spectral Medical, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/immuview.com\/\" target=\"_blank\">SSI Diagnostica A\/S<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ekfusa.com\/\" target=\"_blank\">Stanbio Laboratory L.P.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.stratec.com\/home\" target=\"_blank\">Stratec Biomedical AG<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.streck.com\/\" target=\"_blank\">Streck, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.svarlifescience.com\/\" target=\"_blank\">Svar Life Science AB<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sysmex.com\/\" target=\"_blank\">Sysmex America, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.t2biosystems.com\/\" target=\"_blank\">T2 Biosystems, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/taidoc.com\/\" target=\"_blank\">TaiDoc Technology Corporation<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ibl-international.com\/\" target=\"_blank\">Tecan Trading AG<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.techlab.com\/\" target=\"_blank\">TECHLAB, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.tecodiagnostics.com\/\" target=\"_blank\">Teco Diagnostics, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.rotem.de\/en\/\" target=\"_blank\">TEM Innovations GmbH<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.tbgbio.com\/en\" target=\"_blank\">Texas BioGene, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.thermofisher.com\/\" target=\"_blank\">Thermo Fisher Scientific<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.tokyo-boeki.co.jp\/english\/product\/science\/\" target=\"_blank\">Tokyo Boeki Holdings Corp.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.tosoh.com\/\" target=\"_blank\">Tosoh Corporation<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.trinitybiotech.com\/\" target=\"_blank\">Trinity Biotech Plc<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.universal-meditech.com\/\" target=\"_blank\">Universal Meditech, Inc.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.urit.com\/en2\/index.aspx\" target=\"_blank\">URIT Medical Electronic Group Co., Ltd.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.veladx.com\/\" target=\"_blank\">Vela Diagnostics Pte. Ltd.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.viramed.de\/\" target=\"_blank\">Viramed Biotech AG<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.werfen.com\/\" target=\"_blank\">Werfen<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wiener-lab.com.ar\/EN\/\" target=\"_blank\">Wiener Laboratorios SAIC<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.biohermes.com\/\" target=\"_blank\">Wuxi BioHermes Biomedical Technology Co. Ltd.<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.yd-diagnostics.com\/\" target=\"_blank\">YD Diagnostics Corp.<\/a>\n<\/p>\n<\/td><\/tr><\/tbody><\/table>\n<\/td><\/tr>\n<\/tbody><\/table>\n<h4><span class=\"mw-headline\" id=\"4.1.2_Other_vendors\">4.1.2 Other vendors<\/span><\/h4>\n<p>As previously mentioned, some vendors manufacturing and distributing medical diagnostic and research solutions don't get their instruments and tests CLIA certified in the U.S. It's beyond the scope of this guide to attempt to list them all, but a few representative examples include:\n<\/p>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abacusdiagnostica.com\/\" target=\"_blank\">Abacus Diagnostica Oy<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.zeiss.com\/meditec\/int\/home.html\" target=\"_blank\">Carl Zeiss Meditec AG<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.clonit.it\/en\/\" target=\"_blank\">Clonit SRL<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.devyser.com\/\" target=\"_blank\">Devyser AB<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.diapro.it\/\" target=\"_blank\">Dia.Pro Diagnostic Bioprobes Srl<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/en.dynamiker.com\/\" target=\"_blank\">Dynamiker Biotechnology (Tianjin) Co., Ltd.<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.dynextechnologies.com\/\" target=\"_blank\">Dynex Technologies, Inc.<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.lifehealthmed.com\/\" target=\"_blank\">EasyDx, Inc.<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/entrogen.com\/\" target=\"_blank\">EntroGen, Inc.<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.eppendorf.com\/US-en\/\" target=\"_blank\">Eppendorf AG<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.hitachi-hightech.com\/global\/\" target=\"_blank\">Hitachi High-Technologies Corporation<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.htz.biz\/index.htm\" target=\"_blank\">HTZ Ltd.<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.humasis.com\/en\/\" target=\"_blank\">Humasis Co., Ltd.<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.virion-serion.de\/en\/\" target=\"_blank\">Institut Virion\\Serion GmbH<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.jeolusa.com\/\" target=\"_blank\">JEOL USA, Inc.<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.launchdiagnostics.com\/\" target=\"_blank\">Launch Diagnostics Ltd.<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.mt.com\/us\/en\/home.html\" target=\"_blank\">Mettler-Toledo International, Inc.<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.mkldiagnostics.com\/\" target=\"_blank\">MKL Diagnostics AB<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.healthcare.nikon.com\/en\/\" target=\"_blank\">Nikon Corporation<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.novatec-id.com\/\" target=\"_blank\">NovaTec Immundiagnostica GmbH<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/medical.olympusamerica.com\/\" target=\"_blank\">Olympus Corporation of the Americas<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.orgentec.com\/en\/\" target=\"_blank\">ORGENTEC Diagnostika GmbH<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pentaxmedical.com\/\" target=\"_blank\">PENTAX Europe GmbH<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sartorius.com\/\" target=\"_blank\">Sartorius AG<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.shimadzu.com\/\" target=\"_blank\">Shimadzu Corporation<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/en.vircell.com\/\" target=\"_blank\">Vircell SL<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.waters.com\/\" target=\"_blank\">Waters Corporation<\/a><\/li><\/ul>\n<p>Also, see BioPharmGuy's <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/biopharmguy.com\/links\/company-by-location-diagnostics.php\" target=\"_blank\">worldwide diagnostics companies, by location<\/a>.\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-FDA_CLIA18-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-FDA_CLIA18_1-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">U.S. Food & Drug Administration (25 February 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/medical-devices\/ivd-regulatory-assistance\/clia-categorizations\" target=\"_blank\">\"CLIA Categorizations\"<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.fda.gov\/medical-devices\/ivd-regulatory-assistance\/clia-categorizations\" target=\"_blank\">https:\/\/www.fda.gov\/medical-devices\/ivd-regulatory-assistance\/clia-categorizations<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=CLIA+Categorizations&rft.atitle=&rft.aulast=U.S.+Food+%26+Drug+Administration&rft.au=U.S.+Food+%26+Drug+Administration&rft.date=25+February+2020&rft_id=https%3A%2F%2Fwww.fda.gov%2Fmedical-devices%2Fivd-regulatory-assistance%2Fclia-categorizations&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/Medical_diagnostics_instrumentation_and_equipment_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20220125221419\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.104 seconds\nReal time usage: 0.155 seconds\nPreprocessor visited node count: 994\/1000000\nPost\u2010expand include size: 196456\/2097152 bytes\nTemplate argument size: 1596\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 1647\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 62.263 1 -total\n 52.44% 32.652 1 Template:Reflist\n 47.43% 29.530 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/Medical_diagnostics_instrumentation_and_equipment_vendors\n 41.55% 25.872 1 Template:Cite_web\n 34.09% 21.227 1 Template:Citation\/core\n 9.53% 5.932 1 Template:Date\n 7.19% 4.479 1 Template:Vendors_of_CLIA-waived_items\n 6.03% 3.757 1 Template:Vendors_of_CLIA-certified_moderate_or_complex_items\n 5.17% 3.222 1 Template:Citation\/make_link\n 4.35% 2.707 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12941-0!canonical and timestamp 20220125221419 and revision id 45838. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/Medical_diagnostics_instrumentation_and_equipment_vendors\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/Medical_diagnostics_instrumentation_and_equipment_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>","17733f9801557e7af6825433f338fbef_images":[],"17733f9801557e7af6825433f338fbef_timestamp":1643149333,"139c94fa7dca8686ca8ecb414606eaac_type":"article","139c94fa7dca8686ca8ecb414606eaac_title":"3.4 Middleware vendors","139c94fa7dca8686ca8ecb414606eaac_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/Middleware_vendors","139c94fa7dca8686ca8ecb414606eaac_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 1: Laboratory informatics vendors\/Middleware vendorsFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n3.4 Middleware vendors \nMiddleware is computer software that provides services to software applications beyond those available from the operating system. Middleware is most commonly used for integrating software that enables communication and management of data in distributed applications. The following are examples of notable middleware vendors:\n\nA. Menarini Diagnostics s.r.l.\nAbbott Srl\nAgaram Technologies Pvt. Ltd.\nAttune Technologies Private Limited\nBeckman Coulter, Inc.\nbioM\u00e9rieux SA\nBYG Informatique SAS\nData Innovations, LLC\nGoodmark Medical, LLC dba Relaymed\nGrifols SA\niCD. GmbH\nLabLynx, Inc.\nLabThruPut\nOPTIMIZA\nOrchard Software Corporation\nQIAGEN GmbH\nRoche Diagnostics Limited\nSiemens Healthcare GmbH\nSysmex Corporation\nTechnidata SAS\nTelcor, Inc.\nTerra Systems O\u00dc\n\r\n\n\n-----Go to the next chapter of this guide-----\nCitation information for this chapter \nChapter: 3. Resources for selecting and implementing informatics solutions: Part 1: Laboratory informatics vendors\nTitle: Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\nEdition: 2022 Edition\nAuthor for citation: Shawn E. Douglas\nLicense for content: Creative Commons Attribution-ShareAlike 4.0 International\nPublication date: January 2022\n\r\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/Middleware_vendors\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/Middleware_vendors<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:13.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 36 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","139c94fa7dca8686ca8ecb414606eaac_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Resources_for_selecting_and_implementing_informatics_solutions_Part_1_Laboratory_informatics_vendors_Middleware_vendors rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Resources_for_selecting_and_implementing_informatics_solutions_Part_1_Laboratory_informatics_vendors_Middleware_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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 1: Laboratory informatics vendors\/Middleware 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">the beginning<\/a> of this guide-----<\/div>\n<h3><span class=\"mw-headline\" id=\"3.4_Middleware_vendors\">3.4 Middleware vendors<\/span><\/h3>\n<p>Middleware is computer software that provides services to software applications beyond those available from the operating system. Middleware is most commonly used for integrating software that enables communication and management of data in distributed applications. The following are examples of notable middleware vendors:\n<\/p>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.menarinidiagnostics.fr\/en-us\/home\/laboratory-products\/autoimmunity\/zenit-hub-middleware\" target=\"_blank\">A. Menarini Diagnostics s.r.l.<\/a><\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/Abbott_Srl\" title=\"Abbott Srl\" class=\"wiki-link\" data-key=\"1fb5090cb0ab3c9383a0cf810d68c2cf\">Abbott Srl<\/a><\/li>\n<li><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><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/attunelive.com\/device-integration\/\" target=\"_blank\">Attune Technologies Private Limited<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.beckmancoulter.com\/en\/products\/clinical-information-management-tools\" target=\"_blank\">Beckman Coulter, Inc.<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.biomerieux-diagnostics.com\/it-solutions\/middleware-solutions\" target=\"_blank\">bioM\u00e9rieux SA<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/byg4lab.com\/en\/home-en-2\/\" target=\"_blank\">BYG Informatique SAS<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.datainnovations.com\/\" target=\"_blank\">Data Innovations, LLC<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/relaymed.com\/\" target=\"_blank\">Goodmark Medical, LLC dba Relaymed<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.diagnostic.grifols.com\/en\/middleware-aeskulab\/overview\" target=\"_blank\">Grifols SA<\/a><\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/ICD._GmbH\" class=\"mw-redirect wiki-link\" title=\"ICD. GmbH\" data-key=\"658eded7791436b71f13fbfe41541e6d\">iCD. GmbH<\/a><\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/LabLynx,_Inc.\" title=\"LabLynx, Inc.\" class=\"wiki-link\" data-key=\"da3f96536cf2c54de1960f26fe5712a1\">LabLynx, Inc.<\/a><\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/LabThruPut\" title=\"LabThruPut\" class=\"wiki-link\" data-key=\"9b42521603c99c84b5cfe1c6dc7a3b6a\">LabThruPut<\/a><\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/Al_Faris_National_Company_for_Investment_and_Export_PSC\" title=\"Al Faris National Company for Investment and Export PSC\" class=\"wiki-link\" data-key=\"48e31244c8bb228268bfe70816dc7777\">OPTIMIZA<\/a><\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/Orchard_Software_Corporation\" title=\"Orchard Software Corporation\" class=\"wiki-link\" data-key=\"7b7ed1ca87d09d6e32482f0a87ddfacd\">Orchard Software Corporation<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.qiagen.com\/at\/products\/instruments-and-automation\/genereader-system\/generead-link\/\" target=\"_blank\">QIAGEN GmbH<\/a><\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/Roche_Diagnostics_Limited\" title=\"Roche Diagnostics Limited\" class=\"wiki-link\" data-key=\"ab3031189eab37c836f3a5ab881738bc\">Roche Diagnostics Limited<\/a><\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/Siemens_AG\" title=\"Siemens AG\" class=\"wiki-link\" data-key=\"02158f083dff6f082f3b17048612608d\">Siemens Healthcare GmbH<\/a><\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/Sysmex_Corporation\" title=\"Sysmex Corporation\" class=\"wiki-link\" data-key=\"620036ace43f46204b2b30d03adae037\">Sysmex Corporation<\/a><\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/Technidata_SAS\" title=\"Technidata SAS\" class=\"wiki-link\" data-key=\"7f4e7f8814b4ba7fab1311a70ae0f4be\">Technidata SAS<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/telcor.com\/poc\/\" target=\"_blank\">Telcor, Inc.<\/a><\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/Terra_Systems_O%C3%9C\" title=\"Terra Systems O\u00dc\" class=\"wiki-link\" data-key=\"6bde0a4a2ed9a0481c4b81149d066846\">Terra Systems O\u00dc<\/a><\/li><\/ul>\n<p><br \/>\n<\/p>\n<div align=\"center\">-----Go to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/Medical_diagnostics_instrumentation_and_equipment_vendors\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 2: Other vendors and service providers\/Medical diagnostics instrumentation and equipment vendors\" class=\"wiki-link\" data-key=\"17733f9801557e7af6825433f338fbef\">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. Resources for selecting and implementing informatics solutions: Part 1: Laboratory informatics vendors\n<\/p><p><b>Title<\/b>: <i>Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research<\/i>\n<\/p><p><b>Edition<\/b>: 2022 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 2022\n<\/p><p><br \/>\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20220125221419\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.008 seconds\nReal time usage: 0.019 seconds\nPreprocessor visited node count: 12\/1000000\nPost\u2010expand include size: 1560\/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% 5.022 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/Middleware_vendors\n100.00% 5.022 1 -total\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12940-0!canonical and timestamp 20220125221418 and revision id 45837. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/Middleware_vendors\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/Middleware_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>","139c94fa7dca8686ca8ecb414606eaac_images":[],"139c94fa7dca8686ca8ecb414606eaac_timestamp":1643149333,"2fb9efb02be4d94821197ff6a766cf50_type":"article","2fb9efb02be4d94821197ff6a766cf50_title":"3.3 ELN vendors","2fb9efb02be4d94821197ff6a766cf50_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/ELN_vendors","2fb9efb02be4d94821197ff6a766cf50_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 1: Laboratory informatics vendors\/ELN vendorsFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n3.3 ELN vendors \n\n\n\nVendor\n\nKey ELN offering(s)\n\nSaaS\r\noption?\n\nHeadquarters\r\n(Country)\n\nKey information\n\nAdditional notes\n\n\nAAC Infotray AG\n\nLimsophy DoDoc\n\nNo\n\nSwitzerland\n\n\n\n\n\n\n\n\nAbbott Informatics Corporation \n\nAbbott Informatics Electronic\r\nLaboratory Notebook\n\nNo\n\nUnited States\n\nPricing and demonstration videos\n\nFormerly STARLIMS Corporation\n\n\n\n\nAgaram Technologies Pvt. Ltd.\n\nLogiLab ELN\n\nYes\n\nIndia\n\nDemonstration videos\n\n\n\n\n\n\nAgiLab SAS\n\nAgiLab ELN\n\nYes\n\nFrance\n\n\n\nIn 2019 discontinued ELN Biolab, ChemLab, and FormuLab and introduced AgiLab ELN.\n\n\n\n\nAgileBio\n\nLabCollector\n\nYes\n\nUnited States\n\nPricing and demonstration videos\n\nELN is an add-on to LabCollector LIMS.\n\n \n\n\nAgilent Technologies, Inc. \n\nSLIMS\n\nYes\n\nUnited States\n\nDemonstration videos\n\nSLIMS is a combo LIMS+ELN, through the acquisition of Genohm SA in May 2018.[1][2]\n\n \n\n\nAgilent Technologies, Inc.\n\nSLIMS\n\nYes\n\nUnited States\n\nDemonstration videos\n\nSee Genohm SA for more on SLIMS, a combo LIMS+ELN\n\n\n\n\nAiderbotics Corporation\n\nLabLog\n\nNo\n\nUnited States\n\nPricing and demonstration videos\n\nProduct changed names from Elucidaid to LabLog in November 2017.[3]\n\n\n\n\nAlchemy Cloud, Inc.\n\nAlchemy\n\nYes\n\nUnited States\n\nDemonstration videos\n\nELN-like integrated predictive chemistry platform with a few LIMS-like elements\n\n \n\n\nAmphora Research Systems, Inc.\n\nCompliantPad, OpenELN,\r\nPatentPad, PatentSafe\n\nYes\n\nUnited States\n\n\n\n\n\n\n\n\nArxspan, LLC\n\nArxspan Notebook\n\nYes\n\nUnited States\n\nDemonstration videos\n\nAcquired in March 2019 by Bruker Corporation; presumably now a subsidiary of Bruker.[4]\n\n\n\n\nATGC Labs, LLC\n\nActiveLN\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nBenchling, Inc.\n\nBenchling Notebook\n\nYes\n\nUnited States\n\nPricing and demonstration videos\n\n\n\n\n\n\nBio-ITech BV\n\neLABJournal ELN\n\nYes\n\nThe Netherlands\n\nPricing and demonstration videos\n\n\n\n\n\n\nBiochemLab Solutions\n\nElectronic Lab Notebook\n\nNo\n\nUnited States\n\nPricing and demonstration videos\n\n\n\n\n\n\nBioData Inc.\n\nLabguru\n\nYes\n\nUnited States\n\nDemonstration videos\n\nLabguru replaced LabLife and BioKM on December 5, 2011.[5]\n\n\n\n\nBioSistemika LLC\n\nGENEIO\n\nYes\n\nSlovenia\n\nDemonstration videos\n\n\n\n\n\n\nChemBytes\n\nEspresso ELN\n\nNo\n\nSwitzerland\n\nPricing\n\n\n\n\n\n\nChemInnovation Software, Inc.\n\nCBIS\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nCollaborative Drug Discovery, Inc.\n\nCDD Vault\n\nYes\n\nUnited States\n\nDemonstration videos\n\n\n\n \n\n\nCompuDrug International, Inc.\n\nLaboratory Manager Plus\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nDassault Syst\u00e8mes SA\n\nBIOVIA Notebook, BIOVIA Workbook\n\nYes\n\nFrance\n\nDemonstration videos\n\nDassault acquired Accelrys, Inc. on April 29, 2014.[6]\r\n\n\n\n\n\nDeltaSoft, Inc.\n\nChemCart ELN\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nDotmatics Limited\n\nStudies Notebook, eln.online\n\nYes\n\nUnited Kingdom\n\n\n\n\n\n\n\n\nenso Software GmbH\n\nensochemLab\n\nNo\n\nGermany\n\n\n\n\n\n\n\n\nFindMolecule, Inc.\n\nFindMolecule\n\nNo\n\nCanada\n\nPricing\n\n\n\n\n\n\nFORMULATOR Software, LLC\n\nFORMULATOR\n\nYes\n\nUnited States\n\nPricing\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\nHiTec Zang GmbH\n\neJournal\n\nNo\n\nGermany\n\n\n\n\n\n\n\n\niAdvantage Software, Inc.\n\neStudy\n\nYes\n\nUnited States\n\n\n\n\n\n\n\n\nID Business Solutions Ltd.\n\nBioBook, ChemBook,\r\nE-WorkBook\n\nYes\n\nUnited Kingdom\n\n\n\n\n\n\n\n\nInstem LSS Limited\n\nLogbook\n\nYes\n\nUnited Kingdom\n\n\n\n\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\nKalliste Systems, Inc.\n\nKalliste eSystems\n\nNo\n\nUnited States\n\nDemonstration videos\n\n\n\n\n\n\nKineMatik Ltd.\n\nOpenText ELN\n\nNo\n\nUnited States\n\nDemonstration videos\n\nELN formerly known as KineMatik ELN.\n\n\n\n\nKYLI SAS\n\nLaby\n\nYes\n\nFrance\n\nPricing\n\n\n\n \n\n\nLab-Ally LLC\n\nCERF, RSpace\n\nYes\n\nUnited States\n\n\n\nNorth American distribution arm of ResearchSpace\n\n\n\n\nLabArchives, LLC\n\nLabArchives\n\nYes\n\nUnited States\n\nPricing and demonstration videos\n\n\n\n\n\n\nLabforward GmbH\n\nlabfolder\n\nYes\n\nGermany\n\nPricing and demonstration videos\n\nMerger in May 2019 saw company name change.[7][8]\n\n\n\n\nLabii, Inc.\n\nLabii ELN & LIMS\n\nYes\n\nUnited States\n\nPricing and Demonstration videos\n\nCombination ELN + LIMS\n\n\n\n\nLabSpace, LLC\n\nLabSpace\n\nYes\n\nIsrael\n\nPricing\n\n\n\n\n\n\nLabstep Ltd.\n\nLabstep ELN\n\nYes\n\nUnited Kingdom\n\nDemonstration videos\n\n\n\n\n\n\nLABTrack, LLC\n\nLABTrack ELN\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\nSeemingly integrated its eNotebook ELN directly into LabVantage 8 in early 2019.\n\n\n\n\nLabWare, Inc.\n\nLabWare ELN\n\nYes\n\nUnited States\n\nPricing and demonstration videos\n\n\n\n\n\n\nLaurus Infosystems Pvt. Ltd.\n\nChemia\n\nNo\n\nIndia\n\n\n\n\n\n \n\n\nLex Software Solutions\n\nLabCloud\n\nYes\n\nTurkey\n\n\n\n\n\n\n\n\nMerck KGaA\n\nBrightLab\n\nYes\n\nGermany\n\n\n\n\n\n\n\n\nMestrelab Research S.L.\n\nMBook\n\nYes\n\nSpain\n\nPricing and demonstration videos\n\n\n\n\n\n\nNational Institute of Allergy and Infectious Diseases\n\nLabShare\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nNoteBookMaker, LLC\n\nNoteBookMaker\n\nYes\n\nUnited States\n\nDemonstration videos\n\n\n\n \n\n\nOnline LIMS Canada Limited\n\nOnline Worksheet\n\nNo\n\nCanada\n\n\n\nAn ELN module for OnLIMS\n\n\n\n\nOpen source software solution\n\nCyNote\n\nN\/A\n\nN\/A\n\n\n\nMore information found on SourceForge.net.\n\n\n\n\nOpen source software solution\n\neLabFTW\n\nN\/A\n\nN\/A\n\n\n\nMore information found on the project site.\n\n\n\n\nOpen source software solution\n\neln\n\nN\/A\n\nN\/A\n\n\n\nMore information found on the project site.\n\n\n\n\nOpen source software solution\n\nIndigo ELN\n\nN\/A\n\nN\/A\n\n\n\nMore information found on the project site.\n\n\n\n\nOpen source software solution\n\nLabTrove\n\nN\/A\n\nN\/A\n\n\n\nMore information found on SourceForge.net and the project site.\n\n\n\n\nOpen source software solution\n\nMyLabBook\n\nN\/A\n\nN\/A\n\n\n\nMore information found on GitHub.com and the project site.\n\n \n\n\nOpen source software solution\n\nopen enventory\n\nN\/A\n\nN\/A\n\n\n\nMore information found on SourceForge.net.\n\n\n\n\nOpen source software solution\n\nopenBIS\n\nN\/A\n\nN\/A\n\n\n\nNot a stand-alone ELN, but has an ELN plug-in. More info here and here.\n\n\n\n\nOpen source software solution\n\nsciNote\n\nN\/A\n\nN\/A\n\n\n\nMore information found at sciNote, LLC.\n\n\n\n\nOpen.Co Srl\n\nOpen.Co ELN\n\nNo\n\nItaly\n\n\n\n\n\n\n\n\nPerkinElmer Inc.\n\nE-Notebook, Signals Notebook\n\nYes\n\nUnited States\n\n\n\n\n\n\n\n\nPresearch, Inc.\n\nColabra\n\nNo\n\nUnited States\n\n\n\nELN-like application for data integration and collaboration\n\n \n\n\nProg4biz Software Solutions Ltd.\n\nBookitLab\n\nYes\n\nCanada\n\n\n\n\n\n\n\n\nquattro research GmbH\n\nquattro\/LJ\n\nNo\n\nGermany\n\n\n\n\n\n\n\n\nResearch Innovations Limited\n\nRSpace\n\nYes\n\nScotland\n\nPricing and demonstration videos\n\nLab-Ally LLC is the North American distributor of RSpace.[9] eCat was phased out in 2019.\n\n\n\n\nSapio Sciences, LLC\n\nSapio Seamless ELN\n\nYes\n\nUnited States\n\nDemonstration videos\n\n\n\n \n\n\nSciCord, LLC\n\nSciCord\n\nYes\n\nUnited States\n\nDemonstration videos\n\n\n\n\n\n\nSciformation Consulting GmbH\n\nSciformation ELN\n\nNo\n\nGermany\n\n\n\nBased off the open-source open enventory ELN.[10]\n\n\n\n\nScilligence Corporation\n\nScilligence ELN\n\nYes\n\nUnited States\n\nDemonstration videos\n\n\n\n\n\n\nsciNote, LLC\n\nsciNote\n\nYes\n\nUnited States\n\nPricing\n\n\n\n\n\n\nShanghai Integle Informatics Sci-Tech Co., Ltd.\n\nInELN\n\nYes\n\nChina\n\n\n\n\n\n \n\n\nshazino SAS\n\nhivebench\n\nYes\n\nFrance\n\nPricing\n\nhivebench was purchased by Elsevier on June 1, 2016.[11][12]\n\n\n\n\nSiemens AG\n\nSIMATIC IT R&D\n\nNo\n\nGermany\n\n\n\n\n\n\n\n\nStackWave, LLC\n\nStackWave ELN\n\nYes\n\nUnited States\n\n\n\n\n\n\n\n\nStudylog Systems, Inc.\n\nStudy Director\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nSunBio IT Solutions Pvt. Ltd.\n\nSunBio ELN\n\nNo\n\nIndia\n\n\n\n\n\n\n\n\nSycomore Technologies SAS\n\nLeadAnalytics\n\nNo\n\nFrance\n\nDemonstration videos\n\n\n\n\n\n\nTas India Pvt. Ltd.\n\nTASm2m-ELN\n\nYes\n\nIndia\n\n\n\n\n\n\n\n\nTerrington York Ltd.\n\nLabsform\n\nYes\n\nUnited Kingdom\n\n\n\n\n\n\n\n\nTextco BioSoftware, Inc.\n\nGene Inspector\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nThe Edge Software Consultancy Ltd.\n\nBioRails DM (which includes BioRails ELN)\n\nYes\n\nUnited Kingdom\n\nPricing and demonstration videos\n\n\n\n\n\n\nThermo Fisher Scientific \n\nCore ELN\n\nYes\n\nUnited States\n\nDemonstration videos\n\n\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 ELN.[13]\n\n \n\n\nXC Lab SPRL\n\niQ\n\nNo\n\nBelgium\n\n\n\nLikely acquired from Labage SA in 2019.[14]\n\n\n\nReferences \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 Aiderbotics Corporation (13 November 2017). \"Elucidaid has been replaced by LabLog, a more powerful Lab Notebook App for your research\". YouTube. https:\/\/www.youtube.com\/watch?v=a0usNrSCPXw . Retrieved 06 January 2019 .   \n \n\n\u2191 \"Bruker Announces Acquisition of Scientific Software Provider Arxspan\". PR Newswire. 14 March 2019. https:\/\/www.prnewswire.com\/news-releases\/bruker-announces-acquisition-of-scientific-software-provider-arxspan-300812100.html . Retrieved 29 September 2019 .   \n \n\n\u2191 \"BioData Launches Labguru, a Collaborative Research Management Web Application for Academic Labs\". Digital Science. Macmillan Publishers Limited. 5 December 2011. Archived from the original on 10 May 2012. https:\/\/web.archive.org\/web\/20120510070908\/http:\/\/www.digital-science.com\/biodata-launches-labguru\/ . Retrieved 19 January 2016 .   \n \n\n\u2191 \"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 \"DGAP-News: labfolder acquires cubuslab and becomes Labforward\". MarketWatch. 22 May 2019. https:\/\/www.marketwatch.com\/press-release\/dgap-news-labfolder-acquires-cubuslab-and-becomes-labforward-2019-05-22 . Retrieved 03 October 2019 .   \n \n\n\u2191 \"Joining Forces: Accelerator Startup Alumni labfolder and cubuslab Are Merging!\". Merck Innovation Center. Merck KGaA. 21 May 2019. https:\/\/www.emdgroup.com\/en\/research\/innovation-center\/news-and-events\/all-news\/joining-forces-accelerator-startup-alumni-labfolder-and-cubuslab.html . Retrieved 03 September 2019 .   \n \n\n\u2191 \"Research Space\". Lab-Ally, LLC. http:\/\/lab-ally.com\/research-space\/ . Retrieved 23 April 2014 .   \n \n\n\u2191 Rudolphi, Felix (January 2014). \"Why we chose ZK when creating Sciformation ELN\" (PDF). Potix Corporation. http:\/\/www.zkoss.org\/resource\/file\/CaseStudies\/Sciformation_Case_Study.pdf . Retrieved 16 November 2015 .   \n \n\n\u2191 \"Elsevier Acquires Laboratory Data Management Tool Hivebench\". Elsevier. 7 June 2016. https:\/\/www.elsevier.com\/about\/press-releases\/corporate\/elsevier-acquires-laboratory-data-management-tool-hivebench . Retrieved 20 October 2016 .   \n \n\n\u2191 Avner, P.T. (7 June 2016). \"Putting data in the hands of researchers with Hivebench\". Mendeley Blog. https:\/\/blog.mendeley.com\/2016\/06\/07\/putting-data-in-the-hands-of-researchers-with-hivebench\/ . Retrieved 20 October 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\u2191 \"Discover a new way of working with XC Lab\". XC Lab SPRL. Archived from the original on 02 June 2019. https:\/\/web.archive.org\/web\/20190602170751\/http:\/\/labage.com\/ . Retrieved 12 October 2021 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/ELN_vendors\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/ELN_vendors<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:13.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 30 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","2fb9efb02be4d94821197ff6a766cf50_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Resources_for_selecting_and_implementing_informatics_solutions_Part_1_Laboratory_informatics_vendors_ELN_vendors rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Resources_for_selecting_and_implementing_informatics_solutions_Part_1_Laboratory_informatics_vendors_ELN_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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 1: Laboratory informatics vendors\/ELN 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">the beginning<\/a> of this guide-----<\/div>\n<h3><span class=\"mw-headline\" id=\"3.3_ELN_vendors\">3.3 ELN vendors<\/span><\/h3>\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 ELN 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\/AAC_Infotray_AG\" title=\"AAC Infotray AG\" class=\"wiki-link\" data-key=\"4fbc615d17856b086669d1909e7bab7a\">AAC Infotray AG<\/a>\n<\/td>\n<td>Limsophy DoDoc\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 style=\"line-height: 60px; vertical-align: middle;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/Abbott_Informatics_Corporation\" title=\"Abbott Informatics Corporation\" class=\"wiki-link\" data-key=\"90479bab12020c96864541696a62156f\">Abbott Informatics Corporation<\/a> <div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Vendor284.jpg\" class=\"image wiki-link\" data-key=\"8dabe8a08aa6afbe9fc5360262c53206\"><img alt=\"Vendor284.jpg\" src=\"https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/e\/e3\/Vendor284.jpg\" decoding=\"async\" width=\"110\" height=\"54\" \/><\/a><\/div>\n<\/td>\n<td>Abbott Informatics Electronic<br \/>Laboratory Notebook\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Abbott_Informatics_Corporation#Pricing\" title=\"Abbott Informatics Corporation\" class=\"wiki-link\" data-key=\"6a939ae07fd30a32d0544b2f11771d58\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Abbott_Informatics_Corporation#Demonstration_videos_and_other_media\" title=\"Abbott Informatics Corporation\" class=\"wiki-link\" data-key=\"f2f0097a52372f9574c24d37f5f703b9\">demonstration videos<\/a>\n<\/td>\n<td>Formerly STARLIMS Corporation\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>LogiLab ELN\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>AgiLab ELN\n<\/td>\n<td>Yes\n<\/td>\n<td>France\n<\/td>\n<td>\n<\/td>\n<td>In 2019 discontinued ELN Biolab, ChemLab, and FormuLab and introduced AgiLab ELN.\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>ELN is an add-on to LabCollector LIMS.\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"line-height: 60px; vertical-align: middle;\"><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> <div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Agilent_145.png\" class=\"image wiki-link\" data-key=\"63c7ec01ad1bfa2f09bf695fb947cdc7\"><img alt=\"Agilent 145.png\" src=\"https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/d\/d1\/Agilent_145.png\" decoding=\"async\" width=\"110\" height=\"55\" \/><\/a><\/div>\n<\/td>\n<td>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>SLIMS is a combo LIMS+ELN, through the acquisition of <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_1-0\" class=\"reference\"><a href=\"#cite_note-BarraudUSGroup18-1\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-KCGenohm18_2-0\" class=\"reference\"><a href=\"#cite_note-KCGenohm18-2\">[2]<\/a><\/sup>\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>SLIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Genohm_SA#Demonstration_videos_and_other_media\" title=\"Genohm SA\" class=\"wiki-link\" data-key=\"9ac10f28c8a34f039c7ad0708fb7b7d7\">Demonstration videos<\/a>\n<\/td>\n<td>See <a href=\"https:\/\/www.limswiki.org\/index.php\/Genohm_SA\" title=\"Genohm SA\" class=\"wiki-link\" data-key=\"426b7038bf902fd270a107745d2b6087\">Genohm SA<\/a> for more on SLIMS, a combo LIMS+ELN\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Aiderbotics_Corporation\" title=\"Aiderbotics Corporation\" class=\"wiki-link\" data-key=\"13b290c0aedad754f3de500f7c007c70\">Aiderbotics Corporation<\/a>\n<\/td>\n<td>LabLog\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Aiderbotics_Corporation#Pricing\" title=\"Aiderbotics Corporation\" class=\"wiki-link\" data-key=\"6ff153277a5af52fbf221d7a78fb8574\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Aiderbotics_Corporation#Demonstration_videos_and_other_media\" title=\"Aiderbotics Corporation\" class=\"wiki-link\" data-key=\"3986e31c06f3bab869b0af22c95b019c\">demonstration videos<\/a>\n<\/td>\n<td>Product changed names from Elucidaid to LabLog in November 2017.<sup id=\"rdp-ebb-cite_ref-YTLabLogRename17_3-0\" class=\"reference\"><a href=\"#cite_note-YTLabLogRename17-3\">[3]<\/a><\/sup>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Alchemy_Cloud,_Inc.\" title=\"Alchemy Cloud, Inc.\" class=\"wiki-link\" data-key=\"018af072b4adaa8bb7f4e0069a7e37a5\">Alchemy Cloud, Inc.<\/a>\n<\/td>\n<td>Alchemy\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Alchemy_Cloud,_Inc.#Demonstration_videos_and_other_media\" title=\"Alchemy Cloud, Inc.\" class=\"wiki-link\" data-key=\"2a34504e0386fa553b4bfa4f392aa8b0\">Demonstration videos<\/a>\n<\/td>\n<td>ELN-like integrated predictive chemistry platform with a few LIMS-like elements\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Amphora_Research_Systems,_Inc.\" title=\"Amphora Research Systems, Inc.\" class=\"wiki-link\" data-key=\"0a540f74c4775119a146bee9b28f457e\">Amphora Research Systems, Inc.<\/a>\n<\/td>\n<td>CompliantPad, OpenELN,<br \/>PatentPad, PatentSafe\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\/Arxspan,_LLC\" title=\"Arxspan, LLC\" class=\"wiki-link\" data-key=\"875e28538c82eaf538f6a01887f1c602\">Arxspan, LLC<\/a>\n<\/td>\n<td>Arxspan Notebook\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Arxspan,_LLC#Demonstration_videos_and_other_media\" title=\"Arxspan, LLC\" class=\"wiki-link\" data-key=\"efab5f48c3a1f0cdbd89fa3034d8967f\">Demonstration videos<\/a>\n<\/td>\n<td>Acquired in March 2019 by <a href=\"https:\/\/www.limswiki.org\/index.php\/Bruker_Corporation\" title=\"Bruker Corporation\" class=\"wiki-link\" data-key=\"e2bd7cbc36f8b89babe5bdf05359ad96\">Bruker Corporation<\/a>; presumably now a subsidiary of Bruker.<sup id=\"rdp-ebb-cite_ref-PRNBruker19_4-0\" class=\"reference\"><a href=\"#cite_note-PRNBruker19-4\">[4]<\/a><\/sup>\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>ActiveLN\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\/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>\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>eLABJournal ELN\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>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/BiochemLab_Solutions\" title=\"BiochemLab Solutions\" class=\"wiki-link\" data-key=\"ff73cc5928506ba559397bdd44035cd5\">BiochemLab Solutions<\/a>\n<\/td>\n<td>Electronic Lab Notebook\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/BiochemLab_Solutions#Pricing\" title=\"BiochemLab Solutions\" class=\"wiki-link\" data-key=\"881bb982cf92cddd08ad627e1951136b\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/BiochemLab_Solutions#Demonstration_videos_and_other_media\" title=\"BiochemLab Solutions\" class=\"wiki-link\" data-key=\"e9cbb2874d1594888d8020faef7a4bc1\">demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/BioData_Inc.\" title=\"BioData Inc.\" class=\"wiki-link\" data-key=\"0abb9920aae2ef7f78261a9d37d5573a\">BioData Inc.<\/a>\n<\/td>\n<td>Labguru\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/BioData_Inc.#Demonstration_videos_and_other_media\" title=\"BioData Inc.\" class=\"wiki-link\" data-key=\"04f4fdf221f9b65d9847a25be1619c82\">Demonstration videos<\/a>\n<\/td>\n<td>Labguru replaced LabLife and BioKM on December 5, 2011.<sup id=\"rdp-ebb-cite_ref-LGLaunchArch_5-0\" class=\"reference\"><a href=\"#cite_note-LGLaunchArch-5\">[5]<\/a><\/sup>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/BioSistemika_LLC\" title=\"BioSistemika LLC\" class=\"wiki-link\" data-key=\"f8ebc7d99ca5a21be4a6ee3549cdddc0\">BioSistemika LLC<\/a>\n<\/td>\n<td>GENEIO\n<\/td>\n<td>Yes\n<\/td>\n<td>Slovenia\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/BioSistemika_LLC#Demonstration_videos_and_other_media\" title=\"BioSistemika LLC\" class=\"wiki-link\" data-key=\"4af831047c2562530b76d9252a563bb4\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/ChemBytes\" title=\"ChemBytes\" class=\"wiki-link\" data-key=\"d70d945ed9cbf087854270847b17a199\">ChemBytes<\/a>\n<\/td>\n<td>Espresso ELN\n<\/td>\n<td>No\n<\/td>\n<td>Switzerland\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/ChemBytes#Pricing\" title=\"ChemBytes\" class=\"wiki-link\" data-key=\"5e83f456d6e8957fd08ec88190ef50f3\">Pricing<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/ChemInnovation_Software,_Inc.\" title=\"ChemInnovation Software, Inc.\" class=\"wiki-link\" data-key=\"75e61ae17ca47c7f42c6465811d2d774\">ChemInnovation Software, Inc.<\/a>\n<\/td>\n<td>CBIS\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\/Collaborative_Drug_Discovery,_Inc.\" title=\"Collaborative Drug Discovery, Inc.\" class=\"wiki-link\" data-key=\"b75856c389fcc4ac0737c7868d4f204f\">Collaborative Drug Discovery, Inc.<\/a>\n<\/td>\n<td>CDD Vault\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Collaborative_Drug_Discovery,_Inc.#Demonstration_videos_and_other_media\" title=\"Collaborative Drug Discovery, Inc.\" class=\"wiki-link\" data-key=\"bbee4ed4e30d7d48729c554cb9c5f801\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/CompuDrug_International,_Inc.\" title=\"CompuDrug International, Inc.\" class=\"wiki-link\" data-key=\"ba53da7fc4663bd296fd1bc446dbeaff\">CompuDrug International, Inc.<\/a>\n<\/td>\n<td>Laboratory Manager Plus\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/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 Notebook, BIOVIA Workbook\n<\/td>\n<td>Yes\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_6-0\" class=\"reference\"><a href=\"#cite_note-DassAcqFinal-6\">[6]<\/a><\/sup><br \/>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/DeltaSoft,_Inc.\" title=\"DeltaSoft, Inc.\" class=\"wiki-link\" data-key=\"1e6b7d707e78538ce587c1c15313dbe3\">DeltaSoft, Inc.<\/a>\n<\/td>\n<td>ChemCart ELN\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\/Dotmatics_Limited\" title=\"Dotmatics Limited\" class=\"wiki-link\" data-key=\"db4f898c4c7802b8d20eeb0dece9a048\">Dotmatics Limited<\/a>\n<\/td>\n<td>Studies Notebook, eln.online\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\/Enso_Software_GmbH\" title=\"Enso Software GmbH\" class=\"wiki-link\" data-key=\"8ef103ac75da3bf10e7c4f1609203575\">enso Software GmbH<\/a>\n<\/td>\n<td>ensochemLab\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\/FindMolecule,_Inc.\" title=\"FindMolecule, Inc.\" class=\"wiki-link\" data-key=\"0e1d8cbd471bd8f28437fe9cdee51226\">FindMolecule, Inc.<\/a>\n<\/td>\n<td>FindMolecule\n<\/td>\n<td>No\n<\/td>\n<td>Canada\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/FindMolecule,_Inc.#Pricing\" title=\"FindMolecule, Inc.\" class=\"wiki-link\" data-key=\"f6b61e665b65866bd804995b911d6f37\">Pricing<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/FORMULATOR_Software,_LLC\" title=\"FORMULATOR Software, LLC\" class=\"wiki-link\" data-key=\"e9041092621bd9cac16bea9056071c4a\">FORMULATOR Software, LLC<\/a>\n<\/td>\n<td>FORMULATOR\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/FORMULATOR_Software,_LLC#Pricing\" title=\"FORMULATOR Software, LLC\" class=\"wiki-link\" data-key=\"dd9d366397c229128c413bbba54d651d\">Pricing<\/a>\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\/HiTec_Zang_GmbH\" title=\"HiTec Zang GmbH\" class=\"wiki-link\" data-key=\"6b60549f5ac6952e758298e6729fc0d7\">HiTec Zang GmbH<\/a>\n<\/td>\n<td>eJournal\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\/IAdvantage_Software,_Inc.\" title=\"IAdvantage Software, Inc.\" class=\"wiki-link\" data-key=\"19789c298d4ea9721667e498d0768d1d\">iAdvantage Software, Inc.<\/a>\n<\/td>\n<td>eStudy\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\/ID_Business_Solutions_Ltd.\" title=\"ID Business Solutions Ltd.\" class=\"wiki-link\" data-key=\"b49581258c8af6d250ef45a25e12c899\">ID Business Solutions Ltd.<\/a>\n<\/td>\n<td>BioBook, ChemBook,<br \/>E-WorkBook\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\/Instem_LSS_Limited\" title=\"Instem LSS Limited\" class=\"wiki-link\" data-key=\"9489fbd224d657a73604e010017a73c3\">Instem LSS Limited<\/a>\n<\/td>\n<td>Logbook\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\/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\/Kalliste_Systems,_Inc.\" title=\"Kalliste Systems, Inc.\" class=\"wiki-link\" data-key=\"cf376e456533b1da88af3f739bdddd5a\">Kalliste Systems, Inc.<\/a>\n<\/td>\n<td>Kalliste eSystems\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Kalliste_Systems,_Inc.#Demonstration_videos_and_other_media\" title=\"Kalliste Systems, Inc.\" class=\"wiki-link\" data-key=\"2d83a86d1ca038074a221d32f0dc0bb3\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/KineMatik_Ltd.\" title=\"KineMatik Ltd.\" class=\"wiki-link\" data-key=\"bd997ad0ef1b59eb41ef46a916a79242\">KineMatik Ltd.<\/a>\n<\/td>\n<td>OpenText ELN\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/KineMatik_Ltd.#Demonstration_videos_and_other_media\" title=\"KineMatik Ltd.\" class=\"wiki-link\" data-key=\"4bb5434a31f65e9349d40211fa69ca0e\">Demonstration videos<\/a>\n<\/td>\n<td>ELN formerly known as KineMatik ELN.\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/KYLI_SAS\" title=\"KYLI SAS\" class=\"wiki-link\" data-key=\"4842bf7c366a8cc191d0b4687be352f1\">KYLI SAS<\/a>\n<\/td>\n<td>Laby\n<\/td>\n<td>Yes\n<\/td>\n<td>France\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/KYLI_SAS#Pricing\" title=\"KYLI SAS\" class=\"wiki-link\" data-key=\"510559296c2000f0f361d80b897025f8\">Pricing<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Lab-Ally_LLC\" title=\"Lab-Ally LLC\" class=\"wiki-link\" data-key=\"113a505310f04a7eb4c055b08a8044e7\">Lab-Ally LLC<\/a>\n<\/td>\n<td>CERF, RSpace\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>North American distribution arm of <a href=\"https:\/\/www.limswiki.org\/index.php\/Research_Innovations_Limited\" title=\"Research Innovations Limited\" class=\"wiki-link\" data-key=\"86e4420c2ac1ce0318b81c6b529ac425\">ResearchSpace<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/LabArchives,_LLC\" title=\"LabArchives, LLC\" class=\"wiki-link\" data-key=\"a5bb3fd02213c041f2b90dd24a4ac606\">LabArchives, LLC<\/a>\n<\/td>\n<td>LabArchives\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/LabArchives,_LLC#Pricing\" title=\"LabArchives, LLC\" class=\"wiki-link\" data-key=\"4915a17305e353ad17a32dc524ff291f\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/LabArchives,_LLC#Demonstration_videos_and_other_media\" title=\"LabArchives, LLC\" class=\"wiki-link\" data-key=\"f12363c15f82172326c7903f9b9c9beb\">demonstration videos<\/a>\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>labfolder\n<\/td>\n<td>Yes\n<\/td>\n<td>Germany\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Labforward_GmbH#Pricing\" title=\"Labforward GmbH\" class=\"wiki-link\" data-key=\"7e8c694bb9718dd4d38094f1399e837b\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Labforward_GmbH#Demonstration_videos_and_other_media\" title=\"Labforward GmbH\" class=\"wiki-link\" data-key=\"5993bd65de7c73dbcade485e4cdcba98\">demonstration videos<\/a>\n<\/td>\n<td>Merger in May 2019 saw company name change.<sup id=\"rdp-ebb-cite_ref-MW_DGAP19_7-0\" class=\"reference\"><a href=\"#cite_note-MW_DGAP19-7\">[7]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MerckJoin19_8-0\" class=\"reference\"><a href=\"#cite_note-MerckJoin19-8\">[8]<\/a><\/sup>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Labii,_Inc.\" title=\"Labii, Inc.\" class=\"wiki-link\" data-key=\"26694f1b8383d3bce3421b9e4dc2cfc7\">Labii, Inc.<\/a>\n<\/td>\n<td>Labii ELN & LIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Labii,_Inc.#Pricing\" title=\"Labii, Inc.\" class=\"wiki-link\" data-key=\"9ff93db3690143b30541e5f2caa5fdfa\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Labii,_Inc.#Demonstration_videos_and_other_media\" title=\"Labii, Inc.\" class=\"wiki-link\" data-key=\"f293c56d196d80655380ea5c2a52eac9\">Demonstration videos<\/a>\n<\/td>\n<td>Combination ELN + LIMS\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/LabSpace,_LLC\" title=\"LabSpace, LLC\" class=\"wiki-link\" data-key=\"4c8ac2f4ba5488ed5871231fe453d2d7\">LabSpace, LLC<\/a>\n<\/td>\n<td>LabSpace\n<\/td>\n<td>Yes\n<\/td>\n<td>Israel\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/LabSpace,_LLC#Pricing\" title=\"LabSpace, LLC\" class=\"wiki-link\" data-key=\"065f091527e254bb54007e06cf4be5bc\">Pricing<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Labstep_Ltd.\" title=\"Labstep Ltd.\" class=\"wiki-link\" data-key=\"5a30508688b9be01bc5e543cb47ce9ac\">Labstep Ltd.<\/a>\n<\/td>\n<td>Labstep ELN\n<\/td>\n<td>Yes\n<\/td>\n<td>United Kingdom\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Labstep_Ltd.#Demonstration_videos_and_other_media\" title=\"Labstep Ltd.\" class=\"wiki-link\" data-key=\"4505d3ea99cce93530307eda0b74d096\">Demonstration videos<\/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 ELN\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>Seemingly integrated its eNotebook ELN directly into LabVantage 8 in early 2019.\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 ELN\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\/Laurus_Infosystems_Pvt._Ltd.\" title=\"Laurus Infosystems Pvt. Ltd.\" class=\"wiki-link\" data-key=\"8a4fe238cf950446381376641b2f6443\">Laurus Infosystems Pvt. Ltd.<\/a>\n<\/td>\n<td>Chemia\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\/Lex_Software_Solutions\" title=\"Lex Software Solutions\" class=\"wiki-link\" data-key=\"0ff19e36209b548737c684244eb00983\">Lex Software Solutions<\/a>\n<\/td>\n<td>LabCloud\n<\/td>\n<td>Yes\n<\/td>\n<td>Turkey\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Merck_KGaA\" title=\"Merck KGaA\" class=\"wiki-link\" data-key=\"b24c948e8155fa1bec5bef05449a145b\">Merck KGaA<\/a>\n<\/td>\n<td>BrightLab\n<\/td>\n<td>Yes\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\/Mestrelab_Research_S.L.\" title=\"Mestrelab Research S.L.\" class=\"wiki-link\" data-key=\"64064a4cd659df3ed0b841716bb24cc4\">Mestrelab Research S.L.<\/a>\n<\/td>\n<td>MBook\n<\/td>\n<td>Yes\n<\/td>\n<td>Spain\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Mestrelab_Research_S.L.#Pricing\" title=\"Mestrelab Research S.L.\" class=\"wiki-link\" data-key=\"6367be438514049455a12ae90bf3dfea\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Mestrelab_Research_S.L.#Demonstration_videos_and_other_media\" title=\"Mestrelab Research S.L.\" class=\"wiki-link\" data-key=\"aea1e71c0d50ea2cabd32276de1c295b\">demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/National_Institute_of_Allergy_and_Infectious_Diseases\" title=\"National Institute of Allergy and Infectious Diseases\" class=\"wiki-link\" data-key=\"d9dd8f7161a6be731f2cd8e9f8d281fd\">National Institute of Allergy and Infectious Diseases<\/a>\n<\/td>\n<td>LabShare\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\/NoteBookMaker,_LLC\" title=\"NoteBookMaker, LLC\" class=\"wiki-link\" data-key=\"bec4e5a9a276507d892a08620e7ecee2\">NoteBookMaker, LLC<\/a>\n<\/td>\n<td>NoteBookMaker\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/NoteBookMaker,_LLC#Demonstration_videos_and_other_media\" title=\"NoteBookMaker, LLC\" class=\"wiki-link\" data-key=\"9e19e1bb872bc08e7d62ba5483e054ed\">Demonstration videos<\/a>\n<\/td>\n<td>\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>Online Worksheet\n<\/td>\n<td>No\n<\/td>\n<td>Canada\n<\/td>\n<td>\n<\/td>\n<td>An ELN module for OnLIMS\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\/CyNote\" title=\"CyNote\" class=\"wiki-link\" data-key=\"f072ac75b92c39a6ac301d47def5c236\">CyNote<\/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:\/\/cynote.sourceforge.net\/\" 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\/ELabFTW\" title=\"ELabFTW\" class=\"wiki-link\" data-key=\"155590ac366985a7ee3cf74ade1df84a\">eLabFTW<\/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.elabftw.net\/\" target=\"_blank\">the project site<\/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\/Eln\" class=\"mw-redirect wiki-link\" title=\"Eln\" data-key=\"604b393ff5a85892db8e616d460555b8\">eln<\/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\/eln\" target=\"_blank\">the project site<\/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\/Indigo_ELN\" title=\"Indigo ELN\" class=\"wiki-link\" data-key=\"d95c86e43cf8c5a9596375526b635fa4\">Indigo ELN<\/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:\/\/ggasoftware.com\/opensource\/indigo\/eln\" target=\"_blank\">the project site<\/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\/LabTrove\" title=\"LabTrove\" class=\"wiki-link\" data-key=\"96314c6a72468722216b9af430141606\">LabTrove<\/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\/labtrove\/\" target=\"_blank\">SourceForge.net<\/a> and <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.labtrove.org\/\" target=\"_blank\">the project site<\/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\/MyLabBook\" title=\"MyLabBook\" class=\"wiki-link\" data-key=\"5a80c25c470d73512bbd299802d378bc\">MyLabBook<\/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\/mylabbook\/mylabbook\" target=\"_blank\">GitHub.com<\/a> and <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mylabbook.org\/\" target=\"_blank\">the project site<\/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_enventory\" title=\"Open enventory\" class=\"wiki-link\" data-key=\"7b3fe1fa2243591293cacf8ab2374f0d\">open enventory<\/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\/enventory\/\" 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\/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>Not a stand-alone ELN, but has an ELN plug-in. More info <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/sis.id.ethz.ch\/software\/openbis.html\" target=\"_blank\">here<\/a> and <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/wiki-bsse.ethz.ch\/display\/openBISDoc\/openBIS+ELN-LIMS\" target=\"_blank\">here<\/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\/SciNote\" title=\"SciNote\" class=\"wiki-link\" data-key=\"fcafe5e3de96d8ba319b70f089a53ea0\">sciNote<\/a>\n<\/td>\n<td>N\/A\n<\/td>\n<td>N\/A\n<\/td>\n<td>\n<\/td>\n<td>More information found at <a href=\"https:\/\/www.limswiki.org\/index.php\/SciNote,_LLC\" title=\"SciNote, LLC\" class=\"wiki-link\" data-key=\"c66c5c09cbed1709844904d13174925e\">sciNote, LLC<\/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>Open.Co ELN\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\/PerkinElmer_Inc.\" title=\"PerkinElmer Inc.\" class=\"wiki-link\" data-key=\"dabda40785b60866d056709e611512f8\">PerkinElmer Inc.<\/a>\n<\/td>\n<td>E-Notebook, Signals Notebook\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\/Presearch,_Inc.\" title=\"Presearch, Inc.\" class=\"wiki-link\" data-key=\"8e63f78494cd70f6dd45c25def9e52ae\">Presearch, Inc.<\/a>\n<\/td>\n<td>Colabra\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>ELN-like application for data integration and collaboration\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\/Quattro_research_GmbH\" title=\"Quattro research GmbH\" class=\"wiki-link\" data-key=\"dfe23466c53c4cb3bba2d39698716766\">quattro research GmbH<\/a>\n<\/td>\n<td>quattro\/LJ\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\/Research_Innovations_Limited\" title=\"Research Innovations Limited\" class=\"wiki-link\" data-key=\"86e4420c2ac1ce0318b81c6b529ac425\">Research Innovations Limited<\/a>\n<\/td>\n<td>RSpace\n<\/td>\n<td>Yes\n<\/td>\n<td>Scotland\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Research_Innovations_Limited#Pricing\" title=\"Research Innovations Limited\" class=\"wiki-link\" data-key=\"3a83a0e02f66ff2650b016e58a731e7d\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Research_Innovations_Limited#Demonstration_videos_and_other_media\" title=\"Research Innovations Limited\" class=\"wiki-link\" data-key=\"93bff75bef57dc5a001a5821fc532a4e\">demonstration videos<\/a>\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Lab-Ally_LLC\" title=\"Lab-Ally LLC\" class=\"wiki-link\" data-key=\"113a505310f04a7eb4c055b08a8044e7\">Lab-Ally LLC<\/a> is the North American distributor of RSpace.<sup id=\"rdp-ebb-cite_ref-LARSInfo_9-0\" class=\"reference\"><a href=\"#cite_note-LARSInfo-9\">[9]<\/a><\/sup> eCat was phased out in 2019.\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 Seamless ELN\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\/SciCord,_LLC\" title=\"SciCord, LLC\" class=\"wiki-link\" data-key=\"5bdc1a7e9c079684b28e0d6a970e4d82\">SciCord, LLC<\/a>\n<\/td>\n<td>SciCord\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/SciCord,_LLC#Demonstration_videos_and_other_media\" title=\"SciCord, LLC\" class=\"wiki-link\" data-key=\"29e594bb6df638dd26a0350bb808ddee\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Sciformation_Consulting_GmbH\" title=\"Sciformation Consulting GmbH\" class=\"wiki-link\" data-key=\"b62345f0b1c95bb75364df44c628ea01\">Sciformation Consulting GmbH<\/a>\n<\/td>\n<td>Sciformation ELN\n<\/td>\n<td>No\n<\/td>\n<td>Germany\n<\/td>\n<td>\n<\/td>\n<td>Based off the open-source <a href=\"https:\/\/www.limswiki.org\/index.php\/Open_enventory\" title=\"Open enventory\" class=\"wiki-link\" data-key=\"7b3fe1fa2243591293cacf8ab2374f0d\">open enventory<\/a> ELN.<sup id=\"rdp-ebb-cite_ref-ZKScifo_10-0\" class=\"reference\"><a href=\"#cite_note-ZKScifo-10\">[10]<\/a><\/sup>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Scilligence_Corporation\" title=\"Scilligence Corporation\" class=\"wiki-link\" data-key=\"1ce9c49bd63a8027b40a222adf199a6f\">Scilligence Corporation<\/a>\n<\/td>\n<td>Scilligence ELN\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Scilligence_Corporation#Demonstration_videos_and_other_media\" title=\"Scilligence Corporation\" class=\"wiki-link\" data-key=\"b5c0aeebb769f59465f96d4e032ac9ef\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/SciNote,_LLC\" title=\"SciNote, LLC\" class=\"wiki-link\" data-key=\"c66c5c09cbed1709844904d13174925e\">sciNote, LLC<\/a>\n<\/td>\n<td>sciNote\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/SciNote,_LLC#Services_and_pricing\" title=\"SciNote, LLC\" class=\"wiki-link\" data-key=\"95a210b41cfc7d616c8b9088236db230\">Pricing<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Shanghai_Integle_Informatics_Sci-Tech_Co.,_Ltd.\" title=\"Shanghai Integle Informatics Sci-Tech Co., Ltd.\" class=\"wiki-link\" data-key=\"599cd682dfdcaf0aff0bc60c1a2a927e\">Shanghai Integle Informatics Sci-Tech Co., Ltd.<\/a>\n<\/td>\n<td>InELN\n<\/td>\n<td>Yes\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\/Shazino_SAS\" title=\"Shazino SAS\" class=\"wiki-link\" data-key=\"82033ad38126416056f1272926cf8aa5\">shazino SAS<\/a>\n<\/td>\n<td>hivebench\n<\/td>\n<td>Yes\n<\/td>\n<td>France\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Shazino_SAS#Pricing\" title=\"Shazino SAS\" class=\"wiki-link\" data-key=\"dc3894bcc65b4e57bb8484fdfe410b91\">Pricing<\/a>\n<\/td>\n<td>hivebench was purchased by Elsevier on June 1, 2016.<sup id=\"rdp-ebb-cite_ref-ElsAcquires16_11-0\" class=\"reference\"><a href=\"#cite_note-ElsAcquires16-11\">[11]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-AvnerPutting16_12-0\" class=\"reference\"><a href=\"#cite_note-AvnerPutting16-12\">[12]<\/a><\/sup>\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>SIMATIC IT R&D\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\/StackWave,_LLC\" title=\"StackWave, LLC\" class=\"wiki-link\" data-key=\"97159535fdde6db4ac2bd492ef4cf532\">StackWave, LLC<\/a>\n<\/td>\n<td>StackWave ELN\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\/Studylog_Systems,_Inc.\" title=\"Studylog Systems, Inc.\" class=\"wiki-link\" data-key=\"0ecef6c6dc6c2f04fae7a894b9e386d1\">Studylog Systems, Inc.<\/a>\n<\/td>\n<td>Study Director\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\/SunBio_IT_Solutions_Pvt._Ltd.\" title=\"SunBio IT Solutions Pvt. Ltd.\" class=\"wiki-link\" data-key=\"9048b39a68163d9c41e49296e2f7d552\">SunBio IT Solutions Pvt. Ltd.<\/a>\n<\/td>\n<td>SunBio ELN\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\/Sycomore_Technologies_SAS\" title=\"Sycomore Technologies SAS\" class=\"wiki-link\" data-key=\"4e31b74d29c7266b7c529a32c8ac993d\">Sycomore Technologies SAS<\/a>\n<\/td>\n<td>LeadAnalytics\n<\/td>\n<td>No\n<\/td>\n<td>France\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Sycomore_Technologies_SAS#Demonstration_videos_and_other_media\" title=\"Sycomore Technologies SAS\" class=\"wiki-link\" data-key=\"b6bc26017e2afa8e9fb07cf0ea84a5a5\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Tas_India_Pvt._Ltd.\" title=\"Tas India Pvt. Ltd.\" class=\"wiki-link\" data-key=\"fbfb13dba81a17bb46dd55726cee025d\">Tas India Pvt. Ltd.<\/a>\n<\/td>\n<td>TASm2m-ELN\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\/Terrington_York_Ltd.\" title=\"Terrington York Ltd.\" class=\"wiki-link\" data-key=\"cdc1df5474d08915a1c174d9c2f8d081\">Terrington York Ltd.<\/a>\n<\/td>\n<td>Labsform\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\/Textco_BioSoftware,_Inc.\" title=\"Textco BioSoftware, Inc.\" class=\"wiki-link\" data-key=\"569dcb3568254f8d681fc8bdb8c6b93d\">Textco BioSoftware, Inc.<\/a>\n<\/td>\n<td>Gene Inspector\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\/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 DM (which includes BioRails ELN)\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 style=\"line-height: 50px; vertical-align: middle;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/Thermo_Scientific\" title=\"Thermo Scientific\" class=\"wiki-link\" data-key=\"e914753f99d483d4577b35fed71b3c94\">Thermo Fisher Scientific<\/a> <div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Thermo_Scientific_145.jpg\" class=\"image wiki-link\" data-key=\"5795d6bda6443c24a6841cde67522dad\"><img alt=\"Thermo Scientific 145.jpg\" src=\"https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/c\/cc\/Thermo_Scientific_145.jpg\" decoding=\"async\" width=\"140\" height=\"48\" \/><\/a><\/div>\n<\/td>\n<td>Core ELN\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\/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 ELN.<sup id=\"rdp-ebb-cite_ref-NG8PDF_13-0\" class=\"reference\"><a href=\"#cite_note-NG8PDF-13\">[13]<\/a><\/sup>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/XC_Lab_SPRL\" title=\"XC Lab SPRL\" class=\"wiki-link\" data-key=\"dfe07980e672a581d35e3ccd3319ebe9\">XC Lab SPRL<\/a>\n<\/td>\n<td>iQ\n<\/td>\n<td>No\n<\/td>\n<td>Belgium\n<\/td>\n<td>\n<\/td>\n<td>Likely acquired from <a href=\"https:\/\/www.limswiki.org\/index.php\/Labage_SA\" title=\"Labage SA\" class=\"wiki-link\" data-key=\"53dc0571b27b406c38d5a791ab8e1c88\">Labage SA<\/a> in 2019.<sup id=\"rdp-ebb-cite_ref-XCLabLabageArch19_14-0\" class=\"reference\"><a href=\"#cite_note-XCLabLabageArch19-14\">[14]<\/a><\/sup>\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-BarraudUSGroup18-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BarraudUSGroup18_1-0\">\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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/ELN_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-KCGenohm18-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-KCGenohm18_2-0\">\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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/ELN_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-YTLabLogRename17-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-YTLabLogRename17_3-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Aiderbotics Corporation (13 November 2017). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.youtube.com\/watch?v=a0usNrSCPXw\" target=\"_blank\">\"Elucidaid has been replaced by LabLog, a more powerful Lab Notebook App for your research\"<\/a>. <i>YouTube<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.youtube.com\/watch?v=a0usNrSCPXw\" target=\"_blank\">https:\/\/www.youtube.com\/watch?v=a0usNrSCPXw<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 06 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=Elucidaid+has+been+replaced+by+LabLog%2C+a+more+powerful+Lab+Notebook+App+for+your+research&rft.atitle=YouTube&rft.aulast=Aiderbotics+Corporation&rft.au=Aiderbotics+Corporation&rft.date=13+November+2017&rft_id=https%3A%2F%2Fwww.youtube.com%2Fwatch%3Fv%3Da0usNrSCPXw&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/ELN_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PRNBruker19-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PRNBruker19_4-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.prnewswire.com\/news-releases\/bruker-announces-acquisition-of-scientific-software-provider-arxspan-300812100.html\" target=\"_blank\">\"Bruker Announces Acquisition of Scientific Software Provider Arxspan\"<\/a>. <i>PR Newswire<\/i>. 14 March 2019<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.prnewswire.com\/news-releases\/bruker-announces-acquisition-of-scientific-software-provider-arxspan-300812100.html\" target=\"_blank\">https:\/\/www.prnewswire.com\/news-releases\/bruker-announces-acquisition-of-scientific-software-provider-arxspan-300812100.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 29 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=Bruker+Announces+Acquisition+of+Scientific+Software+Provider+Arxspan&rft.atitle=PR+Newswire&rft.date=14+March+2019&rft_id=https%3A%2F%2Fwww.prnewswire.com%2Fnews-releases%2Fbruker-announces-acquisition-of-scientific-software-provider-arxspan-300812100.html&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/ELN_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-LGLaunchArch-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-LGLaunchArch_5-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20120510070908\/http:\/\/www.digital-science.com\/biodata-launches-labguru\/\" target=\"_blank\">\"BioData Launches Labguru, a Collaborative Research Management Web Application for Academic Labs\"<\/a>. <i>Digital Science<\/i>. Macmillan Publishers Limited. 5 December 2011. Archived from <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.digital-science.com\/biodata-launches-labguru\/\" target=\"_blank\">the original<\/a> on 10 May 2012<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20120510070908\/http:\/\/www.digital-science.com\/biodata-launches-labguru\/\" target=\"_blank\">https:\/\/web.archive.org\/web\/20120510070908\/http:\/\/www.digital-science.com\/biodata-launches-labguru\/<\/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=BioData+Launches+Labguru%2C+a+Collaborative+Research+Management+Web+Application+for+Academic+Labs&rft.atitle=Digital+Science&rft.date=5+December+2011&rft.pub=Macmillan+Publishers+Limited&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20120510070908%2Fhttp%3A%2F%2Fwww.digital-science.com%2Fbiodata-launches-labguru%2F&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/ELN_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-DassAcqFinal-6\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-DassAcqFinal_6-0\">\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>. Dassault Syst\u00e8mes SA. 29 April 2014<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.3ds.com\/press-releases\/single\/dassault-systemes-successfully-completes-acquisition-of-accelrys\/\" target=\"_blank\">http:\/\/www.3ds.com\/press-releases\/single\/dassault-systemes-successfully-completes-acquisition-of-accelrys\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 04 September 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Dassault+Syst%C3%A8mes+Successfully+Completes+Acquisition+of+Accelrys&rft.atitle=&rft.date=29+April+2014&rft.pub=Dassault+Syst%C3%A8mes+SA&rft_id=http%3A%2F%2Fwww.3ds.com%2Fpress-releases%2Fsingle%2Fdassault-systemes-successfully-completes-acquisition-of-accelrys%2F&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/ELN_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MW_DGAP19-7\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MW_DGAP19_7-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.marketwatch.com\/press-release\/dgap-news-labfolder-acquires-cubuslab-and-becomes-labforward-2019-05-22\" target=\"_blank\">\"DGAP-News: labfolder acquires cubuslab and becomes Labforward\"<\/a>. <i>MarketWatch<\/i>. 