Difference between revisions of "Template:LIMSpec/Data integrity"

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   ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
   ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
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   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-17-1]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-17-1]<br />[https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers EMA Guidance on Good Manufacturing Practice and Good Distribution Practice]<br />[https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5, 9.1]
   | style="background-color:white;" |'''31.1''' System functionality should support ALCOA principles.
   | style="background-color:white;" |'''31.1''' System functionality should support ALCOA principles.
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   | style="padding:5px; width:500px;" |
   | style="padding:5px; width:500px;" |
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-17-2]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-17-2]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 8]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 8]<br />
[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 4.13.2.3]<br />
[https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers EMA Guidance on Good Manufacturing Practice and Good Distribution Practice]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.6]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.6]<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://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7]<br />
[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, SI-12]
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, SI-12]
   | style="background-color:white;" |'''31.2''' The system shall protect entered data so as to prevent it from being obscured by new data, keeping both the old and current data available for review.
   | style="background-color:white;" |'''31.2''' The system shall protect entered data so as to prevent it from being obscured by new data, keeping both the old and current data available for review.
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   | style="padding:5px; width:500px;" |
   | style="padding:5px; width:500px;" |
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-17-3]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-17-3]<br />
[https://www.law.cornell.edu/cfr/text/21/58.190 21 CFR Part 58.190]<br />
[https://www.law.cornell.edu/cfr/text/21/58.190 21 CFR Part 58.190]<br />
[https://www.law.cornell.edu/cfr/text/42/93.305 42 CFR Part 93.305]<br />
[https://www.law.cornell.edu/cfr/text/42/93.310 42 CFR Part 93.310]<br />
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.2.2]<br />
[https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers EMA Guidance on Good Manufacturing Practice and Good Distribution Practice]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 8]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 8]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.3.4.1]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.3.4.1]<br />
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[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.9]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.9]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.9]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.9]<br />
[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, SI-12]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, SI-12]<br />
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 10]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 10]<br />
[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 />
[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 4.13.3)]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.2.1]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.2.1]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 8.1.3]
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 8.1.3]<br />
   | style="background-color:white;" |'''31.3''' The system shall maintain a true, readable copy of an instrument's original (raw) data for on-demand review.
[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 and Appendix 1]
   | style="background-color:white;" |'''31.3''' The system shall securely maintain a true, readable copy of an instrument's original (raw) data for on-demand review.
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[https://www.law.cornell.edu/cfr/text/7/91.30 7 CFR Part 91.30]<br />
[https://www.law.cornell.edu/cfr/text/7/331.17 7 CFR Part 331.17 (c)]<br />
[https://www.law.cornell.edu/cfr/text/7/331.17 7 CFR Part 331.17 (c)]<br />
[https://www.law.cornell.edu/cfr/text/9/2.35 9 CFR Part 2.35]<br />
[https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17 (c)]<br />
[https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17 (c)]<br />
[https://www.law.cornell.edu/cfr/text/10/20.2103 10 CFR Part 20.2103–10]<br />
[https://www.law.cornell.edu/cfr/text/10/30.34 10 CFR Part 30.34 (g)]<br />
[https://www.law.cornell.edu/cfr/text/10/30.51 10 CFR Part 30.51–2]<br />
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (c)]<br />
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (c)]<br />
[https://www.law.cornell.edu/cfr/text/21/58.195 21 CFR Part 58.195]<br />
[https://www.law.cornell.edu/cfr/text/21/58.195 21 CFR Part 58.195]<br />
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[https://www.law.cornell.edu/cfr/text/21/812.140 21 CFR Part 812.140 (d)]<br />
[https://www.law.cornell.edu/cfr/text/21/812.140 21 CFR Part 812.140 (d)]<br />
[https://www.law.cornell.edu/cfr/text/21/820.180 21 CFR Part 820.180 (b)]<br />
[https://www.law.cornell.edu/cfr/text/21/820.180 21 CFR Part 820.180 (b)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.120 29 CFR Part 1910.120 (f)(8)]<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/29/1910.1030 29 CFR Part 1910.1030 (h-2)]<br />
[https://www.law.cornell.edu/cfr/text/40/141.33 40 CFR Part 141.33]<br />
[https://www.law.cornell.edu/cfr/text/40/141.33 40 CFR Part 141.33]<br />
[https://www.law.cornell.edu/cfr/text/40/141.722 40 CFR Part 141.722]<br />
[https://www.law.cornell.edu/cfr/text/40/141.722 40 CFR Part 141.722]<br />
[https://www.law.cornell.edu/cfr/text/40/262.11 40 CFR Part 262.11 (f)]<br />
[https://www.law.cornell.edu/cfr/text/40/262.40 40 CFR Part 262.40]<br />
[https://www.law.cornell.edu/cfr/text/40/262.213 40 CFR Part 262.213]<br />
[https://www.law.cornell.edu/cfr/text/40/part-704/subpart-A 40 CFR Part 704 Subpart A]<br />
[https://www.law.cornell.edu/cfr/text/40/part-704/subpart-A 40 CFR Part 704 Subpart A]<br />
[https://www.law.cornell.edu/cfr/text/40/717.15 40 CFR Part 717.15 (d)]<br />
[https://www.law.cornell.edu/cfr/text/40/717.15 40 CFR Part 717.15 (d)]<br />
[https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17 (c)]<br />
[https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17 (c)]<br />
[https://www.law.cornell.edu/cfr/text/42/93.313 42 CFR Part 93.313 (h)]<br />
[https://www.law.cornell.edu/cfr/text/42/93.317 42 CFR Part 93.317]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1105 42 CFR Part 493.1105]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1105 42 CFR Part 493.1105]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1283 42 CFR Part 493.1283]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1283 42 CFR Part 493.1283]<br />
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[https://www.law.cornell.edu/cfr/text/45/164.316 45 CFR Part 164.316]<br />
[https://www.law.cornell.edu/cfr/text/45/164.316 45 CFR Part 164.316]<br />
[https://www.law.cornell.edu/cfr/text/45/164.530 45 CFR Part 164.530]<br />
[https://www.law.cornell.edu/cfr/text/45/164.530 45 CFR Part 164.530]<br />
[https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.4]<br />
[https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.9]<br />
[https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1]<br />
[https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 4.10.1.2]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 4.10.1.2]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 4.10.2.1]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 4.10.2.1]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.4.3.2]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.4.3.2]<br />
