Template:LIMSpec/Data integrity - Revision history

Shawndouglas: Updated for food and bev update

2022-12-01T23:34:16Z

Updated for food and bev update

← Older revision		Revision as of 23:34, 1 December 2022
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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://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 />
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	[https://www.~~astm~~.~~org~~/~~e1578~~-18.~~html ASTM E1578-18 E-17-3~~]<br />		[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/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/42/93.305 42 CFR Part 93.305]<br />
	[https://www.law.cornell.edu/cfr/text/42/93.310 42 CFR Part 93.310]<br />		[https://www.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://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://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 />
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	[https://www.law.cornell.edu/cfr/text/10/30.34 10 CFR Part 30.34 (g)]<br />		[https://www.law.cornell.edu/cfr/text/10/30.34 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/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/21/11.10 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 />
			[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/21/211.180 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/21/211.110 21 CFR Part 212.110 (c)]<br />
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	[https://www.law.cornell.edu/cfr/text/21/312.57 21 CFR Part 312.57]<br />		[https://www.law.cornell.edu/cfr/text/21/312.57 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/21/312.62 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/21/606.160 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/21/812.140 21 CFR Part 812.140 (d)]<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://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 5.4]<br />
	[https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.9]<br />		[https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.9]<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 5.9.3.6 and 5.9.7]<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://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://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.cdc.gov/labs/BMBL.html CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition]<br />
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	[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://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://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/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 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/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. 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://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://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/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 />
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	[https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1450 OSHA 1910.1450(j)(2)]<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://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://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 />

Shawndouglas: Updated for 2022.

2022-05-05T20:44:46Z

Updated for 2022.

Show changes

Shawndouglas: Fixed broken URLs

2021-01-27T21:36:20Z

Fixed broken URLs

Shawndouglas: Added NIST 800-53 to various items

2019-11-14T18:07:20Z

Added NIST 800-53 to various items

Shawndouglas: Created as needed.

2019-09-19T23:22:36Z

Created as needed.

