Template:LIMSpec/Configuration management - Revision history

Shawndouglas: Tweaks

2023-06-23T14:29:43Z

Tweaks

← Older revision		Revision as of 14:29, 23 June 2023
Line 78:		Line 78:
	\| style="background-color:white;" \|'''32.20''' The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.		\| style="background-color:white;" \|'''32.20''' The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.law.cornell.edu/cfr/text/21/11.100 21 CFR Part 11.100 (a)]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-20]<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, CM-5(1)]<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, Appendix 1]		\| style="padding:5px; width:500px;" \|
			[https://www.law.cornell.edu/cfr/text/21/11.100 21 CFR Part 11.100 (a)]<br />
			[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-20]<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, CM-5(1)]<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, Appendix 1]
	\| style="background-color:white;" \|'''32.21''' The system should support rules governing electronic records and electronic signatures in regulated environments.		\| style="background-color:white;" \|'''32.21''' The system should support rules governing electronic records and electronic signatures in regulated environments.
	\|-		\|-

Shawndouglas: NIST tweaks

2023-03-14T15:49:57Z

NIST tweaks

Shawndouglas: Spacing

2023-01-06T15:56:44Z

Spacing

← Older revision		Revision as of 15:56, 6 January 2023
Line 168:		Line 168:
	\| style="background-color:white;" \|'''32.27''' The system shall allow the administrator to define a time period in days after which a user will be prompted to change their password.		\| style="background-color:white;" \|'''32.27''' The system shall allow the administrator to define a time period in days after which a user will be prompted to change their password.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.6.3.1]<br />[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AC-2(3)]<br />		\| style="padding:5px; width:500px;" \|[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.6.3.1]<br />[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AC-2(3)]<br />[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IA-4 and IA-5(1)]<br />[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, PS-4]
	[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IA-4 and IA-5(1)]<br />
	[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, PS-4]
	\| style="background-color:white;" \|'''32.28''' The system shall allow the administrator to define a time period of inactivity for a user identifier, after which it will be disabled and archived.		\| style="background-color:white;" \|'''32.28''' The system shall allow the administrator to define a time period of inactivity for a user identifier, after which it will be disabled and archived.
	\|-		\|-

Shawndouglas: Spacing issues

2023-01-06T15:53:59Z

Spacing issues

← Older revision		Revision as of 15:53, 6 January 2023
Line 68:		Line 68:
	\| style="background-color:white;" \|'''32.17''' The system should allow workflow events and status changes to trigger one or more user-defined actions.		\| style="background-color:white;" \|'''32.17''' The system should allow workflow events and status changes to trigger one or more user-defined actions.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-17]<br />		\| style="padding:5px; width:500px;" \|[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-17]<br />[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.7.1]<br />[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AC-6(1)]<br />[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, CM-7]
	[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.7.1]<br />
	[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AC-6(1)]<br />
	[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, CM-7]
	\| style="background-color:white;" \|'''32.18''' The system should provide an interface for administrative access that permits approved users to configure the system without extra programming or manipulation of data storage systems.		\| style="background-color:white;" \|'''32.18''' The system should provide an interface for administrative access that permits approved users to configure the system without extra programming or manipulation of data storage systems.
	\|-		\|-
Line 80:		Line 77:
	\| style="background-color:white;" \|'''32.20''' The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.		\| style="background-color:white;" \|'''32.20''' The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.law.cornell.edu/cfr/text/21/11.100 21 CFR Part 11.100 (a)]<br />		\| style="padding:5px; width:500px;" \|[https://www.law.cornell.edu/cfr/text/21/11.100 21 CFR Part 11.100 (a)]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-20]<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, CM-5(1)]<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, Appendix 1]
	[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-20]<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, CM-5(1)]<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, Appendix 1]
	\| style="background-color:white;" \|'''32.21''' The system should support rules governing electronic records and electronic signatures in regulated environments.		\| style="background-color:white;" \|'''32.21''' The system should support rules governing electronic records and electronic signatures in regulated environments.
	\|-		\|-

Shawndouglas: 33.22

2022-12-14T19:10:43Z

33.22

← Older revision		Revision as of 19:10, 14 December 2022
Line 113:		Line 113:
	[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.4 and 4.9.14]<br />		[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.4 and 4.9.14]<br />
	[https://ichgcp.net/ ICH GCP 2.10]<br />		[https://ichgcp.net/ ICH GCP 2.10]<br />
			[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 4.2.1]<br />
	[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.11.3]<br />		[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.11.3]<br />
	[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, CM-5 and CM-5(1)]<br />		[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, CM-5 and CM-5(1)]<br />

Shawndouglas: Updated for food and bev update

2022-12-01T23:36:12Z

Updated for food and bev update

← Older revision		Revision as of 23:36, 1 December 2022
Line 123:		Line 123:
	\| style="background-color:white;" \|'''32.22''' The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.		\| style="background-color:white;" \|'''32.22''' The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.5.2.2–3]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.1.14–15]<br />		\| style="padding:5px; width:500px;" \|
			[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 3.2.1]<br />
			[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 3.3.1]<br />
			[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.5.2.2–3]<br />
			[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.1.14–15]<br />
	[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AC-2(11)]		[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AC-2(11)]
	\| style="background-color:white;" \|'''32.23''' The system shall be able to granularly define access control down to the object level, role level, physical location, logical location, network address, and chronometric restriction level for the protection of regulated, patented, confidential, and classified data, methods, or other types of information.		\| style="background-color:white;" \|'''32.23''' The system shall be able to granularly define access control down to the object level, role level, physical location, logical location, network address, and chronometric restriction level for the protection of regulated, patented, confidential, and classified data, methods, or other types of information.

Shawndouglas: Updated for 2022.

2022-05-05T20:46:23Z

Updated for 2022.

