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==Sandbox begins below==
==Sandbox begins below==
{|  
{{About|the international successor to the original OpenELIS software, OpenELIS Global|the original software, which is still actively developed|OpenELIS}}<br />
| STYLE="vertical-align:top;"|
{{Infobox software
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
| name                  = OpenELIS Global
|-
| title                  = OpenELIS Global
  ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
| logo                  = [[File:OpenELIS_logo.jpg|230px]]
|-
| screenshot            = <!-- [[File: ]] -->
  ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
| caption                =
  ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
| collapsible            =
|-
| author                = Casey Iiams-Hauser
  | style="padding:5px; width:500px;" |
| developer              = Digital Initiatives Group (DIGI) – University of Washington
[https://www.law.cornell.edu/cfr/text/7/part-331 7 CFR Part 331 (throughout)]<br />
| released              = {{Start date|2012|02|29}}<ref name="2.4Notes">{{cite web |url=https://sites.google.com/site/openelisglobal/openelis-global-2-4-release-notes |archiveurl=https://web.archive.org/web/20210130143717/https://sites.google.com/site/openelisglobal/openelis-global-2-4-release-notes |title=OpenELIS Global 2.4 Release Notes |publisher=University of Washington I-TECH |date=29 February 2012 |archivedate=30 January 2021 |accessdate=30 July 2026}}</ref>
[https://www.law.cornell.edu/cfr/text/9/part-121 9 CFR Part 121 (throughout)]<br />
| discontinued          =  
[https://www.law.cornell.edu/cfr/text/21/part-7 21 CFR Part 7 (throughout)]<br />
| frequently updated    = yes<!-- Release version update? Don't edit this page, just click on the version number! -->
[https://www.law.cornell.edu/cfr/text/21/part-58 21 CFR Part 58 (throughout)]<br />
| programming language   = Java (Spring), JavaScript (React, Carbon Design System)
[https://www.law.cornell.edu/cfr/text/21/part-211 21 CFR Part 211 (throughout)]<br />
| operating system      = Cross-platform
[https://www.law.cornell.edu/cfr/text/21/part-212 21 CFR Part 212 (throughout)]<br />
| platform              =  
[https://www.law.cornell.edu/cfr/text/21/part-225 21 CFR Part 225 (throughout)]<br />
| size                  =  
[https://www.law.cornell.edu/cfr/text/21/part-226 21 CFR Part 226 (throughout)]<br />
| language              =  
[https://www.law.cornell.edu/cfr/text/21/part-312 21 CFR Part 312 (throughout)]<br />
| status                =  
[https://www.law.cornell.edu/cfr/text/21/part-606 21 CFR Part 606 (throughout)]<br />
| genre                  = [[Laboratory informatics]] software
[https://www.law.cornell.edu/cfr/text/21/part-810 21 CFR Part 810 (throughout)]<br />
| license                = Mozilla Public License 2.0
[https://www.law.cornell.edu/cfr/text/21/part-812 21 CFR Part 812 (throughout)]<br />
| website                = [https://openelis-global.org/ openelis-global.org]
[https://www.law.cornell.edu/cfr/text/21/part-820 21 CFR Part 820 (throughout)]<br />
}}
[https://www.law.cornell.edu/cfr/text/29/1910.134 29 CFR Part 1910.134 (throughout)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (throughout)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1200 29 CFR Part 1910.1200 (throughout)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (throughout)]<br />
[https://www.law.cornell.edu/cfr/text/42/part-73 42 CFR Part 73 (throughout)]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1200 42 CFR Part 493.1200]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1232 42 CFR Part 493.1232]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1239 42 CFR Part 493.1239]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1251 42 CFR Part 493.1251]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1291 42 CFR Part 493.1291 (j)]<br />
[https://www.law.cornell.edu/cfr/text/45/part-164 45 CFR Part 164 (throughout)]<br />
[https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories (throughout)]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL (throughout)]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual (throughout)]<br />
[https://www.astm.org/e1188-11r17.html ASTM E1188-11 3.5.2]<br />
[https://www.astm.org/e1492-11r17.html ASTM E1492-11 4.3.3.3 and 4.4.4]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 D-1-1]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy (throughout)]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 (throughout)]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements (throughout)]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 (throughout)]<br />
[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC (throughout)]<br />
[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point (throughout)]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 4.3]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.5.3]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.9.3]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 5.3]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 5.5]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.3.2]<br />
[https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf NYDOH ELAP Medical Marijuana Microbiology Guidance]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5 (throughout)]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP (throughout)]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP (throughout)]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP (throughout)]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2 (throughout)]
  | style="background-color:white;" |'''7.1''' 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.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/7/part-331 7 CFR Part 331 (throughout)]<br />
[https://www.law.cornell.edu/cfr/text/9/part-121 9 CFR Part 121 (throughout)]<br />
[https://www.law.cornell.edu/cfr/text/21/part-7 21 CFR Part 7 (throughout)]<br />
[https://www.law.cornell.edu/cfr/text/21/part-58 21 CFR Part 58 (throughout)]<br />
[https://www.law.cornell.edu/cfr/text/21/part-211 21 CFR Part 211 (throughout)]<br />
[https://www.law.cornell.edu/cfr/text/21/part-212 21 CFR Part 212 (throughout)]<br />
[https://www.law.cornell.edu/cfr/text/21/part-225 21 CFR Part 225 (throughout)]<br />
[https://www.law.cornell.edu/cfr/text/21/part-226 21 CFR Part 226 (throughout)]<br />
[https://www.law.cornell.edu/cfr/text/21/part-312 21 CFR Part 312 (throughout)]<br />
[https://www.law.cornell.edu/cfr/text/21/part-606 21 CFR Part 606 (throughout)]<br />
[https://www.law.cornell.edu/cfr/text/21/part-810 21 CFR Part 810 (throughout)]<br />
[https://www.law.cornell.edu/cfr/text/21/part-812 21 CFR Part 812 (throughout)]<br />
[https://www.law.cornell.edu/cfr/text/21/part-820 21 CFR Part 820 (throughout)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.134 29 CFR Part 1910.134 (c)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (throughout)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1200 29 CFR Part 1910.1200 (e)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (throughout)]<br />
[https://www.law.cornell.edu/cfr/text/42/part-73 42 CFR Part 73 (throughout)]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1200 42 CFR Part 493.1200]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1232 42 CFR Part 493.1232]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1239 42 CFR Part 493.1239]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1251 42 CFR Part 493.1251]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1291 42 CFR Part 493.1291 (j)]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1773 42 CFR Part 493.1773 (c–d)]<br />
[https://www.law.cornell.edu/cfr/text/45/160.310 45 CFR Part 160.310]<br />
[https://www.law.cornell.edu/cfr/text/45/part-164 45 CFR Part 164 (throughout)]<br />
[https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories (throughout)]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL (throughout)]<br />
[https://www.astm.org/e1188-11r17.html ASTM E1188-11 3.5.2]<br />
[https://www.astm.org/e1492-11r17.html ASTM E1492-11 4.3.3.3 and 4.4.4]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 D-1-2]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy (throughout)]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 (throughout)]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements (throughout)]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 (throughout)]<br />
[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC (throughout)]<br />
[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point (throughout)]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 (throughout)]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 (throughout)]<br />
[https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf NYDOH ELAP Medical Marijuana Microbiology Guidance]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5 (throughout)]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP (throughout)]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP (throughout)]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP (throughout)]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2 (throughout)]
  | style="background-color:white;" |'''7.2''' 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.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/820.40 21 CFR Part 820.40 (a)]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1251 42 CFR Part 493.1251 (e)]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 4.3]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 D-1-3]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. III, Sec. 11]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.2.4.2]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.9]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 4.3]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.5.3]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.9.3]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.5.2]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.3.2]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.5]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.5]
  | style="background-color:white;" |'''7.3''' The system shall be able to clearly provide the most current version of a document and archive prior versions.
|-  
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 D-1-4]
  | style="background-color:white;" |'''7.4''' The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160]<br />
[https://www.law.cornell.edu/cfr/text/21/212.20 21 CFR Part 212.20 (c)]<br />
[https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 212.60 (c)]<br />
[https://www.law.cornell.edu/cfr/text/21/226.58 21 CFR Part 226.58 (e)]<br />
[https://www.law.cornell.edu/cfr/text/21/820.250 21 CFR Part 820.250 (b)]<br />
[https://www.law.cornell.edu/cfr/text/42/493.43 42 CFR Part 493.43 (c)]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 D-1-5]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 5]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.5]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.2.1.3]<br />
[https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf NYDOH ELAP Medical Marijuana Microbiology Guidance]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.4]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.14]
  | style="background-color:white;" |'''7.5''' 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.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/212.20 21 CFR Part 212.20 (c)]<br />
[https://www.law.cornell.edu/cfr/text/21/212.70 21 CFR Part 212.70 (b)]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.4.2.4]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. G-12, -14, and -15]<br />
[https://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.4]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.2.2.1]<br />
[https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf NYDOH ELAP Medical Marijuana Microbiology Guidance]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.4]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 4.11]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.13]
  | style="background-color:white;" |'''7.6''' 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.
|-
   | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/7/331.10 7 CFR Part 331.10]<br />
[https://www.law.cornell.edu/cfr/text/7/331.15 7 CFR Part 331.15]<br />
[https://www.law.cornell.edu/cfr/text/9/121.10 9 CFR Part 121.10 ]<br />
[https://www.law.cornell.edu/cfr/text/9/121.15 9 CFR Part 121.15 ]<br />
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (i)]<br />
[https://www.law.cornell.edu/cfr/text/21/58.29 21 CFR Part 58.29]<br />
[https://www.law.cornell.edu/cfr/text/21/211.25 21 CFR Part 211.25]<br />
[https://www.law.cornell.edu/cfr/text/21/225.10 21 CFR Part 225.10]<br />
[https://www.law.cornell.edu/cfr/text/21/226.10 21 CFR Part 226.10]<br />
[https://www.law.cornell.edu/cfr/text/21/226.40 21 CFR Part 226.40]<br />
[https://www.law.cornell.edu/cfr/text/21/820.25 21 CFR Part 820.25]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.134 29 CFR Part 1910.134 (c)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (g-2)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (h-2)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1200 29 CFR Part 1910.1200 (h)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (f)]<br />
[https://www.law.cornell.edu/cfr/text/42/73.10 42 CFR Part 73.10]<br />
[https://www.law.cornell.edu/cfr/text/42/73.15 42 CFR Part 73.15]<br />
[https://www.law.cornell.edu/cfr/text/42/493.43 42 CFR Part 493.43 (c)]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1235 42 CFR Part 493.1235]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1251 42 CFR Part 493.1251]<br />
[https://www.law.cornell.edu/cfr/text/45/164.308 45 CFR Part 164.308]<br />
[https://www.law.cornell.edu/cfr/text/45/164.530 45 CFR Part 164.530]<br />
[https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.2]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.4.2.2]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Appendix 1]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. B]<br />
[https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2022 (various parts)]<br />
[https://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12]<br />
[https://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1–3]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-3-5]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 D-1-6]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-1-6]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-2]<br />
[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 7.4]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. III, Sec. 10 and 17]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 1]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.8]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 4.1.2.1]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.1.6]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.1.9]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.2.2]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.2.3]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.2.5]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.2.6]<br />
[https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf NYDOH ELAP Medical Marijuana Microbiology Guidance]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 1.1.2]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 6.1]<br />
  | style="background-color:white;" |'''7.7''' 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.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 D-1-7]
  | style="background-color:white;" |'''7.8''' 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.
|-
  | style="padding:5px; width:500px;" |[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.10.6]
  | style="background-color:white;" |'''7.9''' The system shall support the addition of accurate cross-references and page numbers to new documents.
|-
  | style="padding:5px; width:500px;" |[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 4.3.4]
  | style="background-color:white;" |'''7.10''' The system shall be capable of uniquely identifying documents created in and added to the system.
|-
|}
|}