22 May 2019<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.marketwatch.com\/press-release\/dgap-news-labfolder-acquires-cubuslab-and-becomes-labforward-2019-05-22\" target=\"_blank\">https:\/\/www.marketwatch.com\/press-release\/dgap-news-labfolder-acquires-cubuslab-and-becomes-labforward-2019-05-22<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 03 October 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=DGAP-News%3A+labfolder+acquires+cubuslab+and+becomes+Labforward&rft.atitle=MarketWatch&rft.date=22+May+2019&rft_id=https%3A%2F%2Fwww.marketwatch.com%2Fpress-release%2Fdgap-news-labfolder-acquires-cubuslab-and-becomes-labforward-2019-05-22&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/ELN_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MerckJoin19-8\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MerckJoin19_8-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.emdgroup.com\/en\/research\/innovation-center\/news-and-events\/all-news\/joining-forces-accelerator-startup-alumni-labfolder-and-cubuslab.html\" target=\"_blank\">\"Joining Forces: Accelerator Startup Alumni labfolder and cubuslab Are Merging!\"<\/a>. <i>Merck Innovation Center<\/i>. Merck KGaA. 21 May 2019<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.emdgroup.com\/en\/research\/innovation-center\/news-and-events\/all-news\/joining-forces-accelerator-startup-alumni-labfolder-and-cubuslab.html\" target=\"_blank\">https:\/\/www.emdgroup.com\/en\/research\/innovation-center\/news-and-events\/all-news\/joining-forces-accelerator-startup-alumni-labfolder-and-cubuslab.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 03 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=Joining+Forces%3A+Accelerator+Startup+Alumni+labfolder+and+cubuslab+Are+Merging%21&rft.atitle=Merck+Innovation+Center&rft.date=21+May+2019&rft.pub=Merck+KGaA&rft_id=https%3A%2F%2Fwww.emdgroup.com%2Fen%2Fresearch%2Finnovation-center%2Fnews-and-events%2Fall-news%2Fjoining-forces-accelerator-startup-alumni-labfolder-and-cubuslab.html&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/ELN_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-LARSInfo-9\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-LARSInfo_9-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/lab-ally.com\/research-space\/\" target=\"_blank\">\"Research Space\"<\/a>. Lab-Ally, LLC<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/lab-ally.com\/research-space\/\" target=\"_blank\">http:\/\/lab-ally.com\/research-space\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 23 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Research+Space&rft.atitle=&rft.pub=Lab-Ally%2C+LLC&rft_id=http%3A%2F%2Flab-ally.com%2Fresearch-space%2F&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/ELN_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ZKScifo-10\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ZKScifo_10-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Rudolphi, Felix (January 2014). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.zkoss.org\/resource\/file\/CaseStudies\/Sciformation_Case_Study.pdf\" target=\"_blank\">\"Why we chose ZK when creating Sciformation ELN\"<\/a> (PDF). Potix Corporation<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.zkoss.org\/resource\/file\/CaseStudies\/Sciformation_Case_Study.pdf\" target=\"_blank\">http:\/\/www.zkoss.org\/resource\/file\/CaseStudies\/Sciformation_Case_Study.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 16 November 2015<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Why+we+chose+ZK+when+creating+Sciformation+ELN&rft.atitle=&rft.aulast=Rudolphi%2C+Felix&rft.au=Rudolphi%2C+Felix&rft.date=January+2014&rft.pub=Potix+Corporation&rft_id=http%3A%2F%2Fwww.zkoss.org%2Fresource%2Ffile%2FCaseStudies%2FSciformation_Case_Study.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/ELN_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ElsAcquires16-11\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ElsAcquires16_11-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.elsevier.com\/about\/press-releases\/corporate\/elsevier-acquires-laboratory-data-management-tool-hivebench\" target=\"_blank\">\"Elsevier Acquires Laboratory Data Management Tool Hivebench\"<\/a>. Elsevier. 7 June 2016<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.elsevier.com\/about\/press-releases\/corporate\/elsevier-acquires-laboratory-data-management-tool-hivebench\" target=\"_blank\">https:\/\/www.elsevier.com\/about\/press-releases\/corporate\/elsevier-acquires-laboratory-data-management-tool-hivebench<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 20 October 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=Elsevier+Acquires+Laboratory+Data+Management+Tool+Hivebench&rft.atitle=&rft.date=7+June+2016&rft.pub=Elsevier&rft_id=https%3A%2F%2Fwww.elsevier.com%2Fabout%2Fpress-releases%2Fcorporate%2Felsevier-acquires-laboratory-data-management-tool-hivebench&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/ELN_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-AvnerPutting16-12\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-AvnerPutting16_12-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Avner, P.T. (7 June 2016). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/blog.mendeley.com\/2016\/06\/07\/putting-data-in-the-hands-of-researchers-with-hivebench\/\" target=\"_blank\">\"Putting data in the hands of researchers with Hivebench\"<\/a>. <i>Mendeley Blog<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/blog.mendeley.com\/2016\/06\/07\/putting-data-in-the-hands-of-researchers-with-hivebench\/\" target=\"_blank\">https:\/\/blog.mendeley.com\/2016\/06\/07\/putting-data-in-the-hands-of-researchers-with-hivebench\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 20 October 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=Putting+data+in+the+hands+of+researchers+with+Hivebench&rft.atitle=Mendeley+Blog&rft.aulast=Avner%2C+P.T.&rft.au=Avner%2C+P.T.&rft.date=7+June+2016&rft_id=https%3A%2F%2Fblog.mendeley.com%2F2016%2F06%2F07%2Fputting-data-in-the-hands-of-researchers-with-hivebench%2F&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/ELN_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-NG8PDF-13\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-NG8PDF_13-0\">\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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/ELN_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-XCLabLabageArch19-14\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-XCLabLabageArch19_14-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20190602170751\/http:\/\/labage.com\/\" target=\"_blank\">\"Discover a new way of working with XC Lab\"<\/a>. XC Lab SPRL. Archived from <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/labage.com\/\" target=\"_blank\">the original<\/a> on 02 June 2019<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20190602170751\/http:\/\/labage.com\/\" target=\"_blank\">https:\/\/web.archive.org\/web\/20190602170751\/http:\/\/labage.com\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 12 October 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Discover+a+new+way+of+working+with+XC+Lab&rft.atitle=&rft.pub=XC+Lab+SPRL&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20190602170751%2Fhttp%3A%2F%2Flabage.com%2F&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/ELN_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20220125221418\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.171 seconds\nReal time usage: 0.280 seconds\nPreprocessor visited node count: 9542\/1000000\nPost\u2010expand include size: 100118\/2097152 bytes\nTemplate argument size: 28330\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 23087\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 147.704 1 -total\n 84.69% 125.092 1 Template:Reflist\n 68.11% 100.603 14 Template:Cite_web\n 62.57% 92.423 14 Template:Citation\/core\n 15.24% 22.514 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/ELN_vendors\n 13.74% 20.301 11 Template:Date\n 8.24% 12.175 1 Template:All_active_ELN_vendors\n 4.98% 7.357 23 Template:Citation\/make_link\n 2.11% 3.122 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12939-0!canonical and timestamp 20220125221418 and revision id 45836. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/ELN_vendors\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/ELN_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>","2fb9efb02be4d94821197ff6a766cf50_images":["https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/e\/e3\/Vendor284.jpg","https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/d\/d1\/Agilent_145.png","https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/c\/cc\/Thermo_Scientific_145.jpg"],"2fb9efb02be4d94821197ff6a766cf50_timestamp":1643149332,"f087eacd8bde24820f324899f5972c1a_type":"article","f087eacd8bde24820f324899f5972c1a_title":"3.2 LIS vendors","f087eacd8bde24820f324899f5972c1a_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/LIS_vendors","f087eacd8bde24820f324899f5972c1a_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 1: Laboratory informatics vendors\/LIS vendorsFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n3.2 LIS vendors \n\n\n\nVendor\n\nKey LIS offering(s)\n\nSaaS\r\noption?\n\nHeadquarters\r\n(Country)\n\nKey information\n\nAdditional notes\n\n\n3DHISTECH Ltd.\n\nTrack & sign\n\nNo\n\nHungary\n\n\n\n\n\n\n\n\nA&T Corporation\n\nCLINILAN\n\nNo\n\nJapan\n\n\n\n\n\n\n\n\nACG Infotech Ltd.\n\nElectra HMS\n\nNo\n\nIndia\n\n\n\nA HIS with a LIS module\n\n\n\n\nAdvanced Business Software\n\nPHIMS\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nAeon Innovative Solutions, Inc.\n\nPAN LIMS\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nAkhil Systems Pvt. Ltd.\n\nMiracle LIS\n\nYes\n\nIndia\n\n\n\n\n\n\n\n\nAl Faris National Company for Investment and Export PSC\n\nAcculab\n\nYes\n\nJordan\n\nDemonstration videos\n\n\n\n\n\n\nAlfa Wassermann, Inc.\n\nAlfa LIS\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nAllengers Infotech Pvt. Ltd.\n\nAllengers LIS\n\nYes\n\nIndia\n\n\n\n\n\n\n\n\nAlphasoft GmbH\n\nUnilab-700\n\nNo\n\nGermany\n\n\n\n\n\n\n\n\nAlternative BioMedical Solutions, LLC\n\nABS Lab Lync\n\nYes\n\nUnited States\n\n\n\n\n\n \n\n\nAmerican Soft Solutions Corp.\n\nPROLIS\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nAP-Visions, LLC\n\nxLab\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nApex HealthWare, LLC\n\nApex LIS\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nAspyra, LLC\n\nASPYRA LIS\n\nNo\n\nUnited States\n\n\n\n\n\n \n\n\nAsterian, LLC \n\nQuikLIMS\n\nYes\n\nUnited States\n\n\n\nSee the LIMS vendor page for ArgoLIMS.\n\n\n\n\nAttune Technologies Pte. Ltd.\n\nAttune LabKernel\n\nYes\n\nSingapore\n\n\n\n\n\n\n\n\nBARTELT GmbH\n\ndatalabX\n\nNo\n\nAustria\n\n\n\n\n\n\n\n\nBasys Data GmbH\n\nPathoWin+\n\nNo\n\nSwitzerland\n\n\n\n\n\n \n\n\nBioFortis, Inc.\n\nLabmatrix\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nBirlamedisoft Pvt. Ltd.\n\nMaxim LIS, Pathogold\n\nNo\n\nIndia\n\n\n\n\n\n\n\n\nBod\u00e9gro Technische Automatisering CV\n\nLabTrain\n\nNo\n\nNetherlands\n\n\n\n\n\n\n\n\nBrooks Automation, Inc.\n\nLimitLIS\n\nYes\n\nUnited States\n\nDemonstration videos\n\n\n\n \n\n\nBtB Software, LLC\n\nBtB Software\n\nYes\n\nUnited States\n\n\n\n\n\n\n\n\nBusysoft Systems Pvt. Ltd.\n\nLabMate\n\nNo\n\nIndia\n\n\n\n\n\n\n\n\nCare Data Infomatics Pvt. Ltd.\n\nCARE LabTrak\n\nYes\n\nIndia\n\n\n\n\n\n\n\n\nCaresoft Consultancy Private Limited\n\nCaresoft LIS\n\nNo\n\nIndia\n\n\n\n\n\n\n\n\nCCIF SARL\n\nWinlabo SGL\n\nYes\n\nFrance\n\nDemonstration videos\n\n\n\n\n\n\nCerebrum Corporation\n\nLABdivus Anatomic Pathology\r\nLABdivus Clinical Trials\n\nYes\n\nUnited States\n\n\n\n\n\n\n\n\nCerner Corporation\n\nCoPathPlus, PathNet\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nCirdan Imaging Ltd.\n\nULTRA\n\nYes\n\nNorthern Ireland\n\n\n\n\n\n\n\n\nCitadel Health Pty. Ltd.\n\nEVOLUTION\n\nYes\n\nAustralia\n\n\n\nProduct name changed from \"AUSLAB Evolution\" at the beginning of 2019.\n\n\n\n\nClarisys Informatique SARL\n\nClarilab, MCA, OneLink\n\nNo\n\nFrance\n\n\n\n\n\n\n\n\nClin1, LLC\n\nClin1 Suite\n\nNo\n\nUnited States\n\n\n\nCompany was formerly named Clinical Software Solutions.[1]\n\n\n\n\nClinical Systems Ltd.\n\nClinAxys II\n\nNo\n\nUnited Kingdom\n\n\n\n\n\n\n\n\nCliniComp International, Inc.\n\nEHR\n\nNo\n\nUnited States\n\n\n\nAn electronic health record with a LIS module\n\n \n\n\nCliniSys Group Limited\n\nWinPath Enterprise\n\nNo\n\nUnited Kingdom\n\n\n\nLIS marketed as a LIMS\n\n\n\n\nCLTech International Corp.\n\nECLIPSE\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nComp Pro Med, Inc.\n\nPolytech Laboratory\r\nInformation System\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nCompu-Leader SAL\n\nMentor LIMS\n\nNo\n\nLebanon\n\n\n\nLIS marketed as a LIMS\n\n\n\n\nCompuGroup Medical AG\n\nCGM Analytix, LabDAQ, molis,\r\nSchuyLab\n\nNo\n\nGermany\n\n\n\n\n\n\n\n\nCompuMedical Health Care Solutions SAE Co.\n\nRx-Care LIS\n\nNo\n\nEgypt\n\n\n\n\n\n\n\n\nComputer Service and Support, Inc.\n\nAvalon LIS\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nComputer Technology & Services SARL\n\nMilera\n\nNo\n\nLebanon\n\n\n\nA HIS + EMR with a LIS module\n\n\n\n\nComtron Corp.\n\nLabgen LIS\n\nNo\n\nUnited States\n\n\n\n\n\n \n\n\nCreliant Software Pvt. Ltd.\n\nCrelioHealth for Diagnostics\n\nYes\n\nIndia\n\nPricing and demonstration videos\n\n\n\n\n\n\nCustom Software Ltd.\n\nNetAcquire LIS\n\nNo\n\nIreland\n\n\n\n\n\n\n\n\nDataSel Bilgi Sistemleri A.\u015e.\n\nAviCenna\n\nNo\n\nTurkey\n\n\n\nA HIS with a LIS module\n\n\n\n\nDedalus SpA\n\nBioserveur, DNLab, Hexalis\n\nNo\n\nItaly\n\n\n\nAcquired NoemaLife SpA and DNLab in June 2016.[2]\r\nAcquired much of Agfa HealthCare NV's solutions in 2020.[3][4]\n\n\n\n\nDedalus France SA\n\nDxLab, Kalisil\n\nNo\n\nFrance\n\n\n\n\n\n\n\n\nDendi, Inc.\n\nDendi LIS\n\nYes\n\nUnited States\n\n\n\n\n\n\n\n\nDesarrollo Aplicaciones Sanitarias SL\n\nSilverLab\n\nNo\n\nSpain\n\n\n\n\n\n\n\n\nDL Sant\u00e9 SAS\n\nOdancio\n\nNo\n\nFrance\n\n\n\n\n\n\n\n\nDhii Health Tech Pvt. Ltd.\n\nDhii-LIMS\n\nNo\n\nIndia\n\n\n\nLIS software marketed as a LIMS\n\n\n\n\nDiagnostic Systems Consulting, LLC\n\nMidlynx Lite LIS, Robust LIS\n\nNo\n\nUnited States\n\n\n\nDoing business as \"Medicus Laboratory Information Systems\"\n\n\n\n\nDiamond Computing Company\n\nLabGEM\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nDocPulse Technologies Pvt. Ltd.\n\nDocPulse LIMS\n\nNo\n\nIndia\n\n\n\nClinical LIS marketed as a LIMS\n\n \n\n\nDorner GmbH & Co. KG\n\nX\/Lab\n\nNo\n\nGermany\n\n\n\n\n\n\n\n\nDrug Testing Program Management, Inc.\n\nDTPM LIS\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\ndWise Healthcare IT Solutions Pvt. Ltd.\n\nLifetrenz LIS\n\nNo\n\nIndia\n\n\n\n\n\n\n\n\nDynamtek Corporation\n\nLabsis\n\nYes\n\nUnited States\n\n\n\n\n\n\n\n\nE*HealthLine.com, Inc.\n\nCARE HIS\n\nNo\n\nUnited States\n\n\n\nA HIS with a LIS module\n\n\n\n\nE-Adware\n\nPenguin LIMS\n\nNo\n\nIndia\n\n\n\nLIS software marketed as a LIMS\n\n\n\n\nEmergency Care Dictation Services, Inc.\n\nEmpower HIS\n\nYes\n\nUnited States\n\n\n\nA HIS with a LIS module\n\n\n\n\nExhilarant Technologies FZE\n\nLisa\n\nYes\n\nUnited Arab Emirates\n\n\n\n\n\n \n\n\nFillipTech Solutions Pvt. Ltd.\n\nFillip Pathology Information System\n\nNo\n\nIndia\n\n\n\nLIS-like pathology information system\n\n \n\n\nFishifox (Pvt.) Ltd.\n\nMediLab LIMS\n\nNo\n\nSri Lanka\n\nDemonstration videos\n\nLIS software marketed as a LIMS\n\n\n\n\nFonet Bilgi Teknolojileri A.\u015e.\n\nFONET LIS\n\nNo\n\nTurkey\n\n\n\n\n\n\n\n\nGamma Peak, LLC\n\nbLIS\n\nYes\n\nUnited States\n\nPricing\n\n\n\n \n\n\nGeniPulse Technologies\n\nGeniPulse LIS\n\nNo\n\nIndia\n\n\n\n\n\n \n\n\nHemasoft Software SL\n\ne-Delphyn LIS\n\nNo\n\nSpain\n\n\n\n\n\n\n\n\nHex 'ff' Inc.\n\nLAB\/HEX LIS\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nHISTONE Informatique SARL\n\nLAMWeb\n\nNo\n\nFrance\n\n\n\n\n\n\n\n\nHLA Data Systems, LLC\n\nmTilda\n\nNo\n\nUnited States\n\n\n\nTailored towards the fields of histocompatibility and immunogenetics\n\n\n\n\nHotsoft Inform\u00e1tica Ltda.\n\nLabplus, Labmaster\n\nNo\n\nBrazil\n\n\n\n\n\n\n\n\nHumMedAi Technologies, LLC\n\nHEMR\n\nNo\n\nUnited States\n\n\n\nAn EMR with a LIS component\n\n\n\n\niClinic World\n\niLabs\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nIN2 Ltd.\n\nBioNET LIS\n\nNo\n\nHungary\n\n\n\n\n\n\n\n\nInfomed C.S.\n\nsLis\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\nDemonstration videos\n\n\n\n\n\n\nInnovasystem LLC\n\nLIS Innovasystem\n\nYes\n\nRussia\n\n\n\n\n\n\n\n\n\nInovapar Solu\u00e7\u00f4es Ltda.\n\nMotion LIS\n\nNo\n\nBrazil\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\nIntegrated Business Solutions Group, LLC\n\nLABLION\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nIntegrated Quality Laboratory Services SA\n\nTBeLog\n\nNo\n\nFrance\n\n\n\nA tuberculosis- and HIV-specific LIS\n\n \n\n\nIntegrated Software Solutions Ltd.\n\nOMNI-Lab, v-LAB\n\nYes\n\nAustralia\n\n\n\nAbsorbed Point of Care Solutions Pty. Ltd. and v-Lab in 2020.[5]\n\n \n\n\nInterSystems Corporation\n\nTrakCare\n\nNo\n\nUnited States\n\nDemonstration videos\n\n\n\n\n\n\nINTUIT Micro Technology, LLC\n\nSimplex Himes LIS\n\nYes\n\nUnited Arab Emirates\n\n\n\n\n\n \n\n\nIntuitive Global Healthcare Systems Ltd.\n\nIntuitive LIS\n\nNo\n\nNigeria\n\n\n\n\n\n \n\n\nIT Easy Software Solutions\n\nWebLIS Professional\n\nNo\n\nPhillipines\n\n\n\n\n\n\n\n\niTack Solutions\n\ni-Labs\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nITDOSE Infosystems Pvt. Ltd.\n\nInnopath\n\nNo\n\nIndia\n\n\n\n\n\n\n\n\nJ&S Medical Associates, Inc.\n\nLabTrak\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nJVS Technologies Pvt. Ltd.\n\nSoftClinic Platform\n\nYes\n\nIndia\n\n\n\nA platform that offers a HIS, LIS, and pharmacy management module\n\n \n\n\nKameda Infologics Pvt. Ltd.\n\nYASASII\n\nNo\n\nJapan\n\n\n\nA HIS with a LIS module\n\n\n\n\nKriti Microsystems Pvt. Ltd.\n\nKriti LIMS\n\nYes\n\nIndia\n\n\n\n\n\n\n\n\nLab Technologies SA\n\nSmartlis\n\nYes\n\nSwitzerland\n\n\n\n\n\n\n\n\nLabLynx, Inc. \n\nHealthCloudPOL\n\nYes\n\nUnited States\n\nPricing and demonstration videos\n\n\n\n\n\n\nLaboratory System Technologies (Pty) Ltd.\n\nDisa*Lab\n\nNo\n\nSouth Africa\n\n\n\n\n\n\n\n\nLabsolution SARL\n\nLX Lab\n\nNo\n\nLuxembourg\n\n\n\n\n\n\n\n\nLabSoft, Inc.\n\nBeethoven II, EZLink,\r\nLabNet\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nLabWare, Inc.\n\nLabWare LIMS\n\nNo\n\nUnited States\n\nPricing and demonstration videos\n\nLIMS software with additional LIS-like functionality[6]\n\n\n\n\nLandsat ICT Solutions Ltd.\n\nTBLIS\n\nNo\n\nUganda\n\nDemonstration videos\n\nA tuberculosis-specific LIS\n\n\n\n\nLigoLab, LLC\n\nLigoLab LIS\n\nNo\n\nUnited States\n\nDemonstration videos\n\n\n\n\n\n\nLRS Health Pty. Ltd.\n\nMediPATH, MediPATH AP\n\nNo\n\nAustralia\n\n\n\n\n\n\n\n\nMacshell Infotech Pvt. Ltd.\n\nMac LIS\n\nNo\n\nIndia\n\n\n\n\n\n\n\n\nMantrust, LLC\n\nLIS365\n\nYes\n\nUnited States\n\n\n\nDBA AXGuru\n\n\n\n\nMargy Tech Pvt. Ltd.\n\niLIS\n\nYes\n\nIndia\n\n\n\n\n\n\n\n\nMEDCOM Information Systems, Inc.\n\nMEDCOM Lab Manager\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nMEDHOST, Inc.\n\nMEDHOST LIS\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nMedPrecinct Solutions Pvt. Ltd.\n\nPCSLabPlus\n\nNo\n\nIndia\n\n\n\nAcquired LabPlus LIMS from PCS Technology Limited in December 2016.[7]\n\n\n\n\nMILLENSYS SAE\n\nMiClinic Lab\n\nYes\n\nEgypt\n\n\n\n\n\n\n\n\nMIMSYS Technologies Pvt. Ltd.\n\nMIMSYS LIMS ERP\n\nNo\n\nIndia\n\n\n\nLIS is a module for the commercially offered\r\nSage 300 ERP software by Sage Software, Inc.\n\n\n\n\nMinerva Data\n\nHealth Digital Transformation Platform\n\nYes\n\nAustralia\n\nPricing\n\nAn \"all or nothing\" healthcare platform with a LIS\n\n \n\n\nMIPS NV\n\nGLIMS, GLIMS Genetics, DaVinci\n\nNo\n\nBelgium\n\nDemonstration videos\n\n\n\n\n\n\nMoonchase\n\nLab Online\n\nNo\n\nBelgium\n\n\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\nMylab Oy\n\nMy+\n\nNo\n\nFinland\n\n\n\n\n\n\n\n\nNeTLIMS NJ, LLC\n\nLabOS\n\nYes\n\nUnited States\n\n\n\nProduct formerly named \"AutoLims\"\n\n\n\n\nNexix, Inc.\n\nNexix LIS\n\nYes\n\nCanada\n\n\n\n\n\n \n\n\nNorah Technologies Pvt. Ltd.\n\ne-Lab\n\nNo\n\nIndia\n\n\n\n\n\n\n\n\nNorthern Software, Inc.\n\neLab.Sys\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nNortec Software, Inc.\n\nNortec LIS\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nNovoPath, Inc.\n\nNovoPath\n\nYes\n\nUnited States\n\n\n\n\n\n\n\n\nOnGen, Inc.\n\nOnGen LIS\n\nYes\n\nUnited States\n\n\n\n\n\n \n\n\nOpen-source software solution\n\nC4G BLIS\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\nOpenELIS\n\nN\/A\n\nN\/A\n\n\n\nMore information found on the project website.\n\n\n\n\nOptra Systems, Inc.\n\nCLOUDPath\n\nYes\n\nUnited States\n\nDemonstration videos\n\nLIS software marketed as a LIMS\n\n\n\n\nOrchard Software Corporation\n\nOrchard Harvest, Pathology,\r\nand Enterprise Lab\n\nYes\n\nUnited States\n\n\n\n\n\n\n\n\nOSM Vertrieb GmbH\n\nOpus::L\n\nNo\n\nGermany\n\n\n\n\n\n \n\n\nPathagility, LLC\n\nPathagility\n\nYes\n\nUnited States\n\n\n\n\n\n\n\n\nPatientPro, Inc.\n\nPatientMax LIMS\n\nNo\n\nUnited States\n\n\n\nLIS software marketed as a LIMS\n\n\n\n\npdv-software GmbH\n\nPDV-LIS II\n\nNo\n\nGermany\n\n\n\n\n\n\n\n\nPhilips Medical Systems BV\n\nLABOSYS, MICROS\n\nNo\n\nNetherlands\n\n\n\n\n\n\n\n\nPhysicians Independent Management Services, Inc.\n\nPathX\n\nYes\n\nUnited States\n\n\n\n\n\n\n\n\nPinaacle Technologies Pvt. Ltd.\n\nMedStar\n\nYes\n\nIndia\n\n\n\nA hospital information system with a LIS module\n\n\n\n\nPixeon Com\u00e9rcio e Desenvolvimento de Software Ltda.\n\nLIS X Clinic\n\nNo\n\nBrazil\n\n\n\n\n\n\n\n\nPlus91 Technologies Pvt. Ltd.\n\nLabC LIMS\n\nYes\n\nIndia\n\nDemonstration videos\n\nLIS software marketed as a LIMS\n\n\n\n\nPrestij Yaz\u0131l\u0131m ve Bilgi Sistemleri\n\nWinsoft LIS\n\nNo\n\nTurkey\n\n\n\n\n\n\n\n\nPrimero Systems, Inc.\n\nPrimero LIS\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nPsyche Systems Corporation\n\nnucleoLIS \u0112.finity, WindoPath \u0112.ssential\n\nNo\n\nUnited States\n\nDemonstration videos\n\nCompany renamed its products sometime in 2019.\n\n\n\n\nQuality Software Systems, Inc.\n\nLabHealth\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nQLAB, LLC\n\nQLAB\n\nYes\n\nUnited States\n\n\n\n\n\n\n\n\nRemedium Health Technologies Pvt. Ltd.\n\nRemidium HIMS\n\nNo\n\nIndia\n\n\n\nA hospital information system with a LIS module\n\n\n\n\nRennova Health, Inc.\n\nClinLab\n\nNo\n\nUnited States\n\n\n\nFormerly a product of ClinLab, Inc.\n\n\n\n\nRhumba, Inc.\n\nHCLAB\n\nNo\n\nPhilippines\n\n\n\n\n\n\n\n\nRoche Diagnostics Limited\n\ncobas infinity\n\nNo\n\nSwitzerland\n\n\n\n\n\n\n\n\nSafa ITS\n\nSafa ITS LIS\n\nNo\n\nLibya\n\n\n\n\n\n\n\n\nScientificWare s.r.l.\n\nScientificWare LIS\n\nNo\n\nItaly\n\n\n\n\n\n\n\n\nSeacoast Laboratory Data Systems, Inc.\n\nSurroundLab Plus\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nSelect Laboratory Partners, Inc.\n\nSelectIS\/S, SelectIS\/C\n\nYes\n\nUnited States\n\n\n\n\n\n \n\n\nShift Consultoria e Sistemas Ltda.\n\nShift LIS\n\nYes\n\nBrazil\n\n\n\n\n\n\n\n\nSiemens AG\n\nServolab, TD-Synergy\n\nNo\n\nGermany\n\n\n\nUnclear what happened to former product NOVIUS Lab.\n\n\n\n\nSLCLAB Inform\u00e1tica SL\n\nALFA21\n\nNo\n\nSpain\n\nPricing and demonstration videos\n\n\n\n\n\n\nSmall Business Computers of New England, Inc.\n\nAP Easy\n\nYes\n\nUnited States\n\nPricing\n\nAnatomical pathology reporting and LIS software\n\n \n\n\nSoft Computer Consultants, Inc. \n\nSoftLab, SoftMic, SoftPathDx\n\nYes\n\nUnited States\n\n\n\n\n\n\n\n\nSofTov Medical Systems Ltd.\n\nAutoLab\n\nNo\n\nIsrael\n\n\n\nNote: SofTov is NeTLIMS' regional distributor of AutoLab\r\nin the Middle East.\n\n\n\n\nSoftware Point Oy\n\nLABVANTAGE Medical Suite\n\nNo\n\nFinland\n\n\n\nLIS software marketed as a LIMS\n\n\n\n\nSpeedsPath, Inc.\n\nSpeedsPathLIS\n\nYes\n\nUnited States\n\n\n\n\n\n\n\n\nSrishti Software Applications Pvt. Ltd.\n\nPARAS LIS\n\nNo\n\nIndia\n\n\n\n\n\n\n\n\nSTAPRO s.r.o.\n\nFONS Openlims\n\nNo\n\nCzech Republic\n\n\n\nLIS software marketed as a LIMS\n\n\n\n\nSunquest Information Systems, Inc.\n\nICE, Sunquest Laboratory\n\nNo\n\nUnited States\n\n\n\nAlso develops Mitogen LIMS for molecular Dx and precision medicine.\n\n\n\n\nSuvarna Technosoft (P) Ltd.\n\nSuvarna-HIS\n\nNo\n\nIndia\n\n\n\nA HIS with a LIS module\n\n\n\n\nSysmex Corporation\n\nDelphic AP, Delphic LIS, HCLAB\n\nNo\n\nJapan\n\n\n\nProducts may only be available in specific markets.\n\n\n\n\nTainosystems Inc.\n\nSilabmed\n\nNo\n\nCanada\n\n\n\n\n\n\n\n\nTechnidata SAS\n\nLivextens\n\nNo\n\nFrance\n\nDemonstration videos\n\n\n\n\n\n\nTechXect Limited\n\nOneLABz\n\nNo\n\nUnited Kingdom\n\n\n\n\n\n \n\n\nTendercare Infotech India Pvt. Ltd.\n\nCapsule LIS\n\nNo\n\nIndia\n\n\n\n\n\n\n\n\nTenwave Infotech Pvt. Ltd.\n\nSIRIUS-LIS\n\nYes\n\nIndia\n\n\n\n\n\n\n\n\nTerra Systems O\u00dc\n\nMiniLIS, TerraLab\n\nYes\n\nEstonia\n\nPricing\n\nLIS software TerraLab marketed as a LIMS\n\n\n\n\nTHASA Technologies (Pty) Ltd.\n\nChiron\n\nYes\n\nSouth Africa\n\n\n\nLIS software marketed as a LIMS\n\n\n\n\nTimeless Medical Systems\n\nTimeless LIMS\n\nNo\n\nCanada\n\n\n\nLIS software marketed as a LIMS\n\n\n\n\nTitle21 Health Solutions, Inc.\n\nCellular Therapy Solution\n\nNo\n\nUnited States\n\nDemonstration videos\n\nA LIS with a focus on cellular therapy\n\n\n\n\nUniversal Software Solutions, Inc.\n\nVersaSuite LIMS\n\nNo\n\nUnited States\n\n\n\nLIS software marketed as a LIMS\n\n\n\n\nUExel Solutions Private Limited\n\nPrecipio LIS\n\nNo\n\nPakistan\n\n\n\n\n\n \n\n\nVasa Technologies Ltd.\n\nPathosys\n\nNo\n\nIndia\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\nVitalAxis, Inc.\n\nVitalPath\n\nYes\n\nUnited States\n\n\n\nLIS software marketed as a LIMS\n\n\n\n\nWebPathLab, Inc.\n\nWebPathLab\n\nYes\n\nUnited States\n\nPricing and demonstration videos\n\n\n\n\n\n\nWerfenlife SA\n\nModulab\n\nNo\n\nSpain\n\n\n\nFormerly Systelab Technologies SA.\n\n \n\n\nWipro Limited\n\nWipro HIS\n\nNo\n\nIndia\n\n\n\nA hospital information system with a LIS module\n\n\n\n\nWIZARD HEALTH d.o.o.\n\nWizardLab\n\nNo\n\nBosnia and Herzegovina\n\n\n\n\n\n \n\n\nXC Lab SPRL\n\niQ\n\nNo\n\nBelgium\n\n\n\nLikely acquired from Labage SA in 2019.[8]\n\n \n\n\nXIFIN, Inc.\n\nXIFIN LIS\n\nYes\n\nUnited States\n\n\n\n\n\n\n\n\nXybion Corporation \n\nPristima XD\n\nYes\n\nUnited States\n\nDemonstration videos\n\n\n\n\n\nReferences \n\n\n\u2191 \"Clinical Software Solutions, CLIN1 LAB, 2011\". http:\/\/www.captodayonline.com\/productguides\/clinical-software-solutions.html . Retrieved 16 November 2011 .   \n \n\n\u2191 \"Dedalus continues its consolidation strategy through the acquisition of Noemalife\". Three Hills Capital Partners. 29 June 2016. http:\/\/www.thcp.eu\/news\/dedalus-continues-its-consolidation-strategy-through-acquisition-noemalife . Retrieved 19 October 2017 .   \n \n\n\u2191 \"The Dedalus Group, Participated by Ardian, Acquires Part of the Agfa-Gevaert Group's Healthcare IT Business\". Dedalus Group. 5 May 2020. Archived from the original on 21 May 2020. https:\/\/web.archive.org\/web\/20200521021505\/https:\/\/dedalus.eu\/en\/the-dedalus-group-participated-by-ardian-acquires-part-of-the-agfa-gevaert-groups-healthcare-it-business\/ . Retrieved 05 November 2020 .   \n \n\n\u2191 \"Dedalus\". Agfa HealthCare NV. 5 May 2020. Archived from the original on 17 May 2020. https:\/\/web.archive.org\/web\/20200517114837\/https:\/\/global.agfahealthcare.com\/main\/dedalus\/ . Retrieved 05 November 2020 .   \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 \"Clinical Lab Information Management\". LabWare, Inc. http:\/\/www.labware.com\/en\/p\/Industries\/Clinical-Lab-Information-Management . Retrieved 22 September 2014 .   \n \n\n\u2191 Tandon, H.C. (22 December 2016). \"Ref: Security Code No. 517119\" (PDF). PCS Technology Limited. http:\/\/www.pcstech.com\/investors_new\/Sale%20of%20Cos%20Product-LIMS.pdf . Retrieved 06 May 2019 .   \n \n\n\u2191 \"Discover a new way of working with XC Lab\". XC Lab SPRL. Archived from the original on 02 June 2019. https:\/\/web.archive.org\/web\/20190602170751\/http:\/\/labage.com\/ . Retrieved 12 October 2021 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/LIS_vendors\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/LIS_vendors<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:12.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 24 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","f087eacd8bde24820f324899f5972c1a_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Resources_for_selecting_and_implementing_informatics_solutions_Part_1_Laboratory_informatics_vendors_LIS_vendors rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Resources_for_selecting_and_implementing_informatics_solutions_Part_1_Laboratory_informatics_vendors_LIS_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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 1: Laboratory informatics vendors\/LIS 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">the beginning<\/a> of this guide-----<\/div>\n<h3><span class=\"mw-headline\" id=\"3.2_LIS_vendors\">3.2 LIS vendors<\/span><\/h3>\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 LIS 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\/3DHISTECH_Ltd.\" title=\"3DHISTECH Ltd.\" class=\"wiki-link\" data-key=\"09b99df93b02fb87e4e83ed86afb150d\">3DHISTECH Ltd.<\/a>\n<\/td>\n<td>Track & sign\n<\/td>\n<td>No\n<\/td>\n<td>Hungary\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/A%26T_Corporation\" title=\"A&T Corporation\" class=\"wiki-link\" data-key=\"64d00929a35ce839603fdd62ac7ec47d\">A&T Corporation<\/a>\n<\/td>\n<td>CLINILAN\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\/ACG_Infotech_Ltd.\" title=\"ACG Infotech Ltd.\" class=\"wiki-link\" data-key=\"41cc868dd53077659233623a4144f933\">ACG Infotech Ltd.<\/a>\n<\/td>\n<td>Electra HMS\n<\/td>\n<td>No\n<\/td>\n<td>India\n<\/td>\n<td>\n<\/td>\n<td>A <a href=\"https:\/\/www.limswiki.org\/index.php\/Hospital_information_system\" title=\"Hospital information system\" class=\"wiki-link\" data-key=\"d8385de7b1f39a39d793f8ce349b448d\">HIS<\/a> with a LIS module\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Advanced_Business_Software\" title=\"Advanced Business Software\" class=\"wiki-link\" data-key=\"aef66d40d332ebc4215d9b6db541a594\">Advanced Business Software<\/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\/Aeon_Innovative_Solutions,_Inc.\" title=\"Aeon Innovative Solutions, Inc.\" class=\"wiki-link\" data-key=\"13d4e3e6d32d684ef4d0063b4966411d\">Aeon Innovative Solutions, Inc.<\/a>\n<\/td>\n<td>PAN 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\/Akhil_Systems_Pvt._Ltd.\" title=\"Akhil Systems Pvt. Ltd.\" class=\"wiki-link\" data-key=\"25c29e0613c9e2bbd4eb6fe9b2649030\">Akhil Systems Pvt. Ltd.<\/a>\n<\/td>\n<td>Miracle LIS\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\/Al_Faris_National_Company_for_Investment_and_Export_PSC\" title=\"Al Faris National Company for Investment and Export PSC\" class=\"wiki-link\" data-key=\"48e31244c8bb228268bfe70816dc7777\">Al Faris National Company for Investment and Export PSC<\/a>\n<\/td>\n<td>Acculab\n<\/td>\n<td>Yes\n<\/td>\n<td>Jordan\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Al_Faris_National_Company_for_Investment_and_Export_PSC#Demonstration_videos_and_other_media\" title=\"Al Faris National Company for Investment and Export PSC\" class=\"wiki-link\" data-key=\"1a249c545b5641dfd63f197de32f5284\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Alfa_Wassermann,_Inc.\" title=\"Alfa Wassermann, Inc.\" class=\"wiki-link\" data-key=\"0dcfb3c0f8b61595acfa74f48f560001\">Alfa Wassermann, Inc.<\/a>\n<\/td>\n<td>Alfa LIS\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\/Allengers_Infotech_Pvt._Ltd.\" title=\"Allengers Infotech Pvt. Ltd.\" class=\"wiki-link\" data-key=\"8cf3a50ee1dbd3fa218de238865e9106\">Allengers Infotech Pvt. Ltd.<\/a>\n<\/td>\n<td>Allengers LIS\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\/Alphasoft_GmbH\" title=\"Alphasoft GmbH\" class=\"wiki-link\" data-key=\"9b66bd9853d10e317cf9eff678d9a928\">Alphasoft GmbH<\/a>\n<\/td>\n<td>Unilab-700\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\/Alternative_BioMedical_Solutions,_LLC\" title=\"Alternative BioMedical Solutions, LLC\" class=\"wiki-link\" data-key=\"9918b0a7c4c5f7dd6103899d17485f38\">Alternative BioMedical Solutions, LLC<\/a>\n<\/td>\n<td>ABS Lab Lync\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\/American_Soft_Solutions_Corp.\" title=\"American Soft Solutions Corp.\" class=\"wiki-link\" data-key=\"809a01a91ff91e24cbcccc6a152e46e9\">American Soft Solutions Corp.<\/a>\n<\/td>\n<td>PROLIS\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\/AP-Visions,_LLC\" title=\"AP-Visions, LLC\" class=\"wiki-link\" data-key=\"c8051f354945dad92f39607a82ca705f\">AP-Visions, LLC<\/a>\n<\/td>\n<td>xLab\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\/Apex_HealthWare,_LLC\" title=\"Apex HealthWare, LLC\" class=\"wiki-link\" data-key=\"3049ccb3ad04f5dfd444d9b1dc9d67d7\">Apex HealthWare, LLC<\/a>\n<\/td>\n<td>Apex LIS\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\/Aspyra,_LLC\" title=\"Aspyra, LLC\" class=\"wiki-link\" data-key=\"5c99cf6d076ed680734fb8386d04f3fd\">Aspyra, LLC<\/a>\n<\/td>\n<td>ASPYRA LIS\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 style=\"line-height: 60px; vertical-align: middle;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/Asterian,_LLC\" title=\"Asterian, LLC\" class=\"wiki-link\" data-key=\"45e09301b4990df83845279326cd2243\">Asterian, LLC<\/a> <div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Asterian-logo_145.png\" class=\"image wiki-link\" data-key=\"a69ac4b71c1635be104130a6e2724e91\"><img alt=\"Asterian-logo 145.png\" src=\"https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/0\/0d\/Asterian-logo_145.png\" decoding=\"async\" width=\"110\" height=\"55\" \/><\/a><\/div>\n<\/td>\n<td>QuikLIMS\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\/LIMS_vendor\" title=\"LIMS vendor\" class=\"wiki-link\" data-key=\"08236f0cd1dbb49b88a9624fcc944f20\">LIMS vendor<\/a> page for ArgoLIMS.\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Attune_Technologies_Pte._Ltd.\" title=\"Attune Technologies Pte. Ltd.\" class=\"wiki-link\" data-key=\"727b5c160f0ccce13004876517cc4ee8\">Attune Technologies Pte. Ltd.<\/a>\n<\/td>\n<td>Attune LabKernel\n<\/td>\n<td>Yes\n<\/td>\n<td>Singapore\n<\/td>\n<td>\n<\/td>\n<td>\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\/Basys_Data_GmbH\" title=\"Basys Data GmbH\" class=\"wiki-link\" data-key=\"0f3ea95b06d1b2a3834b191198aea704\">Basys Data GmbH<\/a>\n<\/td>\n<td>PathoWin+\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\/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\/Birlamedisoft_Pvt._Ltd.\" title=\"Birlamedisoft Pvt. Ltd.\" class=\"wiki-link\" data-key=\"07b95bf1683f504057f1af41c7c39477\">Birlamedisoft Pvt. Ltd.<\/a>\n<\/td>\n<td>Maxim LIS, Pathogold\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\/Bod%C3%A9gro_Technische_Automatisering_CV\" title=\"Bod\u00e9gro Technische Automatisering CV\" class=\"wiki-link\" data-key=\"caed4cf9af2950aa46d75efcf6ed995e\">Bod\u00e9gro Technische Automatisering CV<\/a>\n<\/td>\n<td>LabTrain\n<\/td>\n<td>No\n<\/td>\n<td>Netherlands\n<\/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>LimitLIS\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.#Demonstration_videos_and_other_media\" title=\"Brooks Automation, Inc.\" class=\"wiki-link\" data-key=\"7e51a247a999d1d5764abfeb2e2cbef2\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/BtB_Software,_LLC\" title=\"BtB Software, LLC\" class=\"wiki-link\" data-key=\"cdadfda55eed0bfe3c05267547fbd786\">BtB Software, LLC<\/a>\n<\/td>\n<td>BtB Software\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\/Busysoft_Systems_Pvt._Ltd.\" title=\"Busysoft Systems Pvt. Ltd.\" class=\"wiki-link\" data-key=\"18127d8ce7c6bbbe194831c9321845bf\">Busysoft Systems Pvt. Ltd.<\/a>\n<\/td>\n<td>LabMate\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\/Care_Data_Infomatics_Pvt._Ltd.\" title=\"Care Data Infomatics Pvt. Ltd.\" class=\"wiki-link\" data-key=\"482a57764d4315f4dbf125293dc1016e\">Care Data Infomatics Pvt. Ltd.<\/a>\n<\/td>\n<td>CARE LabTrak\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\/Caresoft_Consultancy_Private_Limited\" title=\"Caresoft Consultancy Private Limited\" class=\"wiki-link\" data-key=\"28e7af6ff99e5c293d47c31927c4bab8\">Caresoft Consultancy Private Limited<\/a>\n<\/td>\n<td>Caresoft LIS\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\/CCIF_SARL\" title=\"CCIF SARL\" class=\"wiki-link\" data-key=\"a1ce997c2a8d239be18001b8fd87a4b3\">CCIF SARL<\/a>\n<\/td>\n<td>Winlabo SGL\n<\/td>\n<td>Yes\n<\/td>\n<td>France\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/CCIF_SARL#Demonstration_videos_and_other_media\" title=\"CCIF SARL\" class=\"wiki-link\" data-key=\"d688b2716e80d2082daf354899721df0\">Demonstration videos<\/a>\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 Anatomic Pathology<br \/>LABdivus Clinical Trials\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\/Cerner_Corporation\" title=\"Cerner Corporation\" class=\"wiki-link\" data-key=\"44b952d5fb439af88c84f5ad453fee3f\">Cerner Corporation<\/a>\n<\/td>\n<td>CoPathPlus, PathNet\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\/Cirdan_Imaging_Ltd.\" title=\"Cirdan Imaging Ltd.\" class=\"wiki-link\" data-key=\"ed8092b8e466605b25d349c49645b92e\">Cirdan Imaging Ltd.<\/a>\n<\/td>\n<td>ULTRA\n<\/td>\n<td>Yes\n<\/td>\n<td>Northern 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\/Citadel_Health_Pty._Ltd.\" title=\"Citadel Health Pty. Ltd.\" class=\"wiki-link\" data-key=\"4bdae1c6e0fa7a79519c22bcce62d966\">Citadel Health Pty. Ltd.<\/a>\n<\/td>\n<td>EVOLUTION\n<\/td>\n<td>Yes\n<\/td>\n<td>Australia\n<\/td>\n<td>\n<\/td>\n<td>Product name changed from \"AUSLAB Evolution\" at the beginning of 2019.\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Clarisys_Informatique_SARL\" title=\"Clarisys Informatique SARL\" class=\"wiki-link\" data-key=\"f1d01bfe6fa58f34c236e1214570088c\">Clarisys Informatique SARL<\/a>\n<\/td>\n<td>Clarilab, MCA, OneLink\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\/Clin1,_LLC\" title=\"Clin1, LLC\" class=\"wiki-link\" data-key=\"c0a36e1a3dc90d8e81a41fd0db1f0f0e\">Clin1, LLC<\/a>\n<\/td>\n<td>Clin1 Suite\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>Company was formerly named Clinical Software Solutions.<sup id=\"rdp-ebb-cite_ref-1\" class=\"reference\"><a href=\"#cite_note-1\">[1]<\/a><\/sup>\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\/CliniComp_International,_Inc.\" title=\"CliniComp International, Inc.\" class=\"wiki-link\" data-key=\"38967ef0e7ad5c110055b1692cf954db\">CliniComp International, Inc.<\/a>\n<\/td>\n<td>EHR\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>An <a href=\"https:\/\/www.limswiki.org\/index.php\/Electronic_health_record\" title=\"Electronic health record\" class=\"wiki-link\" data-key=\"f2e31a73217185bb01389404c1fd5255\">electronic health record<\/a> with a LIS module\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>LIS marketed as a LIMS\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/CLTech_International_Corp.\" title=\"CLTech International Corp.\" class=\"wiki-link\" data-key=\"6cdf9a7a88b36d82f5c2c9eac27ef822\">CLTech International Corp.<\/a>\n<\/td>\n<td>ECLIPSE\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\/Comp_Pro_Med,_Inc.\" title=\"Comp Pro Med, Inc.\" class=\"wiki-link\" data-key=\"125d4f0bc055e5b0d874dfe9f4b1b354\">Comp Pro Med, Inc.<\/a>\n<\/td>\n<td>Polytech Laboratory<br \/>Information 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\/Compu-Leader_SAL\" title=\"Compu-Leader SAL\" class=\"wiki-link\" data-key=\"40cbc1d64b2ffbdf6102bf12d89a56e2\">Compu-Leader SAL<\/a>\n<\/td>\n<td>Mentor LIMS\n<\/td>\n<td>No\n<\/td>\n<td>Lebanon\n<\/td>\n<td>\n<\/td>\n<td>LIS marketed as a LIMS\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/CompuGroup_Medical_AG\" title=\"CompuGroup Medical AG\" class=\"wiki-link\" data-key=\"0a14f053396fa7d4bf1b18cb223bb1b4\">CompuGroup Medical AG<\/a>\n<\/td>\n<td>CGM Analytix, LabDAQ, molis,<br \/>SchuyLab\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\/CompuMedical_Health_Care_Solutions_SAE_Co.\" title=\"CompuMedical Health Care Solutions SAE Co.\" class=\"wiki-link\" data-key=\"2271d3295c3e1951bb439ccc81578fd4\">CompuMedical Health Care Solutions SAE Co.<\/a>\n<\/td>\n<td>Rx-Care LIS\n<\/td>\n<td>No\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\/Computer_Service_and_Support,_Inc.\" title=\"Computer Service and Support, Inc.\" class=\"wiki-link\" data-key=\"c88be41352c70d527def4d98ba930133\">Computer Service and Support, Inc.<\/a>\n<\/td>\n<td>Avalon LIS\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\/Computer_Technology_%26_Services_SARL\" title=\"Computer Technology & Services SARL\" class=\"wiki-link\" data-key=\"d14ed38034bfa3cccad369a8af5c709a\">Computer Technology & Services SARL<\/a>\n<\/td>\n<td>Milera\n<\/td>\n<td>No\n<\/td>\n<td>Lebanon\n<\/td>\n<td>\n<\/td>\n<td>A HIS + EMR with a LIS module\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Comtron_Corp.\" title=\"Comtron Corp.\" class=\"wiki-link\" data-key=\"e3b82c216d5d2c855c17a1cb67098508\">Comtron Corp.<\/a>\n<\/td>\n<td>Labgen LIS\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\/Creliant_Software_Pvt._Ltd.\" title=\"Creliant Software Pvt. Ltd.\" class=\"wiki-link\" data-key=\"8cb1f2a32d9889a65ec35715998a69cb\">Creliant Software Pvt. Ltd.<\/a>\n<\/td>\n<td>CrelioHealth for Diagnostics\n<\/td>\n<td>Yes\n<\/td>\n<td>India\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Creliant_Software_Pvt._Ltd.#Pricing\" title=\"Creliant Software Pvt. Ltd.\" class=\"wiki-link\" data-key=\"45041f026c491e4d11ae474105109f75\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Creliant_Software_Pvt._Ltd.#Demonstration_videos_and_other_media\" title=\"Creliant Software Pvt. Ltd.\" class=\"wiki-link\" data-key=\"2eca34cb1e4d9c25185ed3c8b0a4e08a\">demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Custom_Software_Ltd.\" title=\"Custom Software Ltd.\" class=\"wiki-link\" data-key=\"9bc94cc0fccf763858d06fd98b6ffe69\">Custom Software Ltd.<\/a>\n<\/td>\n<td>NetAcquire LIS\n<\/td>\n<td>No\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\/DataSel_Bilgi_Sistemleri_A.%C5%9E.\" title=\"DataSel Bilgi Sistemleri A.\u015e.\" class=\"wiki-link\" data-key=\"8b48ec4b8cd3bfb7c05114a667aabf30\">DataSel Bilgi Sistemleri A.\u015e.<\/a>\n<\/td>\n<td>AviCenna\n<\/td>\n<td>No\n<\/td>\n<td>Turkey\n<\/td>\n<td>\n<\/td>\n<td>A <a href=\"https:\/\/www.limswiki.org\/index.php\/Hospital_information_system\" title=\"Hospital information system\" class=\"wiki-link\" data-key=\"d8385de7b1f39a39d793f8ce349b448d\">HIS<\/a> with a LIS module\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Dedalus_SpA\" title=\"Dedalus SpA\" class=\"wiki-link\" data-key=\"75f87494a9c9ccb0614a983fede9e1a2\">Dedalus SpA<\/a>\n<\/td>\n<td>Bioserveur, DNLab, Hexalis\n<\/td>\n<td>No\n<\/td>\n<td>Italy\n<\/td>\n<td>\n<\/td>\n<td>Acquired <a href=\"https:\/\/www.limswiki.org\/index.php\/NoemaLife_SpA\" title=\"NoemaLife SpA\" class=\"wiki-link\" data-key=\"746dead66d13c3b80dd1b1734480d910\">NoemaLife SpA<\/a> and DNLab in June 2016.<sup id=\"rdp-ebb-cite_ref-DedalusAcq_2-0\" class=\"reference\"><a href=\"#cite_note-DedalusAcq-2\">[2]<\/a><\/sup><br \/>Acquired much of <a href=\"https:\/\/www.limswiki.org\/index.php\/Agfa_HealthCare_NV\" title=\"Agfa HealthCare NV\" class=\"wiki-link\" data-key=\"c6a612da224b3a7033fdf4d05fbf4a1c\">Agfa HealthCare NV<\/a>'s solutions in 2020.<sup id=\"rdp-ebb-cite_ref-DedalusTheDedalus20Arch_3-0\" class=\"reference\"><a href=\"#cite_note-DedalusTheDedalus20Arch-3\">[3]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-AgfaDedalus20_4-0\" class=\"reference\"><a href=\"#cite_note-AgfaDedalus20-4\">[4]<\/a><\/sup>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Dedalus_France_SA\" title=\"Dedalus France SA\" class=\"wiki-link\" data-key=\"d4edd507c516f04eb0e557a1a68079b7\">Dedalus France SA<\/a>\n<\/td>\n<td>DxLab, Kalisil\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\/Dendi,_Inc.\" title=\"Dendi, Inc.\" class=\"wiki-link\" data-key=\"a64190a39a89f761d6698d46ea393200\">Dendi, Inc.<\/a>\n<\/td>\n<td>Dendi LIS\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\/Desarrollo_Aplicaciones_Sanitarias_SL\" title=\"Desarrollo Aplicaciones Sanitarias SL\" class=\"wiki-link\" data-key=\"7b410fe90eea8b25154312faf9eeadc9\">Desarrollo Aplicaciones Sanitarias SL<\/a>\n<\/td>\n<td>SilverLab\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\/DL_Sant%C3%A9_SAS\" title=\"DL Sant\u00e9 SAS\" class=\"wiki-link\" data-key=\"d87e4b0b4f5b18be10dc026dbe19d948\">DL Sant\u00e9 SAS<\/a>\n<\/td>\n<td>Odancio\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\/Dhii_Health_Tech_Pvt._Ltd.\" title=\"Dhii Health Tech Pvt. Ltd.\" class=\"wiki-link\" data-key=\"db1a4565f88de002ea21f91cf01330d2\">Dhii Health Tech Pvt. Ltd.<\/a>\n<\/td>\n<td>Dhii-LIMS\n<\/td>\n<td>No\n<\/td>\n<td>India\n<\/td>\n<td>\n<\/td>\n<td>LIS software marketed as a LIMS\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Diagnostic_Systems_Consulting,_LLC\" title=\"Diagnostic Systems Consulting, LLC\" class=\"wiki-link\" data-key=\"16489b3796a9635cbdf88e54b4706a4b\">Diagnostic Systems Consulting, LLC<\/a>\n<\/td>\n<td>Midlynx Lite LIS, Robust LIS\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>Doing business as \"Medicus Laboratory Information Systems\"\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Diamond_Computing_Company\" title=\"Diamond Computing Company\" class=\"wiki-link\" data-key=\"54c798ad37883d8a19da9f0228dee3e1\">Diamond Computing Company<\/a>\n<\/td>\n<td>LabGEM\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\/DocPulse_Technologies_Pvt._Ltd.\" title=\"DocPulse Technologies Pvt. Ltd.\" class=\"wiki-link\" data-key=\"945dd57fc0ab06242bd9289af490d24f\">DocPulse Technologies Pvt. Ltd.<\/a>\n<\/td>\n<td>DocPulse LIMS\n<\/td>\n<td>No\n<\/td>\n<td>India\n<\/td>\n<td>\n<\/td>\n<td>Clinical LIS marketed as a LIMS\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>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\/Drug_Testing_Program_Management,_Inc.\" title=\"Drug Testing Program Management, Inc.\" class=\"wiki-link\" data-key=\"2ae3301dcbb135dc219854038077a2dd\">Drug Testing Program Management, Inc.<\/a>\n<\/td>\n<td>DTPM LIS\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\/DWise_Healthcare_IT_Solutions_Pvt._Ltd.\" title=\"DWise Healthcare IT Solutions Pvt. Ltd.\" class=\"wiki-link\" data-key=\"d3c9c2de1b795a8c43cec77251d6042c\">dWise Healthcare IT Solutions Pvt. Ltd.<\/a>\n<\/td>\n<td>Lifetrenz LIS\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\/Dynamtek_Corporation\" title=\"Dynamtek Corporation\" class=\"wiki-link\" data-key=\"410e2364d0f53b91d130d76771eeb058\">Dynamtek Corporation<\/a>\n<\/td>\n<td>Labsis\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\/E*HealthLine.com,_Inc.\" title=\"E*HealthLine.com, Inc.\" class=\"wiki-link\" data-key=\"3eb13d3a6490f3a506984a3b515112f3\">E*HealthLine.com, Inc.<\/a>\n<\/td>\n<td>CARE HIS\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>A <a href=\"https:\/\/www.limswiki.org\/index.php\/Hospital_information_system\" title=\"Hospital information system\" class=\"wiki-link\" data-key=\"d8385de7b1f39a39d793f8ce349b448d\">HIS<\/a> with a LIS module\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/E-Adware\" title=\"E-Adware\" class=\"wiki-link\" data-key=\"c7d3569c112ebbc0ec92a5a9db818acd\">E-Adware<\/a>\n<\/td>\n<td>Penguin LIMS\n<\/td>\n<td>No\n<\/td>\n<td>India\n<\/td>\n<td>\n<\/td>\n<td>LIS software marketed as a LIMS\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Emergency_Care_Dictation_Services,_Inc.\" title=\"Emergency Care Dictation Services, Inc.\" class=\"wiki-link\" data-key=\"bb01b36e57c25ef44fd21b846cad2097\">Emergency Care Dictation Services, Inc.<\/a>\n<\/td>\n<td>Empower HIS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>A <a href=\"https:\/\/www.limswiki.org\/index.php\/Hospital_information_system\" title=\"Hospital information system\" class=\"wiki-link\" data-key=\"d8385de7b1f39a39d793f8ce349b448d\">HIS<\/a> with a LIS module\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Exhilarant_Technologies_FZE\" title=\"Exhilarant Technologies FZE\" class=\"wiki-link\" data-key=\"57e12d3f09acefa0f980a728c3c190c8\">Exhilarant Technologies FZE<\/a>\n<\/td>\n<td>Lisa\n<\/td>\n<td>Yes\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\/FillipTech_Solutions_Pvt._Ltd.\" title=\"FillipTech Solutions Pvt. Ltd.\" class=\"wiki-link\" data-key=\"f9e5efc03916d31d09413ce8066a0256\">FillipTech Solutions Pvt. Ltd.<\/a>\n<\/td>\n<td>Fillip Pathology Information System\n<\/td>\n<td>No\n<\/td>\n<td>India\n<\/td>\n<td>\n<\/td>\n<td>LIS-like pathology information system\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Fishifox_(Pvt.)_Ltd.\" title=\"Fishifox (Pvt.) Ltd.\" class=\"wiki-link\" data-key=\"1261e69ba0f56842388a9204f352f2b7\">Fishifox (Pvt.) Ltd.<\/a>\n<\/td>\n<td>MediLab LIMS\n<\/td>\n<td>No\n<\/td>\n<td>Sri Lanka\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Fishifox_(Pvt.)_Ltd.#Demonstration_videos_and_other_media\" title=\"Fishifox (Pvt.) Ltd.\" class=\"wiki-link\" data-key=\"3b2d4eea8c85c5b90f38b98eba4dbacd\">Demonstration videos<\/a>\n<\/td>\n<td>LIS software marketed as a LIMS\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Fonet_Bilgi_Teknolojileri_A.%C5%9E.\" title=\"Fonet Bilgi Teknolojileri A.\u015e.\" class=\"wiki-link\" data-key=\"189e2e731e5c0d17ec07666e6385dcbf\">Fonet Bilgi Teknolojileri A.\u015e.<\/a>\n<\/td>\n<td>FONET LIS\n<\/td>\n<td>No\n<\/td>\n<td>Turkey\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Gamma_Peak,_LLC\" title=\"Gamma Peak, LLC\" class=\"wiki-link\" data-key=\"64ad7189480a021dcb7816b507409cef\">Gamma Peak, LLC<\/a>\n<\/td>\n<td>bLIS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Gamma_Peak,_LLC#Pricing\" title=\"Gamma Peak, LLC\" class=\"wiki-link\" data-key=\"c3bad5eba55416ee2a4cf632fb812888\">Pricing<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/GeniPulse_Technologies\" title=\"GeniPulse Technologies\" class=\"wiki-link\" data-key=\"aba78141d1d2eae38f1d5e3527026e8d\">GeniPulse Technologies<\/a>\n<\/td>\n<td>GeniPulse LIS\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\/Hemasoft_Software_SL\" title=\"Hemasoft Software SL\" class=\"wiki-link\" data-key=\"2082e9a69d3c9a6e981fb022d7acbd2c\">Hemasoft Software SL<\/a>\n<\/td>\n<td>e-Delphyn LIS\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\/Hex_%27ff%27_Inc.\" title=\"Hex 'ff' Inc.\" class=\"wiki-link\" data-key=\"5b1f1ddf3abba442c308d1801e527b83\">Hex 'ff' Inc.<\/a>\n<\/td>\n<td>LAB\/HEX LIS\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\/HISTONE_Informatique_SARL\" title=\"HISTONE Informatique SARL\" class=\"wiki-link\" data-key=\"6fe3605264e18abab7f0f5317bc5588c\">HISTONE Informatique SARL<\/a>\n<\/td>\n<td>LAMWeb\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\/HLA_Data_Systems,_LLC\" title=\"HLA Data Systems, LLC\" class=\"wiki-link\" data-key=\"2bb43cc42c8b24265d92c653ddd2329f\">HLA Data Systems, LLC<\/a>\n<\/td>\n<td>mTilda\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>Tailored towards the fields of histocompatibility and immunogenetics\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Hotsoft_Inform%C3%A1tica_Ltda.\" title=\"Hotsoft Inform\u00e1tica Ltda.\" class=\"wiki-link\" data-key=\"0b4ff0d4f13542d329cc78d54ed112a6\">Hotsoft Inform\u00e1tica Ltda.<\/a>\n<\/td>\n<td>Labplus, Labmaster\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\/HumMedAi_Technologies,_LLC\" title=\"HumMedAi Technologies, LLC\" class=\"wiki-link\" data-key=\"2ca9c5d8cd5db4fd49fdb14ed6da73f7\">HumMedAi Technologies, LLC<\/a>\n<\/td>\n<td>HEMR\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>An EMR with a LIS component\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/IClinic_World\" title=\"IClinic World\" class=\"wiki-link\" data-key=\"83d87891a42acf6bb47a60491f7f04c9\">iClinic World<\/a>\n<\/td>\n<td>iLabs\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\/IN2_Ltd.\" title=\"IN2 Ltd.\" class=\"wiki-link\" data-key=\"5bed7d7aaea15c7b67f95ead2de7aba1\">IN2 Ltd.<\/a>\n<\/td>\n<td>BioNET LIS\n<\/td>\n<td>No\n<\/td>\n<td>Hungary\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Infomed_C.S.\" class=\"mw-redirect wiki-link\" title=\"Infomed C.S.\" data-key=\"429731b6b0f8177c0995075e3f1128b4\">Infomed C.S.<\/a>\n<\/td>\n<td>sLis\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.#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\/Innovasystem_LLC\" title=\"Innovasystem LLC\" class=\"wiki-link\" data-key=\"39253b9e5e752c929dc5d9a8d78c209a\">Innovasystem LLC<\/a>\n<\/td>\n<td>LIS Innovasystem\n<\/td>\n<td>Yes\n<\/td>\n<td>Russia\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Inovapar_Solu%C3%A7%C3%B4es_Ltda.\" title=\"Inovapar Solu\u00e7\u00f4es Ltda.\" class=\"wiki-link\" data-key=\"f4b63c4cd52307321750aaccf2bfcb03\">Inovapar Solu\u00e7\u00f4es Ltda.<\/a>\n<\/td>\n<td>Motion LIS\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\/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\/Integrated_Business_Solutions_Group,_LLC\" title=\"Integrated Business Solutions Group, LLC\" class=\"wiki-link\" data-key=\"f133a69b44be54b3bd489f5965153f65\">Integrated Business Solutions Group, LLC<\/a>\n<\/td>\n<td>LABLION\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\/Integrated_Quality_Laboratory_Services_SA\" title=\"Integrated Quality Laboratory Services SA\" class=\"wiki-link\" data-key=\"ecff8d05026fa3b28f636f7a8f99204f\">Integrated Quality Laboratory Services SA<\/a>\n<\/td>\n<td>TBeLog\n<\/td>\n<td>No\n<\/td>\n<td>France\n<\/td>\n<td>\n<\/td>\n<td>A tuberculosis- and HIV-specific LIS\n<\/td><\/tr>\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, v-LAB\n<\/td>\n<td>Yes\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_5-0\" class=\"reference\"><a href=\"#cite_note-PCSArch-5\">[5]<\/a><\/sup>\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\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\/INTUIT_Micro_Technology,_LLC\" title=\"INTUIT Micro Technology, LLC\" class=\"wiki-link\" data-key=\"25342c029b755f95084ec3551cdf39b9\">INTUIT Micro Technology, LLC<\/a>\n<\/td>\n<td>Simplex Himes LIS\n<\/td>\n<td>Yes\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\/Intuitive_Global_Healthcare_Systems_Ltd.\" title=\"Intuitive Global Healthcare Systems Ltd.\" class=\"wiki-link\" data-key=\"d6a9e7d9fba00b93b9576329df12fabd\">Intuitive Global Healthcare Systems Ltd.<\/a>\n<\/td>\n<td>Intuitive LIS\n<\/td>\n<td>No\n<\/td>\n<td>Nigeria\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/IT_Easy_Software_Solutions\" title=\"IT Easy Software Solutions\" class=\"wiki-link\" data-key=\"77f77bf1bc34add6f0e5460235651acb\">IT Easy Software Solutions<\/a>\n<\/td>\n<td>WebLIS Professional\n<\/td>\n<td>No\n<\/td>\n<td>Phillipines\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/ITack_Solutions\" title=\"ITack Solutions\" class=\"wiki-link\" data-key=\"66f56ec2607c9ba01a924393b3d8b064\">iTack Solutions<\/a>\n<\/td>\n<td>i-Labs\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\/ITDOSE_Infosystems_Pvt._Ltd.\" title=\"ITDOSE Infosystems Pvt. Ltd.\" class=\"wiki-link\" data-key=\"d3c075fda35f9af732a1b2dfd40c122d\">ITDOSE Infosystems Pvt. Ltd.<\/a>\n<\/td>\n<td>Innopath\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\/J%26S_Medical_Associates,_Inc.\" title=\"J&S Medical Associates, Inc.\" class=\"wiki-link\" data-key=\"e06609f157c99a39d501e756d682e543\">J&S Medical Associates, Inc.<\/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\/JVS_Technologies_Pvt._Ltd.\" title=\"JVS Technologies Pvt. Ltd.\" class=\"wiki-link\" data-key=\"45910e614bcc60bf8c41ac434ce88f86\">JVS Technologies Pvt. Ltd.<\/a>\n<\/td>\n<td>SoftClinic Platform\n<\/td>\n<td>Yes\n<\/td>\n<td>India\n<\/td>\n<td>\n<\/td>\n<td>A platform that offers a HIS, LIS, and pharmacy management module\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Kameda_Infologics_Pvt._Ltd.\" title=\"Kameda Infologics Pvt. Ltd.\" class=\"wiki-link\" data-key=\"87d5298c005bab0c46ed01d53d5c55de\">Kameda Infologics Pvt. Ltd.<\/a>\n<\/td>\n<td>YASASII\n<\/td>\n<td>No\n<\/td>\n<td>Japan\n<\/td>\n<td>\n<\/td>\n<td>A <a href=\"https:\/\/www.limswiki.org\/index.php\/Hospital_information_system\" title=\"Hospital information system\" class=\"wiki-link\" data-key=\"d8385de7b1f39a39d793f8ce349b448d\">HIS<\/a> with a LIS module\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>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\/Lab_Technologies_SA\" title=\"Lab Technologies SA\" class=\"wiki-link\" data-key=\"0fb55599f6a76280423001e3852c2af9\">Lab Technologies SA<\/a>\n<\/td>\n<td>Smartlis\n<\/td>\n<td>Yes\n<\/td>\n<td>Switzerland\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td style=\"line-height: 50px; vertical-align: middle;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/LabLynx,_Inc.\" title=\"LabLynx, Inc.\" class=\"wiki-link\" data-key=\"da3f96536cf2c54de1960f26fe5712a1\">LabLynx, Inc.<\/a> <div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Official_2022_lablynx_logo.png\" class=\"image wiki-link\" data-key=\"e3103dd7e149abce76e971e77b13e5f2\"><img alt=\"Official 2022 lablynx logo.png\" src=\"https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/5\/5c\/Official_2022_lablynx_logo.png\" decoding=\"async\" width=\"150\" height=\"65\" \/><\/a><\/div>\n<\/td>\n<td>HealthCloudPOL\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\/Laboratory_System_Technologies_(Pty)_Ltd.\" title=\"Laboratory System Technologies (Pty) Ltd.\" class=\"wiki-link\" data-key=\"1c4f734b41d12e59aa9c28b4319982d6\">Laboratory System Technologies (Pty) Ltd.<\/a>\n<\/td>\n<td>Disa*Lab\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\/Labsolution_SARL\" title=\"Labsolution SARL\" class=\"wiki-link\" data-key=\"5418d05953b59d735017c71255ee5c26\">Labsolution SARL<\/a>\n<\/td>\n<td>LX Lab\n<\/td>\n<td>No\n<\/td>\n<td>Luxembourg\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/LabSoft,_Inc.\" title=\"LabSoft, Inc.\" class=\"wiki-link\" data-key=\"a63abaa68897d617287beada1d7db46d\">LabSoft, Inc.<\/a>\n<\/td>\n<td>Beethoven II, EZLink,<br \/>LabNet\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\/LabWare,_Inc.\" title=\"LabWare, Inc.\" class=\"wiki-link\" data-key=\"34254ba2e2bbcd4ce616eba66db7d2f6\">LabWare, Inc.<\/a>\n<\/td>\n<td>LabWare LIMS\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/LabWare,_Inc.\" title=\"LabWare, Inc.\" class=\"wiki-link\" data-key=\"34254ba2e2bbcd4ce616eba66db7d2f6\">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>LIMS software with additional LIS-like functionality<sup id=\"rdp-ebb-cite_ref-LWClin_6-0\" class=\"reference\"><a href=\"#cite_note-LWClin-6\">[6]<\/a><\/sup>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Landsat_ICT_Solutions_Ltd.\" title=\"Landsat ICT Solutions Ltd.\" class=\"wiki-link\" data-key=\"5a0b1ad6b81213e73e694f1086b620a2\">Landsat ICT Solutions Ltd.<\/a>\n<\/td>\n<td>TBLIS\n<\/td>\n<td>No\n<\/td>\n<td>Uganda\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Landsat_ICT_Solutions_Ltd.#Demonstration_videos_and_other_media\" title=\"Landsat ICT Solutions Ltd.\" class=\"wiki-link\" data-key=\"13f31dbb199b79ce57413019386bd8a7\">Demonstration videos<\/a>\n<\/td>\n<td>A tuberculosis-specific LIS\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/LigoLab,_LLC\" title=\"LigoLab, LLC\" class=\"wiki-link\" data-key=\"e7cbd51f9f7d2588ed43f21e175817c8\">LigoLab, LLC<\/a>\n<\/td>\n<td>LigoLab LIS\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/LigoLab,_LLC#Demonstration_videos_and_other_media\" title=\"LigoLab, LLC\" class=\"wiki-link\" data-key=\"a6491e372ab67f93a8969984c7cc83e1\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/LRS_Health_Pty._Ltd.\" title=\"LRS Health Pty. Ltd.\" class=\"wiki-link\" data-key=\"c28c815b518ad846bad2bceb3abc2a84\">LRS Health Pty. Ltd.<\/a>\n<\/td>\n<td>MediPATH, MediPATH AP\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\/Macshell_Infotech_Pvt._Ltd.\" title=\"Macshell Infotech Pvt. Ltd.\" class=\"wiki-link\" data-key=\"e45d55a89caeec7913c4b08538a23683\">Macshell Infotech Pvt. Ltd.<\/a>\n<\/td>\n<td>Mac LIS\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\/Mantrust,_LLC\" title=\"Mantrust, LLC\" class=\"wiki-link\" data-key=\"5d16d40a4d3fc084e043dca18ba8b51d\">Mantrust, LLC<\/a>\n<\/td>\n<td>LIS365\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>DBA AXGuru\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Margy_Tech_Pvt._Ltd.\" title=\"Margy Tech Pvt. Ltd.\" class=\"wiki-link\" data-key=\"eb6c3a6063baaa72c0c28e44066fdd51\">Margy Tech Pvt. Ltd.<\/a>\n<\/td>\n<td>iLIS\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\/MEDCOM_Information_Systems,_Inc.\" title=\"MEDCOM Information Systems, Inc.\" class=\"wiki-link\" data-key=\"1057dbe3618099f5960cd0a70b3153e8\">MEDCOM Information Systems, Inc.<\/a>\n<\/td>\n<td>MEDCOM Lab Manager\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\/MEDHOST,_Inc.\" title=\"MEDHOST, Inc.\" class=\"wiki-link\" data-key=\"f9a4b80e748811afcda94b2ca38163fc\">MEDHOST, Inc.<\/a>\n<\/td>\n<td>MEDHOST LIS\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\/MedPrecinct_Solutions_Pvt._Ltd.\" title=\"MedPrecinct Solutions Pvt. Ltd.\" class=\"wiki-link\" data-key=\"0a071d2d62eaa396b6f5f3aa92b0dd16\">MedPrecinct Solutions Pvt. Ltd.<\/a>\n<\/td>\n<td>PCSLabPlus\n<\/td>\n<td>No\n<\/td>\n<td>India\n<\/td>\n<td>\n<\/td>\n<td>Acquired LabPlus LIMS from <a href=\"https:\/\/www.limswiki.org\/index.php\/PCS_Technology_Limited\" title=\"PCS Technology Limited\" class=\"wiki-link\" data-key=\"c978b14b722c9d27aa7807c44940bfac\">PCS Technology Limited<\/a> in December 2016.<sup id=\"rdp-ebb-cite_ref-TandonSecurity16_7-0\" class=\"reference\"><a href=\"#cite_note-TandonSecurity16-7\">[7]<\/a><\/sup>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/MILLENSYS_SAE\" title=\"MILLENSYS SAE\" class=\"wiki-link\" data-key=\"c10e0db2cb07f8d4e8ee61db44dcdb18\">MILLENSYS SAE<\/a>\n<\/td>\n<td>MiClinic Lab\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\/MIMSYS_Technologies_Pvt._Ltd.\" title=\"MIMSYS Technologies Pvt. Ltd.\" class=\"wiki-link\" data-key=\"5c7d7c7ccd35e5624d779556fb01d853\">MIMSYS Technologies Pvt. Ltd.<\/a>\n<\/td>\n<td>MIMSYS LIMS ERP\n<\/td>\n<td>No\n<\/td>\n<td>India\n<\/td>\n<td>\n<\/td>\n<td>LIS is a module for the commercially offered<br \/>Sage 300 ERP software by Sage Software, Inc.\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Minerva_Data\" title=\"Minerva Data\" class=\"wiki-link\" data-key=\"31a821142019d2f4449ab83252931596\">Minerva Data<\/a>\n<\/td>\n<td>Health Digital Transformation Platform\n<\/td>\n<td>Yes\n<\/td>\n<td>Australia\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Minerva_Data#Pricing\" title=\"Minerva Data\" class=\"wiki-link\" data-key=\"ae38ffc0b88bb14c6979cf23a52b8715\">Pricing<\/a>\n<\/td>\n<td>An \"all or nothing\" healthcare platform with a LIS\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/MIPS_NV\" title=\"MIPS NV\" class=\"wiki-link\" data-key=\"943b31ee7b3e4100743546f4f5f2caed\">MIPS NV<\/a>\n<\/td>\n<td>GLIMS, GLIMS Genetics, DaVinci\n<\/td>\n<td>No\n<\/td>\n<td>Belgium\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/MIPS_NV#Demonstration_videos_and_other_media\" title=\"MIPS NV\" class=\"wiki-link\" data-key=\"8d4b1d190bb3ce3461c11e381a66944f\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Moonchase\" title=\"Moonchase\" class=\"wiki-link\" data-key=\"f109b391ce8d24464db774979b7ff0dc\">Moonchase<\/a>\n<\/td>\n<td>Lab Online\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\/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\/Mylab_Oy\" title=\"Mylab Oy\" class=\"wiki-link\" data-key=\"7499014e7d557a6f619c41343f9f6736\">Mylab Oy<\/a>\n<\/td>\n<td>My+\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\/NeTLIMS_NJ,_LLC\" title=\"NeTLIMS NJ, LLC\" class=\"wiki-link\" data-key=\"9ff4b4c42fbaf72d4f9f4e73b1664688\">NeTLIMS NJ, LLC<\/a>\n<\/td>\n<td>LabOS\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>Product formerly named \"AutoLims\"\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 LIS\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\/Norah_Technologies_Pvt._Ltd.\" title=\"Norah Technologies Pvt. Ltd.\" class=\"wiki-link\" data-key=\"babb4e7221431333f9da5a033c2cd36c\">Norah Technologies Pvt. Ltd.<\/a>\n<\/td>\n<td>e-Lab\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\/Northern_Software,_Inc.\" title=\"Northern Software, Inc.\" class=\"wiki-link\" data-key=\"2c91a3bf5333e83deb3f23ce4d6666aa\">Northern Software, Inc.<\/a>\n<\/td>\n<td>eLab.Sys\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\/Nortec_Software,_Inc.\" title=\"Nortec Software, Inc.\" class=\"wiki-link\" data-key=\"5bbaefbc9c68ff9548c6cc1e65d13689\">Nortec Software, Inc.<\/a>\n<\/td>\n<td>Nortec LIS\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\/NovoPath,_Inc.\" title=\"NovoPath, Inc.\" class=\"wiki-link\" data-key=\"ac4ee88a371656d47381349b3a2abd41\">NovoPath, Inc.<\/a>\n<\/td>\n<td>NovoPath\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\/OnGen,_Inc.\" title=\"OnGen, Inc.\" class=\"wiki-link\" data-key=\"b8ad6b9bc1661c98d6978f7200a6041c\">OnGen, Inc.