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{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
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! 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/Standards/E1578.htm ASTM E1578-18 E-17-1]
| style="background-color:white;" |'''31.1''' System functionality should support ALCOA principles.
|-
| style="padding:5px; width:500px;" |
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-17-2] 
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 8] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.6] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7]
| 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="padding:5px; width:500px;" |
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-17-3] 
[https://www.law.cornell.edu/cfr/text/21/58.190 21 CFR Part 58.190] 
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 8] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.3.4.1] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.6] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.9] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.9] 
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 10] 
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.2.1] 
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 8.1.3]
| 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.
|-
| style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/7/331.17 7 CFR Part 331.17 (c)] 
[https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17 (c)] 
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (c)] 
[https://www.law.cornell.edu/cfr/text/21/58.195 21 CFR Part 58.195] 
[https://www.law.cornell.edu/cfr/text/21/211.180 21 CFR Part 211.180] 
[https://www.law.cornell.edu/cfr/text/21/211.110 21 CFR Part 212.110 (c)] 
[https://www.law.cornell.edu/cfr/text/21/225.42 21 CFR Part 225.42 (b-8)] 
[https://www.law.cornell.edu/cfr/text/21/225.58 21 CFR Part 225.58 (c–d)] 
[https://www.law.cornell.edu/cfr/text/21/225.102 21 CFR Part 225.102] 
[https://www.law.cornell.edu/cfr/text/21/225.110 21 CFR Part 225.110] 
[https://www.law.cornell.edu/cfr/text/21/225.158 21 CFR Part 225.158] 
[https://www.law.cornell.edu/cfr/text/21/225.202 21 CFR Part 225.202] 
[https://www.law.cornell.edu/cfr/text/21/226.42 21 CFR Part 226.42 (a)] 
[https://www.law.cornell.edu/cfr/text/21/226.58 21 CFR Part 226.58 (f)] 
[https://www.law.cornell.edu/cfr/text/21/226.102 21 CFR Part 226.102] 
[https://www.law.cornell.edu/cfr/text/21/226.115 21 CFR Part 226.115] 
[https://www.law.cornell.edu/cfr/text/21/312.57 21 CFR Part 312.57] 
[https://www.law.cornell.edu/cfr/text/21/312.62 21 CFR Part 312.62] 
[https://www.law.cornell.edu/cfr/text/21/606.160 21 CFR Part 606.160 (d)] 
[https://www.law.cornell.edu/cfr/text/21/812.140 21 CFR Part 812.140 (d)] 
[https://www.law.cornell.edu/cfr/text/21/820.180 21 CFR Part 820.180 (b)] 
[https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (h-2)] 
[https://www.law.cornell.edu/cfr/text/40/141.33 40 CFR Part 141.33] 
[https://www.law.cornell.edu/cfr/text/40/141.722 40 CFR Part 141.722] 
[https://www.law.cornell.edu/cfr/text/40/part-704/subpart-A 40 CFR Part 704 Subpart A] 
[https://www.law.cornell.edu/cfr/text/40/717.15 40 CFR Part 717.15 (d)] 
[https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17 (c)] 
[https://www.law.cornell.edu/cfr/text/42/493.1105 42 CFR Part 493.1105] 
[https://www.law.cornell.edu/cfr/text/42/493.1283 42 CFR Part 493.1283] 
[https://www.law.cornell.edu/cfr/text/45/164.105 45 CFR Part 164.105] 
[https://www.law.cornell.edu/cfr/text/45/164.316 45 CFR Part 164.316] 
[https://www.law.cornell.edu/cfr/text/45/164.530 45 CFR Part 164.530] 
[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] 
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 4.10.1.2] 
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 4.10.2.1] 
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.4.3.2] 
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-33] 
[https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018 2A.7.5.1] 
[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] 
[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] 
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-17-4] 
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.3.4] 
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.6–7] 
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.5.2.1] 
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-7.1] 
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2003_94/dir_2003_94_en.pdf E.U. Commission Directive 2003/94/EC Article 9.1] 
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2003_94/dir_2003_94_en.pdf E.U. Commission Directive 2003/94/EC Article 11.4] 
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. III, Sec. 15] 
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 8] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.18] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.17] 
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.9] 
[https://www.iso.org/standard/56115.html ISO 15189:2012 4.3] 
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.4.2] 
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 10] 
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.4] 
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.5] 
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.8–9]
| 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="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-17-6] [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.4]
| 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="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-17-7] [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="padding:5px; width:500px;" |
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-17-8] 
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (e)] 
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.5] 
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-9]
| 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="padding:5px; width:500px;" |[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.2]
| 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.
|-
|}
|}

← Older revision		Revision as of 21:36, 27 January 2021
Line 71:		Line 71:
	[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 />		[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-33]<br />
	[https://www.aihaaccreditedlabs.org/~~Policies/Pages/default.aspx~~ AIHA-LAP Policies 2018 2A.7.5.1]<br />		[https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2018 2A.7.5.1]<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 />		[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 />
	[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 />		[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 />
Line 79:		Line 79:
	[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://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://ec.europa.eu/~~health/sites/health/files/files/eudralex/vol-1/dir_2003_94~~/~~dir_2003_94_en~~.~~pdf~~ 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 9.1]<br />
	[https://ec.europa.eu/~~health/sites/health/files/files/eudralex/vol-1/dir_2003_94~~/~~dir_2003_94_en~~.~~pdf~~ E.U. Commission Directive 2003/94/EC Article 11.4]<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://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 />
Line 94:		Line 94:
	[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/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://~~extranet~~.who.int/~~prequal~~/~~content~~/~~who-technical-report-series~~ WHO Technical Report Series, #986, Annex 2, 15.8–9]		[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]
	\| 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.
	\|-		\|-

← Older revision		Revision as of 18:07, 14 November 2019
Line 15:		Line 15:
	[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 4.8.6]<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]		[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]
	\| 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.
	\|-		\|-
Line 26:		Line 27:
	[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 />
	[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 10]<br />		[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 10]<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 />
Line 86:		Line 88:
	[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://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, 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 />
	[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 10]<br />		[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 10]<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 />
Line 92:		Line 97:
	\| 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.
	\|-		\|-
	\| 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]		\| 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="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.
	\|-		\|-
Line 102:		Line 107:
	[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]		[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;" \|'''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]		\| 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="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.
	\|-		\|-
	\|}		\|}
	\|}		\|}