{|
'''OpenELIS Global''' is a free open-source [[laboratory information system]] (LIS) designed "to run national laboratory networks that serve millions of people,"<ref name="OpenELISGlobalAbout">{{cite web |url=https://openelis-global.org/about/ |title=Laboratory information, built for the public good |publisher=DIGI at the University of Washington |accessdate=30 July 2026}}</ref>, particularly in low- and middle-income countries. The software is as an offshoot of the [[OpenELIS]] open-source software project, which received development contributions from the likes of the Minnesota State Public Health Laboratory and the University of Iowa. The larger international influence on OpenELIS of collaborators such as the Association of Public Health Laboratories (APHL), the U.S. [[Centers for Disease Control and Prevention]] (CDC), and the University of Washington's International Training and Education Center on HIV (I-TECH) later spread the OpenELIS technology (in the form of separate branches of the software) to other parts of the world, including Vietnam, Haiti, and Côte d'Ivoire.<ref name"OpenELISOldAboutArch">{{cite web |url=https://sites.google.com/site/openelisglobal/about |archiveurl=https://web.archive.org/web/20190719065729/https://sites.google.com/site/openelisglobal/about |title=About/Team |publisher=ITECH at Washington University |archivedate=19 July 2019 |accessdate=30 July 2026}}</ref> While OpenELIS continues on as a separate project run by the OpenELIS Foundation, it states that it "has limited involvement in development of global OpenELIS."<ref name="OpenELISOrgAbout">{{cite web |url=https://openelis.org/about-openelis/ |title=About OpenELIS |publisher=OpenELIS Foundation |date=2026 |accessdate=30 July 2026}}</ref>
| STYLE="vertical-align:top;"|
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
|-
  ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
  ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/29/1910.120 29 CFR Part 1910.120]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.134 29 CFR Part 1910.134 (m)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (h-1)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (j)]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.2.3]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.2.4.1]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.8]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AT-4]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 6.1]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3]
  | style="background-color:white;" |'''8.1''' 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.
|-  
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/820.198 21 CFR Part 820.198]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1233 42 CFR Part 493.1233]<br />
[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 13]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (j)]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 5.0]
  | style="background-color:white;" |'''8.2''' The system shall allow authorized personnel to document complaints and problems reported to the laboratory or production facility.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/5/930.301 5 CFR Part 930.301]<br />
[https://www.law.cornell.edu/cfr/text/7/331.15 7 CFR Part 331.15]<br />
[https://www.law.cornell.edu/cfr/text/9/121.15 9 CFR Part 121.15]<br />
[https://www.law.cornell.edu/cfr/text/21/211.25 21 CFR Part 211.25]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (f)]<br />
[https://www.law.cornell.edu/cfr/text/42/73.15 42 CFR Part 73.15]<br />
[https://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-1-1]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.2.1]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.2.4.1]<br />
[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Guidelines]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AT-2 and AT-3]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, CP-3]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IR-2]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.1.2–3]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 10]
  | style="background-color:white;" |'''8.3''' The system shall allow training sessions to be scheduled for personnel.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/5/930.301 5 CFR Part 930.301]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (f)]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. B]<br />
[https://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-1-2]<br />
[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Guidelines]
  | style="background-color:white;" |'''8.4''' The system should provide access to relevant training materials to personnel attending training sessions.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/5/930.301 5 CFR Part 930.301]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (f)]<br />
[https://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12]<br />
[https://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1–3]<br />
[https://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2]<br />
[https://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-1-3]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.2.3]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.2.4.1]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.8]<br />
[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 7.4]<br />
[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Guidelines]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.1.9]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AT-2–AT-4]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, CP-3]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IR-2]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 6.1]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (e)]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 9.4]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 10]
  | style="background-color:white;" |'''8.5''' 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.
|-
  | style="padding:5px; width:500px;" |[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. B]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 E-1-4]
  | style="background-color:white;" |'''8.6''' The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-1-5]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AT-2 and AT-3]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, CP-3]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IR-2]<br />
  | style="background-color:white;" |'''8.7''' The system should be able to produce a training matrix of personnel.
  |-
  | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/7/331.15 7 CFR Part 331.15]<br />
[https://www.law.cornell.edu/cfr/text/9/121.10 9 CFR Part 121.10 ]<br />
[https://www.law.cornell.edu/cfr/text/9/121.15 9 CFR Part 121.15 ]<br />
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (i)]<br />
[https://www.law.cornell.edu/cfr/text/21/58.29 21 CFR Part 58.29]<br />
[https://www.law.cornell.edu/cfr/text/21/211.25 21 CFR Part 211.25]<br />
[https://www.law.cornell.edu/cfr/text/21/225.10 21 CFR Part 225.10]<br />
[https://www.law.cornell.edu/cfr/text/21/226.10 21 CFR Part 226.10]<br />
[https://www.law.cornell.edu/cfr/text/21/226.40 21 CFR Part 226.40]<br />
[https://www.law.cornell.edu/cfr/text/21/820.25 21 CFR Part 820.25]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (g-2)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (h-2)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1200 29 CFR Part 1910.1200 (h)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (e)]<br />
[https://www.law.cornell.edu/cfr/text/42/73.10 42 CFR Part 73.10]<br />
[https://www.law.cornell.edu/cfr/text/42/73.15 42 CFR Part 73.15]<br />
[https://www.law.cornell.edu/cfr/text/42/493.43 42 CFR Part 493.43 (c)]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1235 42 CFR Part 493.1235]<br />
[https://www.law.cornell.edu/cfr/text/45/164.308 45 CFR Part 164.308]<br />
[https://www.law.cornell.edu/cfr/text/45/164.530 45 CFR Part 164.530]<br />
[https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.2]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.4.2.2]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Appendix 1]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. B]<br />
[https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2022 (various parts)]<br />
[https://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12]<br />
[https://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1–3]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-3-5]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 D-1-6]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-1-6]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-2]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. III, Sec. 10 and 17]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 1]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.8]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 4.1.2.1]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.1.6]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.1.9]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.2.2]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.2.3]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.2.5]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.2.6]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 1.1.2]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 6.1]<br />
  | style="background-color:white;" |'''8.8''' 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.
|-
|}
|}