<\/a>\n<\/td>\n<td>OnGen LIS\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>Open-source software solution\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/C4G_BLIS\" title=\"C4G BLIS\" class=\"wiki-link\" data-key=\"bfa1af20f4a68dc928bd873f549e440e\">C4G BLIS<\/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 rel=\"external_link\" class=\"external text\" href=\"http:\/\/blis.cc.gatech.edu\/index.php\" target=\"_blank\">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\/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 the <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/sites.google.com\/site\/openelisglobal\/\" target=\"_blank\">project website<\/a>.\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Optra_Systems,_Inc.\" title=\"Optra Systems, Inc.\" class=\"wiki-link\" data-key=\"fe74d0e6408107cc14afb01ed0444013\">Optra Systems, Inc.<\/a>\n<\/td>\n<td>CLOUDPath\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Optra_Systems,_Inc.#Demonstration_videos_and_other_media\" title=\"Optra Systems, Inc.\" class=\"wiki-link\" data-key=\"02713124493d7e117cbaf5ee880581cb\">Demonstration videos<\/a>\n<\/td>\n<td>LIS software marketed as a LIMS\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Orchard_Software_Corporation\" title=\"Orchard Software Corporation\" class=\"wiki-link\" data-key=\"7b7ed1ca87d09d6e32482f0a87ddfacd\">Orchard Software Corporation<\/a>\n<\/td>\n<td>Orchard Harvest, Pathology,<br \/>and Enterprise Lab\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\/OSM_Vertrieb_GmbH\" title=\"OSM Vertrieb GmbH\" class=\"wiki-link\" data-key=\"9f14d5f1034922424c0cea163b65328d\">OSM Vertrieb GmbH<\/a>\n<\/td>\n<td>Opus::L\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\/Pathagility,_LLC\" title=\"Pathagility, LLC\" class=\"wiki-link\" data-key=\"322b5adfaba1b63adcb73485ab2c78c6\">Pathagility, LLC<\/a>\n<\/td>\n<td>Pathagility\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\/PatientPro,_Inc.\" title=\"PatientPro, Inc.\" class=\"wiki-link\" data-key=\"c4a8e7fa329de5c62a4ea38083f42b68\">PatientPro, Inc.<\/a>\n<\/td>\n<td>PatientMax LIMS\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>LIS software marketed as a LIMS\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-LIS II\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\/Philips_Medical_Systems_BV\" title=\"Philips Medical Systems BV\" class=\"wiki-link\" data-key=\"746740a666d57e3d3e3f48f97fe5a72c\">Philips Medical Systems BV<\/a>\n<\/td>\n<td>LABOSYS, MICROS\n<\/td>\n<td>No\n<\/td>\n<td>Netherlands\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Physicians_Independent_Management_Services,_Inc.\" title=\"Physicians Independent Management Services, Inc.\" class=\"wiki-link\" data-key=\"c12e79cd871cf8b9a6c4b1a2ae77166f\">Physicians Independent Management Services, Inc.<\/a>\n<\/td>\n<td>PathX\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\/Pinaacle_Technologies_Pvt._Ltd.\" title=\"Pinaacle Technologies Pvt. Ltd.\" class=\"wiki-link\" data-key=\"51779d5c84db3af0322fb1113486ae2b\">Pinaacle Technologies Pvt. Ltd.<\/a>\n<\/td>\n<td>MedStar\n<\/td>\n<td>Yes\n<\/td>\n<td>India\n<\/td>\n<td>\n<\/td>\n<td>A <a href=\"https:\/\/www.limswiki.org\/index.php\/Hospital_information_system\" title=\"Hospital information system\" class=\"wiki-link\" data-key=\"d8385de7b1f39a39d793f8ce349b448d\">hospital information system<\/a> with a LIS module\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Pixeon_Com%C3%A9rcio_e_Desenvolvimento_de_Software_Ltda.\" title=\"Pixeon Com\u00e9rcio e Desenvolvimento de Software Ltda.\" class=\"wiki-link\" data-key=\"f631d382537b7a3d65eba04105b5b698\">Pixeon Com\u00e9rcio e Desenvolvimento de Software Ltda.<\/a>\n<\/td>\n<td>LIS X Clinic\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\/Plus91_Technologies_Pvt._Ltd.\" title=\"Plus91 Technologies Pvt. Ltd.\" class=\"wiki-link\" data-key=\"ee741cb9639718be294ff00291b052e7\">Plus91 Technologies Pvt. Ltd.<\/a>\n<\/td>\n<td>LabC LIMS\n<\/td>\n<td>Yes\n<\/td>\n<td>India\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Plus91_Technologies_Pvt._Ltd.#Demonstration_videos_and_other_media\" title=\"Plus91 Technologies Pvt. Ltd.\" class=\"wiki-link\" data-key=\"533ecf7788d0d2c93c2f9577fa278682\">Demonstration videos<\/a>\n<\/td>\n<td>LIS software marketed as a LIMS\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Prestij_Yaz%C4%B1l%C4%B1m_ve_Bilgi_Sistemleri\" title=\"Prestij Yaz\u0131l\u0131m ve Bilgi Sistemleri\" class=\"wiki-link\" data-key=\"50028b1498444becfee90d1eeead5cfc\">Prestij Yaz\u0131l\u0131m ve Bilgi Sistemleri<\/a>\n<\/td>\n<td>Winsoft LIS\n<\/td>\n<td>No\n<\/td>\n<td>Turkey\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Primero_Systems,_Inc.\" title=\"Primero Systems, Inc.\" class=\"wiki-link\" data-key=\"7c3dce20aee90000ff8ad5a4155c1618\">Primero Systems, Inc.<\/a>\n<\/td>\n<td>Primero LIS\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\/Psyche_Systems_Corporation\" title=\"Psyche Systems Corporation\" class=\"wiki-link\" data-key=\"b897ff34db091d33fbb48a145ab65a3e\">Psyche Systems Corporation<\/a>\n<\/td>\n<td>nucleoLIS \u0112.finity, WindoPath \u0112.ssential\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Psyche_Systems_Corporation#Demonstration_videos_and_other_media\" title=\"Psyche Systems Corporation\" class=\"wiki-link\" data-key=\"0648c10ff578a9de038b0af495ea63ea\">Demonstration videos<\/a>\n<\/td>\n<td>Company renamed its products sometime in 2019.\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Quality_Software_Systems,_Inc.\" title=\"Quality Software Systems, Inc.\" class=\"wiki-link\" data-key=\"7865ea2bf98158b9122900dd05dbbc22\">Quality Software Systems, Inc.<\/a>\n<\/td>\n<td>LabHealth\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\/QLAB,_LLC\" title=\"QLAB, LLC\" class=\"wiki-link\" data-key=\"741ff0aeb9628908b7f5655c47b185c7\">QLAB, LLC<\/a>\n<\/td>\n<td>QLAB\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\/Remedium_Health_Technologies_Pvt._Ltd.\" title=\"Remedium Health Technologies Pvt. Ltd.\" class=\"wiki-link\" data-key=\"0a3c0887157c0120624aa2c00a6684a4\">Remedium Health Technologies Pvt. Ltd.<\/a>\n<\/td>\n<td>Remidium HIMS\n<\/td>\n<td>No\n<\/td>\n<td>India\n<\/td>\n<td>\n<\/td>\n<td>A <a href=\"https:\/\/www.limswiki.org\/index.php\/Hospital_information_system\" title=\"Hospital information system\" class=\"wiki-link\" data-key=\"d8385de7b1f39a39d793f8ce349b448d\">hospital information system<\/a> with a LIS module\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Rennova_Health,_Inc.\" title=\"Rennova Health, Inc.\" class=\"wiki-link\" data-key=\"fb93545f5bac468461b35c58e562cfe5\">Rennova Health, Inc.<\/a>\n<\/td>\n<td>ClinLab\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>Formerly a product of <a href=\"https:\/\/www.limswiki.org\/index.php\/ClinLab,_Inc.\" title=\"ClinLab, Inc.\" class=\"wiki-link\" data-key=\"dd3c95819167a721966e867e23893a2d\">ClinLab, Inc.<\/a>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Rhumba,_Inc.\" title=\"Rhumba, Inc.\" class=\"wiki-link\" data-key=\"f22090a5ac79bfddc89be65e80a06aca\">Rhumba, Inc.<\/a>\n<\/td>\n<td>HCLAB\n<\/td>\n<td>No\n<\/td>\n<td>Philippines\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Roche_Diagnostics_Limited\" title=\"Roche Diagnostics Limited\" class=\"wiki-link\" data-key=\"ab3031189eab37c836f3a5ab881738bc\">Roche Diagnostics Limited<\/a>\n<\/td>\n<td>cobas infinity\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\/Safa_ITS\" title=\"Safa ITS\" class=\"wiki-link\" data-key=\"7a5f8925f5ead87d8d8f4ad997d77d52\">Safa ITS<\/a>\n<\/td>\n<td>Safa ITS LIS\n<\/td>\n<td>No\n<\/td>\n<td>Libya\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/ScientificWare_s.r.l.\" title=\"ScientificWare s.r.l.\" class=\"wiki-link\" data-key=\"ae6068c6be793b9dcbf90aa9db1328da\">ScientificWare s.r.l.<\/a>\n<\/td>\n<td>ScientificWare LIS\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\/Seacoast_Laboratory_Data_Systems,_Inc.\" title=\"Seacoast Laboratory Data Systems, Inc.\" class=\"wiki-link\" data-key=\"f14d64d6449df49d5c24104c3f782396\">Seacoast Laboratory Data Systems, Inc.<\/a>\n<\/td>\n<td>SurroundLab 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\/Select_Laboratory_Partners,_Inc.\" title=\"Select Laboratory Partners, Inc.\" class=\"wiki-link\" data-key=\"0e624d372e0ad899a3eab6d32f0c9cef\">Select Laboratory Partners, Inc.<\/a>\n<\/td>\n<td>SelectIS\/S, SelectIS\/C\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\/Shift_Consultoria_e_Sistemas_Ltda.\" title=\"Shift Consultoria e Sistemas Ltda.\" class=\"wiki-link\" data-key=\"c84f74bd9bf9f19d1c25ef618c1f4783\">Shift Consultoria e Sistemas Ltda.<\/a>\n<\/td>\n<td>Shift LIS\n<\/td>\n<td>Yes\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\/Siemens_AG\" title=\"Siemens AG\" class=\"wiki-link\" data-key=\"02158f083dff6f082f3b17048612608d\">Siemens AG<\/a>\n<\/td>\n<td>Servolab, TD-Synergy\n<\/td>\n<td>No\n<\/td>\n<td>Germany\n<\/td>\n<td>\n<\/td>\n<td>Unclear what happened to former product NOVIUS Lab.\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\n<\/td>\n<td>No\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\/Small_Business_Computers_of_New_England,_Inc.\" title=\"Small Business Computers of New England, Inc.\" class=\"wiki-link\" data-key=\"672d1dec7a28cd4bc6b1a47b726d164c\">Small Business Computers of New England, Inc.<\/a>\n<\/td>\n<td>AP Easy\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Small_Business_Computers_of_New_England,_Inc.#Pricing\" title=\"Small Business Computers of New England, Inc.\" class=\"wiki-link\" data-key=\"719f41e2407e80c4eff2d987cc541eea\">Pricing<\/a>\n<\/td>\n<td>Anatomical pathology reporting and LIS software\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"line-height: 50px; vertical-align: middle;\"><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> <div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:SCC_145.jpg\" class=\"image wiki-link\" data-key=\"7187e20e6d78d4d07abbfeb37f03f084\"><img alt=\"SCC 145.jpg\" src=\"https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/6\/63\/SCC_145.jpg\" decoding=\"async\" width=\"130\" height=\"82\" \/><\/a><\/div>\n<\/td>\n<td>SoftLab, SoftMic, SoftPathDx\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\/SofTov_Medical_Systems_Ltd.\" title=\"SofTov Medical Systems Ltd.\" class=\"wiki-link\" data-key=\"0f647812e05856f03d753d599e07c485\">SofTov Medical Systems Ltd.<\/a>\n<\/td>\n<td>AutoLab\n<\/td>\n<td>No\n<\/td>\n<td>Israel\n<\/td>\n<td>\n<\/td>\n<td>Note: SofTov is <a href=\"https:\/\/www.limswiki.org\/index.php\/NeTLIMS_NJ,_LLC\" title=\"NeTLIMS NJ, LLC\" class=\"wiki-link\" data-key=\"9ff4b4c42fbaf72d4f9f4e73b1664688\">NeTLIMS<\/a>' regional distributor of AutoLab<br \/>in the Middle East.\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\n<\/td>\n<td>No\n<\/td>\n<td>Finland\n<\/td>\n<td>\n<\/td>\n<td>LIS software marketed as a LIMS\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/SpeedsPath,_Inc.\" title=\"SpeedsPath, Inc.\" class=\"wiki-link\" data-key=\"4566418a2bcff35d7dcab6c4065ac29f\">SpeedsPath, Inc.<\/a>\n<\/td>\n<td>SpeedsPathLIS\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\/Srishti_Software_Applications_Pvt._Ltd.\" title=\"Srishti Software Applications Pvt. Ltd.\" class=\"wiki-link\" data-key=\"b22c40f33649e34df017763a4fa4e103\">Srishti Software Applications Pvt. Ltd.<\/a>\n<\/td>\n<td>PARAS LIS\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\/STAPRO_s.r.o.\" title=\"STAPRO s.r.o.\" class=\"wiki-link\" data-key=\"80235654839dcce52e794be384bf6df9\">STAPRO s.r.o.<\/a>\n<\/td>\n<td>FONS Openlims\n<\/td>\n<td>No\n<\/td>\n<td>Czech Republic\n<\/td>\n<td>\n<\/td>\n<td>LIS software marketed as a LIMS\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>ICE, Sunquest Laboratory\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>Also develops Mitogen LIMS for molecular Dx and precision medicine.\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Suvarna_Technosoft_(P)_Ltd.\" title=\"Suvarna Technosoft (P) Ltd.\" class=\"wiki-link\" data-key=\"5712589224b4a7e5c6b2347037a289f5\">Suvarna Technosoft (P) Ltd.<\/a>\n<\/td>\n<td>Suvarna-HIS\n<\/td>\n<td>No\n<\/td>\n<td>India\n<\/td>\n<td>\n<\/td>\n<td>A <a href=\"https:\/\/www.limswiki.org\/index.php\/Hospital_information_system\" title=\"Hospital information system\" class=\"wiki-link\" data-key=\"d8385de7b1f39a39d793f8ce349b448d\">HIS<\/a> with a LIS module\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Sysmex_Corporation\" title=\"Sysmex Corporation\" class=\"wiki-link\" data-key=\"620036ace43f46204b2b30d03adae037\">Sysmex Corporation<\/a>\n<\/td>\n<td>Delphic AP, Delphic LIS, HCLAB\n<\/td>\n<td>No\n<\/td>\n<td>Japan\n<\/td>\n<td>\n<\/td>\n<td>Products may only be available in specific markets.\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Tainosystems_Inc.\" title=\"Tainosystems Inc.\" class=\"wiki-link\" data-key=\"2bdb52653fecfe93b305007e8b6c3ec9\">Tainosystems Inc.<\/a>\n<\/td>\n<td>Silabmed\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\/Technidata_SAS\" title=\"Technidata SAS\" class=\"wiki-link\" data-key=\"7f4e7f8814b4ba7fab1311a70ae0f4be\">Technidata SAS<\/a>\n<\/td>\n<td>Livextens\n<\/td>\n<td>No\n<\/td>\n<td>France\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Technidata_SAS#Demonstration_videos_and_other_media\" title=\"Technidata SAS\" class=\"wiki-link\" data-key=\"2036975d445b2ffca0b177b5319e78b5\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/TechXect_Limited\" title=\"TechXect Limited\" class=\"wiki-link\" data-key=\"ef39d128df0d9202cc654e1a427f1b6c\">TechXect Limited<\/a>\n<\/td>\n<td>OneLABz\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\/Tendercare_Infotech_India_Pvt._Ltd.\" title=\"Tendercare Infotech India Pvt. Ltd.\" class=\"wiki-link\" data-key=\"57fc25c410bf79ec51275f6093af7771\">Tendercare Infotech India Pvt. Ltd.<\/a>\n<\/td>\n<td>Capsule LIS\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\/Tenwave_Infotech_Pvt._Ltd.\" title=\"Tenwave Infotech Pvt. Ltd.\" class=\"wiki-link\" data-key=\"fada1ae1b523ca3229bd14bd260537b2\">Tenwave Infotech Pvt. Ltd.<\/a>\n<\/td>\n<td>SIRIUS-LIS\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\/Terra_Systems_O%C3%9C\" title=\"Terra Systems O\u00dc\" class=\"wiki-link\" data-key=\"6bde0a4a2ed9a0481c4b81149d066846\">Terra Systems O\u00dc<\/a>\n<\/td>\n<td>MiniLIS, TerraLab\n<\/td>\n<td>Yes\n<\/td>\n<td>Estonia\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Terra_Systems_O%C3%9C#Pricing\" title=\"Terra Systems O\u00dc\" class=\"wiki-link\" data-key=\"1dd66a88c1b50fb7ddf635cb0b134857\">Pricing<\/a>\n<\/td>\n<td>LIS software TerraLab marketed as a LIMS\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/THASA_Technologies_(Pty)_Ltd.\" title=\"THASA Technologies (Pty) Ltd.\" class=\"wiki-link\" data-key=\"bfc2f8a8f43732548599ac3656c7548d\">THASA Technologies (Pty) Ltd.<\/a>\n<\/td>\n<td>Chiron\n<\/td>\n<td>Yes\n<\/td>\n<td>South Africa\n<\/td>\n<td>\n<\/td>\n<td>LIS software marketed as a LIMS\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Timeless_Medical_Systems\" title=\"Timeless Medical Systems\" class=\"wiki-link\" data-key=\"1e7d1458295f2847895021a9e93a66f5\">Timeless Medical Systems<\/a>\n<\/td>\n<td>Timeless LIMS\n<\/td>\n<td>No\n<\/td>\n<td>Canada\n<\/td>\n<td>\n<\/td>\n<td>LIS software marketed as a LIMS\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 LIS with a focus on cellular therapy\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Universal_Software_Solutions,_Inc.\" title=\"Universal Software Solutions, Inc.\" class=\"wiki-link\" data-key=\"7a4d9fb555f6f3939f5d05f956ce88ae\">Universal Software Solutions, Inc.<\/a>\n<\/td>\n<td>VersaSuite LIMS\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>LIS software marketed as a LIMS\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/UExel_Solutions_Private_Limited\" title=\"UExel Solutions Private Limited\" class=\"wiki-link\" data-key=\"499df969aef8b76474277e468005cdd9\">UExel Solutions Private Limited<\/a>\n<\/td>\n<td>Precipio LIS\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\/Vasa_Technologies_Ltd.\" title=\"Vasa Technologies Ltd.\" class=\"wiki-link\" data-key=\"f2b3dce8c4fcf57c31327d96973b8776\">Vasa Technologies Ltd.<\/a>\n<\/td>\n<td>Pathosys\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\/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\/VitalAxis,_Inc.\" title=\"VitalAxis, Inc.\" class=\"wiki-link\" data-key=\"ceca89607a13af77f2540d8820f60a57\">VitalAxis, Inc.<\/a>\n<\/td>\n<td>VitalPath\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>LIS software marketed as a LIMS\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/WebPathLab,_Inc.\" title=\"WebPathLab, Inc.\" class=\"wiki-link\" data-key=\"1174edfae7425822cc967d2f0169fbb3\">WebPathLab, Inc.<\/a>\n<\/td>\n<td>WebPathLab\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/WebPathLab,_Inc.#Pricing\" title=\"WebPathLab, Inc.\" class=\"wiki-link\" data-key=\"da4e788ef229df75228cec2d28c795da\">Pricing<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/WebPathLab,_Inc.#Demonstration_videos_and_other_media\" title=\"WebPathLab, Inc.\" class=\"wiki-link\" data-key=\"76b35421bd0efa69409cade24bfb7d0d\">demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Werfenlife_SA\" title=\"Werfenlife SA\" class=\"wiki-link\" data-key=\"ba2cdacaa9b7b0afd987376cdaac19fa\">Werfenlife SA<\/a>\n<\/td>\n<td>Modulab\n<\/td>\n<td>No\n<\/td>\n<td>Spain\n<\/td>\n<td>\n<\/td>\n<td>Formerly <a href=\"https:\/\/www.limswiki.org\/index.php\/Systelab_Technologies_SA\" title=\"Systelab Technologies SA\" class=\"wiki-link\" data-key=\"1b0c0572d81f5b1b343a2280f3a57925\">Systelab Technologies SA<\/a>.\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Wipro_Limited\" title=\"Wipro Limited\" class=\"wiki-link\" data-key=\"4a0667ca32a4562e07cbbde0a66b2e54\">Wipro Limited<\/a>\n<\/td>\n<td>Wipro HIS\n<\/td>\n<td>No\n<\/td>\n<td>India\n<\/td>\n<td>\n<\/td>\n<td>A <a href=\"https:\/\/www.limswiki.org\/index.php\/Hospital_information_system\" title=\"Hospital information system\" class=\"wiki-link\" data-key=\"d8385de7b1f39a39d793f8ce349b448d\">hospital information system<\/a> with a LIS module\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/WIZARD_HEALTH_d.o.o.\" title=\"WIZARD HEALTH d.o.o.\" class=\"wiki-link\" data-key=\"6ee91a901a3ad5a61159aa56a293ec70\">WIZARD HEALTH d.o.o.<\/a>\n<\/td>\n<td>WizardLab\n<\/td>\n<td>No\n<\/td>\n<td>Bosnia and Herzegovina\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/XC_Lab_SPRL\" title=\"XC Lab SPRL\" class=\"wiki-link\" data-key=\"dfe07980e672a581d35e3ccd3319ebe9\">XC Lab SPRL<\/a>\n<\/td>\n<td>iQ\n<\/td>\n<td>No\n<\/td>\n<td>Belgium\n<\/td>\n<td>\n<\/td>\n<td>Likely acquired from <a href=\"https:\/\/www.limswiki.org\/index.php\/Labage_SA\" title=\"Labage SA\" class=\"wiki-link\" data-key=\"53dc0571b27b406c38d5a791ab8e1c88\">Labage SA<\/a> in 2019.<sup id=\"rdp-ebb-cite_ref-XCLabLabageArch19_8-0\" class=\"reference\"><a href=\"#cite_note-XCLabLabageArch19-8\">[8]<\/a><\/sup>\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/XIFIN,_Inc.\" title=\"XIFIN, Inc.\" class=\"wiki-link\" data-key=\"5731735cb916241be7b11d82c891ec88\">XIFIN, Inc.<\/a>\n<\/td>\n<td>XIFIN LIS\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 style=\"line-height: 50px; vertical-align: middle;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/Xybion_Corporation\" title=\"Xybion Corporation\" class=\"wiki-link\" data-key=\"ee87743428afb8c831b21e711e9e12e2\">Xybion Corporation<\/a> <div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Xybion_145.png\" class=\"image wiki-link\" data-key=\"06edd4f2bce96c5d44c87386da73313f\"><img alt=\"Xybion 145.png\" src=\"https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/0\/08\/Xybion_145.png\" decoding=\"async\" width=\"135\" height=\"39\" \/><\/a><\/div>\n<\/td>\n<td>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>\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\"><ol class=\"references\">\n<li id=\"cite_note-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-1\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.captodayonline.com\/productguides\/clinical-software-solutions.html\" target=\"_blank\">\"Clinical Software Solutions, CLIN1 LAB, 2011\"<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.captodayonline.com\/productguides\/clinical-software-solutions.html\" target=\"_blank\">http:\/\/www.captodayonline.com\/productguides\/clinical-software-solutions.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 16 November 2011<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Clinical+Software+Solutions%2C+CLIN1+LAB%2C+2011&rft.atitle=&rft_id=http%3A%2F%2Fwww.captodayonline.com%2Fproductguides%2Fclinical-software-solutions.html&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/LIS_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-DedalusAcq-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-DedalusAcq_2-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.thcp.eu\/news\/dedalus-continues-its-consolidation-strategy-through-acquisition-noemalife\" target=\"_blank\">\"Dedalus continues its consolidation strategy through the acquisition of Noemalife\"<\/a>. Three Hills Capital Partners. 29 June 2016<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.thcp.eu\/news\/dedalus-continues-its-consolidation-strategy-through-acquisition-noemalife\" target=\"_blank\">http:\/\/www.thcp.eu\/news\/dedalus-continues-its-consolidation-strategy-through-acquisition-noemalife<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 19 October 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=Dedalus+continues+its+consolidation+strategy+through+the+acquisition+of+Noemalife&rft.atitle=&rft.date=29+June+2016&rft.pub=Three+Hills+Capital+Partners&rft_id=http%3A%2F%2Fwww.thcp.eu%2Fnews%2Fdedalus-continues-its-consolidation-strategy-through-acquisition-noemalife&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/LIS_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-DedalusTheDedalus20Arch-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-DedalusTheDedalus20Arch_3-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20200521021505\/https:\/\/dedalus.eu\/en\/the-dedalus-group-participated-by-ardian-acquires-part-of-the-agfa-gevaert-groups-healthcare-it-business\/\" target=\"_blank\">\"The Dedalus Group, Participated by Ardian, Acquires Part of the Agfa-Gevaert Group's Healthcare IT Business\"<\/a>. Dedalus Group. 5 May 2020. Archived from <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/dedalus.eu\/en\/the-dedalus-group-participated-by-ardian-acquires-part-of-the-agfa-gevaert-groups-healthcare-it-business\/\" target=\"_blank\">the original<\/a> on 21 May 2020<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20200521021505\/https:\/\/dedalus.eu\/en\/the-dedalus-group-participated-by-ardian-acquires-part-of-the-agfa-gevaert-groups-healthcare-it-business\/\" target=\"_blank\">https:\/\/web.archive.org\/web\/20200521021505\/https:\/\/dedalus.eu\/en\/the-dedalus-group-participated-by-ardian-acquires-part-of-the-agfa-gevaert-groups-healthcare-it-business\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 November 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=The+Dedalus+Group%2C+Participated+by+Ardian%2C+Acquires+Part+of+the+Agfa-Gevaert+Group%27s+Healthcare+IT+Business&rft.atitle=&rft.date=5+May+2020&rft.pub=Dedalus+Group&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20200521021505%2Fhttps%3A%2F%2Fdedalus.eu%2Fen%2Fthe-dedalus-group-participated-by-ardian-acquires-part-of-the-agfa-gevaert-groups-healthcare-it-business%2F&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/LIS_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-AgfaDedalus20-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-AgfaDedalus20_4-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20200517114837\/https:\/\/global.agfahealthcare.com\/main\/dedalus\/\" target=\"_blank\">\"Dedalus\"<\/a>. Agfa HealthCare NV. 5 May 2020. Archived from <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/global.agfahealthcare.com\/main\/dedalus\/\" target=\"_blank\">the original<\/a> on 17 May 2020<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20200517114837\/https:\/\/global.agfahealthcare.com\/main\/dedalus\/\" target=\"_blank\">https:\/\/web.archive.org\/web\/20200517114837\/https:\/\/global.agfahealthcare.com\/main\/dedalus\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 November 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=Dedalus&rft.atitle=&rft.date=5+May+2020&rft.pub=Agfa+HealthCare+NV&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20200517114837%2Fhttps%3A%2F%2Fglobal.agfahealthcare.com%2Fmain%2Fdedalus%2F&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/LIS_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PCSArch-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PCSArch_5-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20200118085822\/http:\/\/www.pocsolutions.net\/\" target=\"_blank\">\"Point of Care Solutions\"<\/a>. Point of Care Solutions Pty. Ltd. Archived from <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pocsolutions.net\/\" target=\"_blank\">the original<\/a> on 18 January 2020<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20200118085822\/http:\/\/www.pocsolutions.net\/\" target=\"_blank\">https:\/\/web.archive.org\/web\/20200118085822\/http:\/\/www.pocsolutions.net\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 06 November 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=Point+of+Care+Solutions&rft.atitle=&rft.pub=Point+of+Care+Solutions+Pty.+Ltd&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20200118085822%2Fhttp%3A%2F%2Fwww.pocsolutions.net%2F&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/LIS_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-LWClin-6\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-LWClin_6-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.labware.com\/en\/p\/Industries\/Clinical-Lab-Information-Management\" target=\"_blank\">\"Clinical Lab Information Management\"<\/a>. LabWare, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.labware.com\/en\/p\/Industries\/Clinical-Lab-Information-Management\" target=\"_blank\">http:\/\/www.labware.com\/en\/p\/Industries\/Clinical-Lab-Information-Management<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 22 September 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Clinical+Lab+Information+Management&rft.atitle=&rft.pub=LabWare%2C+Inc&rft_id=http%3A%2F%2Fwww.labware.com%2Fen%2Fp%2FIndustries%2FClinical-Lab-Information-Management&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/LIS_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-TandonSecurity16-7\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-TandonSecurity16_7-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Tandon, H.C. (22 December 2016). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pcstech.com\/investors_new\/Sale%20of%20Cos%20Product-LIMS.pdf\" target=\"_blank\">\"Ref: Security Code No. 517119\"<\/a> (PDF). PCS Technology Limited<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pcstech.com\/investors_new\/Sale%20of%20Cos%20Product-LIMS.pdf\" target=\"_blank\">http:\/\/www.pcstech.com\/investors_new\/Sale%20of%20Cos%20Product-LIMS.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 06 May 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=Ref%3A+Security+Code+No.+517119&rft.atitle=&rft.aulast=Tandon%2C+H.C.&rft.au=Tandon%2C+H.C.&rft.date=22+December+2016&rft.pub=PCS+Technology+Limited&rft_id=http%3A%2F%2Fwww.pcstech.com%2Finvestors_new%2FSale%2520of%2520Cos%2520Product-LIMS.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/LIS_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-XCLabLabageArch19-8\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-XCLabLabageArch19_8-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20190602170751\/http:\/\/labage.com\/\" target=\"_blank\">\"Discover a new way of working with XC Lab\"<\/a>. XC Lab SPRL. Archived from <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/labage.com\/\" target=\"_blank\">the original<\/a> on 02 June 2019<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20190602170751\/http:\/\/labage.com\/\" target=\"_blank\">https:\/\/web.archive.org\/web\/20190602170751\/http:\/\/labage.com\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 12 October 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Discover+a+new+way+of+working+with+XC+Lab&rft.atitle=&rft.pub=XC+Lab+SPRL&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20190602170751%2Fhttp%3A%2F%2Flabage.com%2F&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/LIS_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20220125221418\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.159 seconds\nReal time usage: 0.289 seconds\nPreprocessor visited node count: 5204\/1000000\nPost\u2010expand include size: 83608\/2097152 bytes\nTemplate argument size: 16537\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 12870\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 81.635 1 -total\n 82.57% 67.408 1 Template:Reflist\n 67.93% 55.456 8 Template:Cite_web\n 60.11% 49.067 8 Template:Citation\/core\n 17.35% 14.162 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/LIS_vendors\n 13.51% 11.026 1 Template:All_active_LIS_vendors\n 11.85% 9.674 4 Template:Date\n 5.55% 4.530 12 Template:Citation\/make_link\n 3.44% 2.808 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12938-0!canonical and timestamp 20220125221417 and revision id 45835. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/LIS_vendors\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/LIS_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>","f087eacd8bde24820f324899f5972c1a_images":["https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/0\/0d\/Asterian-logo_145.png","https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/5\/5c\/Official_2022_lablynx_logo.png","https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/6\/63\/SCC_145.jpg","https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/0\/08\/Xybion_145.png"],"f087eacd8bde24820f324899f5972c1a_timestamp":1643149332,"2890fddc077a46958cd6045c0ffa8fb8_type":"article","2890fddc077a46958cd6045c0ffa8fb8_title":"3.1 LIMS vendors","2890fddc077a46958cd6045c0ffa8fb8_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/LIMS_vendors","2890fddc077a46958cd6045c0ffa8fb8_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 1: Laboratory informatics vendors\/LIMS vendorsFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n3. Resources for selecting and implementing informatics solutions: Part 1: Laboratory informatics vendors \nThe following three sections concerning LIMS, LIS, and ELN vendors are directly pulled from LIMSwiki's maintained tabular listings of these types of vendors. Those vendors with logos represent vendors who sponsor LIMSwiki and LIMSforum. The fourth section addresses middleware vendors.\n\r\n\n\n3.1 LIMS vendors \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\nAbbott Informatics Corporation \n\nSTARLIMS\n\nYes\n\nUnited States\n\nDemonstration videos\n\nFormerly STARLIMS Corporation.\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\nAdifo NV\n\nBESTMIX LIMS\n\nNo\n\nBelgium\n\n\n\nFormer product Laboras now seems defunct.\n\n\n\n\nAdvanced Business Software\n\nPHIMS\n\nNo\n\nUnited States\n\n\n\n\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\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\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\nAnalytical Information Systems, Ltd.\n\nAIS LIMS\n\nNo\n\nUnited Kingdom\n\n\n\n\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 Zumatrix, Inc.\r\nuntil it was absorbed into new entity 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\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\nBioSoft Integrators, LLC\n\nLabOptimize\n\nNo\n\nUnited States\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\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\n\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 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\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\nEffiQS\n\nNo\n\nCzech Republic\n\nDemonstration videos\n\n\n\n\n\n\nElysia-raytest GmbH\n\nArgus RPS, SARA\n\nNo\n\nGermany\n\n\n\nSpecializes in radiopharmaceutical LIMS.\n\n\n\n\nElmTree Systems, LLC\n\nElmTree System\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nElmwood Solutions, Inc.\n\nPure Harvest\n\nYes\n\nUnited States\n\n\n\nLIMS-like seed lab software\n\n \n\n\nEnable IT Solutions Pvt. Ltd.\n\nEns\u014d-LIMS\n\nNo\n\nIndia\n\nDemonstration videos\n\n\n\n\n\n\nentimo AG\n\nPhaLIMS\n\nNo\n\nGermany\n\n\n\n\n\n\n\n\nEthoSoft, Inc.\n\nX-LIMS\n\nNo\n\nUnited States\n\nPricing\n\n\n\n\n\n\nEusoft Srl\n\nEuSoft.Lab\n\nYes\n\nItaly\n\nDemonstration videos\n\n\n\n\n\n\nFink & Partner GmbH\n\n[FP]-LIMS\n\nNo\n\nGermany\n\nDemonstration videos\n\nFormer product was [Dia]\n\n\n\n\nForensic Advantage Systems\n\nForensic Advantage\n\nNo\n\nUnited States\n\n\n\nA division of TCSC, Inc.\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\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\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\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\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 Server\n\nYes\n\nUnited States\n\nPricing\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\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\nPricing\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.[14]\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\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\nMicrocline Projects\n\nLabosaurus\n\nYes\n\nCanada\n\nPricing\n\n\n\n\n\n\nModul-Bio SAS\n\nMBioLIMS\n\nNo\n\nFrance\n\n\n\n\n\n\n\n\nMountain States Consulting, LLC\n\nMSC-LIMS\n\nNo\n\nUnited States\n\nPricing\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\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\nLabKey Server\n\nN\/A\n\nN\/A\n\n\n\nMore information found at LabKey Corporation.\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 Chemical &\r\nManufacturing, Food & Beverage,\r\nLIMS, and Wine\n\nNo\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\nPD Evidence, LLC\n\nPDEvidence LIMS\n\nYes\n\nUnited States\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.[15]\n\n\n\n\nPharmaceuticals Systems International, LLC\n\nPharmaway\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\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\nVersaLIMS.NET, WinLIMS.NET\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\nQueTel Corporation\n\nLab TraQ\n\nNo\n\nU.S.\n\n\n\nForensic LIMS\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\nRHAPSODY Software Solutions GmbH\n\nRHAPSODY LIMS\n\nNo\n\nGermany\n\n\n\nOfficially changed name from Softwaresysteme Keeve GmbH in February 2018.[16][17]\n\n\n\n\nRJ Lee Solutions, LLC\n\nTHEMIS\n\nNo\n\nUnited States\n\n\n\n\n\n\n\n\nRoss Group Inc.\n\nUVIS\n\nNo\n\nUnited States\n\n\n\n\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\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\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\nSIMATIC IT Unilab\n\nNo\n\nGermany\n\n\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.[18] C5 LIMS was renamed to\r\n\"LABVANTAGE Medical Suite\" in December 2012.[19] 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.[20][21]\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\nSTaCS DNA Inc.\n\nSTACS Casework, STACS Database\n\nYes\n\nCanada\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\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\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, Darwin, Nautilus,\r\nSampleManager, 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\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\nValdata LIMS\n\nNo\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\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.[22]\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\nXybion Corporation \n\nLabwise XD\n\nYes\n\nUnited States\n\nDemonstration videos\n\n\n\n\n\n\nYokogawa Electric Corporation\n\nOpreX, CIMVisionLIMS\n\nNo\n\nJapan\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 \"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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/LIMS_vendors\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/LIMS_vendors<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:12.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 37 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","2890fddc077a46958cd6045c0ffa8fb8_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Resources_for_selecting_and_implementing_informatics_solutions_Part_1_Laboratory_informatics_vendors_LIMS_vendors rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Resources_for_selecting_and_implementing_informatics_solutions_Part_1_Laboratory_informatics_vendors_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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 1: Laboratory informatics vendors\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">the beginning<\/a> of this guide-----<\/div>\n<h2><span class=\"mw-headline\" id=\"3._Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\">3. Resources for selecting and implementing informatics solutions: Part 1: Laboratory informatics vendors<\/span><\/h2>\n<p>The following three sections concerning LIMS, LIS, and ELN vendors are directly pulled from LIMSwiki's maintained tabular listings of these types of vendors. Those vendors with logos represent vendors who sponsor LIMSwiki and LIMSforum. The fourth section addresses middleware vendors.\n<\/p><p><br \/>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"3.1_LIMS_vendors\">3.1 LIMS vendors<\/span><\/h3>\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 style=\"line-height: 60px; vertical-align: middle;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/Abbott_Informatics_Corporation\" title=\"Abbott Informatics Corporation\" class=\"wiki-link\" data-key=\"90479bab12020c96864541696a62156f\">Abbott Informatics Corporation<\/a> <div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Vendor284.jpg\" class=\"image wiki-link\" data-key=\"8dabe8a08aa6afbe9fc5360262c53206\"><img alt=\"Vendor284.jpg\" src=\"https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/e\/e3\/Vendor284.jpg\" decoding=\"async\" width=\"110\" height=\"54\" \/><\/a><\/div>\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\/Abbott_Informatics_Corporation#Demonstration_videos_and_other_media\" title=\"Abbott Informatics Corporation\" class=\"wiki-link\" data-key=\"f2f0097a52372f9574c24d37f5f703b9\">Demonstration videos<\/a>\n<\/td>\n<td>Formerly STARLIMS Corporation.\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\/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_Business_Software\" title=\"Advanced Business Software\" class=\"wiki-link\" data-key=\"aef66d40d332ebc4215d9b6db541a594\">Advanced Business Software<\/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\/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 style=\"line-height: 60px; vertical-align: middle;\"><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> <div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Agilent_145.png\" class=\"image wiki-link\" data-key=\"63c7ec01ad1bfa2f09bf695fb947cdc7\"><img alt=\"Agilent 145.png\" src=\"https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/d\/d1\/Agilent_145.png\" decoding=\"async\" width=\"110\" height=\"55\" \/><\/a><\/div>\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\/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\/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\/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\/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 style=\"line-height: 60px; vertical-align: middle;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/Asterian,_LLC\" title=\"Asterian, LLC\" class=\"wiki-link\" data-key=\"45e09301b4990df83845279326cd2243\">Asterian, LLC<\/a> <div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Asterian-logo_145.png\" class=\"image wiki-link\" data-key=\"a69ac4b71c1635be104130a6e2724e91\"><img alt=\"Asterian-logo 145.png\" src=\"https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/0\/0d\/Asterian-logo_145.png\" decoding=\"async\" width=\"110\" height=\"55\" \/><\/a><\/div>\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 style=\"line-height: 50px; vertical-align: middle;\"><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> <div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Vendor667.jpg\" class=\"image wiki-link\" data-key=\"400af14cc2536e8fc9f691d5a9ab947a\"><img alt=\"Vendor667.jpg\" src=\"https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/a\/a8\/Vendor667.jpg\" decoding=\"async\" width=\"140\" height=\"34\" \/><\/a><\/div>\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 <a href=\"https:\/\/www.limswiki.org\/index.php\/Zumatrix,_Inc.\" title=\"Zumatrix, Inc.\" class=\"wiki-link\" data-key=\"f45acef05fe5c7eefd6df00e5857f808\">Zumatrix, Inc.<\/a><br \/>until it was absorbed into new 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 style=\"line-height: 50px; vertical-align: middle;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/Benchling,_Inc.\" title=\"Benchling, Inc.\" class=\"wiki-link\" data-key=\"67634090ee7d17da2ed0d3748a65379d\">Benchling, Inc.<\/a> <div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Benchling.jpg\" class=\"image wiki-link\" data-key=\"d4754c8d1dd0af47b4112582d9963a77\"><img alt=\"Benchling.jpg\" src=\"https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/0\/0b\/Benchling.jpg\" decoding=\"async\" width=\"120\" height=\"46\" \/><\/a><\/div>\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\/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\/BioSoft_Integrators,_LLC\" title=\"BioSoft Integrators, LLC\" class=\"wiki-link\" data-key=\"c53828a0bc7dd9162251b66d5b901d07\">BioSoft Integrators, LLC<\/a>\n<\/td>\n<td>LabOptimize\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\/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 style=\"line-height: 60px; vertical-align: middle;\"><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> <div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Vendor244.jpg\" class=\"image wiki-link\" data-key=\"9c605e990b0fc76cbe1f3ef2bb8504f9\"><img alt=\"Vendor244.jpg\" src=\"https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/a\/ac\/Vendor244.jpg\" decoding=\"async\" width=\"100\" height=\"71\" \/><\/a><\/div>\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 style=\"line-height: 50px; vertical-align: middle;\"><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> <div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Caliber_145.png\" class=\"image wiki-link\" data-key=\"60e860484cce3bcdf1739a3d171538ae\"><img alt=\"Caliber 145.png\" src=\"https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/9\/9f\/Caliber_145.png\" decoding=\"async\" width=\"110\" height=\"110\" \/><\/a><\/div>\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\/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>\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 style=\"line-height: 50px; vertical-align: middle;\"><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> <div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Vendor776.jpg\" class=\"image wiki-link\" data-key=\"e74cb26c36579627141517216d79a273\"><img alt=\"Vendor776.jpg\" src=\"https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/1\/18\/Vendor776.jpg\" decoding=\"async\" width=\"120\" height=\"65\" \/><\/a><\/div>\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 style=\"line-height: 50px; vertical-align: middle;\"><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> <div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Vendor253.jpg\" class=\"image wiki-link\" data-key=\"909c3a6b73c9dc3afa78f1384b0fc1be\"><img alt=\"Vendor253.jpg\" src=\"https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/7\/76\/Vendor253.jpg\" decoding=\"async\" width=\"140\" height=\"50\" \/><\/a><\/div>\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_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\/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>EffiQS\n<\/td>\n<td>No\n<\/td>\n<td>Czech Republic\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/EffiChem_s.r.o.#Demonstration_videos_and_other_media\" title=\"EffiChem s.r.o.\" class=\"wiki-link\" data-key=\"b684bc476de9786ff2da2c3d7dc1a4a1\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Elysia-raytest_GmbH\" title=\"Elysia-raytest GmbH\" class=\"wiki-link\" data-key=\"b6e58152b2375851ffb5bf090a767f5d\">Elysia-raytest GmbH<\/a>\n<\/td>\n<td>Argus RPS, SARA\n<\/td>\n<td>No\n<\/td>\n<td>Germany\n<\/td>\n<td>\n<\/td>\n<td>Specializes in radiopharmaceutical LIMS.\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/ElmTree_Systems,_LLC\" title=\"ElmTree Systems, LLC\" class=\"wiki-link\" data-key=\"4273e298c652c7d4abb8d58612c08382\">ElmTree Systems, LLC<\/a>\n<\/td>\n<td>ElmTree System\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Elmwood_Solutions,_Inc.\" title=\"Elmwood Solutions, Inc.\" class=\"wiki-link\" data-key=\"61d66cb9e94b9931e9ac073b6bb0772c\">Elmwood Solutions, Inc.<\/a>\n<\/td>\n<td>Pure Harvest\n<\/td>\n<td>Yes\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>LIMS-like seed lab software\n<\/td><\/tr>\n \n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Enable_IT_Solutions_Pvt._Ltd.\" title=\"Enable IT Solutions Pvt. Ltd.\" class=\"wiki-link\" data-key=\"9fa4641a5889cb112cefcdb89fe00319\">Enable IT Solutions Pvt. Ltd.<\/a>\n<\/td>\n<td>Ens\u014d-LIMS\n<\/td>\n<td>No\n<\/td>\n<td>India\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Enable_IT_Solutions_Pvt._Ltd.#Demonstration_videos_and_other_media\" title=\"Enable IT Solutions Pvt. Ltd.\" class=\"wiki-link\" data-key=\"46f56d474f569685c669edfc9dce6707\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Entimo_AG\" title=\"Entimo AG\" class=\"wiki-link\" data-key=\"ba2e45dc5f9a3c287232d1f6b12aeb8a\">entimo AG<\/a>\n<\/td>\n<td>PhaLIMS\n<\/td>\n<td>No\n<\/td>\n<td>Germany\n<\/td>\n<td>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/EthoSoft,_Inc.\" title=\"EthoSoft, Inc.\" class=\"wiki-link\" data-key=\"156215cce405b4769b309ec10daeb61e\">EthoSoft, Inc.<\/a>\n<\/td>\n<td>X-LIMS\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/EthoSoft,_Inc.#Pricing\" title=\"EthoSoft, Inc.\" class=\"wiki-link\" data-key=\"98e9410f8dfeb0f77a53240d3764c02b\">Pricing<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Eusoft_Srl\" title=\"Eusoft Srl\" class=\"wiki-link\" data-key=\"b325934cae067817cae507c40d9e4e5c\">Eusoft Srl<\/a>\n<\/td>\n<td>EuSoft.Lab\n<\/td>\n<td>Yes\n<\/td>\n<td>Italy\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Eusoft_Srl#Demonstration_videos_and_other_media\" title=\"Eusoft Srl\" class=\"wiki-link\" data-key=\"75b9d2db2057b45e3f80b4ded7c2a6f3\">Demonstration videos<\/a>\n<\/td>\n<td>\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Fink_%26_Partner_GmbH\" title=\"Fink & Partner GmbH\" class=\"wiki-link\" data-key=\"43f0cad9a6e1e7fa5923e3ce0babe9fa\">Fink & Partner GmbH<\/a>\n<\/td>\n<td>[FP]-LIMS\n<\/td>\n<td>No\n<\/td>\n<td>Germany\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Fink_%26_Partner_GmbH#Demonstration_videos_and_other_media\" title=\"Fink & Partner GmbH\" class=\"wiki-link\" data-key=\"4f2fd4c3efc73542316f104696dfe309\">Demonstration videos<\/a>\n<\/td>\n<td>Former product was [Dia]\n<\/td><\/tr>\n\n\n<tr>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Forensic_Advantage_Systems\" title=\"Forensic Advantage Systems\" class=\"wiki-link\" data-key=\"0d40b01c37569fdb317740cb9ea052fc\">Forensic Advantage Systems<\/a>\n<\/td>\n<td>Forensic Advantage\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td>\n<\/td>\n<td>A division of TCSC, Inc.\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\/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\/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\/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\/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 Server\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#Services_and_pricing\" title=\"LabKey Corporation\" class=\"wiki-link\" data-key=\"78f636c551c52266688dd1df50760c03\">Pricing<\/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 style=\"line-height: 50px; vertical-align: middle;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/LabLynx,_Inc.\" title=\"LabLynx, Inc.\" class=\"wiki-link\" data-key=\"da3f96536cf2c54de1960f26fe5712a1\">LabLynx, Inc.<\/a> <div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Official_2022_lablynx_logo.png\" class=\"image wiki-link\" data-key=\"e3103dd7e149abce76e971e77b13e5f2\"><img alt=\"Official 2022 lablynx logo.png\" src=\"https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/5\/5c\/Official_2022_lablynx_logo.png\" decoding=\"async\" width=\"150\" height=\"65\" \/><\/a><\/div>\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\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><a href=\"https:\/\/www.limswiki.org\/index.php\/LabPro_2000_Ltd.#Pricing\" title=\"LabPro 2000 Ltd.\" class=\"wiki-link\" data-key=\"bc43d29c47640b3e67609bb9b5127e71\">Pricing<\/a>\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_14-0\" class=\"reference\"><a href=\"#cite_note-LWPressAcq-14\">[14]<\/a><\/sup>\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\/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\/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\/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\/Mountain_States_Consulting,_LLC\" title=\"Mountain States Consulting, LLC\" class=\"wiki-link\" data-key=\"07aa1abcf286c45d2d5f3b6713e6d43d\">Mountain States Consulting, LLC<\/a>\n<\/td>\n<td>MSC-LIMS\n<\/td>\n<td>No\n<\/td>\n<td>United States\n<\/td>\n<td><a href=\"https:\/\/www.limswiki.org\/index.php\/Mountain_States_Consulting,_LLC#Pricing\" title=\"Mountain States Consulting, LLC\" class=\"wiki-link\" data-key=\"8fd1f2c9d1ec86843204796fa8772995\">Pricing<\/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\/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 style=\"line-height: 50px; vertical-align: middle;\"><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> <div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:OnQSoftware_145.png\" class=\"image wiki-link\" data-key=\"3d7914439b19f904ff77dc87e6c6e822\"><img alt=\"OnQSoftware 145.png\" src=\"https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/2\/24\/OnQSoftware_145.png\" decoding=\"async\" width=\"90\" height=\"60\" \/><\/a><\/div>\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\/LabKey_Server\" title=\"LabKey Server\" class=\"wiki-link\" data-key=\"856c6fe009646beaaed7ecd21dda4932\">LabKey Server<\/a>\n<\/td>\n<td>N\/A\n<\/td>\n<td>N\/A\n<\/td>\n<td>\n<\/td>\n<td>More information found at <a href=\"https:\/\/www.limswiki.org\/index.php\/LabKey_Corporation\" title=\"LabKey Corporation\" class=\"wiki-link\" data-key=\"7946a04728c692073f0c0202ba4bdce9\">LabKey Corporation<\/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 Chemical &<br \/>Manufacturing, Food & Beverage,<br \/>LIMS, and Wine\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\/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\/PD_Evidence,_LLC\" title=\"PD Evidence, LLC\" class=\"wiki-link\" data-key=\"6d46b13c6da263bbc4eee9e4337a642e\">PD Evidence, LLC<\/a>\n<\/td>\n<td>PDEvidence 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\/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-15\" class=\"reference\"><a href=\"#cite_note-15\">[15]<\/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>Pharmaway\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\/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>VersaLIMS.NET, WinLIMS.NET\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\/QueTel_Corporation\" title=\"QueTel Corporation\" class=\"wiki-link\" data-key=\"d50c4634ed6e3035a2d5403393bf54e3\">QueTel Corporation<\/a>\n<\/td>\n<td>Lab TraQ\n<\/td>\n<td>No\n<\/td>\n<td>U.S.\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\/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\/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_16-0\" class=\"reference\"><a href=\"#cite_note-CylexRhapsody-16\">[16]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-OHRSoftwaresysteme_17-0\" class=\"reference\"><a href=\"#cite_note-OHRSoftwaresysteme-17\">[17]<\/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\/Ross_Group_Inc.\" title=\"Ross Group Inc.\" class=\"wiki-link\" data-key=\"8a71ece980c859101a10290f83f86b57\">Ross Group Inc.<\/a>\n<\/td>\n<td>UVIS\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\/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\/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\/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>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\/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 style=\"line-height: 50px; vertical-align: middle;\"><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> <div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:SCC_145.jpg\" class=\"image wiki-link\" data-key=\"7187e20e6d78d4d07abbfeb37f03f084\"><img alt=\"SCC 145.jpg\" src=\"https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/6\/63\/SCC_145.jpg\" decoding=\"async\" width=\"120\" height=\"75\" \/><\/a><\/div>\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-18\" class=\"reference\"><a href=\"#cite_note-18\">[18]<\/a><\/sup> C5 LIMS was renamed to<br \/>\"LABVANTAGE Medical Suite\" in December 2012.<sup id=\"rdp-ebb-cite_ref-19\" class=\"reference\"><a href=\"#cite_note-19\">[19]<\/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_20-0\" class=\"reference\"><a href=\"#cite_note-OSArch1-20\">[20]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-SPArch1_21-0\" class=\"reference\"><a href=\"#cite_note-SPArch1-21\">[21]<\/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\/STaCS_DNA_Inc.\" title=\"STaCS DNA Inc.\" class=\"wiki-link\" data-key=\"0946ef888e904455ee39b28ce981bbdf\">STaCS DNA Inc.<\/a>\n<\/td>\n<td>STACS Casework, STACS Database\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\/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\/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\/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 style=\"line-height: 50px; vertical-align: middle;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/Thermo_Scientific\" title=\"Thermo Scientific\" class=\"wiki-link\" data-key=\"e914753f99d483d4577b35fed71b3c94\">Thermo Fisher Scientific<\/a> <div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Thermo_Scientific_145.jpg\" class=\"image wiki-link\" data-key=\"5795d6bda6443c24a6841cde67522dad\"><img alt=\"Thermo Scientific 145.jpg\" src=\"https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/c\/cc\/Thermo_Scientific_145.jpg\" decoding=\"async\" width=\"140\" height=\"48\" \/><\/a><\/div>\n<\/td>\n<td>Core LIMS, Darwin, Nautilus,<br \/>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\/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>Valdata 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\/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\/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_22-0\" class=\"reference\"><a href=\"#cite_note-NG8PDF-22\">[22]<\/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 style=\"line-height: 50px; vertical-align: middle;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/Xybion_Corporation\" title=\"Xybion Corporation\" class=\"wiki-link\" data-key=\"ee87743428afb8c831b21e711e9e12e2\">Xybion Corporation<\/a> <div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Xybion_145.png\" class=\"image wiki-link\" data-key=\"06edd4f2bce96c5d44c87386da73313f\"><img alt=\"Xybion 145.png\" src=\"https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/0\/08\/Xybion_145.png\" decoding=\"async\" width=\"135\" height=\"39\" \/><\/a><\/div>\n<\/td>\n<td>Labwise 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>\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\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/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\">. 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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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/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>. 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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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/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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(19 January 2019). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.computable.nl\/artikel\/nieuws\/datamanagement\/6549711\/250449\/telekom-healthcare-lijft-finalist-noord-nederland-in.html\" target=\"_blank\">\"Telekom Healthcare lijft Finalist Noord Nederland in\"<\/a>. <i>Computable<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.computable.nl\/artikel\/nieuws\/datamanagement\/6549711\/250449\/telekom-healthcare-lijft-finalist-noord-nederland-in.html\" target=\"_blank\">https:\/\/www.computable.nl\/artikel\/nieuws\/datamanagement\/6549711\/250449\/telekom-healthcare-lijft-finalist-noord-nederland-in.html<\/a><\/span><span class=\"reference-accessdate\">. 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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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/LIMS_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-NG8PDF-22\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-NG8PDF_22-0\">\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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/LIMS_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20220125221417\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.260 seconds\nReal time usage: 0.491 seconds\nPreprocessor visited node count: 14439\/1000000\nPost\u2010expand include size: 190146\/2097152 bytes\nTemplate argument size: 41727\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 35475\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 159.157 1 -total\n 85.61% 136.247 1 Template:Reflist\n 70.21% 111.745 22 Template:Cite_web\n 64.90% 103.296 22 Template:Citation\/core\n 14.35% 22.846 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/LIMS_vendors\n 12.53% 19.948 14 Template:Date\n 12.29% 19.564 1 Template:All_active_LIMS_vendors\n 4.96% 7.898 33 Template:Citation\/make_link\n 1.84% 2.933 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12937-0!canonical and timestamp 20220125221416 and revision id 45834. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/LIMS_vendors\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/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>","2890fddc077a46958cd6045c0ffa8fb8_images":["https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/e\/e3\/Vendor284.jpg","https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/d\/d1\/Agilent_145.png","https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/0\/0d\/Asterian-logo_145.png","https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/a\/a8\/Vendor667.jpg","https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/0\/0b\/Benchling.jpg","https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/a\/ac\/Vendor244.jpg","https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/9\/9f\/Caliber_145.png","https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/1\/18\/Vendor776.jpg","https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/7\/76\/Vendor253.jpg","https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/5\/5c\/Official_2022_lablynx_logo.png","https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/2\/24\/OnQSoftware_145.png","https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/6\/63\/SCC_145.jpg","https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/c\/cc\/Thermo_Scientific_145.jpg","https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/0\/08\/Xybion_145.png"],"2890fddc077a46958cd6045c0ffa8fb8_timestamp":1643149332,"7bd1df22f77cf95dd862bbe685e6087a_type":"article","7bd1df22f77cf95dd862bbe685e6087a_title":"2.4 How a user requirements specification fits into the entire process","7bd1df22f77cf95dd862bbe685e6087a_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/How_a_user_requirements_specification_fits_into_the_entire_process","7bd1df22f77cf95dd862bbe685e6087a_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Choosing laboratory informatics software for your lab\/How a user requirements specification fits into the entire processFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n 2.3 MSW, updates, and other contracted services \nThe maintenance, support, and warranty (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 18 November 2021 .   \n \n\n\u2191 2.0 2.1 Gordon-Byrne, G. (2014). \"Maintenance in the Digital World\". IT Performance Improvement. Taylor & Francis, LLC. http:\/\/www.ittoday.info\/ITPerformanceImprovement\/Articles\/2014-08GordonByrne2.html . Retrieved 18 November 2021 .   \n \n\n\n\r\n\n\n-----Go to the next chapter of this guide-----\nCitation information for this chapter \nChapter: 2. Choosing laboratory informatics software for your lab\nTitle: Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\nEdition: 2022 Edition\nAuthor for citation: Shawn E. Douglas and Alan Vaughan\nLicense for content: Creative Commons Attribution-ShareAlike 4.0 International\nPublication date: January 2022\n\r\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/How_a_user_requirements_specification_fits_into_the_entire_process\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/How_a_user_requirements_specification_fits_into_the_entire_process<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:12.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 23 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","7bd1df22f77cf95dd862bbe685e6087a_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Choosing_laboratory_informatics_software_for_your_lab_How_a_user_requirements_specification_fits_into_the_entire_process rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Choosing_laboratory_informatics_software_for_your_lab_How_a_user_requirements_specification_fits_into_the_entire_process 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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Choosing laboratory informatics software for your lab\/How a user requirements specification fits into the entire process<\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">the beginning<\/a> of this guide-----<\/div>\n<h3><span id=\"rdp-ebb-2.3_MSW,_updates,_and_other_contracted_services\"><\/span><span class=\"mw-headline\" id=\"2.3_MSW.2C_updates.2C_and_other_contracted_services\">2.3 MSW, updates, and other contracted services<\/span><\/h3>\n<p>The maintenance, support, and warranty (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 18 November 2021<\/span>.<\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/How_a_user_requirements_specification_fits_into_the_entire_process\"><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=\"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<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.ittoday.info\/ITPerformanceImprovement\/Articles\/2014-08GordonByrne2.html\" target=\"_blank\">http:\/\/www.ittoday.info\/ITPerformanceImprovement\/Articles\/2014-08GordonByrne2.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/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=http%3A%2F%2Fwww.ittoday.info%2FITPerformanceImprovement%2FArticles%2F2014-08GordonByrne2.html&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/How_a_user_requirements_specification_fits_into_the_entire_process\"><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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/LIMS_vendors\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 1: Laboratory informatics vendors\/LIMS vendors\" class=\"wiki-link\" data-key=\"2890fddc077a46958cd6045c0ffa8fb8\">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. Choosing laboratory informatics software for your lab\n<\/p><p><b>Title<\/b>: <i>Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research<\/i>\n<\/p><p><b>Edition<\/b>: 2022 Edition\n<\/p><p><b>Author for citation<\/b>: Shawn E. Douglas and Alan Vaughan\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 2022\n<\/p><p><br \/>\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20220125221416\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.030 seconds\nReal time usage: 0.053 seconds\nPreprocessor visited node count: 1498\/1000000\nPost\u2010expand include size: 14067\/2097152 bytes\nTemplate argument size: 3597\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 3538\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 41.073 1 -total\n 85.66% 35.182 1 Template:Reflist\n 61.87% 25.412 2 Template:Cite_web\n 51.36% 21.096 2 Template:Citation\/core\n 14.10% 5.792 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/MSW,_updates,_and_other_contracted_services\n 13.31% 5.465 2 Template:Date\n 7.92% 3.253 4 Template:Citation\/make_link\n 6.64% 2.728 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12936-0!canonical and timestamp 20220125221416 and revision id 45833. