Difference between revisions of "Template:LIMSpec/Compliance management"

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[https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17]<br />
[https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1251 42 CFR Part 493.1251 (d)]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1251 42 CFR Part 493.1251 (d)]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-7]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-4-7]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-2-1]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-2-1]<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://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://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14]<br />
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]<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]
   | style="background-color:white;" |'''9.1''' The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.
   | style="background-color:white;" |'''9.1''' The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.
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[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
[https://www.law.cornell.edu/cfr/text/45/170.315 45 CFR Part 170.315 (d)]<br />
[https://www.law.cornell.edu/cfr/text/45/170.315 45 CFR Part 170.315 (d)]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-2-2]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-2-2]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.1.1]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.1.1]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy Appendix G.5]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy Appendix G.5]<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 4.9.1 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://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://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-12.4]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-12.4]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14]<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 9.2]<br />
[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 9.2]<br />
[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, AC-2(4) and AC-6(9)]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AC-2(4) and AC-6(9)]<br />
[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, AU-2 and AU-3]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-2 and AU-3]<br />
[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, CM-5(1)]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, CM-5(1)]<br />
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]<br />
[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9]
[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://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9]<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 (throughout)]
   | style="background-color:white;" |'''9.2''' The system shall document in the audit trail any event—including administrative and privileged functions—that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.
   | style="background-color:white;" |'''9.2''' The system shall document in the audit trail any event—including administrative and privileged functions—that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.
  |-  
  |-  
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[https://www.law.cornell.edu/cfr/text/42/493.1274 42 CFR Part 493.1274]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1274 42 CFR Part 493.1274]<br />
[https://www.law.cornell.edu/cfr/text/45/170.315 45 CFR Part 170.315 (d)]<br />
[https://www.law.cornell.edu/cfr/text/45/170.315 45 CFR Part 170.315 (d)]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-2-3]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-2-3]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.1.1]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.1.1]<br />
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.3.2]<br />
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.4.3]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-12.4]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-12.4]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14]<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 9.2]<br />
[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 9.2]<br />
[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, AU-3 and AU-8]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-3 and AU-8]<br />
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 8.1.4]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 8.1.4]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9]
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9]
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[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
[https://www.law.cornell.edu/cfr/text/45/170.315 45 CFR Part 170.315 (d)]<br />
[https://www.law.cornell.edu/cfr/text/45/170.315 45 CFR Part 170.315 (d)]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-2-4]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-2-4]<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://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14]<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 9.2]<br />
[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 9.2]<br />
[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, AU-3]<br />
[https://ichgcp.net/ ICH GCP 4.9.0 and 4.9.3]<br />
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-3]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9]
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9]
   | style="background-color:white;" |'''9.4''' The system's audit trail shall document the previous and current value of a modified field.
   | style="background-color:white;" |'''9.4''' The system's audit trail shall document the previous and current value of a modified field.
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[https://www.law.cornell.edu/cfr/text/42/493.1251 42 CFR Part 493.1251 (d)]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1251 42 CFR Part 493.1251 (d)]<br />
[https://www.law.cornell.edu/cfr/text/45/164.310 45 CFR Part 164.310]<br />
[https://www.law.cornell.edu/cfr/text/45/164.310 45 CFR Part 164.310]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-2-5]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-2-5]<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://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14]<br />
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]
   | style="background-color:white;" |'''9.5''' The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.
   | style="background-color:white;" |'''9.5''' The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.
  |-  
  |-  
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[https://www.law.cornell.edu/cfr/text/42/493.1274 42 CFR Part 493.1274 (d)]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1274 42 CFR Part 493.1274 (d)]<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-6 and AU-12]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-6 and AU-12]<br />
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]
   | style="background-color:white;" |'''9.7''' The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.
   | style="background-color:white;" |'''9.7''' The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.
  |-  
  |-  
|}
|}
|}
|}

