Difference between revisions of "Template:LIMSpec for Cannabis Testing/Data integrity"
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! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"| | ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"| | ||
|- | |- | ||
! style="color:brown; background-color:#ffffee; width: | ! style="color:brown; background-color:#ffffee; width:250px;"| Regulation, Specification, or Guidance | ||
! style="color:brown; background-color:#ffffee; width:700px;"| Requirement | ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement | ||
|- | |- | ||
| style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/ | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
▪ [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 /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''22.1''' System functionality should support ALCOA principles.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
|- | |- | ||
| style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
▪ [https://www.astm.org/ | ▪ [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://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:// | ▪ [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 /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | 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 /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
|- | |- | ||
| style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
▪ [https://www. | ▪ [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/42/93.310 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://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:// | ▪ [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 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 /> | ||
▪ [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 /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | 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 /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
|- | |- | ||
| style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
▪ [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/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 /> | ||
Line 52: | Line 79: | ||
▪ [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 /> | ||
▪ [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://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.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 /> | ||
▪ [ | ▪ [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 | ▪ [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.astm.org/ | ▪ [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 5.3.4]<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.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://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/ | ▪ [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/ | ▪ [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://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 /> | ||
▪ [https:// | ▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AT-4]<br /> | ||
▪ [https:// | ▪ [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:// | ▪ [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/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; 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 /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | 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 /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
|- | |- | ||
| style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/ | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
▪ [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 /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | 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 /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
|- | |- | ||
| style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/ | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
▪ [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 /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | 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 /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
|- | |- | ||
| style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
▪ [https://www.astm.org/ | ▪ [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 /> |