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-33]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-33]<br />
[https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2018 2A.7.5.1]<br />
[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 C1.5]<br />
[http://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 4.14.1.2 and 4.15.1.2]<br />
[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 C5.6]<br />
[http://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 5.9.3.6 and 5.9.7]<br />
[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 E2.1]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-17-4]<br />
[https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2022 2A.7.5.1]<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 4.14.1.2 and 4.15.1.2]<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 5.9.3.6 and 5.9.7]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-17-4]<br />
[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://www.cdc.gov/labs/BMBL.html CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition]<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 5.3.4]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.6–7]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.6–7]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.5.2.1]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.5.2.1]<br />
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.8.3]<br />
[https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers EMA Guidance on Good Manufacturing Practice and Good Distribution Practice]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-7.1]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-7.1]<br />
[https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:262:0022:0026:en:PDF E.U. Commission Directive 2003/94/EC Article 9.1]<br />
[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 9.1]<br />
[https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:262:0022:0026:en:PDF E.U. Commission Directive 2003/94/EC Article 11.4]<br />
[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 11.4]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. III, Sec. 15]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. III, Sec. 15]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 8]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 8]<br />
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[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.17]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.17]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.9]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.9]<br />
[https://ichgcp.net/ ICH GCP 4.9.5]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 4.3]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 4.3]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.4.2]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.4.2]<br />
[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, AT-4]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AT-4]<br />
[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, AU-11 and AU-11(1)]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-11 and AU-11(1)]<br />
[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, SI-12]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, SI-12]<br />
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 10]<br />
[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 10]<br />
[https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1020 OSHA 1910.1020(d)(1)(i–ii)]<br />
[https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1450 OSHA 1910.1450(j)(2)]<br />
[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 />
[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 (throughout)]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.4]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.4]<br />
[https://www.ams.usda.gov/sites/default/files/media/TestingGuidelinesforHemp.pdf USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 2]<br />
[https://www.ams.usda.gov/services/lab-testing/lab-approval USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 10c]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.5]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.5]<br />
[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 15.8–9]
[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 and 5.4.4]<br />
[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-protection-privacy-and-personal WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.0]<br />
[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 15.8–9]<br />
[https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5, 11.15 and Appendix 1]
   | style="background-color:white;" |'''31.4''' The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.
   | style="background-color:white;" |'''31.4''' The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.
  |-  
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   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-17-6]<br />[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.4]<br />[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, AU-8]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-17-6]<br />[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.4]<br />[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-8]<br />[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 and Appendix 1]
   | style="background-color:white;" |'''31.5''' The system shall accurately reflect the system date and time in its use of electronic record time stamps.
   | style="background-color:white;" |'''31.5''' The system shall accurately reflect the system date and time in its use of electronic record time stamps.
  |-  
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   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-17-7]<br />[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.6.1]
   | style="padding:5px; width:500px;" |[https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 E-17-7]<br />[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.6.1]
   | style="background-color:white;" |'''31.6''' The system shall require each and every user to be assigned a unique user ID.
   | style="background-color:white;" |'''31.6''' The system shall require each and every user to be assigned a unique user ID.
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   | style="padding:5px; width:500px;" |
   | style="padding:5px; width:500px;" |
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-17-8]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-17-8]<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/21/11.10 21 CFR Part 11.10 (e)]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.5]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.5]<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 11-9]<br />
[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, AU-9]
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-9]
   | style="background-color:white;" |'''31.7''' The system shall prevent the modification, deletion, or disabling of its audit trail, as well as record such attempts.
   | style="background-color:white;" |'''31.7''' The system shall prevent the modification, deletion, or disabling of its audit trail, as well as record such attempts.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.2]<br />[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, AU-5]<br />[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, SI-4]
   | style="padding:5px; width:500px;" |[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.2]<br />[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-5]<br />[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, SI-4]
   | style="background-color:white;" |'''31.8''' The system shall be capable of identifying instances of audit processing failure (e.g., write errors, general failure of the audit tool, etc.), sending alerts or notifications to appropriate personnel in such cases.
   | style="background-color:white;" |'''31.8''' The system shall be capable of identifying instances of audit processing failure (e.g., write errors, general failure of the audit tool, etc.), sending alerts or notifications to appropriate personnel in such cases.
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Revision as of 20:44, 5 May 2022