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/How_a_user_requirements_specification_fits_into_the_entire_process\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/How_a_user_requirements_specification_fits_into_the_entire_process<\/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>","7bd1df22f77cf95dd862bbe685e6087a_images":[],"7bd1df22f77cf95dd862bbe685e6087a_timestamp":1643149332,"5cb030452d0554379682604c55bb91f7_type":"article","5cb030452d0554379682604c55bb91f7_title":"2.3 MSW, updates, and other contracted services","5cb030452d0554379682604c55bb91f7_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/MSW,_updates,_and_other_contracted_services","5cb030452d0554379682604c55bb91f7_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Choosing laboratory informatics software for your lab\/MSW, updates, and other contracted servicesFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n 2.3 MSW, updates, and other contracted services \nThe maintenance, support, and warranty (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 18 November 2021 .   \n \n\n\u2191 2.0 2.1 Gordon-Byrne, G. (2014). \"Maintenance in the Digital World\". IT Performance Improvement. Taylor & Francis, LLC. http:\/\/www.ittoday.info\/ITPerformanceImprovement\/Articles\/2014-08GordonByrne2.html . Retrieved 18 November 2021 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/MSW,_updates,_and_other_contracted_services\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/MSW,_updates,_and_other_contracted_services<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:12.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 30 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","5cb030452d0554379682604c55bb91f7_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Choosing_laboratory_informatics_software_for_your_lab_MSW_updates_and_other_contracted_services rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Choosing_laboratory_informatics_software_for_your_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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Choosing laboratory informatics software for your 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">the beginning<\/a> of this guide-----<\/div>\n<h3><span id=\"rdp-ebb-2.3_MSW,_updates,_and_other_contracted_services\"><\/span><span class=\"mw-headline\" id=\"2.3_MSW.2C_updates.2C_and_other_contracted_services\">2.3 MSW, updates, and other contracted services<\/span><\/h3>\n<p>The maintenance, support, and warranty (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 18 November 2021<\/span>.<\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_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=\"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<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.ittoday.info\/ITPerformanceImprovement\/Articles\/2014-08GordonByrne2.html\" target=\"_blank\">http:\/\/www.ittoday.info\/ITPerformanceImprovement\/Articles\/2014-08GordonByrne2.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/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=http%3A%2F%2Fwww.ittoday.info%2FITPerformanceImprovement%2FArticles%2F2014-08GordonByrne2.html&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_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: 20220125221416\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.031 seconds\nReal time usage: 0.065 seconds\nPreprocessor visited node count: 1491\/1000000\nPost\u2010expand include size: 13929\/2097152 bytes\nTemplate argument size: 3597\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 3492\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 59.551 1 -total\n 59.91% 35.677 1 Template:Reflist\n 46.37% 27.614 2 Template:Cite_web\n 39.96% 23.798 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/MSW,_updates,_and_other_contracted_services\n 38.74% 23.073 2 Template:Citation\/core\n 11.36% 6.766 2 Template:Date\n 5.89% 3.510 4 Template:Citation\/make_link\n 4.61% 2.747 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12935-0!canonical and timestamp 20220125221416 and revision id 45832. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/MSW,_updates,_and_other_contracted_services\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_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>","5cb030452d0554379682604c55bb91f7_images":[],"5cb030452d0554379682604c55bb91f7_timestamp":1643149331,"79e014ca9d87d3ecec33775123cbf95d_type":"article","79e014ca9d87d3ecec33775123cbf95d_title":"2.2 Implementation","79e014ca9d87d3ecec33775123cbf95d_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/Implementation","79e014ca9d87d3ecec33775123cbf95d_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Choosing laboratory informatics software for your lab\/ImplementationFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n2.2 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\n2.2.1 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 solution will have integration capability built into the software, but occasionally such interfaces are separate from the main software. Today's interfaces are generally built on standardized communication tools, including messaging formats like Health Level 7 (HL7).[3][4] The HL7 messaging standards are particularly important to laboratory data management because they define how information is packaged and communicated from one party to another. Such standards set the language, structure, and data types required for seamless integration of various systems and instruments.[5] Health Level 7 describes the types of information communicated between such systems in the clinical environment as including \"process control and status information for each device or analyzer, [as well as] each specimen, specimen container, and container carrier; information and detailed data related to patients, orders, and results; and information related to specimen flow algorithms and automated decision making.\"[6]\nYou may also want your 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.[7][8][9] 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.[8]\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 18 November 2021 .   \n \n\n\u2191 Mura, A. (12 July 2018). \"Bullet-Proof Software Implementation Plan: Challenges and Tactics\". Userlane Digital Adoption Blog. Userlane GmbH. https:\/\/blog.userlane.com\/software-implementation-plan\/ . Retrieved 18 November 2021 .   \n \n\n\u2191 Sinard, J. (2006). Practical pathology informatics: Demystifying informatics for the practicing anatomic pathologist. Springer Science+Business Media. ISBN 9780387280585. https:\/\/link.springer.com\/book\/10.1007\/0-387-28058-8 .   \n \n\n\u2191 MLO Staff (1 August 2012). \"Interfacing the LIS\". Medical Laboratory Observer. Endeavor Business Media, LLC. https:\/\/www.mlo-online.com\/home\/article\/13004490\/interfacing-the-lis . Retrieved 18 November 2021 .   \n \n\n\u2191 Kim, Katherine (July 2005). \"Creating Clinical Data Standards in Health Care: Five Case Studies\" (PDF). California HealthCare Foundation. Archived from the original on 14 January 2017. https:\/\/web.archive.org\/web\/20170114055221\/http:\/\/www.kathykim.com\/sitebuildercontent\/sitebuilderfiles\/ClinicalDataStandardsInHealthCare.pdf . Retrieved 10 January 2020 .   \n \n\n\u2191 Health Level Seven International (2011). \"HL7 version 2.7 standard: Chapter 13 - Clinical laboratory automation\". Archived from the original on 11 July 2017. https:\/\/web.archive.org\/web\/20170711070938\/http:\/\/www.hl7.org\/implement\/standards\/product_brief.cfm?product_id=203 . Retrieved 18 November 2021 .   \n \n\n\u2191 Monus, A. (5 March 2021). \"SOAP vs REST vs JSON comparison [2019\"]. Raygun. https:\/\/raygun.com\/blog\/soap-vs-rest-vs-json\/ . Retrieved 18 November 2021 .   \n \n\n\u2191 8.0 8.1 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 18 November 2021 .   \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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/Implementation\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/Implementation<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:11.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 29 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","79e014ca9d87d3ecec33775123cbf95d_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Choosing_laboratory_informatics_software_for_your_lab_Implementation rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Choosing_laboratory_informatics_software_for_your_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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Choosing laboratory informatics software for your 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">the beginning<\/a> of this guide-----<\/div>\n<h3><span class=\"mw-headline\" id=\"2.2_Implementation\">2.2 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=\"2.2.1_Internal_and_external_integrations\">2.2.1 Internal and external integrations<\/span><\/h4>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:LabMachines.jpg\" class=\"image wiki-link\" data-key=\"fb4bae54999541e05ae617d6904a6fcb\"><img alt=\"LabMachines.jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/9\/9e\/LabMachines.jpg\" decoding=\"async\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a><\/div><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 solution will have integration capability built into the software, but occasionally such interfaces are separate from the main software. Today's interfaces are generally built on standardized communication tools, including messaging formats like <a href=\"https:\/\/www.limswiki.org\/index.php\/Health_Level_7\" title=\"Health Level 7\" class=\"wiki-link\" data-key=\"e0bf845fb58d2bae05a846b47629e86f\">Health Level 7<\/a> (HL7).<sup id=\"rdp-ebb-cite_ref-Sinard06_3-0\" class=\"reference\"><a href=\"#cite_note-Sinard06-3\">[3]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MLOStaffInterfacing12_4-0\" class=\"reference\"><a href=\"#cite_note-MLOStaffInterfacing12-4\">[4]<\/a><\/sup> The HL7 messaging standards are particularly important to laboratory data management because they define how information is packaged and communicated from one party to another. Such standards set the language, structure, and data types required for seamless integration of various systems and instruments.<sup id=\"rdp-ebb-cite_ref-KimCreating05_5-0\" class=\"reference\"><a href=\"#cite_note-KimCreating05-5\">[5]<\/a><\/sup> Health Level 7 describes the types of information communicated between such systems in the clinical environment as including \"process control and status information for each device or analyzer, [as well as] each specimen, specimen container, and container carrier; information and detailed data related to patients, orders, and results; and information related to specimen flow algorithms and automated decision making.\"<sup id=\"rdp-ebb-cite_ref-HL711_6-0\" class=\"reference\"><a href=\"#cite_note-HL711-6\">[6]<\/a><\/sup>\n<\/p><p>You may also want your 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_7-0\" class=\"reference\"><a href=\"#cite_note-MonusSOAP19-7\">[7]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-LVAQuick18_8-0\" class=\"reference\"><a href=\"#cite_note-LVAQuick18-8\">[8]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-GrandOneTool19_9-0\" class=\"reference\"><a href=\"#cite_note-GrandOneTool19-9\">[9]<\/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_8-1\" class=\"reference\"><a href=\"#cite_note-LVAQuick18-8\">[8]<\/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 18 November 2021<\/span>.<\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_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:\/\/blog.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:\/\/blog.userlane.com\/software-implementation-plan\/\" target=\"_blank\">https:\/\/blog.userlane.com\/software-implementation-plan\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/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%2Fblog.userlane.com%2Fsoftware-implementation-plan%2F&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/Implementation\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-Sinard06-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-Sinard06_3-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Sinard, J. (2006). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/link.springer.com\/book\/10.1007\/0-387-28058-8\" target=\"_blank\"><i>Practical pathology informatics: Demystifying informatics for the practicing anatomic pathologist<\/i><\/a>. Springer Science+Business Media. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 9780387280585<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/link.springer.com\/book\/10.1007\/0-387-28058-8\" target=\"_blank\">https:\/\/link.springer.com\/book\/10.1007\/0-387-28058-8<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Practical+pathology+informatics%3A+Demystifying+informatics+for+the+practicing+anatomic+pathologist&rft.aulast=Sinard%2C+J.&rft.au=Sinard%2C+J.&rft.date=2006&rft.pub=Springer+Science%2BBusiness+Media&rft.isbn=9780387280585&rft_id=https%3A%2F%2Flink.springer.com%2Fbook%2F10.1007%2F0-387-28058-8&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/Implementation\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MLOStaffInterfacing12-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MLOStaffInterfacing12_4-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">MLO Staff (1 August 2012). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.mlo-online.com\/home\/article\/13004490\/interfacing-the-lis\" target=\"_blank\">\"Interfacing the LIS\"<\/a>. <i>Medical Laboratory Observer<\/i>. Endeavor Business Media, LLC<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.mlo-online.com\/home\/article\/13004490\/interfacing-the-lis\" target=\"_blank\">https:\/\/www.mlo-online.com\/home\/article\/13004490\/interfacing-the-lis<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Interfacing+the+LIS&rft.atitle=Medical+Laboratory+Observer&rft.aulast=MLO+Staff&rft.au=MLO+Staff&rft.date=1+August+2012&rft.pub=Endeavor+Business+Media%2C+LLC&rft_id=https%3A%2F%2Fwww.mlo-online.com%2Fhome%2Farticle%2F13004490%2Finterfacing-the-lis&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/Implementation\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-KimCreating05-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-KimCreating05_5-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Kim, Katherine (July 2005). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20170114055221\/http:\/\/www.kathykim.com\/sitebuildercontent\/sitebuilderfiles\/ClinicalDataStandardsInHealthCare.pdf\" target=\"_blank\">\"Creating Clinical Data Standards in Health Care: Five Case Studies\"<\/a> (PDF). California HealthCare Foundation. Archived from <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.kathykim.com\/sitebuildercontent\/sitebuilderfiles\/ClinicalDataStandardsInHealthCare.pdf\" target=\"_blank\">the original<\/a> on 14 January 2017<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20170114055221\/http:\/\/www.kathykim.com\/sitebuildercontent\/sitebuilderfiles\/ClinicalDataStandardsInHealthCare.pdf\" target=\"_blank\">https:\/\/web.archive.org\/web\/20170114055221\/http:\/\/www.kathykim.com\/sitebuildercontent\/sitebuilderfiles\/ClinicalDataStandardsInHealthCare.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 10 January 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=Creating+Clinical+Data+Standards+in+Health+Care%3A+Five+Case+Studies&rft.atitle=&rft.aulast=Kim%2C+Katherine&rft.au=Kim%2C+Katherine&rft.date=July+2005&rft.pub=California+HealthCare+Foundation&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20170114055221%2Fhttp%3A%2F%2Fwww.kathykim.com%2Fsitebuildercontent%2Fsitebuilderfiles%2FClinicalDataStandardsInHealthCare.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/Implementation\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-HL711-6\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HL711_6-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Health Level Seven International (2011). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20170711070938\/http:\/\/www.hl7.org\/implement\/standards\/product_brief.cfm?product_id=203\" target=\"_blank\">\"HL7 version 2.7 standard: Chapter 13 - Clinical laboratory automation\"<\/a>. Archived from <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.hl7.org\/implement\/standards\/product_brief.cfm?product_id=203\" target=\"_blank\">the original<\/a> on 11 July 2017<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20170711070938\/http:\/\/www.hl7.org\/implement\/standards\/product_brief.cfm?product_id=203\" target=\"_blank\">https:\/\/web.archive.org\/web\/20170711070938\/http:\/\/www.hl7.org\/implement\/standards\/product_brief.cfm?product_id=203<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=HL7+version+2.7+standard%3A+Chapter+13+-+Clinical+laboratory+automation&rft.atitle=&rft.aulast=Health+Level+Seven+International&rft.au=Health+Level+Seven+International&rft.date=2011&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20170711070938%2Fhttp%3A%2F%2Fwww.hl7.org%2Fimplement%2Fstandards%2Fproduct_brief.cfm%3Fproduct_id%3D203&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/Implementation\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MonusSOAP19-7\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MonusSOAP19_7-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Monus, A. (5 March 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/raygun.com\/blog\/soap-vs-rest-vs-json\/\" target=\"_blank\">\"SOAP vs REST vs JSON comparison [2019<\/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 18 November 2021<\/span>.<\/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+comparison+%5B2019%5D&rft.atitle=Raygun&rft.aulast=Monus%2C+A.&rft.au=Monus%2C+A.&rft.date=5+March+2021&rft_id=https%3A%2F%2Fraygun.com%2Fblog%2Fsoap-vs-rest-vs-json%2F&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/Implementation\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-LVAQuick18-8\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-LVAQuick18_8-0\">8.0<\/a><\/sup> <sup><a href=\"#cite_ref-LVAQuick18_8-1\">8.1<\/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 18 November 2021<\/span>.<\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/Implementation\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-GrandOneTool19-9\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-GrandOneTool19_9-0\">\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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/Implementation\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20220125221415\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.130 seconds\nReal time usage: 0.791 seconds\nPreprocessor visited node count: 6526\/1000000\nPost\u2010expand include size: 52295\/2097152 bytes\nTemplate argument size: 18820\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 15232\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 123.920 1 -total\n 82.10% 101.742 1 Template:Reflist\n 53.10% 65.804 9 Template:Citation\/core\n 42.45% 52.604 7 Template:Cite_web\n 17.84% 22.104 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/Implementation\n 16.27% 20.160 1 Template:Cite_book\n 9.56% 11.845 7 Template:Date\n 9.00% 11.152 2 Template:Citation\/identifier\n 8.20% 10.158 1 Template:Cite_journal\n 4.57% 5.663 15 Template:Citation\/make_link\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12934-0!canonical and timestamp 20220125221415 and revision id 45831. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/Implementation\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_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>","79e014ca9d87d3ecec33775123cbf95d_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/9\/9e\/LabMachines.jpg"],"79e014ca9d87d3ecec33775123cbf95d_timestamp":1643149331,"cb123f53ac8e5168a41eb4769be28332_type":"article","cb123f53ac8e5168a41eb4769be28332_title":"2.1 Evaluation and selection","cb123f53ac8e5168a41eb4769be28332_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/Evaluation_and_selection","cb123f53ac8e5168a41eb4769be28332_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Choosing laboratory informatics software for your lab\/Evaluation and selectionFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\nContents \n\n1 2. Choosing laboratory informatics software for your lab \n\n1.1 2.1 Evaluation and selection \n\n1.1.1 2.1.1 Technology considerations \n1.1.2 2.1.2 Features and functions \n1.1.3 2.1.3 Cybersecurity considerations \n1.1.4 2.1.4 Regulatory compliance considerations \n1.1.5 2.1.5 System flexibility \n1.1.6 2.1.6 Cost considerations \n\n\n\n\n2 References \n\n\n\n2. Choosing laboratory informatics software for your lab \n IBM 1130 desk-sized computer from the mid-1960s and '70sComputers in the laboratory are not a recent phenomenon. The mid-1960s saw clinical 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] Researchers imagined potentials such as automatic specimen label generation, daily log and report management, instrument interfacing and data processing, results comparisons, and time management tools. It would take time for some of those potentials to be realized.[1]\nIn 1970, Temple University Medical School'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\nThe most pressing future need for computerization of the laboratory lies in the area of medical diagnosis and guidance of the therapeutic management. This is where the physician's role for the future in the laboratory lies ... We will be gathering vast amounts of information on the health status of many individuals. We can then take advantage of large data processing computers to analyze this information and come up with patterns of disease states. - Leonard Jarett, M.D., Barnes Hospital\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 lab?\" but rather \"how do I choose and implement an informatics system to help my lab?\" What follows is information to help you with that question, while considering the technology, features, security, cost, implementation, and vendor guarantees that come with such a system.\n\n2.1 Evaluation and selection \nWhat exactly is a laboratory information system (LIS) or 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 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 LIS and 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\n2.1.1 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 physician office lab (POL), with its easy-to-use point-of-care testing and relatively simplified laboratory procedures, will invest significantly less into analyzers, instruments, and laboratory software than the molecular diagnostics laboratory, for example. 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 laboratory owner envision a small investment, taking in a slow but steady flow of simple clinical tests of human fluids, or expansive growth, expanding into multiple 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 testing medical cannabis for the state or province's associated program, you'll be considering chromatography and spectroscopy instruments, as well as regulatory requirements for complete track-and-trace activities, including reporting. The public health laboratory will likely have many more instruments to cover all its testing needs, and its data management system will likely need to be able to use the Centers for Disease Control and Prevention's PHIN Messaging System. Third, your laboratory's budget is ever 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. 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 laboratory 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]\n2.1.1.1 Laboratory informatics options\n\nKeeping the above in mind, what are the common software solutions used within a medical diagnostic or research laboratory? One of the more commonly discussed options is the LIS or LIMS. In the past, the term \"laboratory information system\" or \"LIS\" was used for solutions designed for medical labs, whereas \"laboratory information management system\" or \"LIMS\" was commonly used for non-medical functionality. Over the years, some software vendors have blurred these distinctions, with \"LIMS\" being used interchangeably with \"LIS\" in vendor marketing. Today, you'll see both terms being used to reference a laboratory informatics solution designed to assist medical laboratories manage testing workflows, data, and other aspects of their operations. \nA December 2019 survey by Medical Laboratory Observer, consisting of 273 respondents, is somewhat revealing in what a LIS or LIMS is being used for by a medical laboratory. Ninety-five percent of respondents indicated they use it to streamline their electronic order entry and result management, with medical data connectivity being the second most popular use. Automation tools, customer relationship management, scheduling, inventory management, revenue management, quality management, and reporting were all also mentioned as important to users.[12] When asked to select from five choices (or provide some other reason) in regard to what their top priority was in selecting a LIS or LIMS, respondents indicated that their most important priority was providing data analysis mechanisms for all types of pathology. See Table 1 below for all responses.\n\n\n\n\n\n\n\nTable 1. MLO survey responses to what the top priority was when acquiring a LIS or LIMS[12]\n\n\nTop acquisition priority for LIS or LIMS based on a survey; n = 273\n\nPercentage of\r\nrespondents\n\n\nAnalytic solutions for clinical\/anatomical\/molecular pathology\n\n36%\n\n\nMulti-lab networking\/connectivity\n\n25%\n\n\nIntegration with electronic medical records (EMRs)\n\n21%\n\n\nFlexible management capabilities\n\n8%\n\n\nReal-time and\/or automated inventory management\n\n6%\n\n\nOther (e.g., cost, patient safety needs, and training management)\n\n4%\n\n\n\nThese responses help paint a picture of what a LIS or LIMS can do, but there's definitely more to it. (See the next subsection on features and functions.) And other systems are also being used in medical laboratories. The previously mentioned MLO survey indicated that 68 percent of respondents came from a hospital laboratory, highlighting their importance in the medical diagnostic laboratory demographic. As such, we'd be remiss to not mention the hospital information system (HIS), a hospital-level information management system that often incorporates modular functionality similar to that of a LIS or LIMS. However, some such labs will often have their own laboratory data management solution independent of the HIS.\nThe survey also made reference the the EMR. This software, along with the electronic health record (EHR), is most prevalent among health care systems and other ambulatory providers, including physicians. (As of 2019, approximately 89.9 percent of U.S. physicians have adopted EMRs or EHRs.[13]) These systems act as portable, longitudinal collections of patient and population data and a convenient tool for documenting, monitoring, and managing health care delivery. Medical diagnostic laboratory workflow typically sees test data from a LIS get transferred to the respective patient's record in the EHR.[14]\nFinally, you may also see electronic laboratory notebooks (ELN) in medical research labs.[15][16] This software acts as an electronic substitute for the traditional laboratory notebook, assisting researchers with direct recording of experiment data, linking records, and protecting proprietary information. They can typically be integrated with other software systems as well. \nChoosing the right software will largely depend on your laboratory type and what you wish to accomplish. We next review the base features of offerings like an LIS and LIMS, as well as the features required by sub-specialties of medical science.\n\n2.1.2 Features and functions \nBase features\nA LIS or LIMS can have an extravagant list of features, or it may have minimal functionality. Software developers with competent and experienced personnel usually do well with a collection of the required base features, plus any industry-specific features a laboratory may need. But not all developers get it right.\nWhat follows is a list of system functionality that is considered by a variety of experts to be vital to almost any medical diagnostic or research laboratory.[17][18][19][20] Without this functionality, end users may at best grumble about additional workloads or more complicated procedures, and at worse be setting themselves up for major liability issues by not complying with regulations. Arguably, a few items such as mobile device support, voice recognition, and multilingual support may be negotiable, but if the system you are evaluating doesn't contain most of the below bullet-pointed functionality, you may want to look elsewhere.\n\r\n\nTest, experiment, and patient management\n\nspecimen log-in and management, with support for unique IDs\nbatching support\nbarcode and RFID support\nspecimen tracking\nclinical decision support, including test ordering tools and duplicate test checks\ncustom test management\nevent and instrument scheduling\ntemplates, forms, and data fields that are configurable\nanalytical tools, including data visualization, trend analysis, and data mining features\ndata import and export\nrobust query tools\ndocument and image management\nproject and experiment management\nworkflow management\npatient management\ncase management\nphysician and supplier management\n\r\n\nQuality, security, and compliance\n\nquality assurance \/ quality control mechanisms, including tracking of nonconformance\ndata normalization and validation\nresults review and approval\nversion control\nuser qualification, performance, and training management\naudit trails and chain of custody support\nconfigurable and granular role-based security\nconfigurable system access and use (log-in requirements, account usage rules, account locking, etc.)\nelectronic signature support\nconfigurable alarms and alerts\ndata encryption and secure communication protocols\ndata archiving and retention support\nconfigurable data backups\nenvironmental monitoring and control\n\r\n\nOperations management and reporting\n\ncustomizable rich-text reporting, with multiple supported output formats\nsynoptic reporting\nindustry-compliant labeling\nemail integration\ninternal messaging system\nrevenue management\ninstrument interfacing and data management\ninstrument calibration and maintenance tracking\ninventory and reagent management\nthird-party software and database interfacing\nmobile device support\nvoice recognition capability\nresults portal for external parties\nintegrated (or online) system help\nconfigurable language\n\r\n\nSpecialty-specific functionality\nIn the following subsections, the subcategories of labs we looked at in the prior chapter are reviewed, specifically for functionality critical to their specialty. This functionality is supported by four to five citations from vendors and other academic sources.\n\r\n\nAnatomical and clinical pathology lab[21][22][23][24]: \n\nconfigure the system using templates for histology and cytology case types\nadd, view, and link pre-generated organ maps and other diagrams\nadd, view, and link custom annotated pathology imaging\ntrack abnormal results and provide trending reports for monitoring disease populations\nsupport blocks and slides as specimens, with predefined descriptions\ndocument grossing examinations\nprint slides and cassettes\nprovide case management, reporting, and test requisition\nprovide specialty workflow for autopsy\nprovide specialty workflow for gynecological cytology, including HPV + Pap co-testing for cervical cancer\nprovide stain panels and histology worksheets\nsupport shared management of tissue samples among departments\nsupport EHR integration\nsupport polymerase chain reaction (PCR) workflow and reporting\nsupport pathology-specific reflex testing\nprovide option to combine same-day anatomical and clinical pathology results and reporting\nflag unusual cases for conference or committee reporting\n\r\n\n\nForensic pathology lab[25][26][27][28]: \nsupport pre-logging of evidence\nallow full documentation of a crime scene\ntrack storage, movement, and disposal of evidence and property using an ASTM-compliant log\nmanage chain-of-custody transfers of evidence and samples\nprovide quarantine protocol for samples and evidence\nprovide forensic case management, including case status and court testimony\nmanage agency interactions and information\nadd, view, and link forensic imaging into case files\nmanage field scheduling for fingerprinting, homicide casing, and lab work\nprovide custom reporting for toxicology and controlled substance analyses\nprovide support for DNA profile management\nprovide support for convicted offender and other database integration\nsupport the use of personal identity verification and other forms of hardware-based (i.e., public key infrastructure or PKI) token authentication\n\r\n\nPhysician office lab:\nThe physician office laboratory (POL) is arguably a simpler version of the medical diagnostics lab, often depending on CLIA-waived and CLIA-certified point-of-care instruments for making diagnoses. As such, the data management requirements for a POL are typically not as significant as those of a large-scale diagnostic laboratory. That said, a POL employing laboratory informatics will still need much of the same base functionality mentioned prior, and the system will still need to comply with data management and sharing regulations such as those found with HIPAA and CLIA. \nAny POL performing sufficient volumes of testing to benefit from using a laboratory informatics solution may also want to consider the costs and drawbacks, if any, of interfacing to their EHR system, if they have one. In a case where the POL is in a position to consider both an LIS and an EHR at the same time, they should examine the features and potential integration of those products, and they should be sure to consider any future potential of integrating their systems with other external data management systems, including another reference laboratory. \nIn some cases, an EHR with some laboratory management functionality may make a solid alternative. If considering an EHR that includes some LIS functionality, be sure to clearly identify the functional requirements and demo the system thoroughly to ensure test and reporting workflows make sense. Finally, in cases where POL test volumes are low\u2014coming from only one or a few instruments\u2014and an LIS is not required, POL operators may want to simply consider a middleware option that smoothly facilitates the flow of instrument data to the EHR.\n\r\n\nIntegrative medicine lab:\nIf an integrative medicine laboratory is using a laboratory informatics solution, their requirements will be nearly identical to a standard medical diagnostic laboratory, meaning the base functionality mentioned prior will likely be suitable. If there is a major difference or required piece of additional functionality, it will have to do with a more extensive list of available tests and billing codes for them. This usually consists of expansions into nutritional, metabolic, and toxicity test types, as well as support for diagnostic imaging.[29]\n\r\n\nPublic health lab[17][30][31][32]:\n\nprovide specialty workflow for newborn screening\nprovide surge capacity for high-priority analyses\nprovide workflow and tools for managing microorganisms and toxins of elevated risk\nsupport most medical test protocols and specimen types\nsupport ELISA, DNA extraction, sequencing, and other molecular workflows\nsupport for a robust set of decision support rules for reflex testing\nsupport the Centers for Disease Control and Prevention's PHIN Messaging System\nsupport other electronic data exchange standards for critical community partners\n\r\n\nToxicology lab[33][34][35][36][37]:\n\nsupport customizable drug panels and tests\nsupport reference lab activities\ntrack prescribed medicines and associated history\nprovide management for compounds and compound grouping\nprovide medication-based compliance monitoring and interpretive reporting on it\nprovide decision-support rules for pain management and toxicology\nprovide toxicology-specific reporting formats\nmanage drug court cases associated with testing\n\r\n\nBlood bank and transfusion lab[38][39][40][41]:\n\nmanage inventory across multiple facilities\nmanage donor and harvested tissues\nsupport positive patient identification (PPID)\nsupport the ISBT 128 standard for medical products of human origin\nsupport for both autologous and directed medical product management\nallow for emergency release of inventory\nallow for electronic crossmatch of human-based medical products\nmanage medical product recall and documentation\nmanage donor demographics, notification, scheduling, and history\nmanage donation drives and other campaigns\ntrack bag and supply lot numbers\ntrack quality control testing\nmonitor access to and environmental conditions of supply fridges\nprovide workflow management for non-standard patients\nsupport antibody screening processes\n\r\n\n\nCentral and contract research lab[42][43][44][45]:\nmanage and track clinical trial kits\nmanage multi-site logistics of specimens\nprovide a reservation function for specimens\nmanage clinical trials and their various functions, including recruitment, study protocols, treatment groups, metadata, multi-site master scheduling, consent checks, and other required reporting\nprovide special access privileges to sponsors, monitors, and investigators\nsupport a wide variety of data transfer formats, including CDISC, ASCII, SAS, and XML\nprovide patient management, including demographics, consent forms, clinical notation, and test results\nprovide highly configurable \"blinding\" features for reports and the user interface\ntrack contracts, budgets, and other financials\ndevelop exclusion rules and monitor exclusions\nsupport testing for a wide variety of disciplines\nprovide study-specific monitoring and alerts\nprovide granular cumulative reporting\nprovide study-specific project portals that allow review of documents, data visualizations, training material, and other study information\n\r\n\nGenetic diagnostics and cytogenetics labs[46][47][48][49]:\n\nmanage sample collection kits\nmanage informed consent documentation\nprovide customized workflows for molecular and next-generation sequencing (NGS) testing\ntrack specimen and aliquot lineage for cell lines, tissues, slides, etc.\ntrack nucleic acid quantity and quality of specimens\nsupport a wide array of molecular testing and associated data fields, including biochemical and molecular genetics, carrier screening, immunology, molecular profiling, prenatal and newborn testing, and pharmacogenetics\nprovide custom workflows for FISH, PCR, gel electrophoresis, cytogenetics, DNA sequencing, and more\nsupport specialty testing reimbursement and other revenue management unique to this lab type\nsupport single sign-on with imaging platforms\nprovide color coding for turn-around time and other testing statuses\nprovide cleanly formatted rich-text reports customized for molecular diagnostics\n\r\n\nMedical cannabis testing lab[50][51][52][53][54]:\n\nadd, view, and link custom annotated images\ninterface with a wide array of chromatography and spectroscopy instruments\noptimize sample login and management for the industry, including clear differentiation between medical and recreational cannabis\nprovide compliant test protocols, workflows, labels, and reporting for medical cannabis testing\nprovide ability to interface with state-required compliance reporting systems\nsupport inventory reconciliation\nsupport disease testing, sexing, and genetic tracking of cannabis\nsupport stability testing\n2.1.3 Cybersecurity considerations \nFrom law firms[55] to automotive manufacturers[56], 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[57], 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[58] In the end, businesses of all sizes average about $200,000 in losses due to a cybersecurity incident[59], and nearly 60 percent of small and midsize businesses go bankrupt within six months because of it.[60]\nMedical diagnostic and research 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.[61][62][63] Even more importantly are those labs performing digital data management tasks that handle sensitive patient and proprietary data, requiring additional cybersecurity considerations.\nA laboratory can integrate cybersecurity thinking into its laboratory informatics product selection in several ways. First, the lab 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 lab 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.\"[64] 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 a 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. 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\n2.1.4 Regulatory compliance considerations \nWithout a doubt, it's vital that medical diagnostic and research laboratories operate within the bounds of a regulatory atmosphere, not only to better ensure the best patient outcomes but also to ensure the quality of test results, the privacy of patient information, and the safety of personnel. 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 the Clinical Laboratory Improvement Amendments (CLIA) and Health Insurance Portability and Accountability Act (HIPAA) to 21 CFR Part 11 and the General Data Protection Regulation, laboratories have much to consider in regards to what 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[65][66], 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\"[66] 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.[65] 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 laboratories and research centers. 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\n2.1.5 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 toxicology testing, does your existing laboratory informatics system\u2014or the ones you may be considering\u2014have the flexibility to add other types of clinical 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 clinical testing and expand into other markets 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 specimen 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 itself, while minimizing overall costs and reducing the time required to make any necessary modifications.\n\n2.1.6 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 software as a service [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). Afterwards, your subscription and MSW will be the only ongoing expenses (included as one in this example), unless you choose to have additional interfaces or other services performed at any time.\n\nReferences \n\n\n\u2191 1.0 1.1 1.2 Krieg, A.F. (1974). \"Chapter 30: Clinical Laboratory Computerization\". In Davidsohn, I.; Henry, J.B.. Clinical Diagnosis by Laboratory Methods. W.B. Saunders Company. pp. 1340\u201358. ISBN 0721629229.   \n \n\n\u2191 Flynn, F.V. (1965). \"Computer-assisted processing of bio-chemical test data\". In Atkins, H.J.B.. Progress in Medical Computing. Blackwell Science Ltd. p. 46. ISBN 0632001801.   \n \n\n\u2191 Williams, G.Z. (1964). \"The Use of Data Processing and Automation in Clinical Pathology\". Military Medicine 129 (6): 502\u20139. doi:10.1093\/milmed\/129.6.502.   \n \n\n\u2191 Hicks, G.P.; Gieschen, M.M.; Slack, W.V. et al. (1966). \"Routine Use of a Small Digital Computer in the Clinical Laboratory\". 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Orchard Software Corporation. 2021. https:\/\/www.orchardsoft.com\/solutions\/pain-management-toxicology-labs\/ . Retrieved 18 November 2021 .   \n \n\n\u2191 \"Sunquest Blood Bank\". Sunquest Information Systems, Inc. 2021. https:\/\/www.sunquestinfo.com\/software-and-services\/blood-bank-management\/ . Retrieved 18 November 2021 .   \n \n\n\u2191 \"SCC's Blood Services Information Systems Suite\". SCC Soft Computer. 2021. https:\/\/www.softcomputer.com\/products-services\/blood-services\/ . Retrieved 18 November 2021 .   \n \n\n\u2191 \"Hemasoft\". Hemasoft Software SL. 2021. http:\/\/www.hemasoft.com\/ . Retrieved 18 November 2021 .   \n \n\n\u2191 \"TD BloodBank\". Technidata SAS. 2021. https:\/\/www.technidata-web.com\/en-gb\/solutions-services\/solutions\/blood-banking . Retrieved 18 November 2021 .   \n \n\n\u2191 \"Supporting Services - Data management\". 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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 18 November 2021 .   \n \n\n\u2191 Grima, M. (14 November 2019). \"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 18 November 2021 .   \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 18 November 2021 .   \n \n\n\u2191 Talaleve, A. (22 February 2021). \"Website Hacking Statistics You Should Know in 2021\". Patchstack. https:\/\/patchstack.com\/website-hacking-statistics\/ . Retrieved 18 November 2021 .   \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 18 November 2021 .   \n \n\n\u2191 65.0 65.1 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 66.0 66.1 \"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 18 November 2021 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/Evaluation_and_selection\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/Evaluation_and_selection<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:10.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 47 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","cb123f53ac8e5168a41eb4769be28332_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Choosing_laboratory_informatics_software_for_your_lab_Evaluation_and_selection rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Choosing_laboratory_informatics_software_for_your_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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Choosing laboratory informatics software for your 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">the beginning<\/a> of this guide-----<\/div>\n\n\n<h2><span class=\"mw-headline\" id=\"2._Choosing_laboratory_informatics_software_for_your_lab\">2. Choosing laboratory informatics software for your lab<\/span><\/h2>\n<div class=\"thumb tright\"><div class=\"thumbinner\" style=\"width:302px;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:IBM_1130_(16758008839).jpg\" class=\"image wiki-link\" data-key=\"5b152de0fb4915a78d4a153a20c84f02\"><img alt=\"\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/3\/33\/IBM_1130_%2816758008839%29.jpg\" decoding=\"async\" width=\"300\" height=\"200\" class=\"thumbimage\" \/><\/a> <div class=\"thumbcaption\"><div class=\"magnify\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:IBM_1130_(16758008839).jpg\" class=\"internal wiki-link\" title=\"Enlarge\" data-key=\"5b152de0fb4915a78d4a153a20c84f02\"><\/a><\/div>IBM 1130 desk-sized computer from the mid-1960s and '70s<\/div><\/div><\/div><p>Computers in the laboratory are not a recent phenomenon. The mid-1960s saw clinical 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> Researchers imagined potentials such as automatic specimen label generation, daily log and report management, instrument interfacing and data processing, results comparisons, and time management tools. 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 Medical School'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<blockquote><p><i>The most pressing future need for computerization of the laboratory lies in the area of medical diagnosis and guidance of the therapeutic management. This is where the physician's role for the future in the laboratory lies ... We will be gathering vast amounts of information on the health status of many individuals. We can then take advantage of large data processing computers to analyze this information and come up with patterns of disease states.<\/i> - Leonard Jarett, M.D., Barnes Hospital<\/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 lab?\" but rather \"how do I choose and implement an informatics system to help my lab?\" What follows is information to help you with that question, while considering the technology, features, security, cost, implementation, and vendor guarantees that come with such a system.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"2.1_Evaluation_and_selection\">2.1 Evaluation and selection<\/span><\/h3>\n<p>What exactly is a <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) or <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 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 LIS and 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=\"2.1.1_Technology_considerations\">2.1.1 Technology considerations<\/span><\/h4>\n<p>Your laboratory's <a href=\"https:\/\/www.limswiki.org\/index.php\/Workflow\" title=\"Workflow\" class=\"wiki-link\" data-key=\"92bd8748272e20d891008dcb8243e8a8\">workflow<\/a>, instruments, data management requirements, budget, technological expertise, business goals, and risk tolerances will all play a role in deciding what technology to invest in. The <a href=\"https:\/\/www.limswiki.org\/index.php\/Physician_office_laboratory\" title=\"Physician office laboratory\" class=\"wiki-link\" data-key=\"0655647b0091e0dd168f162b621a6cef\">physician office lab<\/a> (POL), with its easy-to-use point-of-care testing and relatively simplified laboratory procedures, will invest significantly less into analyzers, instruments, and laboratory software than the molecular diagnostics laboratory, for example. 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 laboratory owner envision a small investment, taking in a slow but steady flow of simple clinical tests of human fluids, or expansive growth, expanding into multiple 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 testing medical cannabis for the state or province's associated program, 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 regulatory requirements for complete track-and-trace activities, including reporting. The <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> will likely have many more instruments to cover all its testing needs, and its data management system will likely need to be able to use 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>'s PHIN Messaging System. Third, your laboratory's budget is ever 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>. 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 laboratory 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>2.1.1.1 Laboratory informatics options<\/b>\n<\/p>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Icos_Laboratories.JPG\" class=\"image wiki-link\" data-key=\"df3af756412e96d7e4d8a0386662df33\"><img alt=\"Icos Laboratories.JPG\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/d\/dd\/Icos_Laboratories.JPG\" decoding=\"async\" width=\"350\" height=\"263\" \/><\/a><\/div><p>Keeping the above in mind, what are the common software solutions used within a medical diagnostic or research laboratory? One of the more commonly discussed options is the LIS or LIMS. In the past, the term \"laboratory information system\" or \"LIS\" was used for solutions designed for medical labs, whereas \"laboratory information management system\" or \"LIMS\" was commonly used for non-medical functionality. Over the years, some software vendors have blurred these distinctions, with \"LIMS\" being used interchangeably with \"LIS\" in vendor marketing. Today, you'll see both terms being used to reference a laboratory informatics solution designed to assist medical laboratories manage testing workflows, data, and other aspects of their operations. \n<\/p><p>A December 2019 survey by <i>Medical Laboratory Observer<\/i>, consisting of 273 respondents, is somewhat revealing in what a LIS or LIMS is being used for by a medical laboratory. Ninety-five percent of respondents indicated they use it to streamline their electronic order entry and result management, with medical data connectivity being the second most popular use. Automation tools, customer relationship management, scheduling, inventory management, revenue management, quality management, and reporting were all also mentioned as important to users.<sup id=\"rdp-ebb-cite_ref-SilvaITSol19_12-0\" class=\"reference\"><a href=\"#cite_note-SilvaITSol19-12\">[12]<\/a><\/sup> When asked to select from five choices (or provide some other reason) in regard to what their top priority was in selecting a LIS or LIMS, respondents indicated that their most important priority was providing data analysis mechanisms for all types of pathology. See Table 1 below for all responses.\n<\/p>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable\" border=\"1\" cellpadding=\"5\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<td colspan=\"2\" style=\"background-color:white; padding-left:10px; padding-right:10px;\"><b>Table 1.<\/b> <i>MLO<\/i> survey responses to what the top priority was when acquiring a LIS or LIMS<sup id=\"rdp-ebb-cite_ref-SilvaITSol19_12-1\" class=\"reference\"><a href=\"#cite_note-SilvaITSol19-12\">[12]<\/a><\/sup>\n<\/td><\/tr>\n<tr>\n<th style=\"padding-left:10px; padding-right:10px;\">Top acquisition priority for LIS or LIMS based on a survey; <i>n<\/i> = 273\n<\/th>\n<th style=\"padding-left:10px; padding-right:10px;\">Percentage of<br \/>respondents\n<\/th><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Analytic solutions for clinical\/anatomical\/molecular pathology\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">36%\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Multi-lab networking\/connectivity\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">25%\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Integration with <a href=\"https:\/\/www.limswiki.org\/index.php\/Electronic_medical_record\" title=\"Electronic medical record\" class=\"wiki-link\" data-key=\"99a695d2af23397807da0537d29d0be7\">electronic medical records<\/a> (EMRs)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">21%\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Flexible management capabilities\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">8%\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Real-time and\/or automated inventory management\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">6%\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Other (e.g., cost, patient safety needs, and training management)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">4%\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<p>These responses help paint a picture of what a LIS or LIMS can do, but there's definitely more to it. (See the next subsection on features and functions.) And other systems are also being used in medical laboratories. The previously mentioned <i>MLO<\/i> survey indicated that 68 percent of respondents came from a <a href=\"https:\/\/www.limswiki.org\/index.php\/Hospital\" title=\"Hospital\" class=\"wiki-link\" data-key=\"b8f070c66d8123fe91063594befebdff\">hospital<\/a> laboratory, highlighting their importance in the medical diagnostic laboratory demographic. As such, we'd be remiss to not mention the <a href=\"https:\/\/www.limswiki.org\/index.php\/Hospital_information_system\" title=\"Hospital information system\" class=\"wiki-link\" data-key=\"d8385de7b1f39a39d793f8ce349b448d\">hospital information system<\/a> (HIS), a hospital-level information management system that often incorporates modular functionality similar to that of a LIS or LIMS. However, some such labs will often have their own laboratory data management solution independent of the HIS.\n<\/p><p>The survey also made reference the the EMR. This software, along with the <a href=\"https:\/\/www.limswiki.org\/index.php\/Electronic_health_record\" title=\"Electronic health record\" class=\"wiki-link\" data-key=\"f2e31a73217185bb01389404c1fd5255\">electronic health record<\/a> (EHR), is most prevalent among health care systems and other ambulatory providers, including physicians. (As of 2019, approximately 89.9 percent of U.S. physicians have adopted EMRs or EHRs.<sup id=\"rdp-ebb-cite_ref-ONC_EHRAdopt19_13-0\" class=\"reference\"><a href=\"#cite_note-ONC_EHRAdopt19-13\">[13]<\/a><\/sup>) These systems act as portable, longitudinal collections of patient and population data and a convenient tool for documenting, monitoring, and managing health care delivery. Medical diagnostic laboratory workflow typically sees test data from a LIS get transferred to the respective patient's record in the EHR.<sup id=\"rdp-ebb-cite_ref-PerrottaValid16_14-0\" class=\"reference\"><a href=\"#cite_note-PerrottaValid16-14\">[14]<\/a><\/sup>\n<\/p><p>Finally, you may also see <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> (ELN) in medical research labs.<sup id=\"rdp-ebb-cite_ref-ManzelRequire13_15-0\" class=\"reference\"><a href=\"#cite_note-ManzelRequire13-15\">[15]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-GuerreroAnal16_16-0\" class=\"reference\"><a href=\"#cite_note-GuerreroAnal16-16\">[16]<\/a><\/sup> This software acts as an electronic substitute for the traditional <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_notebook\" title=\"Laboratory notebook\" class=\"wiki-link\" data-key=\"be60c7be96aba8e9a84537fd8835fa54\">laboratory notebook<\/a>, assisting researchers with direct recording of experiment data, linking records, and protecting proprietary information. They can typically be integrated with other software systems as well. \n<\/p><p>Choosing the right software will largely depend on your laboratory type and what you wish to accomplish. We next review the base features of offerings like an LIS and LIMS, as well as the features required by sub-specialties of medical science.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"2.1.2_Features_and_functions\">2.1.2 Features and functions<\/span><\/h4>\n<p><b>Base features<\/b>\n<\/p><p>A LIS or LIMS can have an extravagant list of features, or it may have minimal functionality. Software developers with competent and experienced personnel usually do well with a collection of the required base features, plus any industry-specific features a laboratory may need. But not all developers get it right.\n<\/p><p>What follows is a list of system functionality that is considered by a variety of experts to be vital to almost any medical diagnostic or research laboratory.<sup id=\"rdp-ebb-cite_ref-APHLLab19_17-0\" class=\"reference\"><a href=\"#cite_note-APHLLab19-17\">[17]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-KyobeSelecting17_18-0\" class=\"reference\"><a href=\"#cite_note-KyobeSelecting17-18\">[18]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ListEffic14_19-0\" class=\"reference\"><a href=\"#cite_note-ListEffic14-19\">[19]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-APILISTool13_20-0\" class=\"reference\"><a href=\"#cite_note-APILISTool13-20\">[20]<\/a><\/sup> Without this functionality, end users may at best grumble about additional workloads or more complicated procedures, and at worse be setting themselves up for major liability issues by not complying with regulations. Arguably, a few items such as mobile device support, voice recognition, and multilingual support may be negotiable, but if the system you are evaluating doesn't contain most of the below bullet-pointed functionality, you may want to look elsewhere.\n<\/p><p><br \/>\n<i><b>Test, experiment, and patient management<\/b><\/i>\n<\/p>\n<ul><li>specimen log-in and management, with support for unique IDs<\/li>\n<li>batching support<\/li>\n<li>barcode and RFID support<\/li>\n<li>specimen tracking<\/li>\n<li>clinical decision support, including test ordering tools and duplicate test checks<\/li>\n<li>custom test management<\/li>\n<li>event and instrument scheduling<\/li>\n<li>templates, forms, and data fields that are configurable<\/li>\n<li>analytical tools, including data visualization, trend analysis, and data mining features<\/li>\n<li>data import and export<\/li>\n<li>robust query tools<\/li>\n<li>document and image management<\/li>\n<li>project and experiment management<\/li>\n<li>workflow management<\/li>\n<li>patient management<\/li>\n<li>case management<\/li>\n<li>physician and supplier management<\/li><\/ul>\n<p><br \/>\n<i><b>Quality, security, and compliance<\/b><\/i>\n<\/p>\n<ul><li>quality assurance \/ quality control mechanisms, including tracking of nonconformance<\/li>\n<li>data normalization and validation<\/li>\n<li>results review and approval<\/li>\n<li>version control<\/li>\n<li>user qualification, performance, and training management<\/li>\n<li>audit trails and chain of custody support<\/li>\n<li>configurable and granular role-based security<\/li>\n<li>configurable system access and use (log-in requirements, account usage rules, account locking, etc.)<\/li>\n<li>electronic signature support<\/li>\n<li>configurable alarms and alerts<\/li>\n<li>data encryption and secure communication protocols<\/li>\n<li>data archiving and retention support<\/li>\n<li>configurable data backups<\/li>\n<li>environmental monitoring and control<\/li><\/ul>\n<p><br \/>\n<i><b>Operations management and reporting<\/b><\/i>\n<\/p>\n<ul><li>customizable rich-text reporting, with multiple supported output formats<\/li>\n<li>synoptic reporting<\/li>\n<li>industry-compliant labeling<\/li>\n<li>email integration<\/li>\n<li>internal messaging system<\/li>\n<li>revenue management<\/li>\n<li>instrument interfacing and data management<\/li>\n<li>instrument calibration and maintenance tracking<\/li>\n<li>inventory and reagent management<\/li>\n<li>third-party software and database interfacing<\/li>\n<li>mobile device support<\/li>\n<li>voice recognition capability<\/li>\n<li>results portal for external parties<\/li>\n<li>integrated (or online) system help<\/li>\n<li>configurable language<\/li><\/ul>\n<p><br \/>\n<b>Specialty-specific functionality<\/b>\n<\/p><p>In the following subsections, the subcategories of labs we looked at in the prior chapter are reviewed, specifically for functionality critical to their specialty. This functionality is supported by four to five citations from vendors and other academic sources.\n<\/p><p><br \/>\n<i><b>Anatomical and clinical pathology lab<\/b><\/i><sup id=\"rdp-ebb-cite_ref-LabWareAnatomic20_21-0\" class=\"reference\"><a href=\"#cite_note-LabWareAnatomic20-21\">[21]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-SunquestCoPath20_22-0\" class=\"reference\"><a href=\"#cite_note-SunquestCoPath20-22\">[22]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-NovoPathHome20_23-0\" class=\"reference\"><a href=\"#cite_note-NovoPathHome20-23\">[23]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-TDMS_TDHistoCyto20_24-0\" class=\"reference\"><a href=\"#cite_note-TDMS_TDHistoCyto20-24\">[24]<\/a><\/sup>: \n<\/p>\n<ul><li>configure the system using templates for histology and cytology case types<\/li>\n<li>add, view, and link pre-generated organ maps and other diagrams<\/li>\n<li>add, view, and link custom annotated pathology imaging<\/li>\n<li>track abnormal results and provide trending reports for monitoring disease populations<\/li>\n<li>support blocks and slides as specimens, with predefined descriptions<\/li>\n<li>document grossing examinations<\/li>\n<li>print slides and cassettes<\/li>\n<li>provide case management, reporting, and test requisition<\/li>\n<li>provide specialty workflow for autopsy<\/li>\n<li>provide specialty workflow for gynecological cytology, including HPV + Pap co-testing for cervical cancer<\/li>\n<li>provide stain panels and histology worksheets<\/li>\n<li>support shared management of tissue samples among departments<\/li>\n<li>support EHR integration<\/li>\n<li>support polymerase chain reaction (PCR) workflow and reporting<\/li>\n<li>support pathology-specific reflex testing<\/li>\n<li>provide option to combine same-day anatomical and clinical pathology results and reporting<\/li>\n<li>flag unusual cases for conference or committee reporting<\/li><\/ul>\n<p><br \/>\n<\/p>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Harsh_Vardhan_at_the_inaugural_ceremony_of_the_new_campus_of_Centre_for_DNA_Fingerprinting_and_Diagnostics_(CDFD),_in_Hyderabad.JPG\" class=\"image wiki-link\" data-key=\"6e571126b5f740a3eeee7ef0920d05e1\"><img alt=\"Harsh Vardhan at the inaugural ceremony of the new campus of Centre for DNA Fingerprinting and Diagnostics (CDFD), in Hyderabad.JPG\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/e\/e2\/Harsh_Vardhan_at_the_inaugural_ceremony_of_the_new_campus_of_Centre_for_DNA_Fingerprinting_and_Diagnostics_%28CDFD%29%2C_in_Hyderabad.JPG\" decoding=\"async\" width=\"350\" height=\"239\" \/><\/a><\/div><p><b>Forensic pathology lab<\/b><sup id=\"rdp-ebb-cite_ref-AbbotStarlimsForensic20_25-0\" class=\"reference\"><a href=\"#cite_note-AbbotStarlimsForensic20-25\">[25]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-LabLynxForensics20_26-0\" class=\"reference\"><a href=\"#cite_note-LabLynxForensics20-26\">[26]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ThermoFisherLIMSForens20_27-0\" class=\"reference\"><a href=\"#cite_note-ThermoFisherLIMSForens20-27\">[27]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PorterLeeLab20_28-0\" class=\"reference\"><a href=\"#cite_note-PorterLeeLab20-28\">[28]<\/a><\/sup>: \n<\/p><ul><li>support pre-logging of evidence<\/li>\n<li>allow full documentation of a crime scene<\/li>\n<li>track storage, movement, and disposal of evidence and property using an ASTM-compliant log<\/li>\n<li>manage chain-of-custody transfers of evidence and samples<\/li>\n<li>provide quarantine protocol for samples and evidence<\/li>\n<li>provide forensic case management, including case status and court testimony<\/li>\n<li>manage agency interactions and information<\/li>\n<li>add, view, and link forensic imaging into case files<\/li>\n<li>manage field scheduling for fingerprinting, homicide casing, and lab work<\/li>\n<li>provide custom reporting for toxicology and controlled substance analyses<\/li>\n<li>provide support for DNA profile management<\/li>\n<li>provide support for convicted offender and other database integration<\/li>\n<li>support the use of personal identity verification and other forms of hardware-based (i.e., public key infrastructure or PKI) token authentication<\/li><\/ul>\n<p><br \/>\n<i><b>Physician office lab<\/b><\/i>:\n<\/p><p>The <a href=\"https:\/\/www.limswiki.org\/index.php\/Physician_office_laboratory\" title=\"Physician office laboratory\" class=\"wiki-link\" data-key=\"0655647b0091e0dd168f162b621a6cef\">physician office laboratory<\/a> (POL) is arguably a simpler version of the medical diagnostics lab, often depending on CLIA-waived and CLIA-certified point-of-care instruments for making diagnoses. As such, the data management requirements for a POL are typically not as significant as those of a large-scale diagnostic laboratory. That said, a POL employing laboratory informatics will still need much of the same base functionality mentioned prior, and the system will still need to comply with data management and sharing regulations such as those found with HIPAA and CLIA. \n<\/p><p>Any POL performing sufficient volumes of testing to benefit from using a laboratory informatics solution may also want to consider the costs and drawbacks, if any, of interfacing to their EHR system, if they have one. In a case where the POL is in a position to consider both an LIS and an EHR at the same time, they should examine the features and potential integration of those products, and they should be sure to consider any future potential of integrating their systems with other external data management systems, including another reference laboratory. \n<\/p><p>In some cases, an EHR with some laboratory management functionality may make a solid alternative. If considering an EHR that includes some LIS functionality, be sure to clearly identify the functional requirements and demo the system thoroughly to ensure test and reporting workflows make sense. Finally, in cases where POL test volumes are low\u2014coming from only one or a few instruments\u2014and an LIS is not required, POL operators may want to simply consider a <a href=\"https:\/\/www.limswiki.org\/index.php\/Middleware\" title=\"Middleware\" class=\"wiki-link\" data-key=\"82ee1d9577571b4f9e4d83d6d6124c81\">middleware<\/a> option that smoothly facilitates the flow of instrument data to the EHR.