{|
OpenELIS Global is recognized as a Digital Square Global Good and a verified Digital Public Good<ref name="DSGlobalGoods23">{{cite web |url=https://datafi.thepalladiumgroup.com/wp-content/uploads/2024/11/2.-Global_Goods_Guidebook_Version_4.0_FINAL_forpublishing.pdf |format=PDF |title=The Global Goods Guidebook - An Overview of the Software Global Goods Ecosystem |publisher=Digital Square |page=48 |date=May 2023 |accessdate=30 July 2026}}</ref><ref name="DPGAOpenELISArch">{{cite web |url=https://www.digitalpublicgoods.net/registry/openelis-global.html |archiveurl=https://web.archive.org/web/20230526130236/https://www.digitalpublicgoods.net/registry/openelis-global.html |title=OpenELIS Global |publisher=Digital Public Goods Alliance |date=2022 |archivedate=26 May 2023 |accessdate=30 July 2026}}</ref>, and its Cote d'Ivoire implementation was evaluated in a 2024 peer-reviewed study in ''JMIR Public Health and Surveillance''.<ref name="HeLab24">{{cite journal |title=Laboratory Data Timeliness and Completeness Improves Following Implementation of an Electronic Laboratory Information System in Côte d’Ivoire: Quasi-Experimental Study on 21 Clinical Laboratories From 2014 to 2020 |author=He, Y.; Kouabenan, Y.-R.; Assoa, P.H; et al. |journal=JMIR Public Health and Surveillance |year=2024 |volume=10 |issue=e50407 |doi=10.2196/50407 |pmid=38506899}}</ref>
| STYLE="vertical-align:top;"|
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
|-
  ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
  ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/7/331.17 7 CFR Part 331.17]<br />
[https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17 ]<br />
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (e)]<br />
[https://www.law.cornell.edu/cfr/text/21/11.70 21 CFR Part 11.70]<br />
[https://www.law.cornell.edu/cfr/text/21/58.130 21 CFR Part 58.130 (e)]<br />
[https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1251 42 CFR Part 493.1251 (d)]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-4-7]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-2-1]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-9]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 8.1.3]
  | style="background-color:white;" |'''9.1''' 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.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (e)]<br />
[https://www.law.cornell.edu/cfr/text/21/11.70 21 CFR Part 11.70]<br />
[https://www.law.cornell.edu/cfr/text/21/58.130 21 CFR Part 58.130 (e)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68]<br />
[https://www.law.cornell.edu/cfr/text/21/211.100 21 CFR Part 211.100]<br />
[https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (a)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.188 21 CFR Part 211.188]<br />
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
[https://www.law.cornell.edu/cfr/text/45/170.315 45 CFR Part 170.315 (d)]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-2-2]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.1.1]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy Appendix G.5]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-9]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-12.4]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14]<br />
[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 9.2]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AC-2(4) and AC-6(9)]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-2 and AU-3]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, CM-5(1)]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9]
  | style="background-color:white;" |'''9.2''' The system shall document in the audit trail any event—including administrative and privileged functions—that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (e)]<br />
[https://www.law.cornell.edu/cfr/text/21/11.70 21 CFR Part 11.70]<br />
[https://www.law.cornell.edu/cfr/text/21/58.130 21 CFR Part 58.130 (e)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68]<br />
[https://www.law.cornell.edu/cfr/text/21/211.100 21 CFR Part 211.100]<br />
[https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (a)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.188 21 CFR Part 211.188]<br />
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1274 42 CFR Part 493.1274]<br />
[https://www.law.cornell.edu/cfr/text/45/170.315 45 CFR Part 170.315 (d)]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-2-3]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.1.1]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-12.4]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14]<br />
[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 9.2]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-3 and AU-8]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 8.1.4]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9]
  | style="background-color:white;" |'''9.3''' 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.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (e)]<br />
[https://www.law.cornell.edu/cfr/text/21/11.70 21 CFR Part 11.70]<br />
[https://www.law.cornell.edu/cfr/text/21/58.130 21 CFR Part 58.130 (e)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68]<br />
[https://www.law.cornell.edu/cfr/text/21/211.100 21 CFR Part 211.100]<br />
[https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (a)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.188 21 CFR Part 211.188]<br />
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
[https://www.law.cornell.edu/cfr/text/45/170.315 45 CFR Part 170.315 (d)]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-2-4]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.6]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14]<br />
[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 9.2]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-3]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9]
  | style="background-color:white;" |'''9.4''' The system's audit trail shall document the previous and current value of a modified field.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (e)]<br />
[https://www.law.cornell.edu/cfr/text/21/11.70 21 CFR Part 11.70]<br />
[https://www.law.cornell.edu/cfr/text/21/58.130 21 CFR Part 58.130 (e)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1251 42 CFR Part 493.1251 (d)]<br />
[https://www.law.cornell.edu/cfr/text/45/164.310 45 CFR Part 164.310]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-2-5]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.6]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]
  | style="background-color:white;" |'''9.5''' The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.
|-
  | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/11.70 21 CFR Part 11.70]<br />[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14]
  | style="background-color:white;" |'''9.6''' The system shall prevent a user from copying and pasting the electronic signature of another user.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (e)]<br />
[https://www.law.cornell.edu/cfr/text/21/58.130 21 CFR Part 58.130 (e)]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1274 42 CFR Part 493.1274 (d)]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-9]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-6 and AU-12]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]
  | style="background-color:white;" |'''9.7''' The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.
|-
|}
|}