Regulation, Specification, or Guidance Requirement
ASTM E1578-18 E-17-1
EMA Guidance on Good Manufacturing Practice and Good Distribution Practice
WHO Technical Report Series, #996, Annex 5, 9.1
31.1 System functionality should support ALCOA principles.

ASTM E1578-18 E-17-2
EPA 815-R-05-004 Chap. IV, Sec. 8
A2LA C211 4.13.2.3
EMA Guidance on Good Manufacturing Practice and Good Distribution Practice
EPA ERLN Laboratory Requirements 4.8.6
EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7
NIST 800-53, Rev. 5, SI-12

31.2 The system shall protect entered data so as to prevent it from being obscured by new data, keeping both the old and current data available for review.

ASTM E1578-18 E-17-3
21 CFR Part 58.190
42 CFR Part 93.305
42 CFR Part 93.310
CLSI QMS22 2.2.2.2
EMA Guidance on Good Manufacturing Practice and Good Distribution Practice
EPA 815-R-05-004 Chap. IV, Sec. 8
EPA ERLN Laboratory Requirements 4.3.4.1
EPA ERLN Laboratory Requirements 4.8.6
EPA ERLN Laboratory Requirements 4.8.9
EPA ERLN Laboratory Requirements 4.9.9
NIST 800-53, Rev. 5, SI-12
OECD GLP Principles 10
PFP Human and Animal Food Testing Laboratories Best Practices Manual
TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)
USDA Administrative Procedures for the PDP 5.2.1
USDA Data and Instrumentation for PDP 8.1.3
WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1

31.3 The system shall securely maintain a true, readable copy of an instrument's original (raw) data for on-demand review.