\n<\/p><p><br \/>\n<i><b>Integrative medicine lab<\/b><\/i>:\n<\/p><p>If an integrative medicine laboratory is using a laboratory informatics solution, their requirements will be nearly identical to a standard medical diagnostic laboratory, meaning the base functionality mentioned prior will likely be suitable. If there is a major difference or required piece of additional functionality, it will have to do with a more extensive list of available tests and billing codes for them. This usually consists of expansions into nutritional, metabolic, and toxicity test types, as well as support for diagnostic imaging.<sup id=\"rdp-ebb-cite_ref-BralleyBasic_29-0\" class=\"reference\"><a href=\"#cite_note-BralleyBasic-29\">[29]<\/a><\/sup>\n<\/p><p><br \/>\n<i><b>Public health lab<\/b><\/i><sup id=\"rdp-ebb-cite_ref-APHLLab19_17-1\" class=\"reference\"><a href=\"#cite_note-APHLLab19-17\">[17]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-LabWarePublic20_30-0\" class=\"reference\"><a href=\"#cite_note-LabWarePublic20-30\">[30]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-OrchardPublic20_31-0\" class=\"reference\"><a href=\"#cite_note-OrchardPublic20-31\">[31]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CommonCentsApollo20_32-0\" class=\"reference\"><a href=\"#cite_note-CommonCentsApollo20-32\">[32]<\/a><\/sup>:\n<\/p>\n<ul><li>provide specialty workflow for newborn screening<\/li>\n<li>provide surge capacity for high-priority analyses<\/li>\n<li>provide workflow and tools for managing microorganisms and toxins of elevated risk<\/li>\n<li>support most medical test protocols and specimen types<\/li>\n<li>support ELISA, DNA extraction, sequencing, and other molecular workflows<\/li>\n<li>support for a robust set of decision support rules for reflex testing<\/li>\n<li>support the Centers for Disease Control and Prevention's PHIN Messaging System<\/li>\n<li>support other electronic data exchange standards for critical community partners<\/li><\/ul>\n<p><br \/>\n<i><b>Toxicology lab<\/b><\/i><sup id=\"rdp-ebb-cite_ref-APEasyFeatures20_33-0\" class=\"reference\"><a href=\"#cite_note-APEasyFeatures20-33\">[33]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-DataUnlimitedLIMSSol20_34-0\" class=\"reference\"><a href=\"#cite_note-DataUnlimitedLIMSSol20-34\">[34]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-LabLynxToxicology20_35-0\" class=\"reference\"><a href=\"#cite_note-LabLynxToxicology20-35\">[35]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-DTPMOnlineData20_36-0\" class=\"reference\"><a href=\"#cite_note-DTPMOnlineData20-36\">[36]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-OrchardPain20_37-0\" class=\"reference\"><a href=\"#cite_note-OrchardPain20-37\">[37]<\/a><\/sup>:\n<\/p>\n<ul><li>support customizable drug panels and tests<\/li>\n<li>support reference lab activities<\/li>\n<li>track prescribed medicines and associated history<\/li>\n<li>provide management for compounds and compound grouping<\/li>\n<li>provide medication-based compliance monitoring and interpretive reporting on it<\/li>\n<li>provide decision-support rules for pain management and toxicology<\/li>\n<li>provide toxicology-specific reporting formats<\/li>\n<li>manage drug court cases associated with testing<\/li><\/ul>\n<p><br \/>\n<i><b>Blood bank and transfusion lab<\/b><\/i><sup id=\"rdp-ebb-cite_ref-SunquestBloodBank20_38-0\" class=\"reference\"><a href=\"#cite_note-SunquestBloodBank20-38\">[38]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-SCCBlood20_39-0\" class=\"reference\"><a href=\"#cite_note-SCCBlood20-39\">[39]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-HemasoftHome20_40-0\" class=\"reference\"><a href=\"#cite_note-HemasoftHome20-40\">[40]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-TDMS_TDBloodBank20_41-0\" class=\"reference\"><a href=\"#cite_note-TDMS_TDBloodBank20-41\">[41]<\/a><\/sup>:\n<\/p>\n<ul><li>manage inventory across multiple facilities<\/li>\n<li>manage donor and harvested tissues<\/li>\n<li>support positive patient identification (PPID)<\/li>\n<li>support the ISBT 128 standard for medical products of human origin<\/li>\n<li>support for both autologous and directed medical product management<\/li>\n<li>allow for emergency release of inventory<\/li>\n<li>allow for electronic crossmatch of human-based medical products<\/li>\n<li>manage medical product recall and documentation<\/li>\n<li>manage donor demographics, notification, scheduling, and history<\/li>\n<li>manage donation drives and other campaigns<\/li>\n<li>track bag and supply lot numbers<\/li>\n<li>track quality control testing<\/li>\n<li>monitor access to and environmental conditions of supply fridges<\/li>\n<li>provide workflow management for non-standard patients<\/li>\n<li>support antibody screening processes<\/li><\/ul>\n<p><br \/>\n<\/p>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Medical_Examination_of_a_Clinical_Trial_Volunteer_(45116548811).jpg\" class=\"image wiki-link\" data-key=\"302382f8344d03aa7526f825db2694cd\"><img alt=\"Medical Examination of a Clinical Trial Volunteer (45116548811).jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/d\/d4\/Medical_Examination_of_a_Clinical_Trial_Volunteer_%2845116548811%29.jpg\" decoding=\"async\" width=\"350\" height=\"263\" \/><\/a><\/div><p><b>Central and contract research lab<\/b><sup id=\"rdp-ebb-cite_ref-EurofinsSupport20_42-0\" class=\"reference\"><a href=\"#cite_note-EurofinsSupport20-42\">[42]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-AbbotStarlimsClin20_43-0\" class=\"reference\"><a href=\"#cite_note-AbbotStarlimsClin20-43\">[43]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-LabWareClinical20_44-0\" class=\"reference\"><a href=\"#cite_note-LabWareClinical20-44\">[44]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MedpaceClinTrak20_45-0\" class=\"reference\"><a href=\"#cite_note-MedpaceClinTrak20-45\">[45]<\/a><\/sup>:\n<\/p><ul><li>manage and track clinical trial kits<\/li>\n<li>manage multi-site logistics of specimens<\/li>\n<li>provide a reservation function for specimens<\/li>\n<li>manage clinical trials and their various functions, including recruitment, study protocols, treatment groups, metadata, multi-site master scheduling, consent checks, and other required reporting<\/li>\n<li>provide special access privileges to sponsors, monitors, and investigators<\/li>\n<li>support a wide variety of data transfer formats, including CDISC, ASCII, SAS, and XML<\/li>\n<li>provide patient management, including demographics, consent forms, clinical notation, and test results<\/li>\n<li>provide highly configurable \"blinding\" features for reports and the user interface<\/li>\n<li>track contracts, budgets, and other financials<\/li>\n<li>develop exclusion rules and monitor exclusions<\/li>\n<li>support testing for a wide variety of disciplines<\/li>\n<li>provide study-specific monitoring and alerts<\/li>\n<li>provide granular cumulative reporting<\/li>\n<li>provide study-specific project portals that allow review of documents, data visualizations, training material, and other study information<\/li><\/ul>\n<p><br \/>\n<i><b>Genetic diagnostics and cytogenetics labs<\/b><\/i><sup id=\"rdp-ebb-cite_ref-SunquestMitogen20_46-0\" class=\"reference\"><a href=\"#cite_note-SunquestMitogen20-46\">[46]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-XifinMolec20_47-0\" class=\"reference\"><a href=\"#cite_note-XifinMolec20-47\">[47]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PsycheNucleoLIS20_48-0\" class=\"reference\"><a href=\"#cite_note-PsycheNucleoLIS20-48\">[48]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MyersLab18_49-0\" class=\"reference\"><a href=\"#cite_note-MyersLab18-49\">[49]<\/a><\/sup>:\n<\/p>\n<ul><li>manage sample collection kits<\/li>\n<li>manage informed consent documentation<\/li>\n<li>provide customized workflows for molecular and <a href=\"https:\/\/www.limswiki.org\/index.php\/DNA_sequencing#High-throughput_methods\" title=\"DNA sequencing\" class=\"wiki-link\" data-key=\"090351f8c03a4d52a4aa39a94f5b52ba\">next-generation sequencing<\/a> (NGS) testing<\/li>\n<li>track specimen and aliquot lineage for cell lines, tissues, slides, etc.<\/li>\n<li>track nucleic acid quantity and quality of specimens<\/li>\n<li>support a wide array of molecular testing and associated data fields, including biochemical and molecular genetics, carrier screening, immunology, molecular profiling, prenatal and newborn testing, and pharmacogenetics<\/li>\n<li>provide custom workflows for FISH, PCR, gel electrophoresis, cytogenetics, DNA sequencing, and more<\/li>\n<li>support specialty testing reimbursement and other revenue management unique to this lab type<\/li>\n<li>support single sign-on with imaging platforms<\/li>\n<li>provide color coding for turn-around time and other testing statuses<\/li>\n<li>provide cleanly formatted rich-text reports customized for molecular diagnostics<\/li><\/ul>\n<p><br \/>\n<i><b>Medical cannabis testing lab<\/b><\/i><sup id=\"rdp-ebb-cite_ref-LabLynxCanna20_50-0\" class=\"reference\"><a href=\"#cite_note-LabLynxCanna20-50\">[50]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-KhemiaCanna20_51-0\" class=\"reference\"><a href=\"#cite_note-KhemiaCanna20-51\">[51]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-LabWareCanna20_52-0\" class=\"reference\"><a href=\"#cite_note-LabWareCanna20-52\">[52]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-QBenchLIMS20_53-0\" class=\"reference\"><a href=\"#cite_note-QBenchLIMS20-53\">[53]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PaszkoSelecting20_54-0\" class=\"reference\"><a href=\"#cite_note-PaszkoSelecting20-54\">[54]<\/a><\/sup>:\n<\/p>\n<ul><li>add, view, and link custom annotated images<\/li>\n<li>interface with a wide array of chromatography and spectroscopy instruments<\/li>\n<li>optimize sample login and management for the industry, including clear differentiation between medical and recreational cannabis<\/li>\n<li>provide compliant test protocols, workflows, labels, and reporting for medical cannabis testing<\/li>\n<li>provide ability to interface with state-required compliance reporting systems<\/li>\n<li>support inventory reconciliation<\/li>\n<li>support disease testing, sexing, and genetic tracking of cannabis<\/li>\n<li>support stability testing<\/li><\/ul>\n<h4><span class=\"mw-headline\" id=\"2.1.3_Cybersecurity_considerations\">2.1.3 Cybersecurity considerations<\/span><\/h4>\n<p>From law firms<sup id=\"rdp-ebb-cite_ref-SobowaleLaw17_55-0\" class=\"reference\"><a href=\"#cite_note-SobowaleLaw17-55\">[55]<\/a><\/sup> to automotive manufacturers<sup id=\"rdp-ebb-cite_ref-WatneyAddress17_56-0\" class=\"reference\"><a href=\"#cite_note-WatneyAddress17-56\">[56]<\/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_57-0\" class=\"reference\"><a href=\"#cite_note-LewisEcon18-57\">[57]<\/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_58-0\" class=\"reference\"><a href=\"#cite_note-SBDCC_BlogCost17-58\">[58]<\/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_59-0\" class=\"reference\"><a href=\"#cite_note-HiscoxHiscox19.22-59\">[59]<\/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_60-0\" class=\"reference\"><a href=\"#cite_note-Galvin60_18-60\">[60]<\/a><\/sup>\n<\/p><p>Medical diagnostic and research 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_61-0\" class=\"reference\"><a href=\"#cite_note-GrimaTop19-61\">[61]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MoenWhatHack16_62-0\" class=\"reference\"><a href=\"#cite_note-MoenWhatHack16-62\">[62]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-TalalevWebsite19_63-0\" class=\"reference\"><a href=\"#cite_note-TalalevWebsite19-63\">[63]<\/a><\/sup> Even more importantly are those labs performing digital data management tasks that handle sensitive patient and proprietary data, requiring additional cybersecurity considerations.\n<\/p><p>A laboratory can integrate cybersecurity thinking into its laboratory informatics product selection in several ways. First, the lab 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 lab 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_64-0\" class=\"reference\"><a href=\"#cite_note-NISTSecurity19-64\">[64]<\/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 a 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. 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_2019_R1\" title=\"Book:LIMSpec 2019 R1\" class=\"wiki-link\" data-key=\"be4a6879593cf6b89768cf1d794af185\">LIMSpec<\/a>, discussed later\u2014makes the evaluation process even easier.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"2.1.4_Regulatory_compliance_considerations\">2.1.4 Regulatory compliance considerations<\/span><\/h4>\n<p>Without a doubt, it's vital that medical diagnostic and research laboratories operate within the bounds of a regulatory atmosphere, not only to better ensure the best patient outcomes but also to ensure the quality of test results, the privacy of patient information, and the safety of personnel. 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 the <a href=\"https:\/\/www.limswiki.org\/index.php\/Clinical_Laboratory_Improvement_Amendments\" title=\"Clinical Laboratory Improvement Amendments\" class=\"wiki-link\" data-key=\"64bdae1dc17c40c28e0c560396a6ae35\">Clinical Laboratory Improvement Amendments<\/a> (CLIA) and <a href=\"https:\/\/www.limswiki.org\/index.php\/Health_Insurance_Portability_and_Accountability_Act\" title=\"Health Insurance Portability and Accountability Act\" class=\"wiki-link\" data-key=\"b70673a0117c21576016cb7498867153\">Health Insurance Portability and Accountability Act<\/a> (HIPAA) to <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> and the <a href=\"https:\/\/www.limswiki.org\/index.php\/General_Data_Protection_Regulation\" title=\"General Data Protection Regulation\" class=\"wiki-link\" data-key=\"3f4bdf6f0dcb360b1e79aad8674c2447\">General Data Protection Regulation<\/a>, laboratories have much to consider in regards to what 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_65-0\" class=\"reference\"><a href=\"#cite_note-CiocoiuTheRole10-65\">[65]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-JPMorganData18_66-0\" class=\"reference\"><a href=\"#cite_note-JPMorganData18-66\">[66]<\/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_66-1\" class=\"reference\"><a href=\"#cite_note-JPMorganData18-66\">[66]<\/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_65-1\" class=\"reference\"><a href=\"#cite_note-CiocoiuTheRole10-65\">[65]<\/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 laboratories and research centers. 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=\"2.1.5_System_flexibility\">2.1.5 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 toxicology testing, does your existing laboratory informatics system\u2014or the ones you may be considering\u2014have the flexibility to add other types of clinical 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 clinical testing and expand into other markets 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\">specimen<\/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 itself, while minimizing overall costs and reducing the time required to make any necessary modifications.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"2.1.6_Cost_considerations\">2.1.6 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> <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]). 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_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. 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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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-JPMorganData18-66\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-JPMorganData18_66-0\">66.0<\/a><\/sup> <sup><a href=\"#cite_ref-JPMorganData18_66-1\">66.1<\/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 18 November 2021<\/span>.<\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/Evaluation_and_selection\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20220124225325\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.614 seconds\nReal time usage: 2.665 seconds\nPreprocessor visited node count: 45345\/1000000\nPost\u2010expand include size: 343836\/2097152 bytes\nTemplate argument size: 100977\/2097152 bytes\nHighest expansion depth: 20\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 106315\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 454.709 1 -total\n 89.04% 404.879 1 Template:Reflist\n 71.75% 326.240 66 Template:Citation\/core\n 53.18% 241.802 50 Template:Cite_web\n 15.38% 69.922 12 Template:Cite_journal\n 10.94% 49.743 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/Evaluation_and_selection\n 10.48% 47.639 50 Template:Date\n 9.54% 43.394 4 Template:Cite_book\n 4.22% 19.189 26 Template:Citation\/identifier\n 4.15% 18.852 84 Template:Citation\/make_link\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12933-0!canonical and timestamp 20220124225322 and revision id 45830. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/Evaluation_and_selection\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_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>","cb123f53ac8e5168a41eb4769be28332_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/3\/33\/IBM_1130_%2816758008839%29.jpg","https:\/\/upload.wikimedia.org\/wikipedia\/commons\/d\/dd\/Icos_Laboratories.JPG","https:\/\/upload.wikimedia.org\/wikipedia\/commons\/e\/e2\/Harsh_Vardhan_at_the_inaugural_ceremony_of_the_new_campus_of_Centre_for_DNA_Fingerprinting_and_Diagnostics_%28CDFD%29%2C_in_Hyderabad.JPG","https:\/\/upload.wikimedia.org\/wikipedia\/commons\/d\/d4\/Medical_Examination_of_a_Clinical_Trial_Volunteer_%2845116548811%29.jpg"],"cb123f53ac8e5168a41eb4769be28332_timestamp":1643149331,"8c6565d18a721549cc8050be68c730af_type":"article","8c6565d18a721549cc8050be68c730af_title":"1.7 Medical cannabis testing lab","8c6565d18a721549cc8050be68c730af_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_cannabis_testing_lab","8c6565d18a721549cc8050be68c730af_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction to medical diagnostics and research laboratories\/Medical cannabis testing labFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n1.7 Medical cannabis testing lab \nWhile the research, analysis, and processing of cannabis has been ongoing for centuries[1], it wasn't until 1896 that Wood et al. conducted one of the first documented chemical experiments to determine the constituents of cannabis. Several years later, the researchers were able to correctly identify the extracted and isolated cannabinol from the exuded resin of Indian hemp as C21H26O2.[2] As of mid-2018, somewhere between 104 upwards to more than 140 of the more than 750 constituents of Cannabis sativa have been identified as cannabinoids[3][4][5], \"a class of diverse chemical compounds that act on cannabinoid receptors in cells that modulate neurotransmitter release in the brain.\"[6]\nHowever, at least in the United States, when it comes to 1. enacting the broad level of testing required to ensure public safety\u2014whether it be medical, recreational, or industrial use of cannabis\u2014and 2. researching and better understanding the pharmacokinetics and pharmacodynamics (medical use and benefit) of cannabinoids in the human population, many have argued that laboratory testing of cannabis is still in its infancy[7][8][9][10][11][12] and evidence-based research of marijuana continues to be slow and bogged down in regulation.[13][14][15][16][17] As such, legally researching and analyzing the chemical constituents of cannabis is a complicated task, with much more work to be done. \nRegulation and method standardization woes aside, cannabis is also difficult to analyze due to its matrix, and the task becomes even more difficult when it's added to food and other matrix types, requiring established and consistent methods for testing.[18][19] Regulators, patients, and the testing industry are all calling for improved standardization of both the production and testing of medical and recreational cannabis. Without proper testing, several issues are bound to arise[8][9][7][20][21][22]:\n\nlabel claims may not match actual contents;\ncontaminants may linger, causing illness or even death;\nchemical properties and medicinal benefits of specific strains and their unique cannabinoid-terpene profiles can't be isolated; and\nresearch on potential therapeutic qualities can't be replicated, hindering scientific progress.\nCannabis testing labs are increasingly common in regions and countries where legalization efforts have reached fruition. In particular, the labs analyzing medical cannabis are vitally important for ensuring the best outcomes of patient health. These labs are responsible for analyzing many of the constituents of cannabis, including cannabinoids, terpenes, and contaminates (e.g., pesticides, solvents, heavy metals, mycotoxins, and microorganisms). The test equipment and methods used for these analyses continue to develop and evolve. Testing for cannabinoids may involve chromatography methods such as high-performance liquid chromatography with UV detection (HPLC-UV) or supercritical fluid chromatography (SFC)[21][23], while terpene analysis requires various forms of specialized gas chromatography.[21][24] And heavy metal analysis typically involves some sort of inductively coupled plasma mass spectrometry.[21][23][24]\n\nReferences \n\n\n\u2191 Deitch, R. (2003). Hemp \u2013 American History Revisited. New York City: Algora Publishing. pp. 232. ISBN 9780875862262.   \n \n\n\u2191 Wood, T.B.; Newton Spivey, W.T.; Easterfield, T.H. (1899). \"III.\u2014Cannabinol. Part I\". Journal of the Chemical Society, Transactions 75: 30\u201336. doi:10.1039\/CT8997500020.   \n \n\n\u2191 Radwan, M.M.; ElSohly, M.A.; El-Alfy, A.T. et al. (2015). \"Isolation and pharmacological evaluation of minor cannabinoids from high-potency Cannabis sativa\". Journal of Natural Products 78 (6): 1271-6. doi:10.1021\/acs.jnatprod.5b00065. PMC PMC4880513. PMID 26000707. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC4880513 .   \n \n\n\u2191 Solymosi, K.; K\u00f6falvi, A. (2017). \"Cannabis: A Treasure Trove or Pandora's Box?\". Mini-Reviews in Medicinal Chemistry 17: 1123\u201391. doi:10.2174\/1389557516666161004162133.   \n \n\n\u2191 Mudge, E.M.; Murch, S.J.; Brown, P.N. (2018). \"Chemometric Analysis of Cannabinoids: Chemotaxonomy and Domestication Syndrome\". Scientific Reports 8: 13090. doi:10.1038\/s41598-018-31120-2.   \n \n\n\u2191 World Health Organization (2016). Hall, W.; Renstr\u00f6m, M.; Poznyak, V. ed. The health and social effects of nonmedical cannabis use. World Health Organization. pp. 95. ISBN 978921510240. https:\/\/www.who.int\/publications\/i\/item\/9789241510240 .   \n \n\n\u2191 7.0 7.1 Hazekamp, A.; Fischedick, J.T. (2012). \"Cannabis - from cultivar to chemovar\". Drug Testing and Analysis 4 (7\u20138): 660\u20137. doi:10.1002\/dta.407. PMID 22362625.   \n \n\n\u2191 8.0 8.1 Bush, E. (18 February 2015). \"World\u2019s strongest weed? Potency testing challenged\". The Seattle Times. The Seattle Times Company. https:\/\/www.seattletimes.com\/seattle-news\/worldrsquos-strongest-weed-potency-testing-challenged\/ . Retrieved 18 November 2021 .   \n \n\n\u2191 9.0 9.1 Rutsch, P. (24 March 2015). \"Quality-Testing Legal Marijuana: Strong But Not Always Clean\". Shots. National Public Radio. https:\/\/www.npr.org\/sections\/health-shots\/2015\/03\/24\/395065699\/quality-testing-legal-marijuana-strong-but-not-always-clean . Retrieved 18 November 2021 .   \n \n\n\u2191 Kuzdzal, S.; Lipps, W. (2015). \"Unraveling the Cannabinome\". The Analytical Scientist (0915). https:\/\/theanalyticalscientist.com\/techniques-tools\/unraveling-the-cannabinome . Retrieved 18 November 2021 .   \n \n\n\u2191 Crombie, N. (25 July 2016). \"Marijuana labs prepping for regulation and oversight; no lab licenses issued yet\". The Oregonian. Oregon Live LLC. https:\/\/www.oregonlive.com\/marijuana\/2016\/07\/marijuana_labs_prepping_for_st.html . Retrieved 18 November 2021 .   \n \n\n\u2191 Kuzdzal, S.; Clifford, R.; Winkler, P.; Bankert, W. (December 2017). \"A Closer Look at Cannabis Testing\" (PDF). Shimadzu Corporation. https:\/\/www.ssi.shimadzu.com\/sites\/ssi.shimadzu.com\/files\/Industry\/Literature\/Shimadzu_Whitepaper_Emerging_Cannabis_Industry.pdf . Retrieved 18 November 2021 .   \n \n\n\u2191 Bajaj, V. (30 July 2014). \"How the Federal Government Slows Marijuana Research\". Taking Note: The New York Times. The New York Times Company. https:\/\/takingnote.blogs.nytimes.com\/2014\/07\/30\/how-the-federal-government-slows-marijuana-research\/ . Retrieved 18 November 2021 .   \n \n\n\u2191 Chesler, J.; Ard, A. (15 August 2015). \"Government restrictions, lack of funding slow progress on medical marijuana research\". News21: America's Weed Rush. Carnegie Corporation of New York; John S. and James L. Knight Foundation. https:\/\/weedrush.news21.com\/government-restrictions-lack-of-funding-slow-progress-on-medical-marijuana-research\/ . Retrieved 18 November 2021 .   \n \n\n\u2191 Weiss, S.R.B. (13 July 2016). \"Testimony from Susan R.B. Weiss, Ph.D. on The State of the Science on the Therapeutic Potential of Marijuana and Cannabinoids before Judiciary Committee\". ASL Testimony. U.S. Department of Health & Human Services. Archived from the original on 04 May 2017. https:\/\/web.archive.org\/web\/20170504180135\/https:\/\/www.hhs.gov\/about\/agencies\/asl\/testimony\/2016-09\/the-state-of-the-science-on-the-therapeutic-potential-of-marijuana-and-cannabinoids\/index.html . Retrieved 18 November 2021 .   \n \n\n\u2191 Joseph, A. (10 August 2016). \"DEA decision keeps major restrictions in place on marijuana research\". STAT. Boston Globe Media. https:\/\/www.statnews.com\/2016\/08\/10\/marijuana-medical-research-dea\/ . Retrieved 18 November 2021 .   \n \n\n\u2191 Rudroff, T. (21 January 2017). \"Marijuana Regulation Blocks Vital Multiple Sclerosis Research\". Newsweek. IBT Media, Inc. https:\/\/www.newsweek.com\/marijuana-regulation-blocks-vital-ms-research-544886 . Retrieved 18 November 2021 .   \n \n\n\u2191 DePalma, A. (10 September 2018). \"Challenges of Cannabis Contaminant Testing\". Lab Manager. LabX Media Group. https:\/\/www.labmanager.com\/insights\/challenges-of-cannabis-contaminant-testing-1928 . Retrieved 18 November 2021 .   \n \n\n\u2191 Cummings, J., \"Gurus of Pesticide Residue Analysis [The Cannabis Scientist\"] (PDF), The Analytical Scientist (Texere Logo Texere Publishing Ltd) (0218), https:\/\/theanalyticalscientist.com\/fileadmin\/tas\/pdf-versions\/TCS_Issue4.pdf   \n \n\n\u2191 Kuzdzal, S.; Clifford, R.; Winkler, P.; Bankert, W. (December 2017). \"A Closer Look at Cannabis Testing\" (PDF). Shimadzu Corporation. https:\/\/www.ssi.shimadzu.com\/sites\/ssi.shimadzu.com\/files\/Industry\/Literature\/Shimadzu_Whitepaper_Emerging_Cannabis_Industry.pdf . Retrieved 18 November 2020 .   \n \n\n\u2191 21.0 21.1 21.2 21.3 Cassiday, L. (October 2016). \"The Highs and Lows of Cannabis Testing\". INFORM. American Oil Chemists' Society. https:\/\/www.aocs.org\/stay-informed\/inform-magazine\/featured-articles\/the-highs-and-lows-of-cannabis-testing-october-2016 . Retrieved 18 November 2021 .   \n \n\n\u2191 \"How Accurate Is Cannabis Potency Testing?\". California NORML. 21 September 2011. https:\/\/www.canorml.org\/business-resources-for-cannabis-brands\/how-accurate-is-cannabis-potency-testing\/ . Retrieved 18 November 2021 .   \n \n\n\u2191 23.0 23.1 Association of Public Health Laboratories (May 2016). \"Guidance for State Medical Cannabis Testing Programs\" (PDF). pp. 35. https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/EH-Guide-State-Med-Cannabis-052016.pdf . Retrieved 18 November 2021 .   \n \n\n\u2191 24.0 24.1 \"Cannabis Testing Laboratory Solutions\" (PDF). Shimadzu Corporation. Archived from the original on 27 March 2016. https:\/\/web.archive.org\/web\/20160327180816\/https:\/\/www.ssi.shimadzu.com\/products\/literature\/life_science\/shimadzu_cannabis_brochure.pdf . Retrieved 18 November 2021 .   \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 medical diagnostics and research laboratories\nTitle: Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\nEdition: 2022 Edition\nAuthor for citation: Shawn E. Douglas\nLicense for content: Creative Commons Attribution-ShareAlike 4.0 International\nPublication date: January 2022\n\r\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_cannabis_testing_lab\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_cannabis_testing_lab<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:03.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 31 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","8c6565d18a721549cc8050be68c730af_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Introduction_to_medical_diagnostics_and_research_laboratories_Medical_cannabis_testing_lab rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Introduction_to_medical_diagnostics_and_research_laboratories_Medical_cannabis_testing_lab 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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction to medical diagnostics and research laboratories\/Medical cannabis testing lab<\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">the beginning<\/a> of this guide-----<\/div>\n<h3><span class=\"mw-headline\" id=\"1.7_Medical_cannabis_testing_lab\">1.7 Medical cannabis testing lab<\/span><\/h3>\n<p>While the research, analysis, and processing of cannabis has been ongoing for centuries<sup id=\"rdp-ebb-cite_ref-DeitchHemp03_1-0\" class=\"reference\"><a href=\"#cite_note-DeitchHemp03-1\">[1]<\/a><\/sup>, it wasn't until 1896 that Wood <i>et al.<\/i> conducted one of the first documented chemical experiments to determine the constituents of cannabis. Several years later, the researchers were able to correctly identify the extracted and isolated cannabinol from the exuded resin of Indian hemp as C<sub>21<\/sub>H<sub>26<\/sub>O<sub>2<\/sub>.<sup id=\"rdp-ebb-cite_ref-WoodCann1899_2-0\" class=\"reference\"><a href=\"#cite_note-WoodCann1899-2\">[2]<\/a><\/sup> As of mid-2018, somewhere between 104 upwards to more than 140 of the more than 750 constituents of <i>Cannabis sativa<\/i> have been identified as cannabinoids<sup id=\"rdp-ebb-cite_ref-RadwanIso15_3-0\" class=\"reference\"><a href=\"#cite_note-RadwanIso15-3\">[3]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-SolymosiCanna17_4-0\" class=\"reference\"><a href=\"#cite_note-SolymosiCanna17-4\">[4]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MudgeChemo18_5-0\" class=\"reference\"><a href=\"#cite_note-MudgeChemo18-5\">[5]<\/a><\/sup>, \"a class of diverse chemical compounds that act on cannabinoid receptors in cells that modulate neurotransmitter release in the brain.\"<sup id=\"rdp-ebb-cite_ref-WHOTheHealth16_6-0\" class=\"reference\"><a href=\"#cite_note-WHOTheHealth16-6\">[6]<\/a><\/sup>\n<\/p><p>However, at least in the United States, when it comes to 1. enacting the broad level of testing required to ensure public safety\u2014whether it be medical, recreational, or industrial use of cannabis\u2014and 2. researching and better understanding the pharmacokinetics and pharmacodynamics (medical use and benefit) of cannabinoids in the human population, many have argued that laboratory testing of cannabis is still in its infancy<sup id=\"rdp-ebb-cite_ref-HazekampCanna12_7-0\" class=\"reference\"><a href=\"#cite_note-HazekampCanna12-7\">[7]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BushWorlds15_8-0\" class=\"reference\"><a href=\"#cite_note-BushWorlds15-8\">[8]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-RutschQuality15_9-0\" class=\"reference\"><a href=\"#cite_note-RutschQuality15-9\">[9]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-KuzdzalUnrav15_10-0\" class=\"reference\"><a href=\"#cite_note-KuzdzalUnrav15-10\">[10]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CrombieMari16_11-0\" class=\"reference\"><a href=\"#cite_note-CrombieMari16-11\">[11]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-KuzdzalACloser16_12-0\" class=\"reference\"><a href=\"#cite_note-KuzdzalACloser16-12\">[12]<\/a><\/sup> and evidence-based research of marijuana continues to be slow and bogged down in regulation.<sup id=\"rdp-ebb-cite_ref-BajajHowThe14_13-0\" class=\"reference\"><a href=\"#cite_note-BajajHowThe14-13\">[13]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CheslerGov15_14-0\" class=\"reference\"><a href=\"#cite_note-CheslerGov15-14\">[14]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-WeissTestimony16_15-0\" class=\"reference\"><a href=\"#cite_note-WeissTestimony16-15\">[15]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-JosephDEA16_16-0\" class=\"reference\"><a href=\"#cite_note-JosephDEA16-16\">[16]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-RudroffMari17_17-0\" class=\"reference\"><a href=\"#cite_note-RudroffMari17-17\">[17]<\/a><\/sup> As such, legally researching and analyzing the chemical constituents of cannabis is a complicated task, with much more work to be done. \n<\/p><p>Regulation and method standardization woes aside, cannabis is also difficult to analyze due to its matrix, and the task becomes even more difficult when it's added to food and other matrix types, requiring established and consistent methods for testing.<sup id=\"rdp-ebb-cite_ref-DePalmaChallenges18_18-0\" class=\"reference\"><a href=\"#cite_note-DePalmaChallenges18-18\">[18]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CummingsGurus18_19-0\" class=\"reference\"><a href=\"#cite_note-CummingsGurus18-19\">[19]<\/a><\/sup> Regulators, patients, and the testing industry are all calling for improved standardization of both the production and testing of medical and recreational cannabis. Without proper testing, several issues are bound to arise<sup id=\"rdp-ebb-cite_ref-BushWorlds15_8-1\" class=\"reference\"><a href=\"#cite_note-BushWorlds15-8\">[8]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-RutschQuality15_9-1\" class=\"reference\"><a href=\"#cite_note-RutschQuality15-9\">[9]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-HazekampCanna12_7-1\" class=\"reference\"><a href=\"#cite_note-HazekampCanna12-7\">[7]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-KuzdzalACloser17_20-0\" class=\"reference\"><a href=\"#cite_note-KuzdzalACloser17-20\">[20]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CassidayTheHighs16_21-0\" class=\"reference\"><a href=\"#cite_note-CassidayTheHighs16-21\">[21]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CANORMLHow11_22-0\" class=\"reference\"><a href=\"#cite_note-CANORMLHow11-22\">[22]<\/a><\/sup>:\n<\/p>\n<ul><li>label claims may not match actual contents;<\/li>\n<li>contaminants may linger, causing illness or even death;<\/li>\n<li>chemical properties and medicinal benefits of specific strains and their unique cannabinoid-terpene profiles can't be isolated; and<\/li>\n<li>research on potential therapeutic qualities can't be replicated, hindering scientific progress.<\/li><\/ul>\n<p>Cannabis testing labs are increasingly common in regions and countries where legalization efforts have reached fruition. In particular, the labs analyzing medical cannabis are vitally important for ensuring the best outcomes of patient health. These labs are responsible for analyzing many of the constituents of cannabis, including cannabinoids, terpenes, and contaminates (e.g., pesticides, solvents, heavy metals, mycotoxins, and microorganisms). The test equipment and methods used for these analyses continue to develop and evolve. Testing for cannabinoids may involve <a href=\"https:\/\/www.limswiki.org\/index.php\/Chromatography\" title=\"Chromatography\" class=\"wiki-link\" data-key=\"2615535d1f14c6cffdfad7285999ad9d\">chromatography<\/a> methods such as <a href=\"https:\/\/www.limswiki.org\/index.php\/High-performance_liquid_chromatography\" title=\"High-performance liquid chromatography\" class=\"wiki-link\" data-key=\"dc274e995eb18113903eebaef69c0cf9\">high-performance liquid chromatography<\/a> with UV detection (HPLC-UV) or <a href=\"https:\/\/www.limswiki.org\/index.php\/Supercritical_fluid_chromatography\" title=\"Supercritical fluid chromatography\" class=\"wiki-link\" data-key=\"e54a3c2f99b22d52e8aa54e2832319aa\">supercritical fluid chromatography<\/a> (SFC)<sup id=\"rdp-ebb-cite_ref-CassidayTheHighs16_21-1\" class=\"reference\"><a href=\"#cite_note-CassidayTheHighs16-21\">[21]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-APHLGuide16_23-0\" class=\"reference\"><a href=\"#cite_note-APHLGuide16-23\">[23]<\/a><\/sup>, while terpene analysis requires various forms of specialized <a href=\"https:\/\/www.limswiki.org\/index.php\/Gas_chromatography\" title=\"Gas chromatography\" class=\"wiki-link\" data-key=\"e621fc6f90266fbc8db27d516e9cbb94\">gas chromatography<\/a>.<sup id=\"rdp-ebb-cite_ref-CassidayTheHighs16_21-2\" class=\"reference\"><a href=\"#cite_note-CassidayTheHighs16-21\">[21]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ShimadzuCLTS_24-0\" class=\"reference\"><a href=\"#cite_note-ShimadzuCLTS-24\">[24]<\/a><\/sup> And heavy metal analysis typically involves some sort of <a href=\"https:\/\/www.limswiki.org\/index.php\/Inductively_coupled_plasma_mass_spectrometry\" title=\"Inductively coupled plasma mass spectrometry\" class=\"wiki-link\" data-key=\"56b77f19f090a156bf0d78c71c76da21\">inductively coupled plasma mass spectrometry<\/a>.<sup id=\"rdp-ebb-cite_ref-CassidayTheHighs16_21-3\" class=\"reference\"><a href=\"#cite_note-CassidayTheHighs16-21\">[21]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-APHLGuide16_23-1\" class=\"reference\"><a href=\"#cite_note-APHLGuide16-23\">[23]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ShimadzuCLTS_24-1\" class=\"reference\"><a href=\"#cite_note-ShimadzuCLTS-24\">[24]<\/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-DeitchHemp03-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-DeitchHemp03_1-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Deitch, R. (2003). <i>Hemp \u2013 American History Revisited<\/i>. New York City: Algora Publishing. pp. 232. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 9780875862262.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Hemp+%E2%80%93+American+History+Revisited&rft.aulast=Deitch%2C+R.&rft.au=Deitch%2C+R.&rft.date=2003&rft.pages=pp.%26nbsp%3B232&rft.place=New+York+City&rft.pub=Algora+Publishing&rft.isbn=9780875862262&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_cannabis_testing_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-WoodCann1899-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-WoodCann1899_2-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Wood, T.B.; Newton Spivey, W.T.; Easterfield, T.H. (1899). \"III.\u2014Cannabinol. Part I\". <i>Journal of the Chemical Society, Transactions<\/i> <b>75<\/b>: 30\u201336. <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%2FCT8997500020\" target=\"_blank\">10.1039\/CT8997500020<\/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=III.%E2%80%94Cannabinol.+Part+I&rft.jtitle=Journal+of+the+Chemical+Society%2C+Transactions&rft.aulast=Wood%2C+T.B.%3B+Newton+Spivey%2C+W.T.%3B+Easterfield%2C+T.H.&rft.au=Wood%2C+T.B.%3B+Newton+Spivey%2C+W.T.%3B+Easterfield%2C+T.H.&rft.date=1899&rft.volume=75&rft.pages=30%E2%80%9336&rft_id=info:doi\/10.1039%2FCT8997500020&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_cannabis_testing_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-RadwanIso15-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-RadwanIso15_3-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Radwan, M.M.; ElSohly, M.A.; El-Alfy, A.T. et al. (2015). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC4880513\" target=\"_blank\">\"Isolation and pharmacological evaluation of minor cannabinoids from high-potency <i>Cannabis sativa<\/i>\"<\/a>. <i>Journal of Natural Products<\/i> <b>78<\/b> (6): 1271-6. <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\/10.1021%2Facs.jnatprod.5b00065\" target=\"_blank\">10.1021\/acs.jnatprod.5b00065<\/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\/PMC4880513\/\" target=\"_blank\">PMC4880513<\/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\/26000707\" target=\"_blank\">26000707<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC4880513\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC4880513<\/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=Isolation+and+pharmacological+evaluation+of+minor+cannabinoids+from+high-potency+%27%27Cannabis+sativa%27%27&rft.jtitle=Journal+of+Natural+Products&rft.aulast=Radwan%2C+M.M.%3B+ElSohly%2C+M.A.%3B+El-Alfy%2C+A.T.+et+al.&rft.au=Radwan%2C+M.M.%3B+ElSohly%2C+M.A.%3B+El-Alfy%2C+A.T.+et+al.&rft.date=2015&rft.volume=78&rft.issue=6&rft.pages=1271-6&rft_id=info:doi\/10.1021%2Facs.jnatprod.5b00065&rft_id=info:pmc\/PMC4880513&rft_id=info:pmid\/26000707&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC4880513&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_cannabis_testing_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-SolymosiCanna17-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-SolymosiCanna17_4-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Solymosi, K.; K\u00f6falvi, A. (2017). \"<i>Cannabis<\/i>: A Treasure Trove or Pandora's Box?\". <i>Mini-Reviews in Medicinal Chemistry<\/i> <b>17<\/b>: 1123\u201391. <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\/10.2174%2F1389557516666161004162133\" target=\"_blank\">10.2174\/1389557516666161004162133<\/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=%27%27Cannabis%27%27%3A+A+Treasure+Trove+or+Pandora%27s+Box%3F&rft.jtitle=Mini-Reviews+in+Medicinal+Chemistry&rft.aulast=Solymosi%2C+K.%3B+K%C3%B6falvi%2C+A.&rft.au=Solymosi%2C+K.%3B+K%C3%B6falvi%2C+A.&rft.date=2017&rft.volume=17&rft.pages=1123%E2%80%9391&rft_id=info:doi\/10.2174%2F1389557516666161004162133&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_cannabis_testing_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MudgeChemo18-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MudgeChemo18_5-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Mudge, E.M.; Murch, S.J.; Brown, P.N. (2018). \"Chemometric Analysis of Cannabinoids: Chemotaxonomy and Domestication Syndrome\". <i>Scientific Reports<\/i> <b>8<\/b>: 13090. <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\/10.1038%2Fs41598-018-31120-2\" target=\"_blank\">10.1038\/s41598-018-31120-2<\/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=Chemometric+Analysis+of+Cannabinoids%3A+Chemotaxonomy+and+Domestication+Syndrome&rft.jtitle=Scientific+Reports&rft.aulast=Mudge%2C+E.M.%3B+Murch%2C+S.J.%3B+Brown%2C+P.N.&rft.au=Mudge%2C+E.M.%3B+Murch%2C+S.J.%3B+Brown%2C+P.N.&rft.date=2018&rft.volume=8&rft.pages=13090&rft_id=info:doi\/10.1038%2Fs41598-018-31120-2&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_cannabis_testing_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-WHOTheHealth16-6\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-WHOTheHealth16_6-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">World Health Organization (2016). Hall, W.; Renstr\u00f6m, M.; Poznyak, V. ed. <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/publications\/i\/item\/9789241510240\" target=\"_blank\"><i>The health and social effects of nonmedical cannabis use<\/i><\/a>. 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Retrieved 18 November 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Testimony+from+Susan+R.B.+Weiss%2C+Ph.D.+on+The+State+of+the+Science+on+the+Therapeutic+Potential+of+Marijuana+and+Cannabinoids+before+Judiciary+Committee&rft.atitle=ASL+Testimony&rft.aulast=Weiss%2C+S.R.B.&rft.au=Weiss%2C+S.R.B.&rft.date=13+July+2016&rft.pub=U.S.+Department+of+Health+%26+Human+Services&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20170504180135%2Fhttps%3A%2F%2Fwww.hhs.gov%2Fabout%2Fagencies%2Fasl%2Ftestimony%2F2016-09%2Fthe-state-of-the-science-on-the-therapeutic-potential-of-marijuana-and-cannabinoids%2Findex.html&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_cannabis_testing_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-JosephDEA16-16\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-JosephDEA16_16-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Joseph, A. 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Retrieved 18 November 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=DEA+decision+keeps+major+restrictions+in+place+on+marijuana+research&rft.atitle=STAT&rft.aulast=Joseph%2C+A.&rft.au=Joseph%2C+A.&rft.date=10+August+2016&rft.pub=Boston+Globe+Media&rft_id=https%3A%2F%2Fwww.statnews.com%2F2016%2F08%2F10%2Fmarijuana-medical-research-dea%2F&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_cannabis_testing_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-RudroffMari17-17\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-RudroffMari17_17-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Rudroff, T. (21 January 2017). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.newsweek.com\/marijuana-regulation-blocks-vital-ms-research-544886\" target=\"_blank\">\"Marijuana Regulation Blocks Vital Multiple Sclerosis Research\"<\/a>. <i>Newsweek<\/i>. IBT Media, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.newsweek.com\/marijuana-regulation-blocks-vital-ms-research-544886\" target=\"_blank\">https:\/\/www.newsweek.com\/marijuana-regulation-blocks-vital-ms-research-544886<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Marijuana+Regulation+Blocks+Vital+Multiple+Sclerosis+Research&rft.atitle=Newsweek&rft.aulast=Rudroff%2C+T.&rft.au=Rudroff%2C+T.&rft.date=21+January+2017&rft.pub=IBT+Media%2C+Inc&rft_id=https%3A%2F%2Fwww.newsweek.com%2Fmarijuana-regulation-blocks-vital-ms-research-544886&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_cannabis_testing_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-DePalmaChallenges18-18\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-DePalmaChallenges18_18-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">DePalma, A. (10 September 2018). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.labmanager.com\/insights\/challenges-of-cannabis-contaminant-testing-1928\" target=\"_blank\">\"Challenges of Cannabis Contaminant Testing\"<\/a>. <i>Lab Manager<\/i>. LabX Media Group<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.labmanager.com\/insights\/challenges-of-cannabis-contaminant-testing-1928\" target=\"_blank\">https:\/\/www.labmanager.com\/insights\/challenges-of-cannabis-contaminant-testing-1928<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Challenges+of+Cannabis+Contaminant+Testing&rft.atitle=Lab+Manager&rft.aulast=DePalma%2C+A.&rft.au=DePalma%2C+A.&rft.date=10+September+2018&rft.pub=LabX+Media+Group&rft_id=https%3A%2F%2Fwww.labmanager.com%2Finsights%2Fchallenges-of-cannabis-contaminant-testing-1928&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_cannabis_testing_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CummingsGurus18-19\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CummingsGurus18_19-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation\" id=\"rdp-ebb-CITEREFCummings.2C_J.2018\">Cummings, J., <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/theanalyticalscientist.com\/fileadmin\/tas\/pdf-versions\/TCS_Issue4.pdf\" target=\"_blank\">\"Gurus of Pesticide Residue Analysis [The Cannabis Scientist<\/a>\"] (PDF), <i>The Analytical Scientist<\/i> (Texere Logo Texere Publishing Ltd) (0218)<span class=\"printonly\">, <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/theanalyticalscientist.com\/fileadmin\/tas\/pdf-versions\/TCS_Issue4.pdf\" target=\"_blank\">https:\/\/theanalyticalscientist.com\/fileadmin\/tas\/pdf-versions\/TCS_Issue4.pdf<\/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=Gurus+of+Pesticide+Residue+Analysis+%5BThe+Cannabis+Scientist%5D&rft.jtitle=The+Analytical+Scientist&rft.aulast=Cummings%2C+J.&rft.au=Cummings%2C+J.&rft.issue=0218&rft.pub=Texere+Logo+Texere+Publishing+Ltd&rft_id=https%3A%2F%2Ftheanalyticalscientist.com%2Ffileadmin%2Ftas%2Fpdf-versions%2FTCS_Issue4.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_cannabis_testing_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-KuzdzalACloser17-20\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-KuzdzalACloser17_20-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Kuzdzal, S.; Clifford, R.; Winkler, P.; Bankert, W. (December 2017). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ssi.shimadzu.com\/sites\/ssi.shimadzu.com\/files\/Industry\/Literature\/Shimadzu_Whitepaper_Emerging_Cannabis_Industry.pdf\" target=\"_blank\">\"A Closer Look at Cannabis Testing\"<\/a> (PDF). Shimadzu Corporation<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.ssi.shimadzu.com\/sites\/ssi.shimadzu.com\/files\/Industry\/Literature\/Shimadzu_Whitepaper_Emerging_Cannabis_Industry.pdf\" target=\"_blank\">https:\/\/www.ssi.shimadzu.com\/sites\/ssi.shimadzu.com\/files\/Industry\/Literature\/Shimadzu_Whitepaper_Emerging_Cannabis_Industry.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 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=A+Closer+Look+at+Cannabis+Testing&rft.atitle=&rft.aulast=Kuzdzal%2C+S.%3B+Clifford%2C+R.%3B+Winkler%2C+P.%3B+Bankert%2C+W.&rft.au=Kuzdzal%2C+S.%3B+Clifford%2C+R.%3B+Winkler%2C+P.%3B+Bankert%2C+W.&rft.date=December+2017&rft.pub=Shimadzu+Corporation&rft_id=https%3A%2F%2Fwww.ssi.shimadzu.com%2Fsites%2Fssi.shimadzu.com%2Ffiles%2FIndustry%2FLiterature%2FShimadzu_Whitepaper_Emerging_Cannabis_Industry.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_cannabis_testing_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CassidayTheHighs16-21\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-CassidayTheHighs16_21-0\">21.0<\/a><\/sup> <sup><a href=\"#cite_ref-CassidayTheHighs16_21-1\">21.1<\/a><\/sup> <sup><a href=\"#cite_ref-CassidayTheHighs16_21-2\">21.2<\/a><\/sup> <sup><a href=\"#cite_ref-CassidayTheHighs16_21-3\">21.3<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Cassiday, L. (October 2016). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aocs.org\/stay-informed\/inform-magazine\/featured-articles\/the-highs-and-lows-of-cannabis-testing-october-2016\" target=\"_blank\">\"The Highs and Lows of Cannabis Testing\"<\/a>. <i>INFORM<\/i>. American Oil Chemists' Society<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.aocs.org\/stay-informed\/inform-magazine\/featured-articles\/the-highs-and-lows-of-cannabis-testing-october-2016\" target=\"_blank\">https:\/\/www.aocs.org\/stay-informed\/inform-magazine\/featured-articles\/the-highs-and-lows-of-cannabis-testing-october-2016<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/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+Highs+and+Lows+of+Cannabis+Testing&rft.atitle=INFORM&rft.aulast=Cassiday%2C+L.&rft.au=Cassiday%2C+L.&rft.date=October+2016&rft.pub=American+Oil+Chemists%27+Society&rft_id=https%3A%2F%2Fwww.aocs.org%2Fstay-informed%2Finform-magazine%2Ffeatured-articles%2Fthe-highs-and-lows-of-cannabis-testing-october-2016&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_cannabis_testing_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CANORMLHow11-22\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CANORMLHow11_22-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.canorml.org\/business-resources-for-cannabis-brands\/how-accurate-is-cannabis-potency-testing\/\" target=\"_blank\">\"How Accurate Is Cannabis Potency Testing?\"<\/a>. California NORML. 21 September 2011<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.canorml.org\/business-resources-for-cannabis-brands\/how-accurate-is-cannabis-potency-testing\/\" target=\"_blank\">https:\/\/www.canorml.org\/business-resources-for-cannabis-brands\/how-accurate-is-cannabis-potency-testing\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/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+Accurate+Is+Cannabis+Potency+Testing%3F&rft.atitle=&rft.date=21+September+2011&rft.pub=California+NORML&rft_id=https%3A%2F%2Fwww.canorml.org%2Fbusiness-resources-for-cannabis-brands%2Fhow-accurate-is-cannabis-potency-testing%2F&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_cannabis_testing_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-APHLGuide16-23\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-APHLGuide16_23-0\">23.0<\/a><\/sup> <sup><a href=\"#cite_ref-APHLGuide16_23-1\">23.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Association of Public Health Laboratories (May 2016). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/EH-Guide-State-Med-Cannabis-052016.pdf\" target=\"_blank\">\"Guidance for State Medical Cannabis Testing Programs\"<\/a> (PDF). pp. 35<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/EH-Guide-State-Med-Cannabis-052016.pdf\" target=\"_blank\">https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/EH-Guide-State-Med-Cannabis-052016.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Guidance+for+State+Medical+Cannabis+Testing+Programs&rft.atitle=&rft.aulast=Association+of+Public+Health+Laboratories&rft.au=Association+of+Public+Health+Laboratories&rft.date=May+2016&rft.pages=pp.+35&rft_id=https%3A%2F%2Fwww.aphl.org%2FaboutAPHL%2Fpublications%2FDocuments%2FEH-Guide-State-Med-Cannabis-052016.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_cannabis_testing_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ShimadzuCLTS-24\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-ShimadzuCLTS_24-0\">24.0<\/a><\/sup> <sup><a href=\"#cite_ref-ShimadzuCLTS_24-1\">24.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20160327180816\/https:\/\/www.ssi.shimadzu.com\/products\/literature\/life_science\/shimadzu_cannabis_brochure.pdf\" target=\"_blank\">\"Cannabis Testing Laboratory Solutions\"<\/a> (PDF). Shimadzu Corporation. Archived from <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ssi.shimadzu.com\/products\/literature\/life_science\/shimadzu_cannabis_brochure.pdf\" target=\"_blank\">the original<\/a> on 27 March 2016<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20160327180816\/https:\/\/www.ssi.shimadzu.com\/products\/literature\/life_science\/shimadzu_cannabis_brochure.pdf\" target=\"_blank\">https:\/\/web.archive.org\/web\/20160327180816\/https:\/\/www.ssi.shimadzu.com\/products\/literature\/life_science\/shimadzu_cannabis_brochure.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Cannabis+Testing+Laboratory+Solutions&rft.atitle=&rft.pub=Shimadzu+Corporation&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20160327180816%2Fhttps%3A%2F%2Fwww.ssi.shimadzu.com%2Fproducts%2Fliterature%2Flife_science%2Fshimadzu_cannabis_brochure.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_cannabis_testing_lab\"><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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/Evaluation_and_selection\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Choosing laboratory informatics software for your lab\/Evaluation and selection\" class=\"wiki-link\" data-key=\"cb123f53ac8e5168a41eb4769be28332\">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 medical diagnostics and research laboratories\n<\/p><p><b>Title<\/b>: <i>Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research<\/i>\n<\/p><p><b>Edition<\/b>: 2022 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 2022\n<\/p><p><br \/>\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20220125221414\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.186 seconds\nReal time usage: 0.265 seconds\nPreprocessor visited node count: 17267\/1000000\nPost\u2010expand include size: 142654\/2097152 bytes\nTemplate argument size: 53858\/2097152 bytes\nHighest expansion depth: 20\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 45599\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 223.807 1 -total\n 91.96% 205.809 1 Template:Reflist\n 61.43% 137.479 24 Template:Citation\/core\n 37.42% 83.758 15 Template:Cite_web\n 16.58% 37.107 2 Template:Cite_book\n 14.33% 32.075 6 Template:Cite_journal\n 9.20% 20.588 14 Template:Date\n 9.01% 20.174 1 Template:Cite\n 8.01% 17.923 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_cannabis_testing_lab\n 6.06% 13.557 36 Template:Citation\/make_link\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12932-0!canonical and timestamp 20220125221414 and revision id 45829. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_cannabis_testing_lab\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_cannabis_testing_lab<\/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>","8c6565d18a721549cc8050be68c730af_images":[],"8c6565d18a721549cc8050be68c730af_timestamp":1643149331,"2842b58d0dc62a7918e218976fe37109_type":"article","2842b58d0dc62a7918e218976fe37109_title":"1.6 Genetic diagnostics lab","2842b58d0dc62a7918e218976fe37109_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Genetic_diagnostics_lab","2842b58d0dc62a7918e218976fe37109_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction to medical diagnostics and research laboratories\/Genetic diagnostics labFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n1.6 Genetic diagnostics lab \nIn 2018, the World Health Organization (WHO) noted the following about modern genetic testing[1]:\nPrior to the development of modern genetic technologies, genetic services were limited to genetic counselling, where health professionals would attempt to characterize the genetic contribution of diseases based on family histories. With the discovery of DNA, genetic services have dramatically increased in quality and scope. Increasingly sophisticated technologies now permit new methodology and high quality preparations, ensuring greater accuracy in diagnosis.\nA genetic diagnostics lab uses genetic testing to evaluate DNA in the search for a genetic cause for symptoms or a disease. The lab may also have other responsibilities or goals, including interpreting results for physicians, detecting mutations, developing new analytical methods, and improving patient care through its discoveries.[1][2] \nThe WHO classifies genetic testing into five broad categories[1]:\n\nCarrier identification screening: a test that checks one or more individuals for whether or not they carry a genetic marker for a specific disease (e.g., cystic fibrosis)\nPrenatal diagnostic testing: a series of tests using routine in vitro fertilization methods when a gestating child is thought to have a genetically caused disease (e.g., Down syndrome)\nNewborn screening: one or more preventative health tests for treating a newborn early when treatment is available (e.g., congenital hypothyroidism)\nLate-onset disorder testing: testing that occurs later in life to determine susceptibility of an individual to a particular disease (e.g., cancer and heart disease)\nIdentity testing: testing that \"involves profiling the individuals genetic information from DNA test results of genetic markers in order to locate characteristics unique to the individual\" (often used in forensic and criminal investigations)\nAs for the techniques used in genetic testing, the American Association for Clinical Chemistry (AACC) has five categories of techniques: polymerase chain reaction (PCR), DNA sequencing, microarrays, gene expression profiling, and cytogenetics. (For more on cytogenetics, see the following subsection.) The PCR technique is a copying technique that \"enables specific genes or regions of interest to be detected or measured.\" DNA sequencing (e.g., next-generation sequencing or NGS) allows scientists to identify changes or variations in the way DNA is arranged that may indicate a disorder. Microarray testing has multiple uses, among them identifying duplications, deletions, or identical sections in DNA, which may indicate a propensity for a particular disease. Gene expression profiling looks at the genes of cells and determines if they are actively making proteins or not for aiding in prognosis, recurrence, and other types of diagnostic indicators for disease.[3]\n\n1.6.1 Cytogenetics lab \nCytogenetics is a subcategory of genetics that specifically studies chromosomes and their structures. \"Trained cytogeneticists examine the number, shape, and staining pattern of these structures using special technologies. In this way, they can detect extra chromosomes, missing chromosomes, missing or extra pieces of chromosomes, or rearranged chromosomes.\"[3] Some diseases occur as the result of these chromosomal anomalies; for example, amplification of a particular gene in breast cancer or translocation of part of a chromosome in chronic myelogenous leukemia may be spotted with cytogenetic techniques.[3]\nThe cytogenetics laboratory depends on several analytical techniques to make these sorts of genetic discoveries in a patient. Methods include chromosome analysis or karyotyping, fluorescence in situ hybridization (FISH), and microarray-based assays such as comparative genomic hybridization.[3][4][5] Karyotyping involves the separation of whole chromosomes from the nuclei of cells that have been stained with special dyes, cutting and arranging the resulting imagery of those chromosomes, and examining the results. FISH uses special \"probes\" that fluoresce gene segments of chromosomes. The position and number of the fluoresced gene segments is then analyzed for abnormalities.[3] And the comparative genomic hybridization assay uses a complicated process of using a \"competitive\" form of FISH that compares two DNA sources, which are denatured so they are single-stranded, and hybridizes the two samples in a 1:1 ratio to a normal metaphase spread of chromosomes.[6]\nLike a normal medical diagnostic laboratory, the cytogenetics laboratory must follow a set of good practices, many of which are similar to the medical diagnostic lab. However, additional considerations to good practice specific to the cytogenetics laboratory are typically required, particularly in being assessed for accreditation. In Australia, for example, the National Pathology Accreditation Advisory Council (NPAAC) makes recommendations on the accreditation of laboratories providing cytogenetic services.[7] The College of American Pathologists (CAP) does something similar with its Cytogenetics Checklist for its CAP Accreditation Program.[8]\n\nReferences \n\n\n\u2191 1.0 1.1 1.2 \"Genetic laboratories and clinics\". Human Genomics in Global Health. World Health Organization. Archived from the original on 03 October 2018. https:\/\/web.archive.org\/web\/20181003114819\/http:\/\/www.who.int\/genomics\/professionals\/laboratories\/en\/ . Retrieved 18 November 2021 .   \n \n\n\u2191 \"Genetic Diagnostic Laboratory\". Genetics - Perelman School of Medicine. University of Pennsylvania. https:\/\/genetics.med.upenn.edu\/cores\/genetic-diagnostic-laboratory\/ . Retrieved 18 November 2021 .   \n \n\n\u2191 3.0 3.1 3.2 3.3 3.4 \"Genetic Testing Techniques\". Testing.com. OneCare Media. 9 November 2021. https:\/\/www.testing.com\/genetic-testing-techniques\/ . Retrieved 18 November 2021 .   \n \n\n\u2191 \"Cytogenetics Laboratory\". Departments and Centers: Laboratory Medicine and Pathology. Mayo Clinic. https:\/\/www.mayoclinic.org\/departments-centers\/laboratory-medicine-pathology\/overview\/specialty-groups\/laboratory-genetics\/cytogenetics-laboratory . Retrieved 18 November 2021 .   \n \n\n\u2191 \"Cytogenetics Lab Tests\". Cytogenetics Lab. Yale School of Medicine. https:\/\/medicine.yale.edu\/lab\/cytogenetics\/testing\/ . Retrieved 18 November 2021 .   \n \n\n\u2191 Weiss, M.M.; Hermsen, M.A.; Meijer, G.A. et al. (1999). \"Comparative genomic hybridization\". Molecular Pathology 52 (5): 243\u201351. doi:10.1136\/mp.52.5.243. PMC PMC395705. PMID 10748872. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC395705 .   \n \n\n\u2191 National Pathology Accreditation Advisory Council (2013) (PDF). Requirements for Cytogenetic Testing, Third Edition (3rd ed.). Commonwealth of Australia. ISBN 9781742419572. https:\/\/www1.health.gov.au\/internet\/main\/publishing.nsf\/Content\/76FFC342EA4F4CCBCA257BF0001D7A2A\/$File\/V0.22%20Cytogenetics.pdf . Retrieved 18 November 2021 .   \n \n\n\u2191 College of American Pathologists (21 August 2017). \"Cytogenetics Checklist\" (PDF). https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/checklists\/cl-cyg.pdf . Retrieved 18 November 2021 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Genetic_diagnostics_lab\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Genetic_diagnostics_lab<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:03.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 32 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","2842b58d0dc62a7918e218976fe37109_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Introduction_to_medical_diagnostics_and_research_laboratories_Genetic_diagnostics_lab rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Introduction_to_medical_diagnostics_and_research_laboratories_Genetic_diagnostics_lab 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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction to medical diagnostics and research laboratories\/Genetic diagnostics lab<\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">the beginning<\/a> of this guide-----<\/div>\n<h3><span class=\"mw-headline\" id=\"1.6_Genetic_diagnostics_lab\">1.6 Genetic diagnostics lab<\/span><\/h3>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Molecular_Diagnostics.jpg\" class=\"image wiki-link\" data-key=\"6974e526f4f684c9c340c192c226d9e2\"><img alt=\"Molecular Diagnostics.jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/d\/de\/Molecular_Diagnostics.jpg\" decoding=\"async\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a><\/div><p>In 2018, the World Health Organization (WHO) noted the following about modern genetic testing<sup id=\"rdp-ebb-cite_ref-WHOGenetic_1-0\" class=\"reference\"><a href=\"#cite_note-WHOGenetic-1\">[1]<\/a><\/sup>:\n<\/p><blockquote><p>Prior to the development of modern genetic technologies, genetic services were limited to genetic counselling, where health professionals would attempt to characterize the genetic contribution of diseases based on family histories. With the discovery of DNA, genetic services have dramatically increased in quality and scope. Increasingly sophisticated technologies now permit new methodology and high quality preparations, ensuring greater accuracy in diagnosis.<\/p><\/blockquote>\n<p>A genetic diagnostics lab uses genetic testing to evaluate DNA in the search for a genetic cause for symptoms or a disease. The lab may also have other responsibilities or goals, including interpreting results for physicians, detecting mutations, developing new analytical methods, and improving patient care through its discoveries.<sup id=\"rdp-ebb-cite_ref-WHOGenetic_1-1\" class=\"reference\"><a href=\"#cite_note-WHOGenetic-1\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-UPennTheGenetic_2-0\" class=\"reference\"><a href=\"#cite_note-UPennTheGenetic-2\">[2]<\/a><\/sup> \n<\/p><p>The WHO classifies genetic testing into five broad categories<sup id=\"rdp-ebb-cite_ref-WHOGenetic_1-2\" class=\"reference\"><a href=\"#cite_note-WHOGenetic-1\">[1]<\/a><\/sup>:\n<\/p>\n<ol><li>Carrier identification screening: a test that checks one or more individuals for whether or not they carry a genetic marker for a specific disease (e.g., cystic fibrosis)<\/li>\n<li>Prenatal diagnostic testing: a series of tests using routine <i>in vitro<\/i> fertilization methods when a gestating child is thought to have a genetically caused disease (e.g., Down syndrome)<\/li>\n<li>Newborn screening: one or more preventative health tests for treating a newborn early when treatment is available (e.g., congenital hypothyroidism)<\/li>\n<li>Late-onset disorder testing: testing that occurs later in life to determine susceptibility of an individual to a particular disease (e.g., cancer and heart disease)<\/li>\n<li>Identity testing: testing that \"involves profiling the individuals genetic information from DNA test results of genetic markers in order to locate characteristics unique to the individual\" (often used in forensic and criminal investigations)<\/li><\/ol>\n<p>As for the techniques used in genetic testing, the American Association for Clinical Chemistry (AACC) has five categories of techniques: <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), DNA sequencing, microarrays, gene expression profiling, and cytogenetics. (For more on cytogenetics, see the following subsection.) The PCR technique is a copying technique that \"enables specific genes or regions of interest to be detected or measured.\" <a href=\"https:\/\/www.limswiki.org\/index.php\/DNA_sequencing\" title=\"DNA sequencing\" class=\"wiki-link\" data-key=\"7ff86b38049c37e30858efd13bd00925\">DNA sequencing<\/a> (e.g., <a href=\"https:\/\/www.limswiki.org\/index.php\/Next-generation_sequencing\" class=\"mw-redirect wiki-link\" title=\"Next-generation sequencing\" data-key=\"c9d965c11eed1543f2a7e5f1abed4bb7\">next-generation sequencing<\/a> or NGS) allows scientists to identify changes or variations in the way DNA is arranged that may indicate a disorder. Microarray testing has multiple uses, among them identifying duplications, deletions, or identical sections in DNA, which may indicate a propensity for a particular disease. Gene expression profiling looks at the genes of cells and determines if they are actively making proteins or not for aiding in prognosis, recurrence, and other types of diagnostic indicators for disease.<sup id=\"rdp-ebb-cite_ref-AACCGenetic19_3-0\" class=\"reference\"><a href=\"#cite_note-AACCGenetic19-3\">[3]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"1.6.1_Cytogenetics_lab\">1.6.1 Cytogenetics lab<\/span><\/h4>\n<p>Cytogenetics is a subcategory of genetics that specifically studies chromosomes and their structures. \"Trained cytogeneticists examine the number, shape, and staining pattern of these structures using special technologies. In this way, they can detect extra chromosomes, missing chromosomes, missing or extra pieces of chromosomes, or rearranged chromosomes.\"<sup id=\"rdp-ebb-cite_ref-AACCGenetic19_3-1\" class=\"reference\"><a href=\"#cite_note-AACCGenetic19-3\">[3]<\/a><\/sup> Some diseases occur as the result of these chromosomal anomalies; for example, amplification of a particular gene in breast cancer or translocation of part of a chromosome in chronic myelogenous leukemia may be spotted with cytogenetic techniques.<sup id=\"rdp-ebb-cite_ref-AACCGenetic19_3-2\" class=\"reference\"><a href=\"#cite_note-AACCGenetic19-3\">[3]<\/a><\/sup>\n<\/p><p>The cytogenetics laboratory depends on several analytical techniques to make these sorts of genetic discoveries in a patient. Methods include chromosome analysis or karyotyping, fluorescence <i>in situ<\/i> hybridization (FISH), and microarray-based assays such as comparative genomic hybridization.<sup id=\"rdp-ebb-cite_ref-AACCGenetic19_3-3\" class=\"reference\"><a href=\"#cite_note-AACCGenetic19-3\">[3]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MayoClinicCyto_4-0\" class=\"reference\"><a href=\"#cite_note-MayoClinicCyto-4\">[4]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-YaleCyto_5-0\" class=\"reference\"><a href=\"#cite_note-YaleCyto-5\">[5]<\/a><\/sup> Karyotyping involves the separation of whole chromosomes from the nuclei of cells that have been stained with special dyes, cutting and arranging the resulting imagery of those chromosomes, and examining the results. FISH uses special \"probes\" that fluoresce gene segments of chromosomes. The position and number of the fluoresced gene segments is then analyzed for abnormalities.<sup id=\"rdp-ebb-cite_ref-AACCGenetic19_3-4\" class=\"reference\"><a href=\"#cite_note-AACCGenetic19-3\">[3]<\/a><\/sup> And the comparative genomic hybridization assay uses a complicated process of using a \"competitive\" form of FISH that compares two DNA sources, which are denatured so they are single-stranded, and hybridizes the two samples in a 1:1 ratio to a normal metaphase spread of chromosomes.<sup id=\"rdp-ebb-cite_ref-WeissComp99_6-0\" class=\"reference\"><a href=\"#cite_note-WeissComp99-6\">[6]<\/a><\/sup>\n<\/p><p>Like a normal medical diagnostic laboratory, the cytogenetics laboratory must follow a set of good practices, many of which are similar to the medical diagnostic lab. However, additional considerations to good practice specific to the cytogenetics laboratory are typically required, particularly in being assessed for accreditation. In Australia, for example, the National Pathology Accreditation Advisory Council (NPAAC) makes recommendations on the accreditation of laboratories providing cytogenetic services.<sup id=\"rdp-ebb-cite_ref-NPAACRequire13_7-0\" class=\"reference\"><a href=\"#cite_note-NPAACRequire13-7\">[7]<\/a><\/sup> The College of American Pathologists (CAP) does something similar with its Cytogenetics Checklist for its CAP Accreditation Program.<sup id=\"rdp-ebb-cite_ref-CAPCyto17_8-0\" class=\"reference\"><a href=\"#cite_note-CAPCyto17-8\">[8]<\/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-WHOGenetic-1\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-WHOGenetic_1-0\">1.0<\/a><\/sup> <sup><a href=\"#cite_ref-WHOGenetic_1-1\">1.1<\/a><\/sup> <sup><a href=\"#cite_ref-WHOGenetic_1-2\">1.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20181003114819\/http:\/\/www.who.int\/genomics\/professionals\/laboratories\/en\/\" target=\"_blank\">\"Genetic laboratories and clinics\"<\/a>. <i>Human Genomics in Global Health<\/i>. World Health Organization. Archived from <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/genomics\/professionals\/laboratories\/en\/\" target=\"_blank\">the original<\/a> on 03 October 2018<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20181003114819\/http:\/\/www.who.int\/genomics\/professionals\/laboratories\/en\/\" target=\"_blank\">https:\/\/web.archive.org\/web\/20181003114819\/http:\/\/www.who.int\/genomics\/professionals\/laboratories\/en\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Genetic+laboratories+and+clinics&rft.atitle=Human+Genomics+in+Global+Health&rft.pub=World+Health+Organization&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20181003114819%2Fhttp%3A%2F%2Fwww.who.int%2Fgenomics%2Fprofessionals%2Flaboratories%2Fen%2F&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Genetic_diagnostics_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-UPennTheGenetic-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-UPennTheGenetic_2-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/genetics.med.upenn.edu\/cores\/genetic-diagnostic-laboratory\/\" target=\"_blank\">\"Genetic Diagnostic Laboratory\"<\/a>. <i>Genetics - Perelman School of Medicine<\/i>. University of Pennsylvania<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/genetics.med.upenn.edu\/cores\/genetic-diagnostic-laboratory\/\" target=\"_blank\">https:\/\/genetics.med.upenn.edu\/cores\/genetic-diagnostic-laboratory\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Genetic+Diagnostic+Laboratory&rft.atitle=Genetics+-+Perelman+School+of+Medicine&rft.pub=University+of+Pennsylvania&rft_id=https%3A%2F%2Fgenetics.med.upenn.edu%2Fcores%2Fgenetic-diagnostic-laboratory%2F&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Genetic_diagnostics_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-AACCGenetic19-3\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-AACCGenetic19_3-0\">3.0<\/a><\/sup> <sup><a href=\"#cite_ref-AACCGenetic19_3-1\">3.1<\/a><\/sup> <sup><a href=\"#cite_ref-AACCGenetic19_3-2\">3.2<\/a><\/sup> <sup><a href=\"#cite_ref-AACCGenetic19_3-3\">3.3<\/a><\/sup> <sup><a href=\"#cite_ref-AACCGenetic19_3-4\">3.4<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.testing.com\/genetic-testing-techniques\/\" target=\"_blank\">\"Genetic Testing Techniques\"<\/a>. <i>Testing.com<\/i>. OneCare Media. 9 November 2021<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.testing.com\/genetic-testing-techniques\/\" target=\"_blank\">https:\/\/www.testing.com\/genetic-testing-techniques\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Genetic+Testing+Techniques&rft.atitle=Testing.com&rft.date=9+November+2021&rft.pub=OneCare+Media&rft_id=https%3A%2F%2Fwww.testing.com%2Fgenetic-testing-techniques%2F&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Genetic_diagnostics_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MayoClinicCyto-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MayoClinicCyto_4-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.mayoclinic.org\/departments-centers\/laboratory-medicine-pathology\/overview\/specialty-groups\/laboratory-genetics\/cytogenetics-laboratory\" target=\"_blank\">\"Cytogenetics Laboratory\"<\/a>. <i>Departments and Centers: Laboratory Medicine and Pathology<\/i>. Mayo Clinic<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.mayoclinic.org\/departments-centers\/laboratory-medicine-pathology\/overview\/specialty-groups\/laboratory-genetics\/cytogenetics-laboratory\" target=\"_blank\">https:\/\/www.mayoclinic.org\/departments-centers\/laboratory-medicine-pathology\/overview\/specialty-groups\/laboratory-genetics\/cytogenetics-laboratory<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Cytogenetics+Laboratory&rft.atitle=Departments+and+Centers%3A+Laboratory+Medicine+and+Pathology&rft.pub=Mayo+Clinic&rft_id=https%3A%2F%2Fwww.mayoclinic.org%2Fdepartments-centers%2Flaboratory-medicine-pathology%2Foverview%2Fspecialty-groups%2Flaboratory-genetics%2Fcytogenetics-laboratory&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Genetic_diagnostics_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-YaleCyto-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-YaleCyto_5-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/medicine.yale.edu\/lab\/cytogenetics\/testing\/\" target=\"_blank\">\"Cytogenetics Lab Tests\"<\/a>. <i>Cytogenetics Lab<\/i>. Yale School of Medicine<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/medicine.yale.edu\/lab\/cytogenetics\/testing\/\" target=\"_blank\">https:\/\/medicine.yale.edu\/lab\/cytogenetics\/testing\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Cytogenetics+Lab+Tests&rft.atitle=Cytogenetics+Lab&rft.pub=Yale+School+of+Medicine&rft_id=https%3A%2F%2Fmedicine.yale.edu%2Flab%2Fcytogenetics%2Ftesting%2F&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Genetic_diagnostics_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-WeissComp99-6\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-WeissComp99_6-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Weiss, M.M.; Hermsen, M.A.; Meijer, G.A. et al. (1999). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC395705\" target=\"_blank\">\"Comparative genomic hybridization\"<\/a>. <i>Molecular Pathology<\/i> <b>52<\/b> (5): 243\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\/10.1136%2Fmp.52.5.243\" target=\"_blank\">10.1136\/mp.52.5.243<\/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\/PMC395705\/\" target=\"_blank\">PMC395705<\/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\/10748872\" target=\"_blank\">10748872<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC395705\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC395705<\/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=Comparative+genomic+hybridization&rft.jtitle=Molecular+Pathology&rft.aulast=Weiss%2C+M.M.%3B+Hermsen%2C+M.A.%3B+Meijer%2C+G.A.+et+al.&rft.au=Weiss%2C+M.M.%3B+Hermsen%2C+M.A.%3B+Meijer%2C+G.A.+et+al.&rft.date=1999&rft.volume=52&rft.issue=5&rft.pages=243%E2%80%9351&rft_id=info:doi\/10.1136%2Fmp.52.5.243&rft_id=info:pmc\/PMC395705&rft_id=info:pmid\/10748872&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC395705&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Genetic_diagnostics_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-NPAACRequire13-7\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-NPAACRequire13_7-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">National Pathology Accreditation Advisory Council (2013) (PDF). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www1.health.gov.au\/internet\/main\/publishing.nsf\/Content\/76FFC342EA4F4CCBCA257BF0001D7A2A\/$File\/V0.22%20Cytogenetics.pdf\" target=\"_blank\"><i>Requirements for Cytogenetic Testing, Third Edition<\/i><\/a> (3rd ed.). Commonwealth of Australia. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 9781742419572<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www1.health.gov.au\/internet\/main\/publishing.nsf\/Content\/76FFC342EA4F4CCBCA257BF0001D7A2A\/$File\/V0.22%20Cytogenetics.pdf\" target=\"_blank\">https:\/\/www1.health.gov.au\/internet\/main\/publishing.nsf\/Content\/76FFC342EA4F4CCBCA257BF0001D7A2A\/$File\/V0.22%20Cytogenetics.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/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=Requirements+for+Cytogenetic+Testing%2C+Third+Edition&rft.aulast=National+Pathology+Accreditation+Advisory+Council&rft.au=National+Pathology+Accreditation+Advisory+Council&rft.date=2013&rft.edition=3rd&rft.pub=Commonwealth+of+Australia&rft.isbn=9781742419572&rft_id=https%3A%2F%2Fwww1.health.gov.au%2Finternet%2Fmain%2Fpublishing.nsf%2FContent%2F76FFC342EA4F4CCBCA257BF0001D7A2A%2F%24File%2FV0.22%2520Cytogenetics.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Genetic_diagnostics_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CAPCyto17-8\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CAPCyto17_8-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">College of American Pathologists (21 August 2017). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/checklists\/cl-cyg.pdf\" target=\"_blank\">\"Cytogenetics Checklist\"<\/a> (PDF)<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/checklists\/cl-cyg.pdf\" target=\"_blank\">https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/checklists\/cl-cyg.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Cytogenetics+Checklist&rft.atitle=&rft.aulast=College+of+American+Pathologists&rft.au=College+of+American+Pathologists&rft.date=21+August+2017&rft_id=https%3A%2F%2Felss.cap.org%2Felss%2FShowProperty%3FnodePath%3D%2FUCMCON%2FContribution%2520Folders%2FDctmContent%2Feducation%2FOnlineCourseContent%2F2017%2FLAP-TLTM%2Fchecklists%2Fcl-cyg.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Genetic_diagnostics_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20220125221414\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.144 seconds\nReal time usage: 0.769 seconds\nPreprocessor visited node count: 5425\/1000000\nPost\u2010expand include size: 51185\/2097152 bytes\nTemplate argument size: 16584\/2097152 bytes\nHighest expansion depth: 20\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 15819\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 125.514 1 -total\n 87.70% 110.080 1 Template:Reflist\n 55.88% 70.132 8 Template:Citation\/core\n 41.01% 51.478 6 Template:Cite_web\n 21.13% 26.516 1 Template:Cite_journal\n 12.21% 15.330 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Genetic_diagnostics_lab\n 9.92% 12.450 4 Template:Citation\/identifier\n 8.34% 10.465 1 Template:Cite_book\n 7.32% 9.192 14 Template:Citation\/make_link\n 6.41% 8.046 2 Template:Date\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12931-0!canonical and timestamp 20220125221413 and revision id 45828. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Genetic_diagnostics_lab\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Genetic_diagnostics_lab<\/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>","2842b58d0dc62a7918e218976fe37109_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/d\/de\/Molecular_Diagnostics.jpg"],"2842b58d0dc62a7918e218976fe37109_timestamp":1643149331,"05c4e6f32b894e3e23f45f95a1ec3035_type":"article","05c4e6f32b894e3e23f45f95a1ec3035_title":"1.5 Central and contract research lab","05c4e6f32b894e3e23f45f95a1ec3035_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Central_and_contract_research_lab","05c4e6f32b894e3e23f45f95a1ec3035_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction to medical diagnostics and research laboratories\/Central and contract research labFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n1.5 Central and contract research lab \nMedical research laboratories provide a regulated environment for the testing of the safety and efficacy of a variety of medical treatments and diagnostic devices, including medications, implants, and physician test kits. These facilities form the backbone of today's effective medical treatments, from cholesterol-lowering medications to pacemakers for the heart. In the U.S., these types of labs are overseen by the FDA. Medical research labs provide many different analytical and consulting services, including (but not limited to)[1][2]: \n\nclinical studies\nbioequivalence studies\nstudy design and management\nhigh-volume specimen testing\ncustom assay development\ntest kit development and supply\nMedical research can happen in the private, government, and academic sectors. Private medical research labs are most often referred to as \"central laboratories,\" which are contracted by pharmaceutical companies and medical device manufacturers. Though mentioned occasionally in its regulation and guidance, the U.S. Food and Drug Administration doesn't seem to provide a definition of the term \"central laboratory.\" However, it gets used by some in the context of an analytical laboratory that provides analyses of biological specimens associated with clinical and bioequivalence studies (including multi-site studies, prompting the idea of a \"central\" lab handling sample analysis) performed at medical institutions.[1][3] These central labs may also be contracted out to provide \"courier services for delivering lab kits and biosamples from\/to medical institutions where diagnostics and treatment of patients is performed.\"[3] Analytical testing and other services at a central or contract lab include anatomic pathology, digital pathology, immunology, microbiology, flow cytometry, biomarker testing, pharmacokinetic testing, genomic testing, and specimen and biorepository management.[4][5]\n\n1.5.1 Medical and other research in academia \nMedical research also occurs in academia, and they need suitably equipped and staffed laboratories for conducting studies. As such, universities may host their own central or core laboratory for both in-house[6] and contract research services.[7] \nClinical studies and trials aside, other types of academic research may require laboratory services as well. Take for example the archaeology laboratory, which is responsible for cleaning, analyzing, and identifying artifacts and remains from various sites either as part of a greater research effort or as a contract laboratory service.[8][9] Research in information technology and communication also occurs in (dry) laboratories; examples include the privately owned Nokia Bell Laboratory[10] and the university-affiliated University of New Hampshire InterOperability Laboratory.[11]\n\nReferences \n\n\n\u2191 1.0 1.1 \"Definition of Central Laboratory\". FDA Good Clinical Practice (GCP) Q&A. Model Agreements & Guidelines International. 19 April 2004. https:\/\/www.magiworld.org\/FdaGcpRecords?Pkey=1134 . Retrieved 18 November 2021 .   \n \n\n\u2191 Minor, L.K., ed. (2006). \"Handbook of Assay Development in Drug Discovery\". CRC Press. pp. 488. ISBN 9781420015706. https:\/\/books.google.com\/books?id=RmrLBQAAQBAJ&printsec=frontcover .   \n \n\n\u2191 3.0 3.1 Karelin, A.; Belotserkovskiy, M.; Khokhlova, V.; Kumar, A. (6 May 2013). \"Selecting a Central Laboratory\". Contract Pharma. Rodman Media, Inc. https:\/\/www.contractpharma.com\/issues\/2013-05\/view_features\/selecting-a-central-laboratory\/ . Retrieved 18 November 2021 .   \n \n\n\u2191 \"Global Network and Core Services\". Labcorp Drug Development. https:\/\/drugdevelopment.labcorp.com\/services\/clinical-testing\/central-laboratory-services\/core-laboratory-testing-services.html . Retrieved 18 November 2021 .   \n \n\n\u2191 \"Central Lab Services\". ACM Global Laboratories. https:\/\/www.acmgloballab.com\/central-lab-services . Retrieved 18 November 2021 .   \n \n\n\u2191 \"Core Laboratory for Clinical Studies (CLCS)\". Office of the Vice Chancellor for Research. Washington University in St. Louis. https:\/\/research.wustl.edu\/core-facilities\/core-laboratory-clinical-studies\/ . Retrieved 18 November 2021 .   \n \n\n\u2191 \"Clinical Trials Central Laboratory Services\". University of Rochester Medical Center. https:\/\/www.urmc.rochester.edu\/pathology-labs\/central.aspx . Retrieved 18 November 2021 .   \n \n\n\u2191 \"Archeology Laboratory\". Augustana University. https:\/\/www.augie.edu\/academics\/academic-offices-and-centers\/archeology-laboratory . Retrieved 18 November 2021 .   \n \n\n\u2191 \"Lab - Archaeology Lab\". Saint Louis University. https:\/\/www.slu.edu\/arts-and-sciences\/sociology-anthropology\/labs.php . Retrieved 18 November 2021 .   \n \n\n\u2191 \"History\". Nokia Group. https:\/\/www.bell-labs.com\/about\/history\/ . Retrieved 18 November 2021 .   \n \n\n\u2191 \"UNH-IOL FAQ\". University of New Hampshire InterOperability Laboratory. https:\/\/www.iol.unh.edu\/about\/faq . Retrieved 18 November 2021 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Central_and_contract_research_lab\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Central_and_contract_research_lab<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:03.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 24 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","05c4e6f32b894e3e23f45f95a1ec3035_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Introduction_to_medical_diagnostics_and_research_laboratories_Central_and_contract_research_lab rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Introduction_to_medical_diagnostics_and_research_laboratories_Central_and_contract_research_lab 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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction to medical diagnostics and research laboratories\/Central and contract research lab<\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">the beginning<\/a> of this guide-----<\/div>\n<h3><span class=\"mw-headline\" id=\"1.5_Central_and_contract_research_lab\">1.5 Central and contract research lab<\/span><\/h3>\n<p>Medical research laboratories provide a regulated environment for the testing of the safety and efficacy of a variety of medical treatments and diagnostic devices, including medications, implants, and physician test kits. These facilities form the backbone of today's effective medical treatments, from cholesterol-lowering medications to pacemakers for the heart. In the U.S., these types of labs are overseen by the FDA. Medical research labs provide many different analytical and consulting services, including (but not limited to)<sup id=\"rdp-ebb-cite_ref-MAGIDefinition04_1-0\" class=\"reference\"><a href=\"#cite_note-MAGIDefinition04-1\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MinorHandbook06_2-0\" class=\"reference\"><a href=\"#cite_note-MinorHandbook06-2\">[2]<\/a><\/sup>: \n<\/p>\n<ul><li>clinical studies<\/li>\n<li>bioequivalence studies<\/li>\n<li>study design and management<\/li>\n<li>high-volume specimen testing<\/li>\n<li>custom assay development<\/li>\n<li>test kit development and supply<\/li><\/ul>\n<p>Medical research can happen in the private, government, and academic sectors. Private medical research labs are most often referred to as \"central laboratories,\" which are contracted by pharmaceutical companies and medical device manufacturers. Though mentioned occasionally in its regulation and guidance, the U.S. Food and Drug Administration doesn't seem to provide a definition of the term \"central laboratory.\" However, it gets used by some in the context of an analytical laboratory that provides analyses of biological specimens associated with clinical and bioequivalence studies (including multi-site studies, prompting the idea of a \"central\" lab handling sample analysis) performed at medical institutions.<sup id=\"rdp-ebb-cite_ref-MAGIDefinition04_1-1\" class=\"reference\"><a href=\"#cite_note-MAGIDefinition04-1\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-KarelinSelecting13_3-0\" class=\"reference\"><a href=\"#cite_note-KarelinSelecting13-3\">[3]<\/a><\/sup> These central labs may also be contracted out to provide \"courier services for delivering lab kits and biosamples from\/to medical institutions where diagnostics and treatment of patients is performed.\"<sup id=\"rdp-ebb-cite_ref-KarelinSelecting13_3-1\" class=\"reference\"><a href=\"#cite_note-KarelinSelecting13-3\">[3]<\/a><\/sup> Analytical testing and other services at a central or contract lab include anatomic pathology, digital pathology, immunology, microbiology, flow cytometry, biomarker testing, pharmacokinetic testing, genomic testing, and specimen and biorepository management.<sup id=\"rdp-ebb-cite_ref-CovanceClinical_4-0\" class=\"reference\"><a href=\"#cite_note-CovanceClinical-4\">[4]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ACMCentral_5-0\" class=\"reference\"><a href=\"#cite_note-ACMCentral-5\">[5]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"1.5.1_Medical_and_other_research_in_academia\">1.5.1 Medical and other research in academia<\/span><\/h4>\n<p>Medical research also occurs in academia, and they need suitably equipped and staffed laboratories for conducting studies. As such, universities may host their own central or core laboratory for both in-house<sup id=\"rdp-ebb-cite_ref-WashUCore_6-0\" class=\"reference\"><a href=\"#cite_note-WashUCore-6\">[6]<\/a><\/sup> and contract research services.<sup id=\"rdp-ebb-cite_ref-UofRClinical_7-0\" class=\"reference\"><a href=\"#cite_note-UofRClinical-7\">[7]<\/a><\/sup> \n<\/p><p>Clinical studies and trials aside, other types of academic research may require laboratory services as well. Take for example the archaeology laboratory, which is responsible for cleaning, analyzing, and identifying artifacts and remains from various sites either as part of a greater research effort or as a contract laboratory service.<sup id=\"rdp-ebb-cite_ref-AugustanaArchLab_8-0\" class=\"reference\"><a href=\"#cite_note-AugustanaArchLab-8\">[8]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-SLUArchLab_9-0\" class=\"reference\"><a href=\"#cite_note-SLUArchLab-9\">[9]<\/a><\/sup> Research in information technology and communication also occurs in (dry) laboratories; examples include the privately owned Nokia Bell Laboratory<sup id=\"rdp-ebb-cite_ref-NokiaHistoryBell_10-0\" class=\"reference\"><a href=\"#cite_note-NokiaHistoryBell-10\">[10]<\/a><\/sup> and the university-affiliated University of New Hampshire InterOperability Laboratory.<sup id=\"rdp-ebb-cite_ref-UNH-IOL_FAQ_11-0\" class=\"reference\"><a href=\"#cite_note-UNH-IOL_FAQ-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-MAGIDefinition04-1\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-MAGIDefinition04_1-0\">1.0<\/a><\/sup> <sup><a href=\"#cite_ref-MAGIDefinition04_1-1\">1.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.magiworld.org\/FdaGcpRecords?Pkey=1134\" target=\"_blank\">\"Definition of Central Laboratory\"<\/a>. <i>FDA Good Clinical Practice (GCP) Q&A<\/i>. Model Agreements & Guidelines International. 19 April 2004<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.magiworld.org\/FdaGcpRecords?Pkey=1134\" target=\"_blank\">https:\/\/www.magiworld.org\/FdaGcpRecords?Pkey=1134<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Definition+of+Central+Laboratory&rft.atitle=FDA+Good+Clinical+Practice+%28GCP%29+Q%26A&rft.date=19+April+2004&rft.pub=Model+Agreements+%26+Guidelines+International&rft_id=https%3A%2F%2Fwww.magiworld.org%2FFdaGcpRecords%3FPkey%3D1134&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Central_and_contract_research_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MinorHandbook06-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MinorHandbook06_2-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Minor, L.K., ed. (2006). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=RmrLBQAAQBAJ&printsec=frontcover\" target=\"_blank\">\"Handbook of Assay Development in Drug Discovery\"<\/a>. CRC Press. pp. 488. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 9781420015706<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=RmrLBQAAQBAJ&printsec=frontcover\" target=\"_blank\">https:\/\/books.google.com\/books?id=RmrLBQAAQBAJ&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=Handbook+of+Assay+Development+in+Drug+Discovery&rft.atitle=&rft.date=2006&rft.pages=pp.+488&rft.pub=CRC+Press&rft.isbn=9781420015706&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DRmrLBQAAQBAJ%26printsec%3Dfrontcover&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Central_and_contract_research_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-KarelinSelecting13-3\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-KarelinSelecting13_3-0\">3.0<\/a><\/sup> <sup><a href=\"#cite_ref-KarelinSelecting13_3-1\">3.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Karelin, A.; Belotserkovskiy, M.; Khokhlova, V.; Kumar, A. (6 May 2013). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.contractpharma.com\/issues\/2013-05\/view_features\/selecting-a-central-laboratory\/\" target=\"_blank\">\"Selecting a Central Laboratory\"<\/a>. <i>Contract Pharma<\/i>. Rodman Media, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.contractpharma.com\/issues\/2013-05\/view_features\/selecting-a-central-laboratory\/\" target=\"_blank\">https:\/\/www.contractpharma.com\/issues\/2013-05\/view_features\/selecting-a-central-laboratory\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/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+a+Central+Laboratory&rft.atitle=Contract+Pharma&rft.aulast=Karelin%2C+A.%3B+Belotserkovskiy%2C+M.%3B+Khokhlova%2C+V.%3B+Kumar%2C+A.&rft.au=Karelin%2C+A.%3B+Belotserkovskiy%2C+M.%3B+Khokhlova%2C+V.%3B+Kumar%2C+A.&rft.date=6+May+2013&rft.pub=Rodman+Media%2C+Inc&rft_id=https%3A%2F%2Fwww.contractpharma.com%2Fissues%2F2013-05%2Fview_features%2Fselecting-a-central-laboratory%2F&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Central_and_contract_research_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CovanceClinical-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CovanceClinical_4-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/drugdevelopment.labcorp.com\/services\/clinical-testing\/central-laboratory-services\/core-laboratory-testing-services.html\" target=\"_blank\">\"Global Network and Core Services\"<\/a>. Labcorp Drug Development<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/drugdevelopment.labcorp.com\/services\/clinical-testing\/central-laboratory-services\/core-laboratory-testing-services.html\" target=\"_blank\">https:\/\/drugdevelopment.labcorp.com\/services\/clinical-testing\/central-laboratory-services\/core-laboratory-testing-services.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Global+Network+and+Core+Services&rft.atitle=&rft.pub=Labcorp+Drug+Development&rft_id=https%3A%2F%2Fdrugdevelopment.labcorp.com%2Fservices%2Fclinical-testing%2Fcentral-laboratory-services%2Fcore-laboratory-testing-services.html&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Central_and_contract_research_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ACMCentral-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ACMCentral_5-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmgloballab.com\/central-lab-services\" target=\"_blank\">\"Central Lab Services\"<\/a>. ACM Global Laboratories<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.acmgloballab.com\/central-lab-services\" target=\"_blank\">https:\/\/www.acmgloballab.com\/central-lab-services<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Central+Lab+Services&rft.atitle=&rft.pub=ACM+Global+Laboratories&rft_id=https%3A%2F%2Fwww.acmgloballab.com%2Fcentral-lab-services&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Central_and_contract_research_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-WashUCore-6\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-WashUCore_6-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/research.wustl.edu\/core-facilities\/core-laboratory-clinical-studies\/\" target=\"_blank\">\"Core Laboratory for Clinical Studies (CLCS)\"<\/a>. <i>Office of the Vice Chancellor for Research<\/i>. Washington University in St. Louis<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/research.wustl.edu\/core-facilities\/core-laboratory-clinical-studies\/\" target=\"_blank\">https:\/\/research.wustl.edu\/core-facilities\/core-laboratory-clinical-studies\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Core+Laboratory+for+Clinical+Studies+%28CLCS%29&rft.atitle=Office+of+the+Vice+Chancellor+for+Research&rft.pub=Washington+University+in+St.+Louis&rft_id=https%3A%2F%2Fresearch.wustl.edu%2Fcore-facilities%2Fcore-laboratory-clinical-studies%2F&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Central_and_contract_research_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-UofRClinical-7\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-UofRClinical_7-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.urmc.rochester.edu\/pathology-labs\/central.aspx\" target=\"_blank\">\"Clinical Trials Central Laboratory Services\"<\/a>. University of Rochester Medical Center<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.urmc.rochester.edu\/pathology-labs\/central.aspx\" target=\"_blank\">https:\/\/www.urmc.rochester.edu\/pathology-labs\/central.aspx<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Clinical+Trials+Central+Laboratory+Services&rft.atitle=&rft.pub=University+of+Rochester+Medical+Center&rft_id=https%3A%2F%2Fwww.urmc.rochester.edu%2Fpathology-labs%2Fcentral.aspx&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Central_and_contract_research_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-AugustanaArchLab-8\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-AugustanaArchLab_8-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.augie.edu\/academics\/academic-offices-and-centers\/archeology-laboratory\" target=\"_blank\">\"Archeology Laboratory\"<\/a>. Augustana University<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.augie.edu\/academics\/academic-offices-and-centers\/archeology-laboratory\" target=\"_blank\">https:\/\/www.augie.edu\/academics\/academic-offices-and-centers\/archeology-laboratory<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Archeology+Laboratory&rft.atitle=&rft.pub=Augustana+University&rft_id=https%3A%2F%2Fwww.augie.edu%2Facademics%2Facademic-offices-and-centers%2Farcheology-laboratory&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Central_and_contract_research_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-SLUArchLab-9\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-SLUArchLab_9-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.slu.edu\/arts-and-sciences\/sociology-anthropology\/labs.php\" target=\"_blank\">\"Lab - Archaeology Lab\"<\/a>. Saint Louis University<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.slu.edu\/arts-and-sciences\/sociology-anthropology\/labs.php\" target=\"_blank\">https:\/\/www.slu.edu\/arts-and-sciences\/sociology-anthropology\/labs.php<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Lab+-+Archaeology+Lab&rft.atitle=&rft.pub=Saint+Louis+University&rft_id=https%3A%2F%2Fwww.slu.edu%2Farts-and-sciences%2Fsociology-anthropology%2Flabs.php&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Central_and_contract_research_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-NokiaHistoryBell-10\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-NokiaHistoryBell_10-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.bell-labs.com\/about\/history\/\" target=\"_blank\">\"History\"<\/a>. Nokia Group<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.bell-labs.com\/about\/history\/\" target=\"_blank\">https:\/\/www.bell-labs.com\/about\/history\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=History&rft.atitle=&rft.pub=Nokia+Group&rft_id=https%3A%2F%2Fwww.bell-labs.com%2Fabout%2Fhistory%2F&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Central_and_contract_research_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-UNH-IOL_FAQ-11\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-UNH-IOL_FAQ_11-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iol.unh.edu\/about\/faq\" target=\"_blank\">\"UNH-IOL FAQ\"<\/a>. University of New Hampshire InterOperability Laboratory<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.iol.unh.edu\/about\/faq\" target=\"_blank\">https:\/\/www.iol.unh.edu\/about\/faq<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=UNH-IOL+FAQ&rft.atitle=&rft.pub=University+of+New+Hampshire+InterOperability+Laboratory&rft_id=https%3A%2F%2Fwww.iol.unh.edu%2Fabout%2Ffaq&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Central_and_contract_research_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20220125221412\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.076 seconds\nReal time usage: 0.113 seconds\nPreprocessor visited node count: 6674\/1000000\nPost\u2010expand include size: 47018\/2097152 bytes\nTemplate argument size: 14602\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 16622\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 105.449 1 -total\n 89.51% 94.385 1 Template:Reflist\n 69.20% 72.966 11 Template:Cite_web\n 63.07% 66.506 11 Template:Citation\/core\n 11.19% 11.800 1 Template:Citation\/identifier\n 10.42% 10.993 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Central_and_contract_research_lab\n 7.14% 7.526 2 Template:Date\n 5.19% 5.470 14 Template:Citation\/make_link\n 3.96% 4.175 1 Template:Only_in_print\n 2.98% 3.138 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12930-0!canonical and timestamp 20220125221412 and revision id 45827. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Central_and_contract_research_lab\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Central_and_contract_research_lab<\/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>","05c4e6f32b894e3e23f45f95a1ec3035_images":[],"05c4e6f32b894e3e23f45f95a1ec3035_timestamp":1643149331,"72c13351f60d5c0e4e592ea30144c50a_type":"article","72c13351f60d5c0e4e592ea30144c50a_title":"1.4 Blood bank and transfusion lab","72c13351f60d5c0e4e592ea30144c50a_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Blood_bank_and_transfusion_lab","72c13351f60d5c0e4e592ea30144c50a_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction to medical diagnostics and research laboratories\/Blood bank and transfusion labFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n1.4 Blood bank and transfusion lab \nBlood banking is the organized laboratory process of ensuring donated blood or blood products are safe to use for transfusion or other medical procedures.[1][2] As part of this process, blood bank and transfusion labs will include procedures such as[1]:\nABO group typing (the blood type)\nRh typing (positive or negative antigen)\nproblematic antibody screening and removal (e.g., removing white blood cells from leukocyte-reduced blood)\ncurrent or past infection screening (e.g., hepatitis B and C, HIV, syphilis, West Nile)\nT-lymphocyte irradiation\nalbumin, immune globulin, and clotting factor concentrate separation and processing\nAdditional considerations beyond the basic medical diagnostic lab are required at a blood banking lab. Like a medical diagnostic lab, blood banking personnel must use processes that protect them and others from biological infections (i.e., biosafety). Additionally, recipients of blood and blood products from the lab must also be protected, requiring extra procedures for screening, testing, documenting, and providing oversight. This includes screening against high-risk donors such as commercial sex workers and drug users, testing potential donors for infection diseases, documenting and reviewing (lookback of) donors and recipients, ensuring sufficient time is given for blood testing and cross-matching, and ensuring staff are appropriately trained concerning the risks to them and patients.[2] Additionally, staff are required to use a \"first in, first out\" or FIFO approach where stored blood and components are appropriately dated, stored according to date of expiry, and removed oldest first.[3] Blood banks have additional regulatory concerns as well, including monitoring storage temperature and expiry times for blood and blood products based on regulation. For example, in the United States, the FDA mandates\u2014through 21 CFR 610.53\u2014dating period limitations and temperatures.[4]\n\nReferences \n\n\n\u2191 1.0 1.1 \"Blood Banking\". Health Portal. Johns Hopkins Medicine. https:\/\/www.hopkinsmedicine.org\/health\/treatment-tests-and-therapies\/blood-banking . Retrieved 18 November 2021 .   \n \n\n\u2191 2.0 2.1 Curless, M.S.; Forrester, L.A.; Gavin, M.A. (2018). \"Module 8. Laboratories and Blood Banks\" (PDF). Infection Prevention and Control. Jhpiego Corporation. Archived from the original on 08 January 2020. https:\/\/web.archive.org\/web\/20200108173322\/http:\/\/reprolineplus.org\/system\/files\/resources\/IPC_M8_BloodbanksLabs.pdf . Retrieved 18 November 2021 .   \n \n\n\u2191 Bedi, R.K.; Mittal, K.; Sood, T. et al. (2016). \"Segregation of blood inventory: A key driver for optimum blood stock management in a resource-poor setting\". International Journal of Applied and Basic Medical Research 6 (2): 119\u201322. doi:10.4103\/2229-516X.179023. PMC PMC4830151. PMID 27127742. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC4830151 .   \n \n\n\u2191 \"\u00a7610.53 Dating periods for Whole Blood and blood components\". Electronic Code of Federal Regulations. U.S. Government Publishing Office. 16 November 2021. https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-F\/part-610\/subpart-F\/section-610.53 . Retrieved 18 November 2021 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Blood_bank_and_transfusion_lab\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Blood_bank_and_transfusion_lab<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:02.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 26 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","72c13351f60d5c0e4e592ea30144c50a_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Introduction_to_medical_diagnostics_and_research_laboratories_Blood_bank_and_transfusion_lab rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Introduction_to_medical_diagnostics_and_research_laboratories_Blood_bank_and_transfusion_lab 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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction to medical diagnostics and research laboratories\/Blood bank and transfusion lab<\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">the beginning<\/a> of this guide-----<\/div>\n<h3><span class=\"mw-headline\" id=\"1.4_Blood_bank_and_transfusion_lab\">1.4 Blood bank and transfusion lab<\/span><\/h3>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Blood_Research-_Saving_Lives_(8352)_(9759352093).jpg\" class=\"image wiki-link\" data-key=\"81dd2331ae65eebf176703032a9e9d51\"><img alt=\"Blood Research- Saving Lives (8352) (9759352093).jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/5\/58\/Blood_Research-_Saving_Lives_%288352%29_%289759352093%29.jpg\" decoding=\"async\" width=\"350\" height=\"232\" \/><\/a><\/div><p>Blood banking is the organized laboratory process of ensuring donated blood or blood products are safe to use for transfusion or other medical procedures.<sup id=\"rdp-ebb-cite_ref-JHMBlood_1-0\" class=\"reference\"><a href=\"#cite_note-JHMBlood-1\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CurlessInfection18_2-0\" class=\"reference\"><a href=\"#cite_note-CurlessInfection18-2\">[2]<\/a><\/sup> As part of this process, blood bank and transfusion labs will include procedures such as<sup id=\"rdp-ebb-cite_ref-JHMBlood_1-1\" class=\"reference\"><a href=\"#cite_note-JHMBlood-1\">[1]<\/a><\/sup>:\n<\/p><ul><li>ABO group typing (the blood type)<\/li>\n<li>Rh typing (positive or negative antigen)<\/li>\n<li>problematic antibody screening and removal (e.g., removing white blood cells from leukocyte-reduced blood)<\/li>\n<li>current or past infection screening (e.g., hepatitis B and C, HIV, syphilis, West Nile)<\/li>\n<li>T-lymphocyte irradiation<\/li>\n<li>albumin, immune globulin, and clotting factor concentrate separation and processing<\/li><\/ul>\n<p>Additional considerations beyond the basic medical diagnostic lab are required at a blood banking lab. Like a medical diagnostic lab, blood banking personnel must use processes that protect them and others from biological infections (i.e., biosafety). Additionally, recipients of blood and blood products from the lab must also be protected, requiring extra procedures for screening, testing, documenting, and providing oversight. This includes screening against high-risk donors such as commercial sex workers and drug users, testing potential donors for infection diseases, documenting and reviewing (lookback of) donors and recipients, ensuring sufficient time is given for blood testing and cross-matching, and ensuring staff are appropriately trained concerning the risks to them and patients.<sup id=\"rdp-ebb-cite_ref-CurlessInfection18_2-1\" class=\"reference\"><a href=\"#cite_note-CurlessInfection18-2\">[2]<\/a><\/sup> Additionally, staff are required to use a \"first in, first out\" or FIFO approach where stored blood and components are appropriately dated, stored according to date of expiry, and removed oldest first.<sup id=\"rdp-ebb-cite_ref-BediSegreg16_3-0\" class=\"reference\"><a href=\"#cite_note-BediSegreg16-3\">[3]<\/a><\/sup> Blood banks have additional regulatory concerns as well, including monitoring storage temperature and expiry times for blood and blood products based on regulation. For example, in the United States, the FDA mandates\u2014through 21 CFR 610.53\u2014dating period limitations and temperatures.<sup id=\"rdp-ebb-cite_ref-ECFR21CFR610.53_20_4-0\" class=\"reference\"><a href=\"#cite_note-ECFR21CFR610.53_20-4\">[4]<\/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-JHMBlood-1\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-JHMBlood_1-0\">1.0<\/a><\/sup> <sup><a href=\"#cite_ref-JHMBlood_1-1\">1.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.hopkinsmedicine.org\/health\/treatment-tests-and-therapies\/blood-banking\" target=\"_blank\">\"Blood Banking\"<\/a>. <i>Health Portal<\/i>. Johns Hopkins Medicine<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.hopkinsmedicine.org\/health\/treatment-tests-and-therapies\/blood-banking\" target=\"_blank\">https:\/\/www.hopkinsmedicine.org\/health\/treatment-tests-and-therapies\/blood-banking<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Blood+Banking&rft.atitle=Health+Portal&rft.pub=Johns+Hopkins+Medicine&rft_id=https%3A%2F%2Fwww.hopkinsmedicine.org%2Fhealth%2Ftreatment-tests-and-therapies%2Fblood-banking&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Blood_bank_and_transfusion_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CurlessInfection18-2\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-CurlessInfection18_2-0\">2.0<\/a><\/sup> <sup><a href=\"#cite_ref-CurlessInfection18_2-1\">2.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Curless, M.S.; Forrester, L.A.; Gavin, M.A. (2018). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20200108173322\/http:\/\/reprolineplus.org\/system\/files\/resources\/IPC_M8_BloodbanksLabs.pdf\" target=\"_blank\">\"Module 8. Laboratories and Blood Banks\"<\/a> (PDF). <i>Infection Prevention and Control<\/i>. Jhpiego Corporation. Archived from <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/reprolineplus.org\/system\/files\/resources\/IPC_M8_BloodbanksLabs.pdf\" target=\"_blank\">the original<\/a> on 08 January 2020<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20200108173322\/http:\/\/reprolineplus.org\/system\/files\/resources\/IPC_M8_BloodbanksLabs.pdf\" target=\"_blank\">https:\/\/web.archive.org\/web\/20200108173322\/http:\/\/reprolineplus.org\/system\/files\/resources\/IPC_M8_BloodbanksLabs.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Module+8.+Laboratories+and+Blood+Banks&rft.atitle=Infection+Prevention+and+Control&rft.aulast=Curless%2C+M.S.%3B+Forrester%2C+L.A.%3B+Gavin%2C+M.A.&rft.au=Curless%2C+M.S.%3B+Forrester%2C+L.A.%3B+Gavin%2C+M.A.&rft.date=2018&rft.pub=Jhpiego+Corporation&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20200108173322%2Fhttp%3A%2F%2Freprolineplus.org%2Fsystem%2Ffiles%2Fresources%2FIPC_M8_BloodbanksLabs.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Blood_bank_and_transfusion_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BediSegreg16-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BediSegreg16_3-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Bedi, R.K.; Mittal, K.; Sood, T. et al. (2016). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC4830151\" target=\"_blank\">\"Segregation of blood inventory: A key driver for optimum blood stock management in a resource-poor setting\"<\/a>. <i>International Journal of Applied and Basic Medical Research<\/i> <b>6<\/b> (2): 119\u201322. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.4103%2F2229-516X.179023\" target=\"_blank\">10.4103\/2229-516X.179023<\/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\/PMC4830151\/\" target=\"_blank\">PMC4830151<\/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\/27127742\" target=\"_blank\">27127742<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC4830151\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC4830151<\/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=Segregation+of+blood+inventory%3A+A+key+driver+for+optimum+blood+stock+management+in+a+resource-poor+setting&rft.jtitle=International+Journal+of+Applied+and+Basic+Medical+Research&rft.aulast=Bedi%2C+R.K.%3B+Mittal%2C+K.%3B+Sood%2C+T.+et+al.&rft.au=Bedi%2C+R.K.%3B+Mittal%2C+K.%3B+Sood%2C+T.+et+al.&rft.date=2016&rft.volume=6&rft.issue=2&rft.pages=119%E2%80%9322&rft_id=info:doi\/10.4103%2F2229-516X.179023&rft_id=info:pmc\/PMC4830151&rft_id=info:pmid\/27127742&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC4830151&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Blood_bank_and_transfusion_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ECFR21CFR610.53_20-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ECFR21CFR610.53_20_4-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-F\/part-610\/subpart-F\/section-610.53\" target=\"_blank\">\"\u00a7610.53 Dating periods for Whole Blood and blood components\"<\/a>. <i>Electronic Code of Federal Regulations<\/i>. U.S. Government Publishing Office. 16 November 2021<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-F\/part-610\/subpart-F\/section-610.53\" target=\"_blank\">https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-F\/part-610\/subpart-F\/section-610.53<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=%C2%A7610.53+Dating+periods+for+Whole+Blood+and+blood+components&rft.atitle=Electronic+Code+of+Federal+Regulations&rft.date=16+November+2021&rft.pub=U.S.+Government+Publishing+Office&rft_id=https%3A%2F%2Fwww.ecfr.gov%2Fcurrent%2Ftitle-21%2Fchapter-I%2Fsubchapter-F%2Fpart-610%2Fsubpart-F%2Fsection-610.53&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Blood_bank_and_transfusion_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20220125221412\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.082 seconds\nReal time usage: 0.601 seconds\nPreprocessor visited node count: 2943\/1000000\nPost\u2010expand include size: 29523\/2097152 bytes\nTemplate argument size: 11022\/2097152 bytes\nHighest expansion depth: 20\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 8785\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 89.113 1 -total\n 91.44% 81.488 1 Template:Reflist\n 59.85% 53.334 4 Template:Citation\/core\n 38.40% 34.218 3 Template:Cite_web\n 34.78% 30.991 1 Template:Cite_journal\n 16.92% 15.077 8 Template:Citation\/make_link\n 12.19% 10.860 7 Template:Hide_in_print\n 10.66% 9.503 3 Template:Citation\/identifier\n 9.06% 8.074 2 Template:Date\n 8.48% 7.557 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Blood_bank_and_transfusion_lab\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12929-0!canonical and timestamp 20220125221411 and revision id 45826. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Blood_bank_and_transfusion_lab\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Blood_bank_and_transfusion_lab<\/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>","72c13351f60d5c0e4e592ea30144c50a_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/5\/58\/Blood_Research-_Saving_Lives_%288352%29_%289759352093%29.jpg"],"72c13351f60d5c0e4e592ea30144c50a_timestamp":1643149330,"84b3522ac7ff6ca73ca05e12dfc127d6_type":"article","84b3522ac7ff6ca73ca05e12dfc127d6_title":"1.3 Toxicology lab","84b3522ac7ff6ca73ca05e12dfc127d6_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Toxicology_lab","84b3522ac7ff6ca73ca05e12dfc127d6_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction to medical diagnostics and research laboratories\/Toxicology labFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n1.3 Toxicology lab \nToxicology is a multidisciplinary study of the adverse effects of chemical substances on living organisms, and tangentially the diagnosis and treatment of exposures to those chemical substances. Toxicologists determine how plants, animals, and bacterial organisms are affected by agricultural chemicals, industrial chemicals, metals, vapors and gases, naturally occurring toxins, and drugs, typically caused by the absorption, distribution, metabolism, and excretion of those substances.[1] Like other fields, many subspecialties are associated with toxicology, including[1]:\n\nanalytical toxicology, for identifying toxicants;\nbiomedical toxicology, for identifying how toxicants cause disease;\nenvironmental toxicology, for evaluating the effects of environmental chemicals and contaminants;\nforensic toxicology, for evaluating how toxicants and other chemicals caused death;\nmolecular toxicology, for the application of molecular biology to toxicity;\noccupational toxicology, for evaluating the effects of chemical exposure in the workplace; and\nregulatory toxicology, for applying mechanistic information from toxicology to regulations and standards development.\nSimilar to a medical laboratory, a toxicology laboratory may focus on diagnostics or research. Test types may vary based on the focus. For example, toxicity testing on research animals may involve testing for acute toxicity, subacute toxicity, short-term subchronic toxicity, long-term chronic toxicity, reproductive toxicity, developmental toxicity, mutagenicity assays, irritation, allergic reaction, inhalation, and immunotoxicity.[1] However, diagnostic testing will involve testing for drugs of abuse, poisons, and heavy metals, or other toxicants. Pharmacogenetic testing may also be performed to develop dosing regiments for a specific drug.[2][3]\nToxicology laboratories in unique settings such as emergency departments of hospitals require extra consideration. For example, while toxicology testing in the emergency department is normal in regards to supporting and validating clinical findings, the testing must also take into account the legal ramifications of test results. Those results may be used in court cases, requiring strict chain-of-custody, full documentation, methodologies, and quality control results to be maintained. Additional specimens may be required by government bodies for their own testing, and as such the lab may want to add additional specimen collection to its official workflow. Additionally, personnel may need to become familiar with testimony procedures if required to testify in a criminal court case.[4]\n\nReferences \n\n\n\u2191 1.0 1.1 1.2 Eaton, D.L.; Gallagher, E.P. (2010). \"Chapter 1.01 General Overview of Toxicology\". In McQueen, C.A.. Comprehensive Toxicology (2nd ed.). Elsevier. pp. 1\u201346. ISBN 9780080468686. https:\/\/books.google.com\/books?id=jzCAKsa2CpMC&pg=PA1 .   \n \n\n\u2191 \"Clinical Toxicology Testing\". ARUP Consult. ARUP Laboratories. June 2021. https:\/\/arupconsult.com\/content\/clinical-toxicology-testing . Retrieved 18 November 2021 .   \n \n\n\u2191 Sofronescu, A.G. (1 December 2018). \"Purpose-driven Toxicology Services: The Key to Financial Success and Client Confidence\". Clinical Laboratory News. American Association for Clinical Chemistry. https:\/\/www.aacc.org\/cln\/articles\/2018\/december\/purpose-driven-toxicology-services-the-key-to-financial-success-and-client-confidence . Retrieved 18 November 2021 .   \n \n\n\u2191 Magnani, B.; Kwong, T.C. (2012). \"Chapter 2: Supporting the Emergency Department\". In Magnani, B.; Bissell, M.G.; Kwong, T.C.; Wu, A.H.B. (PDF). Clinical Toxicology Testing: A Guide for Laboratory Professionals. College of American Pathologists. pp. 7\u201314. ISBN 9780983706816. http:\/\/webapps.cap.org\/apps\/docs\/store\/PUB220_Toxicol_Sample.pdf .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Toxicology_lab\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Toxicology_lab<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:02.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 24 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","84b3522ac7ff6ca73ca05e12dfc127d6_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Introduction_to_medical_diagnostics_and_research_laboratories_Toxicology_lab rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Introduction_to_medical_diagnostics_and_research_laboratories_Toxicology_lab 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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction to medical diagnostics and research laboratories\/Toxicology lab<\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">the beginning<\/a> of this guide-----<\/div>\n<h3><span class=\"mw-headline\" id=\"1.3_Toxicology_lab\">1.3 Toxicology lab<\/span><\/h3>\n<p>Toxicology is a multidisciplinary study of the adverse effects of chemical substances on living organisms, and tangentially the diagnosis and treatment of exposures to those chemical substances. Toxicologists determine how plants, animals, and bacterial organisms are affected by agricultural chemicals, industrial chemicals, metals, vapors and gases, naturally occurring toxins, and drugs, typically caused by the absorption, distribution, metabolism, and excretion of those substances.<sup id=\"rdp-ebb-cite_ref-EatonGeneral10_1-0\" class=\"reference\"><a href=\"#cite_note-EatonGeneral10-1\">[1]<\/a><\/sup> Like other fields, many subspecialties are associated with toxicology, including<sup id=\"rdp-ebb-cite_ref-EatonGeneral10_1-1\" class=\"reference\"><a href=\"#cite_note-EatonGeneral10-1\">[1]<\/a><\/sup>:\n<\/p>\n<ul><li>analytical toxicology, for identifying toxicants;<\/li>\n<li>biomedical toxicology, for identifying how toxicants cause disease;<\/li>\n<li>environmental toxicology, for evaluating the effects of environmental chemicals and contaminants;<\/li>\n<li>forensic toxicology, for evaluating how toxicants and other chemicals caused death;<\/li>\n<li>molecular toxicology, for the application of molecular biology to toxicity;<\/li>\n<li>occupational toxicology, for evaluating the effects of chemical exposure in the workplace; and<\/li>\n<li>regulatory toxicology, for applying mechanistic information from toxicology to regulations and standards development.<\/li><\/ul>\n<p>Similar to a medical laboratory, a toxicology laboratory may focus on diagnostics or research. Test types may vary based on the focus. For example, toxicity testing on research animals may involve testing for acute toxicity, subacute toxicity, short-term subchronic toxicity, long-term chronic toxicity, reproductive toxicity, developmental toxicity, mutagenicity assays, irritation, allergic reaction, inhalation, and immunotoxicity.<sup id=\"rdp-ebb-cite_ref-EatonGeneral10_1-2\" class=\"reference\"><a href=\"#cite_note-EatonGeneral10-1\">[1]<\/a><\/sup> However, diagnostic testing will involve testing for drugs of abuse, poisons, and heavy metals, or other toxicants. Pharmacogenetic testing may also be performed to develop dosing regiments for a specific drug.<sup id=\"rdp-ebb-cite_ref-ARUPClin19_2-0\" class=\"reference\"><a href=\"#cite_note-ARUPClin19-2\">[2]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-SofronescuPurpose18_3-0\" class=\"reference\"><a href=\"#cite_note-SofronescuPurpose18-3\">[3]<\/a><\/sup>\n<\/p><p>Toxicology laboratories in unique settings such as emergency departments of hospitals require extra consideration. For example, while toxicology testing in the emergency department is normal in regards to supporting and validating clinical findings, the testing must also take into account the legal ramifications of test results. Those results may be used in court cases, requiring strict chain-of-custody, full documentation, methodologies, and quality control results to be maintained. Additional specimens may be required by government bodies for their own testing, and as such the lab may want to add additional specimen collection to its official workflow. Additionally, personnel may need to become familiar with testimony procedures if required to testify in a criminal court case.<sup id=\"rdp-ebb-cite_ref-MagnaniClinical12_4-0\" class=\"reference\"><a href=\"#cite_note-MagnaniClinical12-4\">[4]<\/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-EatonGeneral10-1\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-EatonGeneral10_1-0\">1.0<\/a><\/sup> <sup><a href=\"#cite_ref-EatonGeneral10_1-1\">1.1<\/a><\/sup> <sup><a href=\"#cite_ref-EatonGeneral10_1-2\">1.