{|
==Product history==
| STYLE="vertical-align:top;"|
In 2012, the University of Washington I-TECH began hosting OpenELIS Global, an international version of the OpenELIS software. The intent of the developers—the International Training and Education Center for Health (I-TECH) at Washington University—was to expand the functionality of OpenELIS to be more flexible while still "maintaining a common code base" among the the variation of feature requirements across different countries.<ref name"OpenELISOldAGlobalArch">{{cite web |url=https://sites.google.com/site/openelisglobal/global-implementation |archiveurl=https://web.archive.org/web/20210130143701/https://sites.google.com/site/openelisglobal/global-implementation |title=A Global LIS |publisher=ITECH at Washington University |archivedate=30 January 2021 |accessdate=30 July 2026}}</ref> The first public open-source release of the software was with version 2.4 on February 29, 2012<ref name="2.4Notes" />, followed by a 2.5 release on March 30.<ref name="2.5Notes">{{cite web |url=https://sites.google.com/site/openelisglobal/openelis-global-2-5-release-notes |archiveurl=https://web.archive.org/web/20210130143717/https://sites.google.com/site/openelisglobal/openelis-global-2-5-release-notes |title=OpenELIS Global 2.5 Release Notes |publisher=University of Washington I-TECH |date=30 March 2012 |archivedate=30 January 2021 |accessdate=30 July 2026}}</ref> The incrementation was chosen not as a numerical order of release, but rather as an identifying string as "Version.Pl​annedRelea​se.Unplann​edRelease (build number)," with versions incrementing yearly.<ref name="2.5Notes" />
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
|-
  ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
  ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-1]
  | style="background-color:white;" |'''10.1''' The system should provide a means for tracking usage of laboratory equipment and instruments.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-2]
  | style="background-color:white;" |'''10.2''' The system shall provide a means for planning the use of and reserving equipment and instruments.
|-  
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-3]
  | style="background-color:white;" |'''10.3''' The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-4]
  | style="background-color:white;" |'''10.4''' The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-5]
  | style="background-color:white;" |'''10.5''' 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.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-6]
  | style="background-color:white;" |'''10.6''' The system shall be able to group instruments together in specific ways, including by type and laboratory location.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/211.67 21 CFR Part 211.67–68]<br />
[https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (b-4)]<br />
[https://www.law.cornell.edu/cfr/text/21/212.30 21 CFR Part 212.30 (b)]<br />
[https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 212.60 (e)]<br />
[https://www.law.cornell.edu/cfr/text/21/225.30 21 CFR Part 225.30 (b-4)]<br />
[https://www.law.cornell.edu/cfr/text/21/606.60 21 CFR Part 606.60]<br />
[https://www.law.cornell.edu/cfr/text/21/820.70 21 CFR Part 820.70 (g)]<br />
[https://www.law.cornell.edu/cfr/text/21/820.72 21 CFR Part 820.72]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252 (b-3)]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1255 42 CFR Part 493.1255]<br />
[https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.5]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-20]<br />
[https://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1]<br />
[https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2022 2C.3.7–2C.3.10]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-7]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 7]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.11–13]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.6–7]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.1.4]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.7]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.8]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, MA-2 and MA-2(2)]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.2.4]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 5.2]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 6]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 13.5]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.23]
  | style="background-color:white;" |'''10.7''' The system shall allow for the configuration of calibration and maintenance frequency and time frames for—as well as the manual and automatic scheduling of calibration or maintenance of—equipment, instruments, and systems. Available intervals should be include days, weeks, months, and years.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/225.30 21 CFR Part 225.30 (b-4)]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.5.9]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-8]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.23]
  | style="background-color:white;" |'''10.8''' The system shall provide clear alerts or notifications when an instrument nears its calibration due date.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (b-4)]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-21]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-9]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.1.5]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.9]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 13.10]
  | style="background-color:white;" |'''10.9''' 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.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/820.72 21 CFR Part 820.72 (b-2)]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-10]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.11–13]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.6–7]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.8]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.23]
  | style="background-color:white;" |'''10.10''' The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/820.72 21 CFR Part 820.72 (b-1)]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1255 42 CFR Part 493.1255]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.6.1–2]<br />
[https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2022 2C.3.7]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 7]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.5]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 4.2]
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 6.1]<br />
  | style="background-color:white;" |'''10.11''' The system shall be able to link a calibration activity to certified reference material or designated measurement processes.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-11]
  | style="background-color:white;" |'''10.12''' The system shall support the use of predefined intervals when calculating instrument event dates.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/211.105 21 CFR Part 211.105 (b)]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1255 42 CFR Part 493.1255]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.5.4–5]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-12]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 7]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.6–7]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.1.7]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.8]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.13]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, CM-8]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 7.2]
  | style="background-color:white;" |'''10.13''' The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information—such as manufacturer, model number, serial number, and calibration and maintenance history—within the system.
|-  
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-13]
  | style="background-color:white;" |'''10.14''' The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/58.63 21 CFR Part 58.63]<br />
[https://www.law.cornell.edu/cfr/text/21/211.67 21 CFR Part 211.67–68]<br />
[https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (b-4)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.182 21 CFR Part 211.182]<br />
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194 (d)]<br />
[https://www.law.cornell.edu/cfr/text/21/212.30 21 CFR Part 212.30 (b)]<br />
[https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 212.60 (e)]<br />
[https://www.law.cornell.edu/cfr/text/21/820.70 21 CFR Part 820.70 (g)]<br />
[https://www.law.cornell.edu/cfr/text/21/820.72 21 CFR Part 820.72]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1254 42 CFR Part 493.1254]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1255 42 CFR Part 493.1255]<br />
[https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.5]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-20 and -23]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. F-1 and I-1]<br />
[https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2022 2C.3.7–2C.3.10]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-3-14]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 7]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.11–13]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.6–7]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.1.4]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.4]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 4.2]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.2.4]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 5.4]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.46]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.23]
  | style="background-color:white;" |'''10.15''' 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.
|-
|}
|}