7 CFR Part 91.30
7 CFR Part 331.17 (c)
9 CFR Part 2.35
9 CFR Part 121.17 (c)
10 CFR Part 20.2103–10
10 CFR Part 30.34 (g)
10 CFR Part 30.51–2
21 CFR Part 11.10 (c)
21 CFR Part 58.195
21 CFR Part 211.180
21 CFR Part 212.110 (c)
21 CFR Part 225.42 (b-8)
21 CFR Part 225.58 (c–d)
21 CFR Part 225.102
21 CFR Part 225.110
21 CFR Part 225.158
21 CFR Part 225.202
21 CFR Part 226.42 (a)
21 CFR Part 226.58 (f)
21 CFR Part 226.102
21 CFR Part 226.115
21 CFR Part 312.57
21 CFR Part 312.62
21 CFR Part 606.160 (d)
21 CFR Part 812.140 (d)
21 CFR Part 820.180 (b)
29 CFR Part 1910.120 (f)(8)
29 CFR Part 1910.1030 (h-2)
40 CFR Part 141.33
40 CFR Part 141.722
40 CFR Part 262.11 (f)
40 CFR Part 262.40
40 CFR Part 262.213
40 CFR Part 704 Subpart A
40 CFR Part 717.15 (d)
42 CFR Part 73.17 (c)
42 CFR Part 93.313 (h)
42 CFR Part 93.317
42 CFR Part 493.1105
42 CFR Part 493.1283
45 CFR Part 164.105
45 CFR Part 164.316
45 CFR Part 164.530
A2LA C223 5.4
A2LA C223 5.9
AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1
AAVLD Requirements for an AVMDL Sec. 4.10.1.2
AAVLD Requirements for an AVMDL Sec. 4.10.2.1
AAVLD Requirements for an AVMDL Sec. 5.4.3.2
ABFT Accreditation Manual Sec. E-33
ACMG Technical Standards for Clinical Genetics Laboratories C1.5
ACMG Technical Standards for Clinical Genetics Laboratories C5.6
ACMG Technical Standards for Clinical Genetics Laboratories E2.1
AIHA-LAP Policies 2022 2A.7.5.1
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.14.1.2 and 4.15.1.2
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.6 and 5.9.7
ASTM E1578-18 E-17-4
CAP Laboratory Accreditation Manual
CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition
CJIS Security Policy 5.3.4
CJIS Security Policy 5.4.6–7
CJIS Security Policy 5.5.2.1
CLSI QMS22 2.8.3
EMA Guidance on Good Manufacturing Practice and Good Distribution Practice
E.U. Annex 11-7.1
E.U. Commission Directive 2003/94/EC Article 9.1
E.U. Commission Directive 2003/94/EC Article 11.4
EPA 815-R-05-004 Chap. III, Sec. 15
EPA 815-R-05-004 Chap. IV, Sec. 8
EPA ERLN Laboratory Requirements 4.9.18
EPA ERLN Laboratory Requirements 4.11.17
EPA QA/G-5 2.1.9
ICH GCP 4.9.5
ISO 15189:2012 4.3
ISO/IEC 17025:2017 8.4.2
NIST 800-53, Rev. 5, AT-4
NIST 800-53, Rev. 5, AU-11 and AU-11(1)
NIST 800-53, Rev. 5, SI-12
NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
OECD GLP Principles 10
OSHA 1910.1020(d)(1)(i–ii)
OSHA 1910.1450(j)(2)
PFP Human and Animal Food Testing Laboratories Best Practices Manual
TNI EL-V1-2016-Rev.2.1 (throughout)
USDA Administrative Procedures for the PDP 5.4
USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 2
USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 10c
USDA Sampling Procedures for PDP 6.5
WADA International Standard for Laboratories (ISL) 5.2.3.5 and 5.4.4
WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.0
WHO Technical Report Series, #986, Annex 2, 15.8–9
WHO Technical Report Series, #996, Annex 5, 11.15 and Appendix 1

31.4 The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.
ASTM E1578-18 E-17-6
CJIS Security Policy 5.4.4
NIST 800-53, Rev. 5, AU-8
WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1
31.5 The system shall accurately reflect the system date and time in its use of electronic record time stamps.
APHL 2019 LIS Project Management Guidebook
ASTM E1578-18 E-17-7
CJIS Security Policy 5.6.1
31.6 The system shall require each and every user to be assigned a unique user ID.

ASTM E1578-18 E-17-8
21 CFR Part 11.10 (e)
CJIS Security Policy 5.4.5
E.U. Annex 11-9
NIST 800-53, Rev. 5, AU-9

31.7 The system shall prevent the modification, deletion, or disabling of its audit trail, as well as record such attempts.
CJIS Security Policy 5.4.2
NIST 800-53, Rev. 5, AU-5
NIST 800-53, Rev. 5, SI-4
31.8 The system shall be capable of identifying instances of audit processing failure (e.g., write errors, general failure of the audit tool, etc.), sending alerts or notifications to appropriate personnel in such cases.