View source for LIMSpec for Cannabis Testing/Security and integrity of systems and operations/Data integrity

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  ! style="color:brown; background-color:#ffffee; width:250px;"| Regulation, Specification, or Guidance
  ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
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▪ [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; vertical-align: text-top;" |'''22.1''' System functionality should support ALCOA principles.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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▪ [https://www.govinfo.gov/app/details/FR-1996-07-25/96-17837/summary 61 FR 38806, 9 CFR Part 417.5]<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://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 4.9.1 and 4.9.7]<br />
▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, SI-12]
  | style="background-color:white; vertical-align: text-top;" |'''22.2''' 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.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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▪ [https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1152 (d)]<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://www.astm.org/e1578-18.html ASTM E1578-18 E-17-3]<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://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 4.8.6]<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://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, SI-12]<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 Data and Instrumentation for PDP 8.1.3]<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; vertical-align: text-top;" |'''22.3''' The system shall maintain a true, readable copy of an instrument's original (raw) data for on-demand review.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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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/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/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/part-1 21 CFR Part 1.1154 (a)]<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/part-106 21 CFR Part 106.100 (n)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-112 21 CFR Part 112.164]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-114 21 CFR Part 114.100 (e)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-117 21 CFR Part 117.315]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-120 21 CFR Part 120.12]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-123 21 CFR Part 123.9]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-129 21 CFR Part 129.80 (h)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/211.180 21 CFR Part 211.180]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/211.110 21 CFR Part 212.110 (c)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/225.42 21 CFR Part 225.42 (b-8)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/225.58 21 CFR Part 225.58 (c–d)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/225.102 21 CFR Part 225.102]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/225.110 21 CFR Part 225.110]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/225.158 21 CFR Part 225.158]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/225.202 21 CFR Part 225.202]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/226.42 21 CFR Part 226.42 (a)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/226.58 21 CFR Part 226.58 (f)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/226.102 21 CFR Part 226.102]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/226.115 21 CFR Part 226.115]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/312.57 21 CFR Part 312.57]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/312.62 21 CFR Part 312.62]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-507 21 CFR Part 507.208]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/606.160 21 CFR Part 606.160 (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/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/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/40/262.11 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/40/717.15 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/42/93.313 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/42/493.1283 42 CFR Part 493.1283]<br />
▪ [https://www.law.cornell.edu/cfr/text/45/164.105 45 CFR Part 164.105]<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.govinfo.gov/app/details/FR-1996-07-25/96-17837/summary 61 FR 38806, 9 CFR Part 310.25]<br />
▪ [https://www.govinfo.gov/app/details/FR-1996-07-25/96-17837/summary 61 FR 38806, 9 CFR Part 381.94]<br />
▪ [https://www.govinfo.gov/app/details/FR-1996-07-25/96-17837/summary 61 FR 38806, 9 CFR Part 417.5]<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.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. 5.4.3.2]<br />
▪ [https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-33]<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 />
▪ [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 />
▪ [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.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://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 3.3.2]<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 5.4.6–7]<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.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf Codex Alimentarius CXC 1-1969, Ch.1, 7.4]
▪ [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://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/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 11.4]<br />
▪ [https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02004R0852-20210324 E.U. Commission Reg. No. 852/2004 Annex I, Section III.8.d]<br />
▪ [https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02004R0852-20210324 E.U. Commission Reg. No. 852/2004 Annex I, Section III.9.c]<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://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.18]<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://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I - FSM 9.2.1]<br />
▪ [https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 9.2.2]<br />
▪ [https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, K - FSM 9.2.3]<br />
▪ [https://ichgcp.net/ ICH GCP 4.9.5]<br />
▪ [https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 2.1.2.2]<br />
▪ [https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 2.1.2.2]<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://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AT-4]<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://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, SI-12]<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://laws-lois.justice.gc.ca/eng/regulations/SOR-2018-108/index.html Safe Food for Canadians Regulations SOR/2018-108 Division 3, 48 (4)]<br />
▪ [https://laws-lois.justice.gc.ca/eng/regulations/SOR-2018-108/index.html Safe Food for Canadians Regulations SOR/2018-108 Part 5, 90]<br />
▪ [https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf SQF FSC 9, Food Manufacturing, Part B, 2.2.3.3]<br />
▪ [https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_PetFood_v3-2-Final-w-Links.pdf SQF FSC 9, Pet Food Manufacturing, Part B, 2.2.3.3]<br />
▪ [https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf SQF FSC 9, Manufacture of Food Packaging, Part B, 2.2.3.3]<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/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.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; vertical-align: text-top;" |'''22.4''' 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.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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▪ [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; vertical-align: text-top;" |'''22.5''' The system shall accurately reflect the system date and time in its use of electronic record time stamps.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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▪ [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; vertical-align: text-top;" |'''22.6''' The system shall require each and every user to be assigned a unique user ID.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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▪ [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.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://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, AU-9]
  | style="background-color:white; vertical-align: text-top;" |'''22.7''' The system shall prevent the modification, deletion, or disabling of its audit trail, as well as record such attempts.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [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="background-color:white; vertical-align: text-top;" |'''22.8''' 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.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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