{|
Since then, the software has received regular updates. Following the May 2019 release of version 9.1, work slowed slightly, apparently in favor of a planned rewrite of the code using Java Spring. In August 2019, I-TECH's Casey Iiams-Hauser (the OpenELIS Global project owner) put out a call for a software development team to tackle the transition to Java Spring and [[PostgreSQL]], with a target date of September 15, 2019.<ref name="Liams-HauserComeWork19">{{cite web |url=https://talk.openmrs.org/t/come-work-on-openelis-global-with-i-tech-we-are-looking-for-tech-writers-ui-ux-designers-and-devs-an/24221 |title=Come work on OpenELIS Global with I-TECH! |work=OpenMRS Talk |author=Liams-Hauser, C. |date=05 August 2019 |accessdate=30 July 2026}}</ref> The first release of the new version occurred in January 2020; the release notes stated: "This is a re-write of OpenELIS on modern frameworks and a significant security upgrade. At the end of this process, all tech will be currently supported and up to hardening standards. This software will be certified for use on US Government, and other high-security networks."<ref name="Liams-HauserOpenELISSoft22">{{cite web |url=https://docs.google.com/document/d/1p0zMfoUXRBbr9JyjjMeWRt1dgi7EbOd3IZdP6NCulow/edit?pli=1#heading=h.71anhixmrzil |archiveurl=https://web.archive.org/web/20220328192537/https://docs.google.com/document/d/1p0zMfoUXRBbr9JyjjMeWRt1dgi7EbOd3IZdP6NCulow/edit?pli=1#heading=h.71anhixmrzil |title=OpenELIS Software Release Roadmap |author=Liams-Hauser, C. |date=March 2022 |archivedate=28 March 2022 |accessdate=30 July 2026}}</ref> Updates over the years have added support for [[COVID-19]] testing, the [[Health Level 7#Fast Healthcare Interoperability Resources (FHIR)|FHIR API]], ASTM analyzer interfaces, data warehousing, and more.<ref name="Liams-HauserOpenELISSoft22" />
| STYLE="vertical-align:top;"|
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
|-
  ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
  ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
|-  
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/58.105 21 CFR Part 58.105 (a)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.80 21 CFR Part 211.80]<br />
[https://www.law.cornell.edu/cfr/text/21/225.102 21 CFR Part 225.102]<br />
[https://www.law.cornell.edu/cfr/text/21/226.102 21 CFR Part 226.102]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-4-1]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.3]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.10.1]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 6.2]
  | style="background-color:white;" |'''11.1''' The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/211.80 21 CFR Part 211.80]<br />
[https://www.law.cornell.edu/cfr/text/21/225.102 21 CFR Part 225.102]<br />
[https://www.law.cornell.edu/cfr/text/21/226.102 21 CFR Part 226.102]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-4-2]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.10.1]
  | style="background-color:white;" |'''11.2''' The system shall maintain the links between component parts of a batch and track the batch throughout the system.
|-  
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/211.80 21 CFR Part 211.80]<br />
[https://www.law.cornell.edu/cfr/text/21/225.102 21 CFR Part 225.102]<br />
[https://www.law.cornell.edu/cfr/text/21/226.102 21 CFR Part 226.102]<br />
[https://www.law.cornell.edu/cfr/text/21/820.65 21 CFR Part 820.65]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-4-3]
  | style="background-color:white;" |'''11.3''' 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.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-4-4]
  | style="background-color:white;" |'''11.4''' 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.
|-
  | style="padding:5px; width:500px;" |[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-15]
  | style="background-color:white;" |'''11.5''' The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.
|-
|}
|}


{|
==Features==
| STYLE="vertical-align:top;"|
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
|-
  ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
  ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-5-1]<br />[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 5.6–7]<br />
  | style="background-color:white;" |'''12.1''' The system shall allow users to create, maintain, and revise schedules for various laboratory tasks and processes.
|-
  | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/212.61 21 CFR Part 212.61 (a)]<br />[https://www.law.cornell.edu/cfr/text/21/211.166 21 CFR Part 211.166 (b)]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 E-5-2]
  | style="background-color:white;" |'''12.2''' The system scheduler shall be capable of working with a variety of laboratory tasks like calibrations, maintenance, and stability studies.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-5-3]
  | style="background-color:white;" |'''12.3''' The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-5-4]
  | style="background-color:white;" |'''12.4''' The system shall be capable of handling industry-specific testing characteristics (e.g., sampling points, human body sampling location).
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-5-5]
  | style="background-color:white;" |'''12.5''' The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.
|-
|}
|}


{|
Known features of OpenELIS Global include<ref name="2.4Notes" /><ref name="2.5Notes" /><ref name="Liams-HauserOpenELISSoft22" />:
| STYLE="vertical-align:top;"|
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
|-
  ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
  ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-6-1]
  | style="background-color:white;" |'''13.1''' The system shall be able to trigger an instrument event after a definable number of uses of that instrument.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-6-2]
  | style="background-color:white;" |'''13.2''' 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.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-6-3]
  | style="background-color:white;" |'''13.3''' The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.
|-  
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-6-4]
  | style="background-color:white;" |'''13.4''' The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-6-5]
  | style="background-color:white;" |'''13.5''' The system should be able to accept the results uploaded from an interfaced instrument.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-6-6]
  | style="background-color:white;" |'''13.6''' The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-6-7]
  | style="background-color:white;" |'''13.7''' The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP/IP, and USB.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-6-8]
  | style="background-color:white;" |'''13.8''' The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.
|-
|}
|}


