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| ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
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| ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
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| ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
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| [https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68 (b)]<br />
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| [https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br />
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| [https://www.astm.org/e1578-18.html ASTM E1578-18 C-4-1]<br />
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| [https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<br />
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| [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.1.2]<br />
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| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br />
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| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br />
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| [https://www.iso.org/standard/56115.html ISO 15189:2012 5.5.1.4]<br />
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| [https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
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| [https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5, Appendix 1]
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| | style="background-color:white;" |'''4.1''' The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.
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| [https://www.astm.org/e1578-18.html ASTM E1578-18 C-4-2]<br />
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| [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI AUTO15 1.2]
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| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.2]<br />
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| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br />
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| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br />
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| [https://www.iso.org/standard/56115.html ISO 15189:2012 5.9.2]<br />
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| [https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
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| | style="background-color:white;" |'''4.2''' The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.
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| | style="padding:5px; width:500px;" |
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| [https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68]<br />
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| [https://www.law.cornell.edu/cfr/text/21/211.100 21 CFR Part 211.100]<br />
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| [https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (a)]<br />
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| [https://www.law.cornell.edu/cfr/text/21/211.188 21 CFR Part 211.188]<br />
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| [https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
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| [https://www.law.cornell.edu/cfr/text/45/170.315 45 CFR Part 170.315 (d)]<br />
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| [https://www.astm.org/e1578-18.html ASTM E1578-18 C-4-3]<br />
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| [https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<br />
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| [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.1.1]<br />
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| [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.2.2]<br />
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| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7]<br />
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| [https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 9.2]<br />
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| [https://ichgcp.net/ ICH GCP 4.9.0 and 4.9.3]<br />
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| [https://ris.dls.virginia.gov/uploads/1VAC30/dibr/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)]<br />
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| [https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.2.3.5]<br />
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| [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9]<br />
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| [https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5, 4.12]
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| | style="background-color:white;" |'''4.3''' The system shall accurately maintain a full audit trail for modified results.
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| | style="padding:5px; width:500px;" |
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| [https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68 (b)]<br />
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| [https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.9.1]<br />
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| [https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 4.13]<br />
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| [https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-28–29]<br />
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| [https://www.acmg.net/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards.aspx ACMG Technical Standards for Clinical Genetics Laboratories G15.1]<br />
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| [https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2022 2A.7.7.2 and 7.7.3]<br />
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| [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 />
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| [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 5.9.4–5]<br />
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| [https://www.astm.org/e1578-18.html ASTM E1578-18 C-4-4]<br />
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| [https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<br />
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| [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.2.2]<br />
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| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2.6]<br />
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| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.2–3 and 4.9.11]<br />
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| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.4]<br />
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| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br />
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| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br />
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| [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6]<br />
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| [https://www.iso.org/standard/56115.html ISO 15189:2012 5.7.1]<br />
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| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.1.1]<br />
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| [https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
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| [https://www.pfp-ifss.org/ifss-resources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/ PFP Human and Animal Food Testing Laboratories Best Practices Manual]<br />
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| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 10]<br />
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| [https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.8.1]<br />
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| [https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5, 11.9 and Appendix 1]
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| | style="background-color:white;" |'''4.4''' The system shall provide one or more levels of review, as well as interpretation and documentation of results—whether entered manually or via an automated process—before release.
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| | style="padding:5px; width:500px;" |
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| [https://www.astm.org/e1578-18.html ASTM E1578-18 C-4-5]<br />
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| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br />
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| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br />
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| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br />
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| [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6]<br />
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| [https://www.iso.org/standard/56115.html ISO 15189:2012 5.9.2]<br />
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| [https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
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| [https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5, Appendix 1]
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| | style="background-color:white;" |'''4.5''' The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.
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| | style="padding:5px; width:500px;" |
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| [https://www.astm.org/e1578-18.html ASTM E1578-18 C-4-6]<br />
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| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br />
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| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br />
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| [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6]
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| | style="background-color:white;" |'''4.6''' The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits.
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| | style="padding:5px; width:500px;" |[https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<br />[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI AUTO15 4.0]<br />[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]
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| | style="background-color:white;" |'''4.7''' The system's autoverification system should be able to be validated and have a rapid means to automatically or manually shut it down in the event of a problem or manual changes being made to the autoverification system. The autoverification should be able to be revalidated afterwards.
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| |}
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| |}
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