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Eaton, D.L.; Gallagher, E.P. (2010). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=jzCAKsa2CpMC&pg=PA1\" target=\"_blank\">\"Chapter 1.01 General Overview of Toxicology\"<\/a>. In McQueen, C.A.. <i>Comprehensive Toxicology<\/i> (2nd ed.). Elsevier. pp. 1\u201346. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 9780080468686<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=jzCAKsa2CpMC&pg=PA1\" target=\"_blank\">https:\/\/books.google.com\/books?id=jzCAKsa2CpMC&pg=PA1<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+1.01+General+Overview+of+Toxicology&rft.atitle=Comprehensive+Toxicology&rft.aulast=Eaton%2C+D.L.%3B+Gallagher%2C+E.P.&rft.au=Eaton%2C+D.L.%3B+Gallagher%2C+E.P.&rft.date=2010&rft.pages=pp.%26nbsp%3B1%E2%80%9346&rft.edition=2nd&rft.pub=Elsevier&rft.isbn=9780080468686&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DjzCAKsa2CpMC%26pg%3DPA1&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Toxicology_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ARUPClin19-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ARUPClin19_2-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/arupconsult.com\/content\/clinical-toxicology-testing\" target=\"_blank\">\"Clinical Toxicology Testing\"<\/a>. <i>ARUP Consult<\/i>. ARUP Laboratories. June 2021<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/arupconsult.com\/content\/clinical-toxicology-testing\" target=\"_blank\">https:\/\/arupconsult.com\/content\/clinical-toxicology-testing<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Clinical+Toxicology+Testing&rft.atitle=ARUP+Consult&rft.date=June+2021&rft.pub=ARUP+Laboratories&rft_id=https%3A%2F%2Farupconsult.com%2Fcontent%2Fclinical-toxicology-testing&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Toxicology_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-SofronescuPurpose18-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-SofronescuPurpose18_3-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Sofronescu, A.G. (1 December 2018). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aacc.org\/cln\/articles\/2018\/december\/purpose-driven-toxicology-services-the-key-to-financial-success-and-client-confidence\" target=\"_blank\">\"Purpose-driven Toxicology Services: The Key to Financial Success and Client Confidence\"<\/a>. <i>Clinical Laboratory News<\/i>. American Association for Clinical Chemistry<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.aacc.org\/cln\/articles\/2018\/december\/purpose-driven-toxicology-services-the-key-to-financial-success-and-client-confidence\" target=\"_blank\">https:\/\/www.aacc.org\/cln\/articles\/2018\/december\/purpose-driven-toxicology-services-the-key-to-financial-success-and-client-confidence<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Purpose-driven+Toxicology+Services%3A+The+Key+to+Financial+Success+and+Client+Confidence&rft.atitle=Clinical+Laboratory+News&rft.aulast=Sofronescu%2C+A.G.&rft.au=Sofronescu%2C+A.G.&rft.date=1+December+2018&rft.pub=American+Association+for+Clinical+Chemistry&rft_id=https%3A%2F%2Fwww.aacc.org%2Fcln%2Farticles%2F2018%2Fdecember%2Fpurpose-driven-toxicology-services-the-key-to-financial-success-and-client-confidence&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Toxicology_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MagnaniClinical12-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MagnaniClinical12_4-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Magnani, B.; Kwong, T.C. (2012). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/webapps.cap.org\/apps\/docs\/store\/PUB220_Toxicol_Sample.pdf\" target=\"_blank\">\"Chapter 2: Supporting the Emergency Department\"<\/a>. In Magnani, B.; Bissell, M.G.; Kwong, T.C.; Wu, A.H.B. (PDF). <i>Clinical Toxicology Testing: A Guide for Laboratory Professionals<\/i>. College of American Pathologists. pp. 7\u201314. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 9780983706816<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/webapps.cap.org\/apps\/docs\/store\/PUB220_Toxicol_Sample.pdf\" target=\"_blank\">http:\/\/webapps.cap.org\/apps\/docs\/store\/PUB220_Toxicol_Sample.pdf<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+2%3A+Supporting+the+Emergency+Department&rft.atitle=Clinical+Toxicology+Testing%3A+A+Guide+for+Laboratory+Professionals&rft.aulast=Magnani%2C+B.%3B+Kwong%2C+T.C.&rft.au=Magnani%2C+B.%3B+Kwong%2C+T.C.&rft.date=2012&rft.pages=pp.%26nbsp%3B7%E2%80%9314&rft.pub=College+of+American+Pathologists&rft.isbn=9780983706816&rft_id=http%3A%2F%2Fwebapps.cap.org%2Fapps%2Fdocs%2Fstore%2FPUB220_Toxicol_Sample.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Toxicology_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20220125221411\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.049 seconds\nReal time usage: 0.082 seconds\nPreprocessor visited node count: 3013\/1000000\nPost\u2010expand include size: 26453\/2097152 bytes\nTemplate argument size: 9182\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 7915\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 76.375 1 -total\n 90.07% 68.793 1 Template:Reflist\n 54.78% 41.842 4 Template:Citation\/core\n 42.56% 32.504 2 Template:Cite_book\n 24.62% 18.800 2 Template:Cite_web\n 13.22% 10.094 2 Template:Citation\/identifier\n 9.84% 7.512 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Toxicology_lab\n 8.59% 6.564 2 Template:Date\n 5.39% 4.120 8 Template:Citation\/make_link\n 3.65% 2.787 2 Template:Only_in_print\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12928-0!canonical and timestamp 20220125221411 and revision id 45825. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Toxicology_lab\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Toxicology_lab<\/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>","84b3522ac7ff6ca73ca05e12dfc127d6_images":[],"84b3522ac7ff6ca73ca05e12dfc127d6_timestamp":1643149330,"4afbb1e18840d48a4da4502ab88912bd_type":"article","4afbb1e18840d48a4da4502ab88912bd_title":"1.2 Public health lab","4afbb1e18840d48a4da4502ab88912bd_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Public_health_lab","4afbb1e18840d48a4da4502ab88912bd_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction to medical diagnostics and research laboratories\/Public health labFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n1.2 Public health lab \nA public health laboratory is a type of medical laboratory that serves regional, national, or in some cases global communities by providing clinical diagnostic testing, environmental testing, disease diagnosis and evaluation, emergency response support, applied research, regulation and standards recommendations, laboratory training, and other essential services to the communities they serve.[1][2][3][4] \nA public health laboratory is unlike the average medical laboratory because it is \"integrated into the broader public health system.\"[1] The public health laboratory must typically meet more stringent requirements, including adhering to not only CLIA (for labs in the United States), but also additional regulations laid out by the departments, agencies, and other regulatory bodies of local, state, and\/or national governments. Finally, the private medical laboratory focuses on tests that diagnose the diseases of individuals, while the functions of the public health laboratory serve entire populations.[1][4]\nA 2002 Association of Public Health Laboratories (APHL) report helped identify 11 core functions that state public health laboratories in the United States should accomplish, giving clearer insight into how the average public health laboratory in most parts of the world should operate. Note that this is not a guarantee every lab will perform these tasks, but it's a standard of what the lab should be responsible for doing. Those suggested 11 core functions are[5]:\n\ndisease prevention, control, and surveillance: provide timely and accurate analytical results for the assessment and surveillance of exposures; rapidly recognize and prevent the spread of communicable diseases; detect and identify biologic agents of significance in human disease; provide specialized tests for low-incidence, high-risk diseases;\nintegrated data management: accumulate, blend, and disseminate scientific information in support of public health programs; collect, monitor, and analyze laboratory data using national database systems; assist state epidemiologists, other laboratories, and practitioners with data needs\nreference and specialized testing: serve as a primary reference microbiology laboratory for a wide variety of needs\nenvironmental health and protection: conduct scientific analyses of potentially threatening environmental samples; detect, identify, and quantify toxic contaminants in environmental and biological specimens; provide air, water, soil, and other environmental laboratory testing services; provide environmental chemistry testing; determine the relationship between environmental hazards and human health; determine extent of a community's exposure to environmental hazards; provide industrial hygiene\/occupational health testing\nfood safety: test specimens implicated in foodborne illness outbreaks to identify causes and sources; detect, identify, and quantify toxic contaminants in food specimens; monitor radioactive contamination of water, milk, shellfish, and other foods\nlaboratory improvement and regulation: coordinate and promote quality assurance programs in other laboratories; act as a standard and leader for other laboratories; develop and oversee quality assurance and laboratory improvement programs; oversee the licensure, certification, and accreditation of other laboratories\npolicy development: assist the development of state and federal public health policy; assist in the development of standards for all health-related laboratories\nemergency response: provide laboratory support to state and national disaster preparedness plans and environmental or health emergencies\npublic health-related research: evaluate and implement new technologies and analytical methodologies in support of public health and healthcare communities; adapt emerging technologies to public health laboratories; conduct applied studies into new and improved analytical methods and services; assist the private sector with newly marketed tests\ntraining and education: sponsor training opportunities for public health laboratory staff; provide or facilitate training and workshops for laboratory staff in private and public sectors; provide training opportunities for careers in public health laboratory practice; provide continuing education opportunities to staff\npartnerships and communication: develop and strengthen partnerships among state, county, and city entities public and private; emphasize the role and value of the public health laboratory to state public health programs; participate in strategic policy planning and development processes; build and strengthen diverse communication networks\nReferences \n\n\n\u2191 1.0 1.1 1.2 Becker, S.; Perlman, E.J. (2010). \"Chapter 1: An Introduction to Public Health Laboratories\". In Jenkins, W.. Public Health Laboratories: Analysis, Operations, and Management. Jones & Bartlett Learning. pp. 1\u201314. ISBN 0763771023. https:\/\/books.google.com\/books?id=6SDqL72zPRUC .   \n \n\n\u2191 Committee on Assuring the Health of the Public in the 21st Century, Board on Health Promotion and Disease Prevention (2003). \"Chapter 3: The Governmental Public Health Structure\". The Future of the Public's Health in the 21st Century. National Academies Press. pp. 136\u2013146. ISBN 0309133181. https:\/\/books.google.com\/books?id=qa8XYZQprt0C .   \n \n\n\u2191 \"About Public Health Laboratories\". Association of Public Health Laboratories. https:\/\/www.aphl.org\/aboutAPHL\/Pages\/aboutphls.aspx . Retrieved 18 November 2021 .   \n \n\n\u2191 4.0 4.1 Becker, S.J.; Blank, E.C.; Martin, R.; Skeels, M. (2005). \"Chapter 27: Public Health Laboratory Administration\". In Novick, L.F.; Mays, G.P.. Public Health Administration: Principles for Population-based Management. Jones & Bartlett Learning. pp. 623\u2013627. ISBN 0763740780. https:\/\/books.google.com\/books?id=bFBPMcQe6ogC .   \n \n\n\u2191 Witt-Kushner, J.; Astles, J.R.; Ridderhof, J.C. et al. (20 September 2002). \"Core Functions and Capabilities of State Public Health Laboratories\". Morbidity and Mortality Weekly Report 51 (RR14): 1\u20138. https:\/\/www.cdc.gov\/mmwr\/preview\/mmwrhtml\/rr5114a1.htm . Retrieved 18 November 2021 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Public_health_lab\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Public_health_lab<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:02.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 29 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","4afbb1e18840d48a4da4502ab88912bd_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Introduction_to_medical_diagnostics_and_research_laboratories_Public_health_lab rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Introduction_to_medical_diagnostics_and_research_laboratories_Public_health_lab 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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction to medical diagnostics and research laboratories\/Public health lab<\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">the beginning<\/a> of this guide-----<\/div>\n<h3><span class=\"mw-headline\" id=\"1.2_Public_health_lab\">1.2 Public health lab<\/span><\/h3>\n<p>A public health laboratory is a type of medical laboratory that serves regional, national, or in some cases global communities by providing clinical diagnostic testing, environmental testing, disease diagnosis and evaluation, emergency response support, applied research, regulation and standards recommendations, laboratory training, and other essential services to the communities they serve.<sup id=\"rdp-ebb-cite_ref-BeckerAnIntro10_1-0\" class=\"reference\"><a href=\"#cite_note-BeckerAnIntro10-1\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CommitteeTheGov03_2-0\" class=\"reference\"><a href=\"#cite_note-CommitteeTheGov03-2\">[2]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-APHLAbout_3-0\" class=\"reference\"><a href=\"#cite_note-APHLAbout-3\">[3]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BeckerPublic05_4-0\" class=\"reference\"><a href=\"#cite_note-BeckerPublic05-4\">[4]<\/a><\/sup> \n<\/p><p>A public health laboratory is unlike the average medical laboratory because it is \"integrated into the broader public health system.\"<sup id=\"rdp-ebb-cite_ref-BeckerAnIntro10_1-1\" class=\"reference\"><a href=\"#cite_note-BeckerAnIntro10-1\">[1]<\/a><\/sup> The public health laboratory must typically meet more stringent requirements, including adhering to not only CLIA (for labs in the United States), but also additional regulations laid out by the departments, agencies, and other regulatory bodies of local, state, and\/or national governments. Finally, the private medical laboratory focuses on tests that diagnose the diseases of individuals, while the functions of the public health laboratory serve entire populations.<sup id=\"rdp-ebb-cite_ref-BeckerAnIntro10_1-2\" class=\"reference\"><a href=\"#cite_note-BeckerAnIntro10-1\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BeckerPublic05_4-1\" class=\"reference\"><a href=\"#cite_note-BeckerPublic05-4\">[4]<\/a><\/sup>\n<\/p><p>A 2002 Association of Public Health Laboratories (APHL) report helped identify 11 core functions that state public health laboratories in the United States should accomplish, giving clearer insight into how the average public health laboratory in most parts of the world should operate. Note that this is not a guarantee every lab will perform these tasks, but it's a standard of what the lab should be responsible for doing. Those suggested 11 core functions are<sup id=\"rdp-ebb-cite_ref-MMWR2_5-0\" class=\"reference\"><a href=\"#cite_note-MMWR2-5\">[5]<\/a><\/sup>:\n<\/p>\n<ul><li><i>disease prevention, control, and surveillance<\/i>: provide timely and accurate analytical results for the assessment and surveillance of exposures; rapidly recognize and prevent the spread of communicable diseases; detect and identify biologic agents of significance in human disease; provide specialized tests for low-incidence, high-risk diseases;<\/li>\n<li><i>integrated data management<\/i>: accumulate, blend, and disseminate scientific <a href=\"https:\/\/www.limswiki.org\/index.php\/Information\" title=\"Information\" class=\"wiki-link\" data-key=\"6300a14d9c2776dcca0999b5ed940e7d\">information<\/a> in support of public health programs; collect, monitor, and analyze laboratory data using national database systems; assist state epidemiologists, other laboratories, and practitioners with data needs<\/li>\n<li><i>reference and specialized testing<\/i>: serve as a primary reference microbiology laboratory for a wide variety of needs<\/li>\n<li><i>environmental health and protection<\/i>: conduct scientific analyses of potentially threatening environmental samples; detect, identify, and quantify toxic contaminants in environmental and biological specimens; provide air, water, soil, and other environmental laboratory testing services; provide environmental chemistry testing; determine the relationship between environmental hazards and human health; determine extent of a community's exposure to environmental hazards; provide industrial hygiene\/occupational health testing<\/li>\n<li><i>food safety<\/i>: test specimens implicated in foodborne illness outbreaks to identify causes and sources; detect, identify, and quantify toxic contaminants in food specimens; monitor radioactive contamination of water, milk, shellfish, and other foods<\/li>\n<li><i>laboratory improvement and regulation<\/i>: coordinate and promote quality assurance programs in other laboratories; act as a standard and leader for other laboratories; develop and oversee quality assurance and laboratory improvement programs; oversee the licensure, certification, and accreditation of other laboratories<\/li>\n<li><i>policy development<\/i>: assist the development of state and federal public health policy; assist in the development of standards for all health-related laboratories<\/li>\n<li><i>emergency response<\/i>: provide laboratory support to state and national disaster preparedness plans and environmental or health emergencies<\/li>\n<li><i>public health-related research<\/i>: evaluate and implement new technologies and analytical methodologies in support of public health and healthcare communities; adapt emerging technologies to public health laboratories; conduct applied studies into new and improved analytical methods and services; assist the private sector with newly marketed tests<\/li>\n<li><i>training and education<\/i>: sponsor training opportunities for public health laboratory staff; provide or facilitate training and workshops for laboratory staff in private and public sectors; provide training opportunities for careers in public health laboratory practice; provide continuing education opportunities to staff<\/li>\n<li><i>partnerships and communication<\/i>: develop and strengthen partnerships among state, county, and city entities public and private; emphasize the role and value of the public health laboratory to state public health programs; participate in strategic policy planning and development processes; build and strengthen diverse communication networks<\/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-BeckerAnIntro10-1\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-BeckerAnIntro10_1-0\">1.0<\/a><\/sup> <sup><a href=\"#cite_ref-BeckerAnIntro10_1-1\">1.1<\/a><\/sup> <sup><a href=\"#cite_ref-BeckerAnIntro10_1-2\">1.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Becker, S.; Perlman, E.J. (2010). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=6SDqL72zPRUC\" target=\"_blank\">\"Chapter 1: An Introduction to Public Health Laboratories\"<\/a>. In Jenkins, W.. <i>Public Health Laboratories: Analysis, Operations, and Management<\/i>. Jones & Bartlett Learning. pp. 1\u201314. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 0763771023<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=6SDqL72zPRUC\" target=\"_blank\">https:\/\/books.google.com\/books?id=6SDqL72zPRUC<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+1%3A+An+Introduction+to+Public+Health+Laboratories&rft.atitle=Public+Health+Laboratories%3A+Analysis%2C+Operations%2C+and+Management&rft.aulast=Becker%2C+S.%3B+Perlman%2C+E.J.&rft.au=Becker%2C+S.%3B+Perlman%2C+E.J.&rft.date=2010&rft.pages=pp.%26nbsp%3B1%E2%80%9314&rft.pub=Jones+%26+Bartlett+Learning&rft.isbn=0763771023&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3D6SDqL72zPRUC&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Public_health_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CommitteeTheGov03-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CommitteeTheGov03_2-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Committee on Assuring the Health of the Public in the 21st Century, Board on Health Promotion and Disease Prevention (2003). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=qa8XYZQprt0C\" target=\"_blank\">\"Chapter 3: The Governmental Public Health Structure\"<\/a>. <i>The Future of the Public's Health in the 21st Century<\/i>. National Academies Press. pp. 136\u2013146. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 0309133181<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=qa8XYZQprt0C\" target=\"_blank\">https:\/\/books.google.com\/books?id=qa8XYZQprt0C<\/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+3%3A+The+Governmental+Public+Health+Structure&rft.atitle=The+Future+of+the+Public%27s+Health+in+the+21st+Century&rft.aulast=Committee+on+Assuring+the+Health+of+the+Public+in+the+21st+Century%2C+Board+on+Health+Promotion+and+Disease+Prevention&rft.au=Committee+on+Assuring+the+Health+of+the+Public+in+the+21st+Century%2C+Board+on+Health+Promotion+and+Disease+Prevention&rft.date=2003&rft.pages=pp.%26nbsp%3B136%E2%80%93146&rft.pub=National+Academies+Press&rft.isbn=0309133181&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3Dqa8XYZQprt0C&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Public_health_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-APHLAbout-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-APHLAbout_3-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/Pages\/aboutphls.aspx\" target=\"_blank\">\"About Public Health Laboratories\"<\/a>. Association of Public Health Laboratories<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/Pages\/aboutphls.aspx\" target=\"_blank\">https:\/\/www.aphl.org\/aboutAPHL\/Pages\/aboutphls.aspx<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/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+Public+Health+Laboratories&rft.atitle=&rft.pub=Association+of+Public+Health+Laboratories&rft_id=https%3A%2F%2Fwww.aphl.org%2FaboutAPHL%2FPages%2Faboutphls.aspx&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Public_health_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BeckerPublic05-4\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-BeckerPublic05_4-0\">4.0<\/a><\/sup> <sup><a href=\"#cite_ref-BeckerPublic05_4-1\">4.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Becker, S.J.; Blank, E.C.; Martin, R.; Skeels, M. (2005). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=bFBPMcQe6ogC\" target=\"_blank\">\"Chapter 27: Public Health Laboratory Administration\"<\/a>. In Novick, L.F.; Mays, G.P.. <i>Public Health Administration: Principles for Population-based Management<\/i>. Jones & Bartlett Learning. pp. 623\u2013627. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 0763740780<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=bFBPMcQe6ogC\" target=\"_blank\">https:\/\/books.google.com\/books?id=bFBPMcQe6ogC<\/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+27%3A+Public+Health+Laboratory+Administration&rft.atitle=Public+Health+Administration%3A+Principles+for+Population-based+Management&rft.aulast=Becker%2C+S.J.%3B+Blank%2C+E.C.%3B+Martin%2C+R.%3B+Skeels%2C+M.&rft.au=Becker%2C+S.J.%3B+Blank%2C+E.C.%3B+Martin%2C+R.%3B+Skeels%2C+M.&rft.date=2005&rft.pages=pp.%26nbsp%3B623%E2%80%93627&rft.pub=Jones+%26+Bartlett+Learning&rft.isbn=0763740780&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DbFBPMcQe6ogC&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Public_health_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MMWR2-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MMWR2_5-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Witt-Kushner, J.; Astles, J.R.; Ridderhof, J.C. et al. (20 September 2002). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/mmwr\/preview\/mmwrhtml\/rr5114a1.htm\" target=\"_blank\">\"Core Functions and Capabilities of State Public Health Laboratories\"<\/a>. <i>Morbidity and Mortality Weekly Report<\/i> <b>51<\/b> (RR14): 1\u20138<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cdc.gov\/mmwr\/preview\/mmwrhtml\/rr5114a1.htm\" target=\"_blank\">https:\/\/www.cdc.gov\/mmwr\/preview\/mmwrhtml\/rr5114a1.htm<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/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=Core+Functions+and+Capabilities+of+State+Public+Health+Laboratories&rft.jtitle=Morbidity+and+Mortality+Weekly+Report&rft.aulast=Witt-Kushner%2C+J.%3B+Astles%2C+J.R.%3B+Ridderhof%2C+J.C.+et+al.&rft.au=Witt-Kushner%2C+J.%3B+Astles%2C+J.R.%3B+Ridderhof%2C+J.C.+et+al.&rft.date=20+September+2002&rft.volume=51&rft.issue=RR14&rft.pages=1%E2%80%938&rft_id=https%3A%2F%2Fwww.cdc.gov%2Fmmwr%2Fpreview%2Fmmwrhtml%2Frr5114a1.htm&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Public_health_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20220125221411\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.060 seconds\nReal time usage: 0.100 seconds\nPreprocessor visited node count: 3615\/1000000\nPost\u2010expand include size: 34236\/2097152 bytes\nTemplate argument size: 11054\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 10057\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 92.537 1 -total\n 86.49% 80.031 1 Template:Reflist\n 51.36% 47.528 5 Template:Citation\/core\n 42.23% 39.076 3 Template:Cite_book\n 16.36% 15.135 1 Template:Cite_journal\n 13.71% 12.686 3 Template:Citation\/identifier\n 13.43% 12.428 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Public_health_lab\n 8.89% 8.228 1 Template:Cite_web\n 6.57% 6.081 1 Template:Date\n 4.72% 4.369 6 Template:Hide_in_print\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12927-0!canonical and timestamp 20220125221411 and revision id 45824. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Public_health_lab\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Public_health_lab<\/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>","4afbb1e18840d48a4da4502ab88912bd_images":[],"4afbb1e18840d48a4da4502ab88912bd_timestamp":1643149330,"e275b81a96253b411988d17555a58563_type":"article","e275b81a96253b411988d17555a58563_title":"1.1 Medical diagnostics lab","e275b81a96253b411988d17555a58563_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_diagnostics_lab","e275b81a96253b411988d17555a58563_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction to medical diagnostics and research laboratories\/Medical diagnostics labFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\nContents \n\n1 1. Introduction to medical diagnostics and research laboratories \n\n1.1 1.1 Medical diagnostics lab \n\n1.1.1 1.1.1 Pathology \n1.1.2 1.1.2 Physician office lab \n1.1.3 1.1.3 Integrative medicine lab \n\n\n\n\n2 References \n\n\n\n1. Introduction to medical diagnostics and research laboratories \nThose who work in a medical diagnostics or research laboratory have a lot on their plate. (Or is that \"on their slides\"? \"In their blood collection tubes\"?) From small- to high-volume laboratories, the analysts in them must follow strict workflows and procedures in order to produce timely and accurate results for the best possible patient health outcomes. Many of those analysts will also have additional ancillary roles within the laboratory, including controlling quality, managing regulatory and cybersecurity requirements, and managing and updating documentation. Particularly in medical labs with significant volume, the chance for human error to impact operations and patient health may increase, requiring systematic and continual improvement approaches to collecting, analyzing, and protecting patient data.[1][2] The introduction of laboratory informatics solutions and other information technology within the medical diagnostic and research fields has made those approaches easier to adopt, resulting in smoother procedures and improved patient safety.[2][3][4]\nEvaluating, selecting, implementing, and maintaining a laboratory informatics solution is no simple task, however. The laboratory team (or individual) taking these actions must consider their laboratory's business goals, current and future workflows, and the regulations that affect them, as well as the budget for the lab, its technology requirements, and its cybersecurity goals. And then of course there's the matter of understanding the options available and working with vendors to make the theoretical solution a reality, backed up with updates to training, business processes, and responsibilities within the organization. This can, for some, lead to a state of anxiety.\nBut the acquisition and implementation of a laboratory informatics solution doesn't have to be painful. With advance preparation and a full understanding of both how your lab's internal processes work and how acquiring a system should ideally occur, you'll be better prepared to take the leap.\nThis guide aims to assist you in that preparation, providing referenced information about the various processes and details of putting a laboratory informatics solution to work for you and your medical lab. We begin below by providing background on a variety of medical diagnostic and research laboratories, from pathology and public health labs to genetic diagnostic and central labs. Afterwards, the second chapter covers a wide array of considerations to make when evaluating, selecting, implementing, and maintaining an informatics solution, including an introduction to the benefits of a user requirements specification (URS) for that process. The third, fourth, and fifth chapters offer a wealth of resources for putting chapter two's information to use, including vendor lists, service providers, organizations, conferences, and other information sources. It also introduces LIMSpec, an ever-evolving software URS for laboratory informatics systems. The sixth chapter then gets into the nuts and bolts of the value of a URS, and more specifically LIMSpec, as well as how to get the most out of it. We provide closing comments afterwards, followed by an appendix that contains a blank version of the LIMSpec for medical diagnostic and research labs, along with a downloadable Microsoft Word version of the same document.\n\n1.1 Medical diagnostics lab \nOften referred to as simply a medical or clinical laboratory, the medical diagnostics lab performs tests on clinical specimens in order to get information about the health of a patient as it pertains to the diagnosis, treatment, and prevention of disease.[5] An additional definition is provided by the Clinical Laboratory Improvement Amendments (CLIA) program, as \"a facility that performs testing on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or assessment of the health of, human beings.\"[6]\nAt a basic level, the medical laboratory, whether chemistry or pathology, operates like many other analytical testing laboratories. However, there are a few nuances between the medical laboratory and other analytical laboratories. Aside from handling human and animal specimens, one of these differences is the need to have a specific unidirectional workflow. This is intended to both minimize the risk of biohazard contamination and to establish assurance that sample cross contamination is minimized.[7][8] Another major difference concerns the regulations governing the management of patient data (e.g., the Health Insurance Portability and Accountability Act [HIPAA] in the U.S. and General Data Protection Regulation [GDPR] in Europe). This creates a significant challenge not generally experienced by other types of analytical laboratories.\nIn most parts of the world, the medical laboratory is either attached to a hospital, performing tests on their patients, or acts as a private (or public) laboratory that receives analysis requests and samples from physicians, insurance companies, clinical research sites, and other health clinics for analysis. In cases where a particularly specialized analysis is required and a standard medical laboratory is not equipped to handle it, a research laboratory with the appropriate equipment and expertise may be employed. In other cases, a laboratory may decide it's simply more cost effective to contract more specialized, less common analyses out to specialized medical labs rather than heavily invest in the equipment and training to perform such analyses. Examples include the molecular diagnostics and cytogenetics laboratory, which provide diagnoses and treatment options for genetic or cancer-related disorders.\nLike other analytical laboratories, regulations, laws, and standards typically drive how vital aspects of the laboratory operate. In the United States, clinical laboratories are primarily regulated by the Department of Health and Human Services. Inside that infrastructure are sub-entities like the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) to apply standards and regulations through their respective Laboratory Quality Assurance and Standardization Programs, and the Clinical Laboratory Improvement Amendments.[9][10][11] Although generally not as strict as the regulations regarding pharmaceutical and diagnostic manufacturers, the regulations affecting the medical laboratory nonetheless act as a significant hurdle to managing the overall operations of the laboratory, from acquiring customers and samples, to testing, reporting results, and handling billing for the completed tests.\nInternationally, regulatory bodies vary from country to country. However, organizations like the not-for-profit Clinical and Laboratory Standards Institute (CLSI)[12] and associations like the Research Quality Association (RQA)[13] exist to promote a more global approach to regulations and guidance affecting medical diagnostic and research laboratories. Additionally, a set of Good Clinical Laboratory Practice standards\u2014originally developed in 2002 and since adopted by the World Health Organisation (WHO), non-governmental organizations (NGOs), and research institutions worldwide\u2014provide guidance on implementing laboratory practices that are critical for laboratory operations around the world.[14][15]\n\n1.1.1 Pathology \n Pathological view of a blood clotPathology is at the heart of a medical laboratory's operations. In the context of modern medical treatment, the laboratory practice of pathology involves analytical workflow, which falls within the contemporary medical field of \"general pathology,\" and the associated determination of the causes and effects of disease and other medical ailments. General pathology is broadly composed of a number of distinct but inter-related medical specialties that involve the analysis of tissue, cell, and body fluid specimens to better understand the cause, pathogenesis, morphologic changes, and clinical manifestations of a disease.[16] In common medical practice, general pathology is mostly concerned with analyzing known clinical abnormalities that are markers or precursors for both infectious and non-infectious disease and is conducted by experts in one of two major specialties: anatomical pathology and clinical pathology. Additional subspecialties of pathology may further specialize in specific diseases (such as cancer) or situational focuses (such as cause of death).\n1.1.1.1 Anatomical vs. clinical pathology\nAnatomical (or \"anatomic\") pathology is a medical specialty of pathology that is concerned with the gross, microscopic, chemical, immunologic, and molecular examination of organs, tissues, and whole bodies (as in autopsy) to determine the presence of disease. Its subspecialties include surgical pathology (e.g., neuropathology, dermatopathology, etc.), cytopathology, and forensic pathology.[17] Clinical pathology, however, is concerned with the diagnosis of disease based on the laboratory analysis of bodily fluids such as blood, urine, and tissues using the tools of chemistry, microbiology, hematology, and molecular analysis. Its subspecialties include hematopathology, immunopathology, and molecular pathology.[17] Both anatomical and clinical pathologists work in close collaboration with clinical scientists (i.e., clinical biochemists, clinical microbiologists, etc.), medical technologists, surgeons, hospital administrators, and referring physicians to ensure the accuracy and optimal utilization of laboratory testing. Yet some argue the distinction between anatomic and clinical pathology is increasingly blurred by the introduction of molecular technologies that require new expertise and the need to provide patients and referring physicians with integrated diagnostic reports.[18][19]\nRegardless, some differences between anatomical and clinical pathology remain distinct[20]:\n\nSpecific dictionary-driven tests are found in clinical pathology environments, but not so much in anatomic pathology environments.\nOrdered anatomic pathology tests typically require more information than clinical pathology tests.\nA single anatomic pathology order may be comprised of several tissues from several organs; clinical pathology orders usually do not.\nAnatomic pathology specimen collection may be a procedural, multi-step process, while clinical pathology specimen collection is routinely more simple.\nThe differences between the two may appear to be small, but a differentiation in laboratory workflow between the two is apparent, to the point that developers of laboratory information systems (LIS) and anatomic pathology computer systems used in the pathology fields have created different functionality for them. Specimen collection, receipt, and tracking; work distribution; and report generation may vary\u2013sometimes significantly\u2013between the two, requiring targeted functionality in the utilized software.[21][22]\n1.1.1.2 Forensic pathology\nTypically associated with a medical examiner or coroner, forensic pathology is focused on identifying and determining the cause of death of an individual. This includes not only the analysis of wounds and injuries but also full tissue specimens, identifying traumas\u2014as well as chemical, biological, and solid foreign bodies and contaminates\u2014that may have played a role in the individual's death. Anatomic pathology plays an important part of the examiner's analyses\u2014represented by the forensic pathologist's required training\u2014though clinical pathology also plays a role.[23] Outside the gross examination of a body, the forensic pathologist will rely on the lab to conduct a variety of analyses. Whole organs and slides containing cross-sectional slivers of organs, as well as blood, urine, bile, and vitreous humor may be analyzed for toxicology, DNA typing, infectious diseases, disorders, or other chemical tests.[24] In particular, maintaining chain of custody for such specimens is vital to ensure analyses are correct and evidence is not compromised. Though a medical laboratory, the forensic pathology laboratory isn't held to the same CLIA standards; they must be accredited by a related organization such as The American Society of Crime Laboratory Directors\/Laboratory Accreditation Board to ensure the lab operates at prescribed standards.[24]\n\n1.1.2 Physician office lab \n Point-of-care devices such as this rapid syphilis test are commonly used in the POL.The physician office lab, or POL, is a physician-, partnership-, or group-maintained laboratory that performs medical diagnostic tests or examines specimens in order to diagnose, prevent, and\/or treat a disease or impairment in a patient as part of the physician practice.[25][26] The POL shows up in primary care physician offices as well as the offices of specialists like urologists, hematologists, gynecologists, and endocrinologists. In many countries like the United States, the POL is considered a clinical laboratory and is thus regulated by federal, state, and\/or local laws affecting such laboratories.[26][27] In October 2021, the Centers for Medicare and Medicaid Services (CMS) reported 41% of all CLIA-approved laboratories in the United States (130,335) were physician office laboratories.[28] However, as of 2014, POLs were estimated to be processing only about nine percent of all clinical laboratory tests.[29]\nTesting and reporting at a POL, at least in the U.S., is largely concentrated on the realm of waived CLIA testing. As of October 2021, 68% of the POLs in the United States were primarily running CLIA waived tests.[30] CLIA test complexity has three levels: high, moderate, and waived.[31] Waived tests are simple to perform and have a relatively low risk of an incorrect test result. Moderately complex tests include tests like provider performed microscopy (PPM), which requires the use of a microscope during the office visit. Providers that want to perform PPM tests must be qualified to do so under CLIA regulations.[31] High-complexity tests require the most regulation. These tests are the most complicated and run the highest risk of an inaccurate result, as determined during the Food and Drug Administration (FDA) pre-market approval process. Tests may come from the manufacturer with their complexity level on them, or one can search the FDA database to determine the complexity of the test.[31] \nCommonly performed tests include[32]:\n\nurine analysis\nurine pregnancy\nblood occult\nglucose blood\npathology consultation during surgery\ncrystal identification by microscope\nsperm identification and analyses\nbilirubin total\nblood gasses\ncomplete blood count\nbone marrow smear\nblood bank services\ntransfusion medicine\n1.1.3 Integrative medicine lab \nDr. Ralph Snyderman, Director of the Center for Personalized Health Care at Duke University, defines integrative medicine as a process that creates and encourages \"a seamless engagement by patients and caregivers in the full range of physical, psychological, social, preventive, and therapeutic factors known to be effective and necessary for the achievement of optimal health over the course of one's life.\"[33] This type of personalized healthcare takes a more holistic approach to the causes of illnesses, including the biological, behavioral, psychosocial, and environmental contributors.[34] Some medical laboratories such as those found within Duke Integrative Medicine[35], as well as Harvard Medical School's Contemplative Neuroscience and Integrative Medicine Laboratory[36], include an integrative medicine approach to their medical diagnostic and research activities. Laboratories associated with integrative medicine approaches are quite similar to standard medical laboratories, though, broadly speaking, they may focus more on nutritional, metabolic, and toxicity test types.[37]\n\nReferences \n\n\n\u2191 Jafri, L.; Khan, A.H.; Ghani, F. et al. (2015). \"Error identification in a high-volume clinical chemistry laboratory: Five-year experience\". Scandinavian Journal of Clinical and Laboratory Investigation 75 (4): 296\u2013300. doi:10.3109\/00365513.2015.1010175. PMID 25723890.   \n \n\n\u2191 2.0 2.1 Agarwal, R. (2014). \"Quality-Improvement Measures as Effective Ways of Preventing Laboratory Errors\". Laboratory Medicine 45 (2): e80\u2013e88. doi:10.1309\/LMD0YIFPTOWZONAD.   \n \n\n\u2191 Alotaibi, Y.K.; Federico, F. (2017). \"The impact of health information technology on patient safety\". Saudi Medical Journal 38 (12): 1173\u201380. doi:10.15537\/smj.2017.12.20631. PMC PMC5787626. PMID 29209664. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC5787626 .   \n \n\n\u2191 Raeen, M.R. (2018). \"How Laboratory Informatics has Impacted Healthcare Overall\". Applied Research Projects: 54. doi:10.21007\/chp.hiim.0056. https:\/\/dc.uthsc.edu\/hiimappliedresearch\/54\/ .   \n \n\n\u2191 Sood, R. (2006). \"Chapter 1: Laboratory\". Textbook of Medical Laboratory Technology. Jaypee Brothers Publishers. pp. 01\u201328. ISBN 818061591X. https:\/\/books.google.com\/books?id=hpNhAQAACAAJ .   \n \n\n\u2191 \"CLIA - How to Obtain a CLIA Certificate of Waiver\" (PDF). Centers for Disease Control and Prevention. March 2019. https:\/\/www.cms.gov\/Regulations-and-Guidance\/Legislation\/CLIA\/downloads\/HowObtainCertificateofWaiver.pdf . Retrieved 18 November 2021 .   \n \n\n\u2191 Chen, B.; Gagnon, M.; Shahangian, S. et al. (12 June 2009). \"Good Laboratory Practices for Molecular Genetic Testing for Heritable Diseases and Conditions\". Morbidity and Mortality Weekly Report 58 (RR06): 1\u201329. https:\/\/www.cdc.gov\/mmwr\/preview\/mmwrhtml\/rr5806a1.htm . Retrieved 18 November 2021 .   \n \n\n\u2191 Viana, R.V.; Wallis, C.L. (2011). \"Chapter 3: Good Clinical Laboratory Practice (GCLP) for Molecular Based Tests Used in Diagnostic Laboratories\". In Isin, A. (PDF). Wide Spectra of Quality Control. InTech. pp. 29\u201352. ISBN 9789533076836. https:\/\/cdn.intechopen.com\/pdfs\/23728.pdf .   \n \n\n\u2191 \"HHS Organizational Chart\". U.S. Department of Health & Human Services. 31 December 2019. https:\/\/www.hhs.gov\/about\/agencies\/orgchart\/index.html . Retrieved 18 November 2021 .   \n \n\n\u2191 \"Laboratory Quality Assurance and Standardization Programs\". Centers for Disease Control and Prevention. 25 July 2017. https:\/\/www.cdc.gov\/labstandards\/ . Retrieved 18 November 2021 .   \n \n\n\u2191 \"Clinical Laboratory Improvement Amendments (CLIA)\". Centers for Medicare and Medicaid Services. 16 November 2021. https:\/\/www.cms.gov\/regulations-and-guidance\/legislation\/clia . Retrieved 18 November 2021 .   \n \n\n\u2191 \"About CLSI\". Clinical and Laboratory Standards Institute. https:\/\/clsi.org\/about\/ . Retrieved 18 November 2021 .   \n \n\n\u2191 \"What is RQA?\". Research Quality Association. https:\/\/www.therqa.com\/about\/ . Retrieved 18 November 2021 .   \n \n\n\u2191 \"Good Clinical Laboratory Practice (GCLP)\". Research Quality Association. January 2012. https:\/\/www.therqa.com\/resources\/publications\/booklets\/good-clinical-laboratory-practice-booklet\/ . Retrieved 18 November 2021 .   \n \n\n\u2191 Ezzelle, J.; Rodriguez-Chavez, I.R.; Darden, J.M. et al. (2008). \"Guidelines on Good Clinical Laboratory Practice - Bridging Operations between Research and Clinical Research Laboratories\". Journal of Pharmaceutical and Biomedical Analysis 46 (1): 18\u201329. doi:10.1016\/j.jpba.2007.10.010. PMC PMC2213906. PMID 18037599. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC2213906 .   \n \n\n\u2191 Kumar, V.; Abbas, A.; Fausto, N.; Aster, J., ed. (2010). Robbins and Cotran Pathologic Basis of Disease, Professional Edition (8th ed.). Saunders Elsevier. ISBN 9781416031215.   \n \n\n\u2191 17.0 17.1 Adelman, H.C. (2009). Forensic Medicine. Infobase Publishing. pp. 3\u20134. ISBN 1438103816. https:\/\/books.google.com\/books?id=x5FftcZOv1UC&pg=PA3 .   \n \n\n\u2191 Friedberg, R. (July 2013). \"Evolving Changes in Health Care and Implications for Pathology and Laboratory Practice\". 2013 Summer Anatomic Pathology Conference. Florida Society of Pathologists. https:\/\/scholarlycommons.libraryinfo.bhs.org\/all_works\/7637\/ . Retrieved 18 November 2021 . \"The advent of molecular pathology and molecular imaging tools only serves to further blur the distinction between anatomic and clinical pathology...\"   \n \n\n\u2191 Paxton, A. (February 2011). \"All for one\u2014unifying CP and AP data\". CAP Today. College of American Pathologists. http:\/\/www.captodayonline.com\/Archives\/0211\/0211a_cp_ap.html . Retrieved 18 November 2021 . \"Traditionally, CP systems are based on discrete data elements while AP systems are based on blocks of text. But that distinction is starting to blur, because AP is moving to synoptic reporting, and that includes the creation of discrete data components as well as textual reporting\"   \n \n\n\u2191 Park, S.L.; Pantanowitz, L.; Sharma, G. et al. (2012). \"Anatomic Pathology Laboratory Information Systems: A Review\". Advances in Anatomic Pathology 19 (2): 81\u201396. doi:10.1097\/PAP.0b013e318248b787. PMID 22313836.   \n \n\n\u2191 Henricks, W.H. (9 October 2012). \"LIS Basics: CP and AP LIS Design and Operations\" (PDF). Pathology Informatics 2012. Archived from the original on 10 September 2015. https:\/\/web.archive.org\/web\/20150910050825\/http:\/\/www.pathinformatics.pitt.edu\/sites\/default\/files\/2012Powerpoints\/01HenricksTues.pdf . Retrieved 18 November 2021 .   \n \n\n\u2191 Clifford, L.-J. (August 2011). \"The evolving LIS needs to be \"everything\" for today's laboratories\". Medical Laboratory Observer. Endeavor Business Media, LLC. https:\/\/www.mlo-online.com\/home\/article\/13004085\/the-evolving-lis-needs-to-be-everything-for-todays-laboratories . Retrieved 18 November 2021 .   \n \n\n\u2191 Prahlow, J. (2010). \"Chapter 3: Introduction to Forensic Pathology\". Forensic Pathology for Police, Death Investigators, Attorneys, and Forensic Scientists. Humana Press. pp. 35\u201348. doi:10.1007\/978-1-59745-404-9. ISBN 9781588299758. https:\/\/books.google.com\/books?id=rF1WTiX0nHEC&pg=PA35 .   \n \n\n\u2191 24.0 24.1 \"The World of Forensic Laboratory Testing\". Testing.com. OneCare Media. 9 November 2021. https:\/\/www.testing.com\/articles\/forensic-testing\/ . Retrieved 18 November 2021 .   \n \n\n\u2191 \"Chapter 16 - Laboratory Services\" (PDF). Medicare Claims Processing Manual. Centers for Medicare and Medicaid Services. 9 March 2021. https:\/\/www.cms.gov\/Regulations-and-Guidance\/Guidance\/Manuals\/downloads\/clm104c16.pdf . Retrieved 18 November 2021 .   \n \n\n\u2191 26.0 26.1 \"Physician Office Laboratory Evaluation Program (POLEP)\". Wadsworth Center New York State Department of Health. https:\/\/www.wadsworth.org\/regulatory\/polep . Retrieved 18 November 2021 .   \n \n\n\u2191 \"Physician Office Laboratories or Clinics - Frequently Asked Questions about Clinical Laboratory Licensing and Registration\" (PDF). California Department of Public Health. May 2008. Archived from the original on 29 December 2016. https:\/\/web.archive.org\/web\/20161229143212\/http:\/\/www.cdph.ca.gov\/programs\/lfs\/Documents\/POL-FAQ.pdf . Retrieved 03 January 2020 .   \n \n\n\u2191 \"Laboratories by Type of Facility\" (PDF). Centers for Medicare and Medicaid Services. October 2021. https:\/\/www.cms.gov\/Regulations-and-Guidance\/Legislation\/CLIA\/downloads\/factype.pdf . Retrieved 18 November 2021 .   \n \n\n\u2191 \"How and Where IVD Will Find Growth in the Global POL Market \u2013 Part 2\". Kalorama Information. November 2014. Archived from the original on 17 April 2015. https:\/\/web.archive.org\/web\/20150417204832\/http:\/\/www.kaloramainformation.com\/article\/2014-11\/How-and-Where-IVD-Will-Find-Growth-Global-POL-Market-%E2%80%93-Part-2 . Retrieved 03 January 2020 .   \n \n\n\u2191 Centers for Medicare and Medicaid Services, Division of Laboratory Services (October 2021). \"Enrollment, CLIA exempt states, and certification of accreditation by organization\" (PDF). https:\/\/www.cms.gov\/Regulations-and-Guidance\/Legislation\/CLIA\/Downloads\/statupda.pdf . Retrieved 18 November 2021 .   \n \n\n\u2191 31.0 31.1 31.2 Centers for Disease Control and Prevention (6 August 2018). \"Clinical Laboratory Improvement Amendments (CLIA): Test complexities\". https:\/\/www.cdc.gov\/clia\/test-complexities.html . Retrieved 18 November 2021 .   \n \n\n\u2191 UnitedHealthcare Oxford (1 January 2018). \"UnitedHealthcare Oxford's in-office laboratory testing and procedures list\" (PDF). https:\/\/www.oxhp.com\/secure\/policy\/in_office_laboratory_testing_and_procedures_list.pdf . Retrieved 18 November 2021 .   \n \n\n\u2191 Snyderman, R. (30 March 2011). \"Integrative Medicine: A Comprehensive Approach to Personalized Care\" (PDF). Scripps Clinic Green Hospital Grand Rounds. https:\/\/www.scripps.org\/assets\/documents\/ralph_snyderman_md_03-30-11.pdf . Retrieved 18 November 2021 .   \n \n\n\u2191 \"Integrative Medicine\". The Bravewell Collaborative. 2015. https:\/\/bravewell.org\/integrative_medicine\/ . Retrieved 18 November 2021 .   \n \n\n\u2191 \"Duke Integrative Medicine\". The Bravewell Collaborative. 2015. https:\/\/bravewell.org\/current_projects\/clinical_network\/duke_center\/ . Retrieved 18 November 2021 .   \n \n\n\u2191 \"Contemplative Neuroscience and Integrative Medicine (CNIM) Laboratory\". David R. Vago - Brigham and Women's Hospital. Harvard Medical School. 2020. https:\/\/davidvago.bwh.harvard.edu\/contemplative-neuroscience-and-integrative-medicine-cnim-laboratory\/ . Retrieved 18 November 2021 .   \n \n\n\u2191 Bralley, J.A.; Lord, R.S. (2008). \"Chapter 1: Basic Concepts\". Laboratory Evaluations for Integrative and Functional Medicine (2nd ed.). MetaMetrix Institute. pp. 1\u201316. ISBN 0967394945. https:\/\/books.google.com\/books?id=CpXVAwgOv7sC&pg=PT11 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_diagnostics_lab\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_diagnostics_lab<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:01.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 33 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","e275b81a96253b411988d17555a58563_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Introduction_to_medical_diagnostics_and_research_laboratories_Medical_diagnostics_lab rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Introduction_to_medical_diagnostics_and_research_laboratories_Medical_diagnostics_lab 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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction to medical diagnostics and research laboratories\/Medical diagnostics lab<\/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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction\" class=\"wiki-link\" data-key=\"629f817ccc0007fa646508ddcd735ca7\">the beginning<\/a> of this guide-----<\/div>\n\n\n<h2><span class=\"mw-headline\" id=\"1._Introduction_to_medical_diagnostics_and_research_laboratories\">1. Introduction to medical diagnostics and research laboratories<\/span><\/h2>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Medical_Laboratory_Scientist_US_NIH.jpg\" class=\"image wiki-link\" data-key=\"3f511b16db27b5fe7e44c5ba90684100\"><img alt=\"Medical Laboratory Scientist US NIH.jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/e\/e3\/Medical_Laboratory_Scientist_US_NIH.jpg\" decoding=\"async\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a><\/div><p>Those who work in a <a href=\"https:\/\/www.limswiki.org\/index.php\/Clinical_laboratory\" title=\"Clinical laboratory\" class=\"wiki-link\" data-key=\"307bcdf1bdbcd1bb167cee435b7a5463\">medical diagnostics<\/a> or <a href=\"https:\/\/www.limswiki.org\/index.php\/Medical_research\" title=\"Medical research\" class=\"wiki-link\" data-key=\"0ee7e4e2a32a422d78fe6bd1ab0d1cbc\">research<\/a> laboratory have a lot on their plate. (Or is that \"on their slides\"? \"In their blood collection tubes\"?) From small- to high-volume <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory\" title=\"Laboratory\" class=\"wiki-link\" data-key=\"c57fc5aac9e4abf31dccae81df664c33\">laboratories<\/a>, the analysts in them must follow strict <a href=\"https:\/\/www.limswiki.org\/index.php\/Workflow\" title=\"Workflow\" class=\"wiki-link\" data-key=\"92bd8748272e20d891008dcb8243e8a8\">workflows<\/a> and procedures in order to produce timely and accurate results for the best possible patient health outcomes. Many of those analysts will also have additional ancillary roles within the laboratory, including <a href=\"https:\/\/www.limswiki.org\/index.php\/Quality_control\" title=\"Quality control\" class=\"wiki-link\" data-key=\"1e0e0c2eb3e45aff02f5d61799821f0f\">controlling quality<\/a>, managing <a href=\"https:\/\/www.limswiki.org\/index.php\/Regulatory_compliance\" title=\"Regulatory compliance\" class=\"wiki-link\" data-key=\"7dbc9be278a8efda25a4b592ee6ef0ca\">regulatory<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Cybersecurity\" class=\"mw-redirect wiki-link\" title=\"Cybersecurity\" data-key=\"ba653dc2a1384e5f9f6ac9dc1a740109\">cybersecurity<\/a> requirements, and managing and updating <a href=\"https:\/\/www.limswiki.org\/index.php\/Document_management_system\" title=\"Document management system\" class=\"wiki-link\" data-key=\"b9d429b16b89b35fe74097a3e0c2d1ee\">documentation<\/a>. Particularly in medical labs with significant volume, the chance for human error to impact operations and patient health may increase, requiring systematic and <a href=\"https:\/\/www.limswiki.org\/index.php\/Continual_improvement_process\" title=\"Continual improvement process\" class=\"wiki-link\" data-key=\"fd7b54be3f6cdd0e8ed84d501486d668\">continual improvement<\/a> approaches to collecting, <a href=\"https:\/\/www.limswiki.org\/index.php\/Data_analysis\" title=\"Data analysis\" class=\"wiki-link\" data-key=\"545c95e40ca67c9e63cd0a16042a5bd1\">analyzing<\/a>, and <a href=\"https:\/\/www.limswiki.org\/index.php\/Information_security\" title=\"Information security\" class=\"wiki-link\" data-key=\"9eff362d944224ff1d4ffe3a149d7cff\">protecting<\/a> patient data.<sup id=\"rdp-ebb-cite_ref-JafriError15_1-0\" class=\"reference\"><a href=\"#cite_note-JafriError15-1\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-AgarwalQuality14_2-0\" class=\"reference\"><a href=\"#cite_note-AgarwalQuality14-2\">[2]<\/a><\/sup> The introduction of <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_informatics\" title=\"Laboratory informatics\" class=\"wiki-link\" data-key=\"00edfa43edcde538a695f6d429280301\">laboratory informatics<\/a> solutions and other information technology within the medical diagnostic and research fields has made those approaches easier to adopt, resulting in smoother procedures and improved patient safety.<sup id=\"rdp-ebb-cite_ref-AgarwalQuality14_2-1\" class=\"reference\"><a href=\"#cite_note-AgarwalQuality14-2\">[2]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-AlotaibiTheImpact17_3-0\" class=\"reference\"><a href=\"#cite_note-AlotaibiTheImpact17-3\">[3]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-RaeenHowLab18_4-0\" class=\"reference\"><a href=\"#cite_note-RaeenHowLab18-4\">[4]<\/a><\/sup>\n<\/p><p>Evaluating, selecting, implementing, and maintaining a laboratory informatics solution is no simple task, however. The laboratory team (or individual) taking these actions must consider their laboratory's business goals, current and future workflows, and the regulations that affect them, as well as the budget for the lab, its technology requirements, and its cybersecurity goals. And then of course there's the matter of understanding the options available and working with vendors to make the theoretical solution a reality, backed up with updates to training, business processes, and responsibilities within the organization. This can, for some, lead to a state of anxiety.\n<\/p><p>But the acquisition and implementation of a laboratory informatics solution doesn't have to be painful. With advance preparation and a full understanding of both how your lab's internal processes work and how acquiring a system should ideally occur, you'll be better prepared to take the leap.\n<\/p><p>This guide aims to assist you in that preparation, providing referenced information about the various processes and details of putting a laboratory informatics solution to work for you and your medical lab. We begin below by providing background on a variety of medical diagnostic and research laboratories, from pathology and <a href=\"https:\/\/www.limswiki.org\/index.php\/Public_health_laboratory\" title=\"Public health laboratory\" class=\"wiki-link\" data-key=\"34ffb658cb79bf322c65efaad95996f5\">public health labs<\/a> to genetic diagnostic and central labs. Afterwards, the second chapter covers a wide array of considerations to make when evaluating, selecting, implementing, and maintaining an informatics solution, including an introduction to the benefits of a user requirements specification (URS) for that process. The third, fourth, and fifth chapters offer a wealth of resources for putting chapter two's information to use, including vendor lists, service providers, organizations, conferences, and other information sources. It also introduces LIMSpec, an ever-evolving software URS for laboratory informatics systems. The sixth chapter then gets into the nuts and bolts of the value of a URS, and more specifically LIMSpec, as well as how to get the most out of it. We provide closing comments afterwards, followed by an appendix that contains a blank version of the LIMSpec for medical diagnostic and research labs, along with a downloadable Microsoft Word version of the same document.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"1.1_Medical_diagnostics_lab\">1.1 Medical diagnostics lab<\/span><\/h3>\n<p>Often referred to as simply a medical or clinical laboratory, the medical diagnostics lab performs tests on clinical specimens in order to get information about the health of a patient as it pertains to the diagnosis, treatment, and prevention of disease.<sup id=\"rdp-ebb-cite_ref-MedLabTech_5-0\" class=\"reference\"><a href=\"#cite_note-MedLabTech-5\">[5]<\/a><\/sup> An additional definition is provided by the <a href=\"https:\/\/www.limswiki.org\/index.php\/Clinical_Laboratory_Improvement_Amendments\" title=\"Clinical Laboratory Improvement Amendments\" class=\"wiki-link\" data-key=\"64bdae1dc17c40c28e0c560396a6ae35\">Clinical Laboratory Improvement Amendments<\/a> (CLIA) program, as \"a facility that performs testing on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or assessment of the health of, human beings.\"<sup id=\"rdp-ebb-cite_ref-CLIACDCLab_6-0\" class=\"reference\"><a href=\"#cite_note-CLIACDCLab-6\">[6]<\/a><\/sup>\n<\/p><p>At a basic level, the medical laboratory, whether chemistry or pathology, operates like many other analytical testing laboratories. However, there are a few nuances between the medical laboratory and other analytical laboratories. Aside from handling human and animal specimens, one of these differences is the need to have a specific unidirectional workflow. This is intended to both minimize the risk of biohazard contamination and to establish assurance that sample cross contamination is minimized.<sup id=\"rdp-ebb-cite_ref-ChenGood09_7-0\" class=\"reference\"><a href=\"#cite_note-ChenGood09-7\">[7]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-VianaGood11_8-0\" class=\"reference\"><a href=\"#cite_note-VianaGood11-8\">[8]<\/a><\/sup> Another major difference concerns the regulations governing the management of patient data (e.g., the <a href=\"https:\/\/www.limswiki.org\/index.php\/Health_Insurance_Portability_and_Accountability_Act\" title=\"Health Insurance Portability and Accountability Act\" class=\"wiki-link\" data-key=\"b70673a0117c21576016cb7498867153\">Health Insurance Portability and Accountability Act<\/a> [HIPAA] in the U.S. and General Data Protection Regulation [GDPR] in Europe). This creates a significant challenge not generally experienced by other types of analytical laboratories.\n<\/p><p>In most parts of the world, the medical laboratory is either attached to a <a href=\"https:\/\/www.limswiki.org\/index.php\/Hospital\" title=\"Hospital\" class=\"wiki-link\" data-key=\"b8f070c66d8123fe91063594befebdff\">hospital<\/a>, performing tests on their patients, or acts as a private (or public) laboratory that receives analysis requests and samples from physicians, insurance companies, clinical research sites, and other health clinics for analysis. In cases where a particularly specialized analysis is required and a standard medical laboratory is not equipped to handle it, a research laboratory with the appropriate equipment and expertise may be employed. In other cases, a laboratory may decide it's simply more cost effective to contract more specialized, less common analyses out to specialized medical labs rather than heavily invest in the equipment and training to perform such analyses. Examples include the molecular diagnostics and cytogenetics laboratory, which provide diagnoses and treatment options for genetic or <a href=\"https:\/\/www.limswiki.org\/index.php\/Cancer\" title=\"Cancer\" class=\"wiki-link\" data-key=\"fcd6751ee9aef5d96b8448c082d5e582\">cancer<\/a>-related disorders.\n<\/p><p>Like other analytical laboratories, regulations, laws, and standards typically drive how vital aspects of the laboratory operate. In the United States, clinical laboratories are primarily regulated by the <a href=\"https:\/\/www.limswiki.org\/index.php\/United_States_Department_of_Health_and_Human_Services\" title=\"United States Department of Health and Human Services\" class=\"wiki-link\" data-key=\"efa106bcbb93039b1a6c3c596daedec3\">Department of Health and Human Services<\/a>. Inside that infrastructure are sub-entities like 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) and the <a href=\"https:\/\/www.limswiki.org\/index.php\/Centers_for_Medicare_and_Medicaid_Services\" title=\"Centers for Medicare and Medicaid Services\" class=\"wiki-link\" data-key=\"654b4449e4816e190325b420c264df1a\">Centers for Medicare and Medicaid Services<\/a> (CMS) to apply standards and regulations through their respective Laboratory Quality Assurance and Standardization Programs, and the Clinical Laboratory Improvement Amendments.