{|
* sample entry
| STYLE="vertical-align:top;"|
* results entry
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
* user management and administration
|-
* role-based security
  ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
* reporting
|-
* data validation
  ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
* workplans
  ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
* patient reports
|-
* study reports
  | style="padding:5px; width:500px;" |
* test catalogs
[https://www.law.cornell.edu/cfr/text/21/58.83 21 CFR Part 58.83]<br />
* workflow management
[https://www.law.cornell.edu/cfr/text/29/1910.1200 29 CFR Part 1910.1200 (g)]<br />
* barcoded labels
[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (h)]<br />
* raw data export
[https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252 (c)]<br />
* audit trail logging
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-17]<br />
* electronic signatures
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-7-1]<br />
* instrument integration
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.2.4–5]<br />
* email and SMS support
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 4.4]
* LOINC code compatibility
  | style="background-color:white;" |'''14.1''' 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.
* FHIR support
|-  
* English or French language configuration
  | style="padding:5px; width:500px;" |
* iSante interoperability
[https://www.law.cornell.edu/cfr/text/7/331.3 7 CFR Part 331.3]<br />
[https://www.law.cornell.edu/cfr/text/9/121.3 9 CFR Part 121.3]<br />
[https://www.law.cornell.edu/cfr/text/21/312.58 21 CFR Part 312.58 (b)]<br />
[https://www.law.cornell.edu/cfr/text/42/73.3 42 CFR Part 73.3–4 (c)]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-7-2]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.1.12]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.2.4]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 12.20]
  | style="background-color:white;" |'''14.2''' 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.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-7-3]<br />[https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.2.4]
  | style="background-color:white;" |'''14.3''' 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.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-7-4]<br />[https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.2.4]
  | style="background-color:white;" |'''14.4''' 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.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-7-5]<br />[https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.2.4]
  | style="background-color:white;" |'''14.5''' 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.
|-
|}
|}


{|
==Hardware/software requirements==
| STYLE="vertical-align:top;"|
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
|-
  ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
  ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-8-1]
  | style="background-color:white;" |'''15.1''' The system should be capable of accurately tracking the specific quantities of received and consumed test samples.
|-
  | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 212.60 (d)]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 E-8-2]
  | style="background-color:white;" |'''15.2''' 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.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84]<br />
[https://www.law.cornell.edu/cfr/text/21/211.101 21 CFR Part 211.101]<br />
[https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 212.60 (d)]<br />
[https://www.law.cornell.edu/cfr/text/21/226.80 21 CFR Part 226.80]<br />
[https://www.law.cornell.edu/cfr/text/21/606.120 21 CFR Part 606.120 (b)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (g)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1096 29 CFR Part 1910.1096 (e-6)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1200 29 CFR Part 1910.1200 (f-6) and (f-10)]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-8-3]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.10–12]
  | style="background-color:white;" |'''15.3''' The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/212.40 21 CFR Part 212.40 (c)]<br />
[https://www.law.cornell.edu/cfr/text/21/820.50 21 CFR Part 820.50]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-8-4]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 7.1]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 14.8]
  | style="background-color:white;" |'''15.4''' The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/211.196 21 CFR Part 211.196]<br />
[https://www.law.cornell.edu/cfr/text/21/212.90 21 CFR Part 212.90]<br />
[https://www.law.cornell.edu/cfr/text/21/225.110 21 CFR Part 225.110]<br />
[https://www.law.cornell.edu/cfr/text/21/606.165 21 CFR Part 606.165]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 Appendix A (I)]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-8-5]
  | style="background-color:white;" |'''15.5''' The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/211.82 21 CFR Part 211.82 (b)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84 (a)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.89 21 CFR Part 211.89]<br />
[https://www.law.cornell.edu/cfr/text/21/211.110 21 CFR Part 211.110 (d)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.142 21 CFR Part 211.142 (a)]<br />
[https://www.law.cornell.edu/cfr/text/21/212.40 21 CFR Part 212.40 (c)]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-8-6]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 12.18]
  | style="background-color:white;" |'''15.6''' The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/211.89 21 CFR Part 211.89]<br />
[https://www.law.cornell.edu/cfr/text/21/211.110 21 CFR Part 211.110 (d)]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252 (d)]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-8-7]
  | style="background-color:white;" |'''15.7''' The system should allow authorized personnel to retire faulty or poor quality materials from use.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/211.89 21 CFR Part 211.89]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 E-8-8]
  | style="background-color:white;" |'''15.8''' The system shall clearly designate a standard or reagent as being disposed or consumed.
|-
|}
|}


{|
OpenELIS Global can be run in a virtual machine like VirtualBox or it can be built and installed from source code.
| STYLE="vertical-align:top;"|
 
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
===Virtual machine===
|-
 
  ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
System requirements for an OpenELIS Global [https://openelis-global.org/getting-started/ virtual machine] installation will be based on the requirements to run the virtual machine.
|-
 
  ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
===Source code===
  ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
 
|-
To build and install from source, you'll need:
  | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/312.62 21 CFR Part 312.62 (b)]<br />[https://www.law.cornell.edu/cfr/text/21/812.140 21 CFR Part 812.140 (a-3)]
 
  | style="background-color:white;" |'''16.1''' The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.
* Ubuntu 20.04 LTS
|-
* Net Tools
  | style="padding:5px; width:500px;" |
* Python
[https://www.law.cornell.edu/cfr/text/21/312.57 21 CFR Part 312.57 (a)]<br />
 
[https://www.law.cornell.edu/cfr/text/21/312.62 21 CFR Part 312.62 (a)]<br />
More information can be found [http://docs.openelis-global.org/en/latest/ here].
[https://www.law.cornell.edu/cfr/text/21/606.165 21 CFR Part 606.165]<br />
 
[https://www.law.cornell.edu/cfr/text/21/812.140 21 CFR Part 812.140 (a-2) and (b-2)]
==Videos, screenshots, and other media==
  | style="background-color:white;" |'''16.2''' 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.
 
|-
===Videos===
  | style="padding:5px; width:500px;" |
 
[https://www.law.cornell.edu/cfr/text/21/58.81 21 CFR Part 58.81 (a)]<br />
The following YouTube videos exist for OpenELIS Global:
[https://www.law.cornell.edu/cfr/text/21/211.100 21 CFR Part 211.100]<br />
 