Revision as of 20:27, 5 May 2022

Regulation, Specification, or Guidance Requirement

7 CFR Part 331.17
9 CFR Part 121.17
21 CFR Part 11.10 (e)
21 CFR Part 11.70
21 CFR Part 58.130 (e)
42 CFR Part 73.17
42 CFR Part 493.1251 (d)
ASTM E1578-18 C-4-7
ASTM E1578-18 E-2-1
EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7
E.U. Annex 11-9
E.U. Annex 11-14
OECD GLP Principles 8.3.5
USDA Data and Instrumentation for PDP 8.1.3

9.1 The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.

21 CFR Part 11.10 (e)
21 CFR Part 11.70
21 CFR Part 58.130 (e)
21 CFR Part 211.68
21 CFR Part 211.100
21 CFR Part 211.160 (a)
21 CFR Part 211.188
21 CFR Part 211.194
45 CFR Part 170.315 (d)
ASTM E1578-18 E-2-2
CJIS Security Policy 5.4.1.1
CJIS Security Policy Appendix G.5
EMA Guidance on Good Manufacturing Practice and Good Distribution Practice
EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7
E.U. Annex 11-9
E.U. Annex 11-12.4
E.U. Annex 11-14
E.U. Commission Directive 2003/94/EC Article 9.2
NIST 800-53, Rev. 5, AC-2(4) and AC-6(9)
NIST 800-53, Rev. 5, AU-2 and AU-3
NIST 800-53, Rev. 5, CM-5(1)
OECD GLP Principles 8.3.5
PFP Human and Animal Food Testing Laboratories Best Practices Manual
TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)
WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9
WHO Technical Report Series, #996, Annex 5 (throughout)

9.2 The system shall document in the audit trail any event—including administrative and privileged functions—that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.

21 CFR Part 11.10 (e)
21 CFR Part 11.70
21 CFR Part 58.130 (e)
21 CFR Part 211.68
21 CFR Part 211.100
21 CFR Part 211.160 (a)
21 CFR Part 211.188
21 CFR Part 211.194
42 CFR Part 493.1274
45 CFR Part 170.315 (d)
ASTM E1578-18 E-2-3
CJIS Security Policy 5.4.1.1
CLSI QMS22 2.2.3.2
CLSI QMS22 2.4.3
E.U. Annex 11-12.4
E.U. Annex 11-14
E.U. Commission Directive 2003/94/EC Article 9.2
NIST 800-53, Rev. 5, AU-3 and AU-8
OECD GLP Principles 8.3.5
USDA Data and Instrumentation for PDP 8.1.4
WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9

9.3 The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.

21 CFR Part 11.10 (e)
21 CFR Part 11.70
21 CFR Part 58.130 (e)
21 CFR Part 211.68
21 CFR Part 211.100
21 CFR Part 211.160 (a)
21 CFR Part 211.188
21 CFR Part 211.194
45 CFR Part 170.315 (d)
ASTM E1578-18 E-2-4
EPA ERLN Laboratory Requirements 4.8.6
E.U. Annex 11-14
E.U. Commission Directive 2003/94/EC Article 9.2
ICH GCP 4.9.0 and 4.9.3
NIST 800-53, Rev. 5, AU-3
OECD GLP Principles 8.3.5
WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9

9.4 The system's audit trail shall document the previous and current value of a modified field.

21 CFR Part 11.10 (e)
21 CFR Part 11.70
21 CFR Part 58.130 (e)
21 CFR Part 211.194
42 CFR Part 493.1251 (d)
45 CFR Part 164.310
ASTM E1578-18 E-2-5
EPA ERLN Laboratory Requirements 4.8.6
E.U. Annex 11-14
OECD GLP Principles 8.3.5

9.5 The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.
21 CFR Part 11.70
E.U. Annex 11-14
9.6 The system shall prevent a user from copying and pasting the electronic signature of another user.

21 CFR Part 11.10 (e)
21 CFR Part 58.130 (e)
42 CFR Part 493.1274 (d)
E.U. Annex 11-9
NIST 800-53, Rev. 5, AU-6 and AU-12
OECD GLP Principles 8.3.5

9.7 The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.