Template:LIMSpec/Compliance management - Revision history

Shawndouglas: NIST tweaks

2023-03-14T15:51:28Z

NIST tweaks

← Older revision		Revision as of 15:51, 14 March 2023
Line 112:		Line 112:
	[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://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-10]<br />
	[https://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.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.law.cornell.edu/cfr/text/21/11.70 21 CFR Part 11.70]<br />[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14]		\| style="padding:5px; width:500px;" \|[https://www.law.cornell.edu/cfr/text/21/11.70 21 CFR Part 11.70]<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://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-10]
	\| style="background-color:white;" \|'''9.6''' The system shall prevent a user from copying and pasting the electronic signature of another user.		\| style="background-color:white;" \|'''9.6''' The system shall prevent a user from copying and pasting the electronic signature of another user.
	\|-		\|-

Shawndouglas: Updated for food and bev update

2022-12-01T20:17:19Z

Updated for food and bev update

← Older revision		Revision as of 20:17, 1 December 2022
Line 16:		Line 16:
	[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.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.astm.org/e1578-18.html 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/e1578-18.html ASTM E1578-18 E-2-1]<br />		[https://www.astm.org/e1578-18.html ASTM E1578-18 E-2-1]<br />
			[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 3.3.1]<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 />
Line 66:		Line 69:
	[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/e1578-18.html ASTM E1578-18 E-2-3]<br />		[https://www.astm.org/e1578-18.html ASTM E1578-18 E-2-3]<br />
			[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 3.2.1]<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 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 2.2.3.2]<br />

Shawndouglas: Updated for 2022.

2022-05-05T20:27:43Z

Updated for 2022.

Show changes

Shawndouglas: Fixed broken URLs

2021-01-27T20:55:37Z

Fixed broken URLs

Shawndouglas: 9.2

2019-11-14T18:28:46Z

9.2

← Older revision		Revision as of 18:28, 14 November 2019
Line 45:		Line 45:
	[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://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, 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://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, 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 />
	[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]<br />		[http://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]

Shawndouglas: Added NIST 800-53 to various items

2019-11-12T21:09:14Z

Added NIST 800-53 to various items

Shawndouglas: Created as needed.

2019-09-19T22:34:30Z

Created as needed.

New page

{|
| STYLE="vertical-align:top;"|
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
! 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.law.cornell.edu/cfr/text/7/331.17 7 CFR Part 331.17] 
[https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17 ] 
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (e)] 
[https://www.law.cornell.edu/cfr/text/21/11.70 21 CFR Part 11.70] 
[https://www.law.cornell.edu/cfr/text/21/58.130 21 CFR Part 58.130 (e)] 
[https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17] 
[https://www.law.cornell.edu/cfr/text/42/493.1251 42 CFR Part 493.1251 (d)] 
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-7] 
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-2-1] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7] 
[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 11-14] 
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5] 
[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="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (e)] 
[https://www.law.cornell.edu/cfr/text/21/11.70 21 CFR Part 11.70] 
[https://www.law.cornell.edu/cfr/text/21/58.130 21 CFR Part 58.130 (e)] 
[https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68] 
[https://www.law.cornell.edu/cfr/text/21/211.100 21 CFR Part 211.100] 
[https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (a)] 
[https://www.law.cornell.edu/cfr/text/21/211.188 21 CFR Part 211.188] 
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194] 
[https://www.law.cornell.edu/cfr/text/45/170.315 45 CFR Part 170.315 (d)] 
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-2-2] 
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.1.1] 
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy Appendix G.5] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7] 
[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 11-12.4] 
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14] 
[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 9.2] 
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5] 
[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;" |'''9.2''' 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="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (e)] 
[https://www.law.cornell.edu/cfr/text/21/11.70 21 CFR Part 11.70] 
[https://www.law.cornell.edu/cfr/text/21/58.130 21 CFR Part 58.130 (e)] 
[https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68] 
[https://www.law.cornell.edu/cfr/text/21/211.100 21 CFR Part 211.100] 
[https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (a)] 
[https://www.law.cornell.edu/cfr/text/21/211.188 21 CFR Part 211.188] 
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194] 
[https://www.law.cornell.edu/cfr/text/42/493.1274 42 CFR Part 493.1274] 
[https://www.law.cornell.edu/cfr/text/45/170.315 45 CFR Part 170.315 (d)] 
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-2-3] 
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.1.1] 
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-12.4] 
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14] 
[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 9.2] 
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5] 
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 8.1.4] 
[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;" |'''9.3''' 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.
|-
| style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (e)] 
[https://www.law.cornell.edu/cfr/text/21/11.70 21 CFR Part 11.70] 
[https://www.law.cornell.edu/cfr/text/21/58.130 21 CFR Part 58.130 (e)] 
[https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68] 
[https://www.law.cornell.edu/cfr/text/21/211.100 21 CFR Part 211.100] 
[https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (a)] 
[https://www.law.cornell.edu/cfr/text/21/211.188 21 CFR Part 211.188] 
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194] 
[https://www.law.cornell.edu/cfr/text/45/170.315 45 CFR Part 170.315 (d)] 
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-2-4] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.6] 
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14] 
[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 9.2] 
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5] 
[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="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (e)] 
[https://www.law.cornell.edu/cfr/text/21/11.70 21 CFR Part 11.70] 
[https://www.law.cornell.edu/cfr/text/21/58.130 21 CFR Part 58.130 (e)] 
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194] 
[https://www.law.cornell.edu/cfr/text/42/493.1251 42 CFR Part 493.1251 (d)] 
[https://www.law.cornell.edu/cfr/text/45/164.310 45 CFR Part 164.310] 
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-2-5] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.6] 
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14] 
[http://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="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/11.70 21 CFR Part 11.70] [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14]
| style="background-color:white;" |'''9.6''' The system shall prevent a user from copying and pasting the electronic signature of another user.
|-
| style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (e)] 
[https://www.law.cornell.edu/cfr/text/21/58.130 21 CFR Part 58.130 (e)] 
[https://www.law.cornell.edu/cfr/text/42/493.1274 42 CFR Part 493.1274 (d)] 
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-9] 
[http://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.
|-
|}
|}

← Older revision		Revision as of 20:55, 27 January 2021
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	[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://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 9.2]<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://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, AC-2(4) and AC-6(9)]<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://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, AU-2 and AU-3]<br />		[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, 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://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, CM-5(1)]<br />
	[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]<br />		[http://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://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]
	\| 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.
	\|-		\|-
Line 65:		Line 65:
	[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://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 9.2]<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://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, AU-3 and AU-8]<br />		[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, AU-3 and AU-8]<br />
	[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]<br />		[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]<br />
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	[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://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 9.2]<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://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, AU-3]<br />		[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, AU-3]<br />
	[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]<br />		[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]<br />

← Older revision		Revision as of 21:09, 12 November 2019
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	[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://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 9.2]<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 9.2]<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://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, AU-2 and AU-3]<br />
	[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]<br />		[http://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]
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	[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://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 9.2]<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 9.2]<br />
			[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, AU-3 and AU-8]<br />
	[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]<br />		[http://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 />
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	[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://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 9.2]<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 9.2]<br />
			[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, AU-3]<br />
	[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]<br />		[http://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]
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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 />
	[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]		[http://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.