[https://www.law.cornell.edu/cfr/text/21/211.111 21 CFR Part 211.111]<br />
* [https://www.youtube.com/watch?v=jJMJzEmiyVg OpenELIS Global Airport Arrival Webapp for Covid testing]
[https://www.law.cornell.edu/cfr/text/21/211.192 21 CFR Part 211.192]<br />
* [https://www.youtube.com/watch?v=ZBx0p2xRXOw After the airport passenger locator form, we have the OpenELIS system itself through to result]
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
* [https://www.youtube.com/watch?v=MReLJoiDcwc OpenELIS and OpenMRS Lab Orders and Results Exchange Demo]
[https://www.law.cornell.edu/cfr/text/21/606.171 21 CFR Part 606.171]<br />
* [https://www.youtube.com/watch?v=vceADLpaDNc OpenELIS Global QuanStudio 3 and 5 Analyzer Integration]
[https://www.law.cornell.edu/cfr/text/42/493.1253 42 CFR Part 493.1253 (b-2)]<br />
* [https://www.youtube.com/watch?v=BbDuvrUBpIs Setting up the analyzer script]
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual C-16]<br />
 
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual F-2]<br />
===Demos===
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual J-3]<br />
 
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-9-1]<br />
An online demo of OpenELIS Global can be found on the [https://openelis-global.org/getting-started/demo/ OpenELIS website].
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.3]<br />
 
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.4]<br />
===Documentation===
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.2.1.7]<br />
 
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.2.2.1]<br />
Documentation for OpenELIS Global can be [http://docs.openelisci.org/en/latest/ found here].
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.10.2]<br />
 
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.7.1]<br />
==Entities using OpenELIS==
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 7.3]<br />
 
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.2.2]<br />
The following entities are known to be utilizing or have used some form of OpenELIS:
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.3]
 
  | style="background-color:white;" |'''16.3''' 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.
CDC Retrovirus Côte d'Ivoire, Clinical Informatics Research Group, Institut Pasteur Côte d'Ivoire, Laboratoire National de Santé Publique - Côte d'Ivoire, Laboratoire National de Santé Publique - Haiti, Minnesota State Public Health Laboratory, State Hygienic Laboratory at the University of Iowa
|-
 
  | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/42/493.1282 42 CFR Part 493.1282]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 E-9-2]
==Further reading==
  | style="background-color:white;" |'''16.4''' The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.
 
|-
* {{cite journal |title=Laboratory Data Timeliness and Completeness Improves Following Implementation of an Electronic Laboratory Information System in Côte d’Ivoire: Quasi-Experimental Study on 21 Clinical Laboratories From 2014 to 2020 |author=He, Y.; Kouabenan, Y.-R.; Assoa, P.H; et al. |journal=JMIR Public Health and Surveillance |year=2024 |volume=10 |issue=e50407 |doi=10.2196/50407 |pmid=38506899}}
  | style="padding:5px; width:500px;" |
 
[https://www.law.cornell.edu/cfr/text/21/606.100 21 CFR Part 606.100 (c)]<br />
==External links==
[https://www.law.cornell.edu/cfr/text/42/493.1282 42 CFR Part 493.1282]<br />
 
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-9-3]<br />
* [https://github.com/DIGI-UW/OpenELIS-Global-2 OpenELIS Global (current) on GitHub]
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br />
* [https://github.com/openelisglobal/openelisglobal-core/ OpenELIS (pre-2.0) at GitHub]
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.12]
* [https://code.google.com/archive/p/openelisglobal/ OpenELIS Global at Google Code] (Archived)
  | style="background-color:white;" |'''16.5''' The system should trigger an alert or notification when an OOS/OOT status is found, prompting a documented investigation to identify the root cause.
 
|-
* NOTE: The country specific blogs for Haiti and Cote d'Ivoire have been combined at: [http://openelis.blogspot.com/ OpenELIS Global blog]
  | style="padding:5px; width:500px;" |
 
[https://www.law.cornell.edu/cfr/text/21/225.58 21 CFR Part 225.58 (d)]<br />
==References==
[https://www.law.cornell.edu/cfr/text/21/225.158 21 CFR Part 225.158]<br />
<references />
[https://www.law.cornell.edu/cfr/text/21/606.100 21 CFR Part 606.100 (c)]<br />
 
[https://www.law.cornell.edu/cfr/text/21/820.100 21 CFR Part 820.100]<br />
<!---Place all category tags here-->
[https://www.law.cornell.edu/cfr/text/42/493.1282 42 CFR Part 493.1282]<br />
[[Category:Health informatics software (open source)]]
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-9-4]<br />
[[Category:Laboratory informatics software (open source)]]
[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 13]<br />
[[Category:Laboratory information systems (open source)]]
[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 5]<br />
[[Category:Public health software (open source)]]
[https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf NYDOH ELAP Medical Marijuana Microbiology Guidance]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IR-5]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 5.0]
  | style="background-color:white;" |'''16.6''' The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/225.58 21 CFR Part 225.58 (d)]<br />
[https://www.law.cornell.edu/cfr/text/21/225.158 21 CFR Part 225.158]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1282 42 CFR Part 493.1282]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1289 42 CFR Part 493.1289]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-9-5]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.3.4]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy Appendix G.7]<br />
[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 13]<br />
[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 5]<br />
[https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf NYDOH ELAP Medical Marijuana Microbiology Guidance]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-6(1)]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IR-4(1) and IR-5]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, SI-2 and SI-4]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 5.0]
  | style="background-color:white;" |'''16.7''' 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.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-9-6]
  | style="background-color:white;" |'''16.8''' The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization’s standard operating procedures.
|-
|}
|}

Latest revision as of 23:29, 30 July 2026

This is sublevel22 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see my discussion page instead.

Sandbox begins below

This page is about the international successor to the original OpenELIS software, OpenELIS Global. For the original software, which is still actively developed, see OpenELIS.


OpenELIS Global
OpenELIS logo.jpg
Original author(s) Casey Iiams-Hauser
Developer(s) Digital Initiatives Group (DIGI) – University of Washington
Initial release February 29, 2012 (2012-02-29)[1]
Stable release

3.2.1.11  (July 13, 2026; 20 days ago (2026-07-13))

[±]
Written in Java (Spring), JavaScript (React, Carbon Design System)
Operating system Cross-platform
Type Laboratory informatics software
License(s) Mozilla Public License 2.0
Website openelis-global.org

OpenELIS Global is a free open-source laboratory information system (LIS) designed "to run national laboratory networks that serve millions of people,"[2], particularly in low- and middle-income countries. The software is as an offshoot of the OpenELIS open-source software project, which received development contributions from the likes of the Minnesota State Public Health Laboratory and the University of Iowa. The larger international influence on OpenELIS of collaborators such as the Association of Public Health Laboratories (APHL), the U.S. Centers for Disease Control and Prevention (CDC), and the University of Washington's International Training and Education Center on HIV (I-TECH) later spread the OpenELIS technology (in the form of separate branches of the software) to other parts of the world, including Vietnam, Haiti, and Côte d'Ivoire.[3] While OpenELIS continues on as a separate project run by the OpenELIS Foundation, it states that it "has limited involvement in development of global OpenELIS."[4]