<sup id=\"rdp-ebb-cite_ref-DHHS_HHS19_9-0\" class=\"reference\"><a href=\"#cite_note-DHHS_HHS19-9\">[9]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CDCLaboratory17_10-0\" class=\"reference\"><a href=\"#cite_note-CDCLaboratory17-10\">[10]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CMS_CLIA_11-0\" class=\"reference\"><a href=\"#cite_note-CMS_CLIA-11\">[11]<\/a><\/sup> Although generally not as strict as the regulations regarding pharmaceutical and diagnostic manufacturers, the regulations affecting the medical laboratory nonetheless act as a significant hurdle to managing the overall operations of the laboratory, from acquiring customers and samples, to testing, reporting results, and handling billing for the completed tests.\n<\/p><p>Internationally, regulatory bodies vary from country to country. However, organizations like the not-for-profit Clinical and Laboratory Standards Institute (CLSI)<sup id=\"rdp-ebb-cite_ref-CLSIAbout_12-0\" class=\"reference\"><a href=\"#cite_note-CLSIAbout-12\">[12]<\/a><\/sup> and associations like the Research Quality Association (RQA)<sup id=\"rdp-ebb-cite_ref-RQAAbout_13-0\" class=\"reference\"><a href=\"#cite_note-RQAAbout-13\">[13]<\/a><\/sup> exist to promote a more global approach to regulations and guidance affecting medical diagnostic and research laboratories. Additionally, a set of Good Clinical Laboratory Practice standards\u2014originally developed in 2002 and since adopted by the World Health Organisation (WHO), non-governmental organizations (NGOs), and research institutions worldwide\u2014provide guidance on implementing laboratory practices that are critical for laboratory operations around the world.<sup id=\"rdp-ebb-cite_ref-RQAGCLP_14-0\" class=\"reference\"><a href=\"#cite_note-RQAGCLP-14\">[14]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-GCLPEzzelle_15-0\" class=\"reference\"><a href=\"#cite_note-GCLPEzzelle-15\">[15]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"1.1.1_Pathology\">1.1.1 Pathology<\/span><\/h4>\n<div class=\"thumb tright\"><div class=\"thumbinner\" style=\"width:302px;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Blood_clot.jpg\" class=\"image wiki-link\" data-key=\"7d1394a113642ad69dec9d580012140b\"><img alt=\"\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/4\/42\/Blood_clot.jpg\" decoding=\"async\" width=\"300\" height=\"225\" class=\"thumbimage\" \/><\/a> <div class=\"thumbcaption\"><div class=\"magnify\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Blood_clot.jpg\" class=\"internal wiki-link\" title=\"Enlarge\" data-key=\"7d1394a113642ad69dec9d580012140b\"><\/a><\/div>Pathological view of a blood clot<\/div><\/div><\/div><p>Pathology is at the heart of a medical laboratory's operations. In the context of modern medical treatment, the laboratory practice of pathology involves analytical workflow, which falls within the contemporary medical field of \"general pathology,\" and the associated determination of the causes and effects of disease and other medical ailments. General pathology is broadly composed of a number of distinct but inter-related medical specialties that involve the analysis of tissue, cell, and body fluid specimens to better understand the cause, pathogenesis, morphologic changes, and clinical manifestations of a disease.<sup id=\"rdp-ebb-cite_ref-KumarRobbins09_16-0\" class=\"reference\"><a href=\"#cite_note-KumarRobbins09-16\">[16]<\/a><\/sup> In common medical practice, general pathology is mostly concerned with analyzing known clinical abnormalities that are markers or precursors for both infectious and non-infectious disease and is conducted by experts in one of two major specialties: <a href=\"https:\/\/www.limswiki.org\/index.php\/Anatomical_pathology\" title=\"Anatomical pathology\" class=\"wiki-link\" data-key=\"5668db6faf37e8c1432a1d7953f30cb7\">anatomical pathology<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Clinical_pathology\" title=\"Clinical pathology\" class=\"wiki-link\" data-key=\"9b0b91aa13ae0209e073db6f30493daf\">clinical pathology<\/a>. Additional subspecialties of pathology may further specialize in specific diseases (such as cancer) or situational focuses (such as cause of death).\n<\/p><p><b>1.1.1.1 Anatomical vs. clinical pathology<\/b>\n<\/p><p>Anatomical (or \"anatomic\") pathology is a medical specialty of pathology that is concerned with the gross, microscopic, chemical, immunologic, and molecular examination of organs, tissues, and whole bodies (as in autopsy) to determine the presence of disease. Its subspecialties include surgical pathology (e.g., neuropathology, dermatopathology, etc.), cytopathology, and forensic pathology.<sup id=\"rdp-ebb-cite_ref-AdelmanForensic09_17-0\" class=\"reference\"><a href=\"#cite_note-AdelmanForensic09-17\">[17]<\/a><\/sup> Clinical pathology, however, is concerned with the diagnosis of disease based on the laboratory analysis of bodily fluids such as blood, urine, and tissues using the tools of chemistry, microbiology, <a href=\"https:\/\/www.limswiki.org\/index.php\/Hematology\" title=\"Hematology\" class=\"wiki-link\" data-key=\"de8b49c7b0be3cec33af362e763b9b0c\">hematology<\/a>, and molecular analysis. Its subspecialties include hematopathology, immunopathology, and molecular pathology.<sup id=\"rdp-ebb-cite_ref-AdelmanForensic09_17-1\" class=\"reference\"><a href=\"#cite_note-AdelmanForensic09-17\">[17]<\/a><\/sup> Both anatomical and clinical pathologists work in close collaboration with clinical scientists (i.e., clinical biochemists, clinical microbiologists, etc.), medical technologists, surgeons, <a href=\"https:\/\/www.limswiki.org\/index.php\/Hospital\" title=\"Hospital\" class=\"wiki-link\" data-key=\"b8f070c66d8123fe91063594befebdff\">hospital<\/a> administrators, and referring physicians to ensure the accuracy and optimal utilization of laboratory testing. Yet some argue the distinction between anatomic and clinical pathology is increasingly blurred by the introduction of molecular technologies that require new expertise and the need to provide patients and referring physicians with integrated diagnostic reports.<sup id=\"rdp-ebb-cite_ref-FriedbergEvolv13_18-0\" class=\"reference\"><a href=\"#cite_note-FriedbergEvolv13-18\">[18]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PaxtonAllFor11_19-0\" class=\"reference\"><a href=\"#cite_note-PaxtonAllFor11-19\">[19]<\/a><\/sup>\n<\/p><p>Regardless, some differences between anatomical and clinical pathology remain distinct<sup id=\"rdp-ebb-cite_ref-ParkAnatom12_20-0\" class=\"reference\"><a href=\"#cite_note-ParkAnatom12-20\">[20]<\/a><\/sup>:\n<\/p>\n<ul><li>Specific dictionary-driven tests are found in clinical pathology environments, but not so much in anatomic pathology environments.<\/li>\n<li>Ordered anatomic pathology tests typically require more <a href=\"https:\/\/www.limswiki.org\/index.php\/Information\" title=\"Information\" class=\"wiki-link\" data-key=\"6300a14d9c2776dcca0999b5ed940e7d\">information<\/a> than clinical pathology tests.<\/li>\n<li>A single anatomic pathology order may be comprised of several tissues from several organs; clinical pathology orders usually do not.<\/li>\n<li>Anatomic pathology specimen collection may be a procedural, multi-step process, while clinical pathology specimen collection is routinely more simple.<\/li><\/ul>\n<p>The differences between the two may appear to be small, but a differentiation in laboratory workflow between the two is apparent, to the point that developers of <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_information_system\" title=\"Laboratory information system\" class=\"wiki-link\" data-key=\"37add65b4d1c678b382a7d4817a9cf64\">laboratory information systems<\/a> (LIS) and anatomic pathology computer systems used in the pathology fields have created different functionality for them. Specimen collection, receipt, and tracking; work distribution; and report generation may vary\u2013sometimes significantly\u2013between the two, requiring targeted functionality in the utilized software.<sup id=\"rdp-ebb-cite_ref-HenricksLIS12Arch_21-0\" class=\"reference\"><a href=\"#cite_note-HenricksLIS12Arch-21\">[21]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CliffordTheEvo11_22-0\" class=\"reference\"><a href=\"#cite_note-CliffordTheEvo11-22\">[22]<\/a><\/sup>\n<\/p><p><b>1.1.1.2 Forensic pathology<\/b>\n<\/p><p>Typically associated with a medical examiner or coroner, forensic pathology is focused on identifying and determining the cause of death of an individual. This includes not only the analysis of wounds and injuries but also full tissue specimens, identifying traumas\u2014as well as chemical, biological, and solid foreign bodies and contaminates\u2014that may have played a role in the individual's death. Anatomic pathology plays an important part of the examiner's analyses\u2014represented by the forensic pathologist's required training\u2014though clinical pathology also plays a role.<sup id=\"rdp-ebb-cite_ref-PrahlowIntro_23-0\" class=\"reference\"><a href=\"#cite_note-PrahlowIntro-23\">[23]<\/a><\/sup> Outside the gross examination of a body, the forensic pathologist will rely on the lab to conduct a variety of analyses. Whole organs and slides containing cross-sectional slivers of organs, as well as blood, urine, bile, and vitreous humor may be analyzed for toxicology, DNA typing, infectious diseases, disorders, or other chemical tests.<sup id=\"rdp-ebb-cite_ref-AACCTheWorld19_24-0\" class=\"reference\"><a href=\"#cite_note-AACCTheWorld19-24\">[24]<\/a><\/sup> In particular, maintaining chain of custody for such specimens is vital to ensure analyses are correct and evidence is not compromised. Though a medical laboratory, the forensic pathology laboratory isn't held to the same CLIA standards; they must be accredited by a related organization such as <a href=\"https:\/\/www.limswiki.org\/index.php\/The_American_Society_of_Crime_Laboratory_Directors\/Laboratory_Accreditation_Board\" title=\"The American Society of Crime Laboratory Directors\/Laboratory Accreditation Board\" class=\"wiki-link\" data-key=\"f364a7d9dca831de0caaaba41cf0b7ea\">The American Society of Crime Laboratory Directors\/Laboratory Accreditation Board<\/a> to ensure the lab operates at prescribed standards.<sup id=\"rdp-ebb-cite_ref-AACCTheWorld19_24-1\" class=\"reference\"><a href=\"#cite_note-AACCTheWorld19-24\">[24]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"1.1.2_Physician_office_lab\">1.1.2 Physician office lab<\/span><\/h4>\n<div class=\"thumb tright\"><div class=\"thumbinner\" style=\"width:302px;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Rapid_point-of-care_syphilis_test-CDC.jpg\" class=\"image wiki-link\" data-key=\"864971a85992d10a830e210b02a63472\"><img alt=\"\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/6\/61\/Rapid_point-of-care_syphilis_test-CDC.jpg\" decoding=\"async\" width=\"300\" height=\"183\" class=\"thumbimage\" \/><\/a> <div class=\"thumbcaption\"><div class=\"magnify\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Rapid_point-of-care_syphilis_test-CDC.jpg\" class=\"internal wiki-link\" title=\"Enlarge\" data-key=\"864971a85992d10a830e210b02a63472\"><\/a><\/div>Point-of-care devices such as this rapid syphilis test are commonly used in the POL.<\/div><\/div><\/div><p>The physician office lab, or POL, is a physician-, partnership-, or group-maintained <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory\" title=\"Laboratory\" class=\"wiki-link\" data-key=\"c57fc5aac9e4abf31dccae81df664c33\">laboratory<\/a> that performs medical diagnostic tests or examines specimens in order to diagnose, prevent, and\/or treat a disease or impairment in a patient as part of the physician practice.<sup id=\"rdp-ebb-cite_ref-CMSPOLDef_25-0\" class=\"reference\"><a href=\"#cite_note-CMSPOLDef-25\">[25]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-WasPOLEP_26-0\" class=\"reference\"><a href=\"#cite_note-WasPOLEP-26\">[26]<\/a><\/sup> The POL shows up in primary care physician offices as well as the offices of specialists like urologists, hematologists, gynecologists, and endocrinologists. In many countries like the United States, the POL is considered a clinical laboratory and is thus regulated by federal, state, and\/or local laws affecting such laboratories.<sup id=\"rdp-ebb-cite_ref-WasPOLEP_26-1\" class=\"reference\"><a href=\"#cite_note-WasPOLEP-26\">[26]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CDPHLabs_27-0\" class=\"reference\"><a href=\"#cite_note-CDPHLabs-27\">[27]<\/a><\/sup> In October 2021, the <a href=\"https:\/\/www.limswiki.org\/index.php\/Centers_for_Medicare_and_Medicaid_Services\" title=\"Centers for Medicare and Medicaid Services\" class=\"wiki-link\" data-key=\"654b4449e4816e190325b420c264df1a\">Centers for Medicare and Medicaid Services<\/a> (CMS) reported 41% of all CLIA-approved laboratories in the United States (130,335) were physician office laboratories.<sup id=\"rdp-ebb-cite_ref-CMSDec13Count_28-0\" class=\"reference\"><a href=\"#cite_note-CMSDec13Count-28\">[28]<\/a><\/sup> However, as of 2014, POLs were estimated to be processing only about nine percent of all clinical laboratory tests.<sup id=\"rdp-ebb-cite_ref-KalHow14Arch_29-0\" class=\"reference\"><a href=\"#cite_note-KalHow14Arch-29\">[29]<\/a><\/sup>\n<\/p><p>Testing and reporting at a POL, at least in the U.S., is largely concentrated on the realm of waived CLIA testing. As of October 2021, 68% of the POLs in the United States were primarily running CLIA waived tests.<sup id=\"rdp-ebb-cite_ref-CMS13Enroll_30-0\" class=\"reference\"><a href=\"#cite_note-CMS13Enroll-30\">[30]<\/a><\/sup> CLIA test complexity has three levels: high, moderate, and waived.<sup id=\"rdp-ebb-cite_ref-CDCTestCom_31-0\" class=\"reference\"><a href=\"#cite_note-CDCTestCom-31\">[31]<\/a><\/sup> Waived tests are simple to perform and have a relatively low risk of an incorrect test result. Moderately complex tests include tests like provider performed microscopy (PPM), which requires the use of a microscope during the office visit. Providers that want to perform PPM tests must be qualified to do so under CLIA regulations.<sup id=\"rdp-ebb-cite_ref-CDCTestCom_31-1\" class=\"reference\"><a href=\"#cite_note-CDCTestCom-31\">[31]<\/a><\/sup> High-complexity tests require the most regulation. These tests are the most complicated and run the highest risk of an inaccurate result, as determined during the <a href=\"https:\/\/www.limswiki.org\/index.php\/Food_and_Drug_Administration\" title=\"Food and Drug Administration\" class=\"wiki-link\" data-key=\"e2be8927071ac419c0929f7aa1ede7fe\">Food and Drug Administration<\/a> (FDA) pre-market approval process. Tests may come from the manufacturer with their complexity level on them, or one can search the FDA database to determine the complexity of the test.<sup id=\"rdp-ebb-cite_ref-CDCTestCom_31-2\" class=\"reference\"><a href=\"#cite_note-CDCTestCom-31\">[31]<\/a><\/sup> \n<\/p><p>Commonly performed tests include<sup id=\"rdp-ebb-cite_ref-UHOxInOffice_32-0\" class=\"reference\"><a href=\"#cite_note-UHOxInOffice-32\">[32]<\/a><\/sup>:\n<\/p>\n<ul><li>urine analysis<\/li>\n<li>urine pregnancy<\/li>\n<li>blood occult<\/li>\n<li>glucose blood<\/li>\n<li>pathology consultation during surgery<\/li>\n<li>crystal identification by microscope<\/li>\n<li>sperm identification and analyses<\/li>\n<li>bilirubin total<\/li>\n<li>blood gasses<\/li>\n<li>complete blood count<\/li>\n<li>bone marrow smear<\/li>\n<li>blood bank services<\/li>\n<li>transfusion medicine<\/li><\/ul>\n<h4><span class=\"mw-headline\" id=\"1.1.3_Integrative_medicine_lab\">1.1.3 Integrative medicine lab<\/span><\/h4>\n<p>Dr. Ralph Snyderman, Director of the Center for Personalized Health Care at Duke University, defines integrative medicine as a process that creates and encourages \"a seamless engagement by patients and caregivers in the full range of physical, psychological, social, preventive, and therapeutic factors known to be effective and necessary for the achievement of optimal health over the course of one's life.\"<sup id=\"rdp-ebb-cite_ref-SnydermanInteg11_33-0\" class=\"reference\"><a href=\"#cite_note-SnydermanInteg11-33\">[33]<\/a><\/sup> This type of personalized healthcare takes a more holistic approach to the causes of illnesses, including the biological, behavioral, psychosocial, and environmental contributors.<sup id=\"rdp-ebb-cite_ref-BravewellInteg15_34-0\" class=\"reference\"><a href=\"#cite_note-BravewellInteg15-34\">[34]<\/a><\/sup> Some medical laboratories such as those found within Duke Integrative Medicine<sup id=\"rdp-ebb-cite_ref-BravewellDuke15_35-0\" class=\"reference\"><a href=\"#cite_note-BravewellDuke15-35\">[35]<\/a><\/sup>, as well as Harvard Medical School's Contemplative Neuroscience and Integrative Medicine Laboratory<sup id=\"rdp-ebb-cite_ref-HarvardCNIM20_36-0\" class=\"reference\"><a href=\"#cite_note-HarvardCNIM20-36\">[36]<\/a><\/sup>, include an integrative medicine approach to their medical diagnostic and research activities. Laboratories associated with integrative medicine approaches are quite similar to standard medical laboratories, though, broadly speaking, they may focus more on nutritional, metabolic, and toxicity test types.<sup id=\"rdp-ebb-cite_ref-BralleyBasic_37-0\" class=\"reference\"><a href=\"#cite_note-BralleyBasic-37\">[37]<\/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-JafriError15-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-JafriError15_1-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Jafri, L.; Khan, A.H.; Ghani, F. et al. 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(2014). \"Quality-Improvement Measures as Effective Ways of Preventing Laboratory Errors\". <i>Laboratory Medicine<\/i> <b>45<\/b> (2): e80\u2013e88. <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\/10.1309%2FLMD0YIFPTOWZONAD\" target=\"_blank\">10.1309\/LMD0YIFPTOWZONAD<\/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=Quality-Improvement+Measures+as+Effective+Ways+of+Preventing+Laboratory+Errors&rft.jtitle=Laboratory+Medicine&rft.aulast=Agarwal%2C+R.&rft.au=Agarwal%2C+R.&rft.date=2014&rft.volume=45&rft.issue=2&rft.pages=e80%E2%80%93e88&rft_id=info:doi\/10.1309%2FLMD0YIFPTOWZONAD&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_diagnostics_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-AlotaibiTheImpact17-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-AlotaibiTheImpact17_3-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Alotaibi, Y.K.; Federico, F. (2017). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC5787626\" target=\"_blank\">\"The impact of health information technology on patient safety\"<\/a>. <i>Saudi Medical Journal<\/i> <b>38<\/b> (12): 1173\u201380. <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\/10.15537%2Fsmj.2017.12.20631\" target=\"_blank\">10.15537\/smj.2017.12.20631<\/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\/PMC5787626\/\" target=\"_blank\">PMC5787626<\/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\/29209664\" target=\"_blank\">29209664<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC5787626\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC5787626<\/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+impact+of+health+information+technology+on+patient+safety&rft.jtitle=Saudi+Medical+Journal&rft.aulast=Alotaibi%2C+Y.K.%3B+Federico%2C+F.&rft.au=Alotaibi%2C+Y.K.%3B+Federico%2C+F.&rft.date=2017&rft.volume=38&rft.issue=12&rft.pages=1173%E2%80%9380&rft_id=info:doi\/10.15537%2Fsmj.2017.12.20631&rft_id=info:pmc\/PMC5787626&rft_id=info:pmid\/29209664&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC5787626&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_diagnostics_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-RaeenHowLab18-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-RaeenHowLab18_4-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Raeen, M.R. (2018). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/dc.uthsc.edu\/hiimappliedresearch\/54\/\" target=\"_blank\">\"How Laboratory Informatics has Impacted Healthcare Overall\"<\/a>. <i>Applied Research Projects<\/i>: 54. <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\/10.21007%2Fchp.hiim.0056\" target=\"_blank\">10.21007\/chp.hiim.0056<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/dc.uthsc.edu\/hiimappliedresearch\/54\/\" target=\"_blank\">https:\/\/dc.uthsc.edu\/hiimappliedresearch\/54\/<\/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=How+Laboratory+Informatics+has+Impacted+Healthcare+Overall&rft.jtitle=Applied+Research+Projects&rft.aulast=Raeen%2C+M.R.&rft.au=Raeen%2C+M.R.&rft.date=2018&rft.pages=54&rft_id=info:doi\/10.21007%2Fchp.hiim.0056&rft_id=https%3A%2F%2Fdc.uthsc.edu%2Fhiimappliedresearch%2F54%2F&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_diagnostics_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MedLabTech-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MedLabTech_5-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Sood, R. (2006). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=hpNhAQAACAAJ\" target=\"_blank\">\"Chapter 1: Laboratory\"<\/a>. <i>Textbook of Medical Laboratory Technology<\/i>. Jaypee Brothers Publishers. pp. 01\u201328. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 818061591X<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=hpNhAQAACAAJ\" target=\"_blank\">https:\/\/books.google.com\/books?id=hpNhAQAACAAJ<\/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+Laboratory&rft.atitle=Textbook+of+Medical+Laboratory+Technology&rft.aulast=Sood%2C+R.&rft.au=Sood%2C+R.&rft.date=2006&rft.pages=pp.%26nbsp%3B01%E2%80%9328&rft.pub=Jaypee+Brothers+Publishers&rft.isbn=818061591X&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DhpNhAQAACAAJ&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_diagnostics_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CLIACDCLab-6\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CLIACDCLab_6-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cms.gov\/Regulations-and-Guidance\/Legislation\/CLIA\/downloads\/HowObtainCertificateofWaiver.pdf\" target=\"_blank\">\"CLIA - How to Obtain a CLIA Certificate of Waiver\"<\/a> (PDF). 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Retrieved 18 November 2021<\/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=Good+Laboratory+Practices+for+Molecular+Genetic+Testing+for+Heritable+Diseases+and+Conditions&rft.jtitle=Morbidity+and+Mortality+Weekly+Report&rft.aulast=Chen%2C+B.%3B+Gagnon%2C+M.%3B+Shahangian%2C+S.+et+al.&rft.au=Chen%2C+B.%3B+Gagnon%2C+M.%3B+Shahangian%2C+S.+et+al.&rft.date=12+June+2009&rft.volume=58&rft.issue=RR06&rft.pages=1%E2%80%9329&rft_id=https%3A%2F%2Fwww.cdc.gov%2Fmmwr%2Fpreview%2Fmmwrhtml%2Frr5806a1.htm&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_diagnostics_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-VianaGood11-8\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-VianaGood11_8-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Viana, R.V.; Wallis, C.L. 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Retrieved 18 November 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Laboratory+Quality+Assurance+and+Standardization+Programs&rft.atitle=&rft.date=25+July+2017&rft.pub=Centers+for+Disease+Control+and+Prevention&rft_id=https%3A%2F%2Fwww.cdc.gov%2Flabstandards%2F&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_diagnostics_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CMS_CLIA-11\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CMS_CLIA_11-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cms.gov\/regulations-and-guidance\/legislation\/clia\" target=\"_blank\">\"Clinical Laboratory Improvement Amendments (CLIA)\"<\/a>. 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Retrieved 18 November 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Clinical+Laboratory+Improvement+Amendments+%28CLIA%29&rft.atitle=&rft.date=16+November+2021&rft.pub=Centers+for+Medicare+and+Medicaid+Services&rft_id=https%3A%2F%2Fwww.cms.gov%2Fregulations-and-guidance%2Flegislation%2Fclia&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_diagnostics_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CLSIAbout-12\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CLSIAbout_12-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/about\/\" target=\"_blank\">\"About CLSI\"<\/a>. Clinical and Laboratory Standards Institute<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/clsi.org\/about\/\" target=\"_blank\">https:\/\/clsi.org\/about\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/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+CLSI&rft.atitle=&rft.pub=Clinical+and+Laboratory+Standards+Institute&rft_id=https%3A%2F%2Fclsi.org%2Fabout%2F&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_diagnostics_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-RQAAbout-13\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-RQAAbout_13-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.therqa.com\/about\/\" target=\"_blank\">\"What is RQA?\"<\/a>. Research Quality Association<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.therqa.com\/about\/\" target=\"_blank\">https:\/\/www.therqa.com\/about\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/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+RQA%3F&rft.atitle=&rft.pub=Research+Quality+Association&rft_id=https%3A%2F%2Fwww.therqa.com%2Fabout%2F&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_diagnostics_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-RQAGCLP-14\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-RQAGCLP_14-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.therqa.com\/resources\/publications\/booklets\/good-clinical-laboratory-practice-booklet\/\" target=\"_blank\">\"Good Clinical Laboratory Practice (GCLP)\"<\/a>. Research Quality Association. January 2012<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.therqa.com\/resources\/publications\/booklets\/good-clinical-laboratory-practice-booklet\/\" target=\"_blank\">https:\/\/www.therqa.com\/resources\/publications\/booklets\/good-clinical-laboratory-practice-booklet\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/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+Clinical+Laboratory+Practice+%28GCLP%29&rft.atitle=&rft.date=January+2012&rft.pub=Research+Quality+Association&rft_id=https%3A%2F%2Fwww.therqa.com%2Fresources%2Fpublications%2Fbooklets%2Fgood-clinical-laboratory-practice-booklet%2F&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_diagnostics_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-GCLPEzzelle-15\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-GCLPEzzelle_15-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Ezzelle, J.; Rodriguez-Chavez, I.R.; Darden, J.M. et al. (2008). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC2213906\" target=\"_blank\">\"Guidelines on Good Clinical Laboratory Practice - Bridging Operations between Research and Clinical Research Laboratories\"<\/a>. <i>Journal of Pharmaceutical and Biomedical Analysis<\/i> <b>46<\/b> (1): 18\u201329. <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.jpba.2007.10.010\" target=\"_blank\">10.1016\/j.jpba.2007.10.010<\/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\/PMC2213906\/\" target=\"_blank\">PMC2213906<\/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\/18037599\" target=\"_blank\">18037599<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC2213906\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC2213906<\/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=Guidelines+on+Good+Clinical+Laboratory+Practice+-+Bridging+Operations+between+Research+and+Clinical+Research+Laboratories&rft.jtitle=Journal+of+Pharmaceutical+and+Biomedical+Analysis&rft.aulast=Ezzelle%2C+J.%3B+Rodriguez-Chavez%2C+I.R.%3B+Darden%2C+J.M.+et+al.&rft.au=Ezzelle%2C+J.%3B+Rodriguez-Chavez%2C+I.R.%3B+Darden%2C+J.M.+et+al.&rft.date=2008&rft.volume=46&rft.issue=1&rft.pages=18%E2%80%9329&rft_id=info:doi\/10.1016%2Fj.jpba.2007.10.010&rft_id=info:pmc\/PMC2213906&rft_id=info:pmid\/18037599&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC2213906&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_diagnostics_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-KumarRobbins09-16\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-KumarRobbins09_16-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Kumar, V.; Abbas, A.; Fausto, N.; Aster, J., ed. (2010). <i>Robbins and Cotran Pathologic Basis of Disease, Professional Edition<\/i> (8th ed.). Saunders Elsevier. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 9781416031215.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Robbins+and+Cotran+Pathologic+Basis+of+Disease%2C+Professional+Edition&rft.date=2010&rft.edition=8th&rft.pub=Saunders+Elsevier&rft.isbn=9781416031215&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_diagnostics_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-AdelmanForensic09-17\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-AdelmanForensic09_17-0\">17.0<\/a><\/sup> <sup><a href=\"#cite_ref-AdelmanForensic09_17-1\">17.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Adelman, H.C. (2009). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=x5FftcZOv1UC&pg=PA3\" target=\"_blank\"><i>Forensic Medicine<\/i><\/a>. Infobase Publishing. pp. 3\u20134. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 1438103816<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=x5FftcZOv1UC&pg=PA3\" target=\"_blank\">https:\/\/books.google.com\/books?id=x5FftcZOv1UC&pg=PA3<\/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=Forensic+Medicine&rft.aulast=Adelman%2C+H.C.&rft.au=Adelman%2C+H.C.&rft.date=2009&rft.pages=pp.%26nbsp%3B3%E2%80%934&rft.pub=Infobase+Publishing&rft.isbn=1438103816&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3Dx5FftcZOv1UC%26pg%3DPA3&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_diagnostics_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-FriedbergEvolv13-18\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-FriedbergEvolv13_18-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Friedberg, R. (July 2013). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/scholarlycommons.libraryinfo.bhs.org\/all_works\/7637\/\" target=\"_blank\">\"Evolving Changes in Health Care and Implications for Pathology and Laboratory Practice\"<\/a>. <i>2013 Summer Anatomic Pathology Conference<\/i>. Florida Society of Pathologists<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/scholarlycommons.libraryinfo.bhs.org\/all_works\/7637\/\" target=\"_blank\">https:\/\/scholarlycommons.libraryinfo.bhs.org\/all_works\/7637\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>. \"The advent of molecular pathology and molecular imaging tools only serves to further blur the distinction between anatomic and clinical pathology...\"<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Evolving+Changes+in+Health+Care+and+Implications+for+Pathology+and+Laboratory+Practice&rft.atitle=2013+Summer+Anatomic+Pathology+Conference&rft.aulast=Friedberg%2C+R.&rft.au=Friedberg%2C+R.&rft.date=July+2013&rft.pub=Florida+Society+of+Pathologists&rft_id=https%3A%2F%2Fscholarlycommons.libraryinfo.bhs.org%2Fall_works%2F7637%2F&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_diagnostics_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PaxtonAllFor11-19\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PaxtonAllFor11_19-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Paxton, A. (February 2011). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.captodayonline.com\/Archives\/0211\/0211a_cp_ap.html\" target=\"_blank\">\"All for one\u2014unifying CP and AP data\"<\/a>. <i>CAP Today<\/i>. College of American Pathologists<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.captodayonline.com\/Archives\/0211\/0211a_cp_ap.html\" target=\"_blank\">http:\/\/www.captodayonline.com\/Archives\/0211\/0211a_cp_ap.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>. \"Traditionally, CP systems are based on discrete data elements while AP systems are based on blocks of text. But that distinction is starting to blur, because AP is moving to synoptic reporting, and that includes the creation of discrete data components as well as textual reporting\"<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=All+for+one%E2%80%94unifying+CP+and+AP+data&rft.atitle=CAP+Today&rft.aulast=Paxton%2C+A.&rft.au=Paxton%2C+A.&rft.date=February+2011&rft.pub=College+of+American+Pathologists&rft_id=http%3A%2F%2Fwww.captodayonline.com%2FArchives%2F0211%2F0211a_cp_ap.html&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_diagnostics_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ParkAnatom12-20\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ParkAnatom12_20-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Park, S.L.; Pantanowitz, L.; Sharma, G. et al. (2012). \"Anatomic Pathology Laboratory Information Systems: A Review\". <i>Advances in Anatomic Pathology<\/i> <b>19<\/b> (2): 81\u201396. <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\/10.1097%2FPAP.0b013e318248b787\" target=\"_blank\">10.1097\/PAP.0b013e318248b787<\/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\/22313836\" target=\"_blank\">22313836<\/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=Anatomic+Pathology+Laboratory+Information+Systems%3A+A+Review&rft.jtitle=Advances+in+Anatomic+Pathology&rft.aulast=Park%2C+S.L.%3B+Pantanowitz%2C+L.%3B+Sharma%2C+G.+et+al.&rft.au=Park%2C+S.L.%3B+Pantanowitz%2C+L.%3B+Sharma%2C+G.+et+al.&rft.date=2012&rft.volume=19&rft.issue=2&rft.pages=81%E2%80%9396&rft_id=info:doi\/10.1097%2FPAP.0b013e318248b787&rft_id=info:pmid\/22313836&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_diagnostics_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-HenricksLIS12Arch-21\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HenricksLIS12Arch_21-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Henricks, W.H. (9 October 2012). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20150910050825\/http:\/\/www.pathinformatics.pitt.edu\/sites\/default\/files\/2012Powerpoints\/01HenricksTues.pdf\" target=\"_blank\">\"LIS Basics: CP and AP LIS Design and Operations\"<\/a> (PDF). <i>Pathology Informatics 2012<\/i>. Archived from <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pathinformatics.pitt.edu\/sites\/default\/files\/2012Powerpoints\/01HenricksTues.pdf\" target=\"_blank\">the original<\/a> on 10 September 2015<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20150910050825\/http:\/\/www.pathinformatics.pitt.edu\/sites\/default\/files\/2012Powerpoints\/01HenricksTues.pdf\" target=\"_blank\">https:\/\/web.archive.org\/web\/20150910050825\/http:\/\/www.pathinformatics.pitt.edu\/sites\/default\/files\/2012Powerpoints\/01HenricksTues.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=LIS+Basics%3A+CP+and+AP+LIS+Design+and+Operations&rft.atitle=Pathology+Informatics+2012&rft.aulast=Henricks%2C+W.H.&rft.au=Henricks%2C+W.H.&rft.date=9+October+2012&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20150910050825%2Fhttp%3A%2F%2Fwww.pathinformatics.pitt.edu%2Fsites%2Fdefault%2Ffiles%2F2012Powerpoints%2F01HenricksTues.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_diagnostics_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CliffordTheEvo11-22\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CliffordTheEvo11_22-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Clifford, L.-J. (August 2011). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.mlo-online.com\/home\/article\/13004085\/the-evolving-lis-needs-to-be-everything-for-todays-laboratories\" target=\"_blank\">\"The evolving LIS needs to be \"everything\" for today's laboratories\"<\/a>. <i>Medical Laboratory Observer<\/i>. Endeavor Business Media, LLC<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.mlo-online.com\/home\/article\/13004085\/the-evolving-lis-needs-to-be-everything-for-todays-laboratories\" target=\"_blank\">https:\/\/www.mlo-online.com\/home\/article\/13004085\/the-evolving-lis-needs-to-be-everything-for-todays-laboratories<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/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+evolving+LIS+needs+to+be+%22everything%22+for+today%27s+laboratories&rft.atitle=Medical+Laboratory+Observer&rft.aulast=Clifford%2C+L.-J.&rft.au=Clifford%2C+L.-J.&rft.date=August+2011&rft.pub=Endeavor+Business+Media%2C+LLC&rft_id=https%3A%2F%2Fwww.mlo-online.com%2Fhome%2Farticle%2F13004085%2Fthe-evolving-lis-needs-to-be-everything-for-todays-laboratories&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_diagnostics_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PrahlowIntro-23\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PrahlowIntro_23-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Prahlow, J. (2010). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=rF1WTiX0nHEC&pg=PA35\" target=\"_blank\">\"Chapter 3: Introduction to Forensic Pathology\"<\/a>. <i>Forensic Pathology for Police, Death Investigators, Attorneys, and Forensic Scientists<\/i>. Humana Press. pp. 35\u201348. <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%2F978-1-59745-404-9\" target=\"_blank\">10.1007\/978-1-59745-404-9<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 9781588299758<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=rF1WTiX0nHEC&pg=PA35\" target=\"_blank\">https:\/\/books.google.com\/books?id=rF1WTiX0nHEC&pg=PA35<\/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+3%3A+Introduction+to+Forensic+Pathology&rft.atitle=Forensic+Pathology+for+Police%2C+Death+Investigators%2C+Attorneys%2C+and+Forensic+Scientists&rft.aulast=Prahlow%2C+J.&rft.au=Prahlow%2C+J.&rft.date=2010&rft.pages=pp.%26nbsp%3B35%E2%80%9348&rft.pub=Humana+Press&rft_id=info:doi\/10.1007%2F978-1-59745-404-9&rft.isbn=9781588299758&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DrF1WTiX0nHEC%26pg%3DPA35&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_diagnostics_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-AACCTheWorld19-24\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-AACCTheWorld19_24-0\">24.0<\/a><\/sup> <sup><a href=\"#cite_ref-AACCTheWorld19_24-1\">24.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.testing.com\/articles\/forensic-testing\/\" target=\"_blank\">\"The World of Forensic Laboratory Testing\"<\/a>. <i>Testing.com<\/i>. 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Kalorama Information. November 2014. Archived from <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.kaloramainformation.com\/article\/2014-11\/How-and-Where-IVD-Will-Find-Growth-Global-POL-Market-%E2%80%93-Part-2\" target=\"_blank\">the original<\/a> on 17 April 2015<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20150417204832\/http:\/\/www.kaloramainformation.com\/article\/2014-11\/How-and-Where-IVD-Will-Find-Growth-Global-POL-Market-%E2%80%93-Part-2\" target=\"_blank\">https:\/\/web.archive.org\/web\/20150417204832\/http:\/\/www.kaloramainformation.com\/article\/2014-11\/How-and-Where-IVD-Will-Find-Growth-Global-POL-Market-%E2%80%93-Part-2<\/a><\/span><span class=\"reference-accessdate\">. 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Retrieved 18 November 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Integrative+Medicine&rft.atitle=&rft.date=2015&rft.pub=The+Bravewell+Collaborative&rft_id=https%3A%2F%2Fbravewell.org%2Fintegrative_medicine%2F&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_diagnostics_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BravewellDuke15-35\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BravewellDuke15_35-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/bravewell.org\/current_projects\/clinical_network\/duke_center\/\" target=\"_blank\">\"Duke Integrative Medicine\"<\/a>. The Bravewell Collaborative. 2015<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/bravewell.org\/current_projects\/clinical_network\/duke_center\/\" target=\"_blank\">https:\/\/bravewell.org\/current_projects\/clinical_network\/duke_center\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Duke+Integrative+Medicine&rft.atitle=&rft.date=2015&rft.pub=The+Bravewell+Collaborative&rft_id=https%3A%2F%2Fbravewell.org%2Fcurrent_projects%2Fclinical_network%2Fduke_center%2F&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_diagnostics_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-HarvardCNIM20-36\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HarvardCNIM20_36-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/davidvago.bwh.harvard.edu\/contemplative-neuroscience-and-integrative-medicine-cnim-laboratory\/\" target=\"_blank\">\"Contemplative Neuroscience and Integrative Medicine (CNIM) Laboratory\"<\/a>. <i>David R. Vago - Brigham and Women's Hospital<\/i>. Harvard Medical School. 2020<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/davidvago.bwh.harvard.edu\/contemplative-neuroscience-and-integrative-medicine-cnim-laboratory\/\" target=\"_blank\">https:\/\/davidvago.bwh.harvard.edu\/contemplative-neuroscience-and-integrative-medicine-cnim-laboratory\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Contemplative+Neuroscience+and+Integrative+Medicine+%28CNIM%29+Laboratory&rft.atitle=David+R.+Vago+-+Brigham+and+Women%27s+Hospital&rft.date=2020&rft.pub=Harvard+Medical+School&rft_id=https%3A%2F%2Fdavidvago.bwh.harvard.edu%2Fcontemplative-neuroscience-and-integrative-medicine-cnim-laboratory%2F&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_diagnostics_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BralleyBasic-37\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BralleyBasic_37-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Bralley, J.A.; Lord, R.S. (2008). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=CpXVAwgOv7sC&pg=PT11\" target=\"_blank\">\"Chapter 1: Basic Concepts\"<\/a>. <i>Laboratory Evaluations for Integrative and Functional Medicine<\/i> (2nd ed.). MetaMetrix Institute. pp. 1\u201316. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 0967394945<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=CpXVAwgOv7sC&pg=PT11\" target=\"_blank\">https:\/\/books.google.com\/books?id=CpXVAwgOv7sC&pg=PT11<\/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+Basic+Concepts&rft.atitle=Laboratory+Evaluations+for+Integrative+and+Functional+Medicine&rft.aulast=Bralley%2C+J.A.%3B+Lord%2C+R.S.&rft.au=Bralley%2C+J.A.%3B+Lord%2C+R.S.&rft.date=2008&rft.pages=pp.%26nbsp%3B1%E2%80%9316&rft.edition=2nd&rft.pub=MetaMetrix+Institute&rft.isbn=0967394945&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DCpXVAwgOv7sC%26pg%3DPT11&rfr_id=info:sid\/en.wikipedia.org:Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_diagnostics_lab\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20220125221410\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.362 seconds\nReal time usage: 2.068 seconds\nPreprocessor visited node count: 26005\/1000000\nPost\u2010expand include size: 214049\/2097152 bytes\nTemplate argument size: 73490\/2097152 bytes\nHighest expansion depth: 20\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 65931\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 273.198 1 -total\n 92.88% 253.733 1 Template:Reflist\n 69.82% 190.743 37 Template:Citation\/core\n 44.26% 120.914 24 Template:Cite_web\n 22.44% 61.296 7 Template:Cite_journal\n 11.76% 32.129 6 Template:Cite_book\n 10.61% 28.979 22 Template:Date\n 7.10% 19.389 1 Template:Laboratory_Informatics_Buyer's_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_diagnostics_lab\n 6.26% 17.100 19 Template:Citation\/identifier\n 4.62% 12.634 52 Template:Citation\/make_link\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12926-0!canonical and timestamp 20220125221408 and revision id 45823. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_diagnostics_lab\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_diagnostics_lab<\/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>","e275b81a96253b411988d17555a58563_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/e\/e3\/Medical_Laboratory_Scientist_US_NIH.jpg","https:\/\/upload.wikimedia.org\/wikipedia\/commons\/4\/42\/Blood_clot.jpg","https:\/\/upload.wikimedia.org\/wikipedia\/commons\/6\/61\/Rapid_point-of-care_syphilis_test-CDC.jpg"],"e275b81a96253b411988d17555a58563_timestamp":1643149330,"629f817ccc0007fa646508ddcd735ca7_type":"article","629f817ccc0007fa646508ddcd735ca7_title":"Introduction","629f817ccc0007fa646508ddcd735ca7_url":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction","629f817ccc0007fa646508ddcd735ca7_plaintext":"\n\nBook:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/IntroductionFrom LIMSWikiJump to navigationJump to search\nTitle: Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\nEdition: 2022 Edition\nAuthor for citation: Shawn E. Douglas and Alan Vaughan\nLicense for content: Creative Commons Attribution-ShareAlike 4.0 International\nPublication date: January 2022\n\r\n\nMedical labs of all types\u2014from the clinical diagnostics labs of the hospital to the clinical research labs of a medical device manufacturer\u2014at their heart have an overall goal of doing their part towards improving health outcomes among humans and animals. On the surface, this goal sounds relatively mundane; however, the work conducted in these laboratories is anything but mundane. From the use of advanced clinical workflows to the requirement of accurate and timely results, these labs are under a lot of stress to operate effectively, efficiently, and according to regulations. However, well-designed laboratory informatics solutions, when implemented, used, and maintained effectively, provide a means to better achieve that primary goal.\nThis guide addresses the medical diagnostics and research laboratories in their myriad forms, as well as how laboratory informatics solutions can benefit them. Yet it's more than \"here's a laboratory, here's a software system: marry the two, and the magic begins!\" These systems have their own intricacies, and its up to laboratory personnel, often not well-versed in such automation solutions, to evaluate and implement them. This guide addresses the numerous considerations that should be made beforehand, and it provides several chapters of resources to help practically put those considerations to work. It also addresses the usefulness of a requirements specification and how to put it to use. In particular, a slightly modified version of LIMSpec is suggested to get the most out of developing and using any requirements specification as part of software and vendor selection.\nThe table of contents for Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research is as follows:\n\r\n\n\n1. Introduction to medical diagnostics and research laboratories\n1.1 Medical diagnostics lab\n1.1.1 Pathology\n1.1.1.1 Anatomical vs. clinical pathology\n1.1.1.2 Forensic pathology<\/dd>\n1.1.2 Physician office lab\n1.1.3 Integrative medicine lab<\/dd>\n1.2 Public health lab\n1.3 Toxicology lab\n1.4 Blood bank and transfusion lab\n1.5 Central and contract research lab\n1.5.1 Medical and other research in academia<\/dd>\n1.6 Genetic diagnostics lab\n1.6.1 Cytogenetics lab<\/dd>\n1.7 Medical cannabis testing lab<\/dd>\n2. Choosing laboratory informatics software for your lab\n2.1 Evaluation and selection\n2.1.1 Technology considerations\n2.1.1.1 Laboratory informatics options<\/dd>\n2.1.2 Features and functions\n2.1.3 Cybersecurity considerations\n2.1.4 Regulatory compliance considerations\n2.1.5 System flexibility\n2.1.6 Cost considerations<\/dd>\n2.2 Implementation\n2.2.1 Internal and external integrations<\/dd>\n2.3 MSW, updates, and other contracted services\n2.4 How a user requirements specification fits into the entire process (LIMSpec)<\/dd>\n3. Resources for selecting and implementing informatics solutions: Part 1: Laboratory informatics vendors\n3.1 LIMS vendors\n3.2 LIS vendors\n3.3 ELN vendors\n3.4 Middleware vendors<\/dd>\n4. Resources for selecting and implementing informatics solutions: Part 2: Other vendors and service providers\n4.1 Medical diagnostics instrumentation vendors\n4.1.1 CLIA-certified vendors\n4.1.2 Other vendors<\/dd>\n4.2 EHR vendors\n4.3 Laboratory business intelligence and workflow solution vendors\n4.4 Laboratory billing service providers\n4.5 Consultants<\/dd>\n5. Resources for selecting and implementing informatics solutions: Part 3: Industry and community resources\n5.1 Trade organizations\n5.2 Conferences and trade shows\n5.3 User communities\n5.4 Books and journals\n5.5 Standards\n5.6 Further reading\n5.7 LIMSpec<\/dd>\n6. Taking the next step\n6.1 Conduct initial research into a specification document tailored to your lab's needs\n6.2 Issue some of the specification as part of a request for information (RFI)\n6.3 Respond to or open dialogue with vendors\n6.3.1 The value of demonstrations<\/dd>\n6.4 Finalize the requirements specification and choose a vendor<\/dd>\n7. Closing remarks\nAppendix 1. Blank LIMSpec template for medical diagnostics and research labs\nIntroduction and methodology\nPrimary laboratory workflow\nMaintaining laboratory workflow and operations\nSpecialty laboratory functions\nTechnology and performance improvements\nSecurity and integrity of systems and operations\nPutting those requirements to practical use and caveats\nLIMSpec in Microsoft Word format<\/dd>\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\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 20 January 2022, at 22:01.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 22 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","629f817ccc0007fa646508ddcd735ca7_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_Introduction rootpage-Book_Laboratory_Informatics_Buyer_s_Guide_for_Medical_Diagnostics_and_Research_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:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/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:Vial_of_blood_to_be_tested.jpg\" class=\"image wiki-link\" data-key=\"33ea93b6ceb5e5c17cb1a46d37cf73f2\"><img alt=\"Vial of blood to be tested.jpg\" src=\"https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/1\/1d\/Vial_of_blood_to_be_tested.jpg\" decoding=\"async\" width=\"230\" height=\"325\" \/><\/a><\/div>\n<p><b>Title<\/b>: <i>Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research<\/i>\n<\/p><p><b>Edition<\/b>: 2022 Edition\n<\/p><p><b>Author for citation<\/b>: Shawn E. Douglas and Alan Vaughan\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 2022\n<\/p><p><br \/>\nMedical labs of all types\u2014from the clinical diagnostics labs of the <a href=\"https:\/\/www.limswiki.org\/index.php\/Hospital\" title=\"Hospital\" class=\"wiki-link\" data-key=\"b8f070c66d8123fe91063594befebdff\">hospital<\/a> to the clinical research labs of a <a href=\"https:\/\/www.limswiki.org\/index.php\/Medical_device\" title=\"Medical device\" class=\"wiki-link\" data-key=\"8e821122daa731f0fa8782fae57831fa\">medical device<\/a> manufacturer\u2014at their heart have an overall goal of doing their part towards improving health outcomes among humans and animals. On the surface, this goal sounds relatively mundane; however, the work conducted in these laboratories is anything but mundane. From the use of advanced clinical to the requirement of accurate and timely results, these labs are under a lot of stress to operate effectively, efficiently, and according to regulations. However, well-designed <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_informatics\" title=\"Laboratory informatics\" class=\"wiki-link\" data-key=\"00edfa43edcde538a695f6d429280301\">laboratory informatics<\/a> solutions, when implemented, used, and maintained effectively, provide a means to better achieve that primary goal.\n<\/p><p>This guide addresses the medical diagnostics and research laboratories in their myriad forms, as well as how laboratory informatics solutions can benefit them. Yet it's more than \"here's a laboratory, here's a software system: marry the two, and the magic begins!\" These systems have their own intricacies, and its up to laboratory personnel, often not well-versed in such automation solutions, to evaluate and implement them. This guide addresses the numerous considerations that should be made beforehand, and it provides several chapters of resources to help practically put those considerations to work. It also addresses the usefulness of a requirements specification and how to put it to use. In particular, a slightly modified version of is suggested to get the most out of developing and using any requirements specification as part of software and vendor selection.\n<\/p><p>The table of contents for <i>Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research<\/i> is as follows:\n<\/p><p><br \/>\n<\/p>\n<dl><dd><a href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_diagnostics_lab\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Introduction to medical diagnostics and research laboratories\/Medical diagnostics lab\" class=\"wiki-link\" data-key=\"e275b81a96253b411988d17555a58563\">1. Introduction to medical diagnostics and research laboratories<\/a>\n<dl><dd>1.1 Medical diagnostics lab\n<dl><dd>1.1.1 Pathology\n<dl><dd>1.1.1.1 Anatomical vs. clinical pathology<\/dd>\n<dd>1.1.1.2 Forensic pathology<\/dd><\/dl><\/dd>\n<dd>1.1.2 Physician office lab<\/dd>\n<dd>1.1.3 Integrative medicine lab<\/dd><\/dl><\/dd>\n<dd>1.2 Public health lab<\/dd>\n<dd>1.3 Toxicology lab<\/dd>\n<dd>1.4 Blood bank and transfusion lab<\/dd>\n<dd>1.5 Central and contract research lab\n<dl><dd>1.5.1 Medical and other research in academia<\/dd><\/dl><\/dd>\n<dd>1.6 Genetic diagnostics lab\n<dl><dd>1.6.1 Cytogenetics lab<\/dd><\/dl><\/dd>\n<dd>1.7 Medical cannabis testing lab<\/dd><\/dl><\/dd><\/dl>\n<dl><dd><a href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/Evaluation_and_selection\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Choosing laboratory informatics software for your lab\/Evaluation and selection\" class=\"wiki-link\" data-key=\"cb123f53ac8e5168a41eb4769be28332\">2. Choosing laboratory informatics software for your lab<\/a>\n<dl><dd>2.1 Evaluation and selection\n<dl><dd>2.1.1 Technology considerations\n<dl><dd>2.1.1.1 Laboratory informatics options<\/dd><\/dl><\/dd>\n<dd>2.1.2 Features and functions<\/dd>\n<dd>2.1.3 Cybersecurity considerations<\/dd>\n<dd>2.1.4 Regulatory compliance considerations<\/dd>\n<dd>2.1.5 System flexibility<\/dd>\n<dd>2.1.6 Cost considerations<\/dd><\/dl><\/dd>\n<dd>2.2 Implementation\n<dl><dd>2.2.1 Internal and external integrations<\/dd><\/dl><\/dd>\n<dd>2.3 MSW, updates, and other contracted services<\/dd>\n<dd>2.4 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/LIMS_vendors\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 1: Laboratory informatics vendors\/LIMS vendors\" class=\"wiki-link\" data-key=\"2890fddc077a46958cd6045c0ffa8fb8\">3. Resources for selecting and implementing informatics solutions: Part 1: Laboratory informatics vendors<\/a>\n<dl><dd>3.1 LIMS vendors<\/dd>\n<dd>3.2 LIS vendors<\/dd>\n<dd>3.3 ELN vendors<\/dd>\n<dd>3.4 Middleware vendors<\/dd><\/dl><\/dd><\/dl>\n<dl><dd><a href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/Medical_diagnostics_instrumentation_and_equipment_vendors\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 2: Other vendors and service providers\/Medical diagnostics instrumentation and equipment vendors\" class=\"wiki-link\" data-key=\"17733f9801557e7af6825433f338fbef\">4. Resources for selecting and implementing informatics solutions: Part 2: Other vendors and service providers<\/a>\n<dl><dd>4.1 Medical diagnostics instrumentation vendors\n<dl><dd>4.1.1 CLIA-certified vendors<\/dd>\n<dd>4.1.2 Other vendors<\/dd><\/dl><\/dd>\n<dd>4.2 EHR vendors<\/dd>\n<dd>4.3 Laboratory business intelligence and workflow solution vendors<\/dd>\n<dd>4.4 Laboratory billing service providers<\/dd>\n<dd>4.5 Consultants<\/dd><\/dl><\/dd><\/dl>\n<dl><dd><a href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Trade_organizations\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Resources for selecting and implementing informatics solutions: Part 3: Industry and community resources\/Trade organizations\" class=\"wiki-link\" data-key=\"1dca96282078cc576add1d583de19527\">5. Resources for selecting and implementing informatics solutions: Part 3: Industry and community resources<\/a>\n<dl><dd>5.1 Trade organizations<\/dd>\n<dd>5.2 Conferences and trade shows<\/dd>\n<dd>5.3 User communities<\/dd>\n<dd>5.4 Books and journals<\/dd>\n<dd>5.5 Standards<\/dd>\n<dd>5.6 Further reading<\/dd>\n<dd>5.7 LIMSpec<\/dd><\/dl><\/dd><\/dl>\n<dl><dd><a href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Taking the next step\/Conduct initial research into a specification document\" class=\"wiki-link\" data-key=\"a81f595d27ceee9f009e979f2f949ead\">6. Taking the next step<\/a>\n<dl><dd>6.1 Conduct initial research into a specification document tailored to your lab's needs<\/dd>\n<dd>6.2 Issue some of the specification as part of a request for information (RFI)<\/dd>\n<dd>6.3 Respond to or open dialogue with vendors\n<dl><dd>6.3.1 The value of demonstrations<\/dd><\/dl><\/dd>\n<dd>6.4 Finalize the requirements specification and choose a vendor<\/dd><\/dl><\/dd><\/dl>\n<dl><dd><a href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Closing_remarks\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Closing remarks\" class=\"wiki-link\" data-key=\"f56dfc21dd4796864f8737a0566b64cd\">7. Closing remarks<\/a><\/dd><\/dl>\n<dl><dd><a href=\"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Taking_the_next_step\/Blank_LIMSpec_template_for_medical_diagnostics_and_research_labs\/Introduction_and_methodology\" title=\"Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research\/Taking the next step\/Blank LIMSpec template for medical diagnostics and research labs\/Introduction and methodology\" class=\"wiki-link\" data-key=\"362e9c62dacc255c1076806a8cefae5f\">Appendix 1. Blank LIMSpec template for medical diagnostics and research labs<\/a>\n<dl><dd>Introduction and methodology<\/dd>\n<dd>Primary laboratory workflow<\/dd>\n<dd>Maintaining laboratory workflow and operations<\/dd>\n<dd>Specialty laboratory functions<\/dd>\n<dd>Technology and performance improvements<\/dd>\n<dd>Security and integrity of systems and operations<\/dd>\n<dd>Putting those requirements to practical use and caveats<\/dd>\n<dd>LIMSpec in Microsoft Word format<\/dd><\/dl><\/dd><\/dl>\n<!-- \nNewPP limit report\nCached time: 20220125221408\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.028 seconds\nReal time usage: 0.113 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:12966-0!canonical and timestamp 20220125221408 and revision id 45822. 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:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction\">https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/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>","629f817ccc0007fa646508ddcd735ca7_images":["https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/1\/1d\/Vial_of_blood_to_be_tested.jpg"],"629f817ccc0007fa646508ddcd735ca7_timestamp":1643149330,"816bc5ee048c8669f9d42b30425606b4":{"type":"chapter","title":"About this book","key":"816bc5ee048c8669f9d42b30425606b4"}},"link":"https:\/\/www.limswiki.org\/index.php\/User:Shawndouglas\/sandbox\/sublevel1","price_currency":"","price_amount":"","book_size":"","download_url":"https:\/\/www.limsforum.com?ebb_action=book_download&book_id=100692","language":"","cta_button_content":"","toc":[{"type":"chapter","name":"About this book","id":"816bc5ee048c8669f9d42b30425606b4","children":[{"type":"article","name":"Introduction","id":"629f817ccc0007fa646508ddcd735ca7","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction"}]},{"type":"chapter","name":"1. Introduction to medical diagnostics and research laboratories","id":"8fcdd98bf065d8ca3c941d1017ddb8e9","children":[{"type":"article","name":"1.1 Medical diagnostics lab","id":"e275b81a96253b411988d17555a58563","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_diagnostics_lab"},{"type":"article","name":"1.2 Public health lab","id":"4afbb1e18840d48a4da4502ab88912bd","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Public_health_lab"},{"type":"article","name":"1.3 Toxicology lab","id":"84b3522ac7ff6ca73ca05e12dfc127d6","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Toxicology_lab"},{"type":"article","name":"1.4 Blood bank and transfusion lab","id":"72c13351f60d5c0e4e592ea30144c50a","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Blood_bank_and_transfusion_lab"},{"type":"article","name":"1.5 Central and contract research lab","id":"05c4e6f32b894e3e23f45f95a1ec3035","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Central_and_contract_research_lab"},{"type":"article","name":"1.6 Genetic diagnostics lab","id":"2842b58d0dc62a7918e218976fe37109","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Genetic_diagnostics_lab"},{"type":"article","name":"1.7 Medical cannabis testing lab","id":"8c6565d18a721549cc8050be68c730af","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Introduction_to_medical_diagnostics_and_research_laboratories\/Medical_cannabis_testing_lab"}]},{"type":"chapter","name":"2. Choosing laboratory informatics software for your lab","id":"096e0090a397d880dfc62f8d8a63a180","children":[{"type":"article","name":"2.1 Evaluation and selection","id":"cb123f53ac8e5168a41eb4769be28332","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/Evaluation_and_selection"},{"type":"article","name":"2.2 Implementation","id":"79e014ca9d87d3ecec33775123cbf95d","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/Implementation"},{"type":"article","name":"2.3 MSW, updates, and other contracted services","id":"5cb030452d0554379682604c55bb91f7","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/MSW,_updates,_and_other_contracted_services"},{"type":"article","name":"2.4 How a user requirements specification fits into the entire process","id":"7bd1df22f77cf95dd862bbe685e6087a","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Choosing_laboratory_informatics_software_for_your_lab\/How_a_user_requirements_specification_fits_into_the_entire_process"}]},{"type":"chapter","name":"3. Resources for selecting and implementing informatics solutions","id":"7a2ef644f59cfc10ed549bc2233c8229","children":[{"type":"article","name":"3.1 LIMS vendors","id":"2890fddc077a46958cd6045c0ffa8fb8","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/LIMS_vendors"},{"type":"article","name":"3.2 LIS vendors","id":"f087eacd8bde24820f324899f5972c1a","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/LIS_vendors"},{"type":"article","name":"3.3 ELN vendors","id":"2fb9efb02be4d94821197ff6a766cf50","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/ELN_vendors"},{"type":"article","name":"3.4 Middleware vendors","id":"139c94fa7dca8686ca8ecb414606eaac","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_1:_Laboratory_informatics_vendors\/Middleware_vendors"}]},{"type":"chapter","name":"4. Resources for selecting and implementing informatics solutions","id":"3d2601f7d4ff73414a0dff836bc54304","children":[{"type":"article","name":"4.1 Medical diagnostics instrumentation and equipment vendors","id":"17733f9801557e7af6825433f338fbef","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/Medical_diagnostics_instrumentation_and_equipment_vendors"},{"type":"article","name":"4.2 EHR vendors","id":"ed5267dc612120980decc29d603ba1e8","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/EHR_vendors"},{"type":"article","name":"4.3 Laboratory business intelligence (BI) and workflow solution vendors","id":"4bdc6fd01d0fcfb0f617fefa536a6e60","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/Laboratory_business_intelligence_(BI)_and_workflow_solution_vendors"},{"type":"article","name":"4.4 Laboratory billing service providers","id":"e05bbc55003d6664467a36acf6d8a411","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/Laboratory_billing_service_providers"},{"type":"article","name":"4.5 Consultants","id":"b89eb59ef012aafa0f5cde1de5ac497a","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_2:_Other_vendors_and_service_providers\/Consultants"}]},{"type":"chapter","name":"5. Resources for selecting and implementing informatics solutions","id":"f6ffb09399876fa4d9b10b794735a539","children":[{"type":"article","name":"5.1 Trade organizations","id":"1dca96282078cc576add1d583de19527","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Trade_organizations"},{"type":"article","name":"5.2 Conferences and trade shows","id":"2574a22b8ca0940242424fa5279a406b","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Conferences_and_trade_shows"},{"type":"article","name":"5.3 User communities","id":"88266dfb459e745c2f5143f10ba7dc70","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/User_communities"},{"type":"article","name":"5.4 Books and journals","id":"c66d9b96add95cb4cc2d112e2f143e6c","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Books_and_journals"},{"type":"article","name":"5.5 Standards, regulations, and guidance","id":"4224406d16f2e95eee34cf47467ccd7d","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Standards,_regulations,_and_guidance"},{"type":"article","name":"5.6 Further reading","id":"df7a5eb4b2a9d9dc9dc9a30ae1ad4e49","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/Further_reading"},{"type":"article","name":"5.7 LIMSpec","id":"644cc5c11e93b1af5a2b02d40240bf94","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:Laboratory_Informatics_Buyer%27s_Guide_for_Medical_Diagnostics_and_Research\/Resources_for_selecting_and_implementing_informatics_solutions:_Part_3:_Industry_and_community_resources\/LIMSpec"}]},{"type":"chapter","name":"6. 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Laboratory Informatics Buyer\'s Guide for Medical Diagnostics and Research
2022 Edition
Editor: Shawn Douglas
Publisher: LabLynx Press
Copyright LabLynx Inc. All rights reserved.