OpenELIS Global is recognized as a Digital Square Global Good and a verified Digital Public Good[5][6], and its Cote d'Ivoire implementation was evaluated in a 2024 peer-reviewed study in JMIR Public Health and Surveillance.[7]

Product history

In 2012, the University of Washington I-TECH began hosting OpenELIS Global, an international version of the OpenELIS software. The intent of the developers—the International Training and Education Center for Health (I-TECH) at Washington University—was to expand the functionality of OpenELIS to be more flexible while still "maintaining a common code base" among the the variation of feature requirements across different countries.[8] The first public open-source release of the software was with version 2.4 on February 29, 2012[1], followed by a 2.5 release on March 30.[9] The incrementation was chosen not as a numerical order of release, but rather as an identifying string as "Version.Pl​annedRelea​se.Unplann​edRelease (build number)," with versions incrementing yearly.[9]

Since then, the software has received regular updates. Following the May 2019 release of version 9.1, work slowed slightly, apparently in favor of a planned rewrite of the code using Java Spring. In August 2019, I-TECH's Casey Iiams-Hauser (the OpenELIS Global project owner) put out a call for a software development team to tackle the transition to Java Spring and PostgreSQL, with a target date of September 15, 2019.[10] The first release of the new version occurred in January 2020; the release notes stated: "This is a re-write of OpenELIS on modern frameworks and a significant security upgrade. At the end of this process, all tech will be currently supported and up to hardening standards. This software will be certified for use on US Government, and other high-security networks."[11] Updates over the years have added support for COVID-19 testing, the FHIR API, ASTM analyzer interfaces, data warehousing, and more.[11]

Features

Known features of OpenELIS Global include[1][9][11]:

  • sample entry
  • results entry
  • user management and administration
  • role-based security
  • reporting
  • data validation
  • workplans
  • patient reports
  • study reports
  • test catalogs
  • workflow management
  • barcoded labels
  • raw data export
  • audit trail logging
  • electronic signatures
  • instrument integration
  • email and SMS support
  • LOINC code compatibility
  • FHIR support
  • English or French language configuration
  • iSante interoperability

Hardware/software requirements

OpenELIS Global can be run in a virtual machine like VirtualBox or it can be built and installed from source code.

Virtual machine

System requirements for an OpenELIS Global virtual machine installation will be based on the requirements to run the virtual machine.

Source code

To build and install from source, you'll need:

  • Ubuntu 20.04 LTS
  • Net Tools
  • Python

More information can be found here.

Videos, screenshots, and other media

Videos

The following YouTube videos exist for OpenELIS Global:

Demos

An online demo of OpenELIS Global can be found on the OpenELIS website.

Documentation

Documentation for OpenELIS Global can be found here.

Entities using OpenELIS

The following entities are known to be utilizing or have used some form of OpenELIS:

CDC Retrovirus Côte d'Ivoire, Clinical Informatics Research Group, Institut Pasteur Côte d'Ivoire, Laboratoire National de Santé Publique - Côte d'Ivoire, Laboratoire National de Santé Publique - Haiti, Minnesota State Public Health Laboratory, State Hygienic Laboratory at the University of Iowa

Further reading

  • He, Y.; Kouabenan, Y.-R.; Assoa, P.H; et al. (2024). "Laboratory Data Timeliness and Completeness Improves Following Implementation of an Electronic Laboratory Information System in Côte d’Ivoire: Quasi-Experimental Study on 21 Clinical Laboratories From 2014 to 2020". JMIR Public Health and Surveillance 10 (e50407). doi:10.2196/50407. PMID 38506899. 


External links

  • NOTE: The country specific blogs for Haiti and Cote d'Ivoire have been combined at: OpenELIS Global blog

References

  1. ↑ 1.0 1.1 1.2 "OpenELIS Global 2.4 Release Notes". University of Washington I-TECH. 29 February 2012. Archived from the original on 30 January 2021. https://web.archive.org/web/20210130143717/https://sites.google.com/site/openelisglobal/openelis-global-2-4-release-notes. Retrieved 30 July 2026. 
  2. ↑ "Laboratory information, built for the public good". DIGI at the University of Washington. https://openelis-global.org/about/. Retrieved 30 July 2026. 
  3. ↑ "About/Team". ITECH at Washington University. Archived from the original on 19 July 2019. https://web.archive.org/web/20190719065729/https://sites.google.com/site/openelisglobal/about. Retrieved 30 July 2026. 
  4. ↑ "About OpenELIS". OpenELIS Foundation. 2026. https://openelis.org/about-openelis/. Retrieved 30 July 2026. 
  5. ↑ "The Global Goods Guidebook - An Overview of the Software Global Goods Ecosystem" (PDF). Digital Square. May 2023. p. 48. https://datafi.thepalladiumgroup.com/wp-content/uploads/2024/11/2.-Global_Goods_Guidebook_Version_4.0_FINAL_forpublishing.pdf. Retrieved 30 July 2026. 
  6. ↑ "OpenELIS Global". Digital Public Goods Alliance. 2022. Archived from the original on 26 May 2023. https://web.archive.org/web/20230526130236/https://www.digitalpublicgoods.net/registry/openelis-global.html. Retrieved 30 July 2026. 
  7. ↑ He, Y.; Kouabenan, Y.-R.; Assoa, P.H; et al. (2024). "Laboratory Data Timeliness and Completeness Improves Following Implementation of an Electronic Laboratory Information System in Côte d’Ivoire: Quasi-Experimental Study on 21 Clinical Laboratories From 2014 to 2020". JMIR Public Health and Surveillance 10 (e50407). doi:10.2196/50407. PMID 38506899. 
  8. ↑ "A Global LIS". ITECH at Washington University. Archived from the original on 30 January 2021. https://web.archive.org/web/20210130143701/https://sites.google.com/site/openelisglobal/global-implementation. Retrieved 30 July 2026. 
  9. ↑ 9.0 9.1 9.2 "OpenELIS Global 2.5 Release Notes". University of Washington I-TECH. 30 March 2012. Archived from the original on 30 January 2021. https://web.archive.org/web/20210130143717/https://sites.google.com/site/openelisglobal/openelis-global-2-5-release-notes. Retrieved 30 July 2026. 
  10. ↑ Liams-Hauser, C. (5 August 2019). "Come work on OpenELIS Global with I-TECH!". OpenMRS Talk. https://talk.openmrs.org/t/come-work-on-openelis-global-with-i-tech-we-are-looking-for-tech-writers-ui-ux-designers-and-devs-an/24221. Retrieved 30 July 2026. 
  11. ↑ 11.0 11.1 11.2 Liams-Hauser, C. (March 2022). "OpenELIS Software Release Roadmap". Archived from the original on 28 March 2022. https://web.archive.org/web/20220328192537/https://docs.google.com/document/d/1p0zMfoUXRBbr9JyjjMeWRt1dgi7EbOd3IZdP6NCulow/edit?pli=1#heading=h.71anhixmrzil. Retrieved 30 July 2026. 
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