Show changes

Shawndouglas: Fixed broken URLs

2021-01-27T21:51:28Z

Fixed broken URLs

Shawndouglas: 32.8

2020-12-30T19:08:22Z

32.8

← Older revision		Revision as of 19:08, 30 December 2020
Line 30:		Line 30:
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 S-1-6]		\| style="padding:5px; width:500px;" \|[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 S-1-6]
	\| style="background-color:white;" \|'''32.8''' The system should be capable of providing a complete list of all pending tests loaded in the system, the amount of material required for each test, and to which location the samples are to be sent for testing.		\| style="background-color:white;" \|'''32.8''' The system should be capable of providing a complete list of all pending tests loaded in the system, the amount of material required for each test, and to which location the associated samples are to be sent for testing.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 S-1-7]		\| style="padding:5px; width:500px;" \|[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 S-1-7]

Shawndouglas: 32.8

2020-12-30T19:07:29Z

32.8

← Older revision		Revision as of 19:07, 30 December 2020
Line 30:		Line 30:
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 S-1-6]		\| style="padding:5px; width:500px;" \|[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 S-1-6]
	\| style="background-color:white;" \|'''32.8''' The system should be capable of providing a complete list of all tests loaded in the system, the amount of material required for each test, and to which location the samples are to be sent for testing.		\| style="background-color:white;" \|'''32.8''' The system should be capable of providing a complete list of all pending tests loaded in the system, the amount of material required for each test, and to which location the samples are to be sent for testing.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 S-1-7]		\| style="padding:5px; width:500px;" \|[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 S-1-7]

← Older revision		Revision as of 15:49, 14 March 2023
Line 31:		Line 31:
	[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 C13.3]<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 C13.3]<br />
	[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-5]<br />		[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-5]<br />
			[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-10]<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, Appendix 1]		[https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5, Appendix 1]
	\| style="background-color:white;" \|'''32.7''' The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports.		\| style="background-color:white;" \|'''32.7''' The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports.
Line 242:		Line 243:
	[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-24]<br />		[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-24]<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 and AU-10(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, Appendix 1]		[https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5, Appendix 1]
	\| style="background-color:white;" \|'''32.36''' The system shall force a user's electronic signature to be unique and traceable to a specific user's account.		\| style="background-color:white;" \|'''32.36''' The system shall force a user's electronic signature to be unique and traceable to a specific user's account.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.law.cornell.edu/cfr/text/21/11.100 21 CFR Part 11.100 (a)]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-24]<br />		\| style="padding:5px; width:500px;" \|[https://www.law.cornell.edu/cfr/text/21/11.100 21 CFR Part 11.100 (a)]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-24]<br />[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-10 and AU-10(3)]
	\| style="background-color:white;" \|'''32.37''' The system shall prevent the reuse or reassignment of a user's electronic signature.		\| style="background-color:white;" \|'''32.37''' The system shall prevent the reuse or reassignment of a user's electronic signature.
	\|-		\|-

← Older revision		Revision as of 21:51, 27 January 2021
Line 45:		Line 45:
	\|-		\|-
	\| style="padding:5px; width:500px;" \|		\| style="padding:5px; width:500px;" \|
	[https://www.aihaaccreditedlabs.org/~~Policies/Pages/default.aspx~~ AIHA-LAP Policies 2018 2A.7.8.4]<br />		[https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2018 2A.7.8.4]<br />
	[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 S-1-11]<br />		[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 S-1-11]<br />
	[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.6]<br />		[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.6]<br />
Line 82:		Line 82:
	\|-		\|-
	\| style="padding:5px; width:500px;" \|		\| style="padding:5px; width:500px;" \|
	[https://www.law.cornell.edu/cfr/text/7/~~332~~.11 7 CFR Part ~~332~~.11]<br />		[https://www.law.cornell.edu/cfr/text/7/331.11 7 CFR Part 331.11]<br />
	[https://www.law.cornell.edu/cfr/text/9/121.11 9 CFR Part 121.11]<br />		[https://www.law.cornell.edu/cfr/text/9/121.11 9 CFR Part 121.11]<br />
	[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (d)]<br />		[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (d)]<br />
Line 103:		Line 103:
	[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, CM-5 and CM-5(1)]<br />		[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, CM-5 and CM-5(1)]<br />
	[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.2.4]<br />		[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.2.4]<br />
	[https://~~extranet~~.who.int/~~prequal~~/~~content~~/~~who-technical-report-seriesWHO~~ Technical Report Series, #986, Annex 2, 15.9]		[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 15.9]
	\| style="background-color:white;" \|'''32.22''' The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.		\| style="background-color:white;" \|'''32.22''' The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.
	\|-		\|-
Line 165:		Line 165:
	[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E17-5 and S-3-1]<br />		[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E17-5 and S-3-1]<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://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://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]<br />		[https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]<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 />
	[https://~~extranet~~.who.int/~~prequal~~/~~content~~/~~who-technical-report-series~~ WHO Technical Report Series, #986, Annex 2, 15.9]		[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 15.9]
	\| style="background-color:white;" \|'''32.31''' The system shall keep an accurate audit trail of login activities, including failed login attempts and electronic signings.		\| style="background-color:white;" \|'''32.31''' The system shall keep an accurate audit trail of login activities, including failed login attempts and electronic signings.
	\|-		\|-
Line 183:		Line 183:
	\|-		\|-
	\| style="padding:5px; width:500px;" \|		\| style="padding:5px; width:500px;" \|
	[https://www.law.cornell.edu/cfr/text/7/~~332~~.11 7 CFR Part ~~332~~.11]<br />		[https://www.law.cornell.edu/cfr/text/7/331.11 7 CFR Part 331.11]<br />
	[https://www.law.cornell.edu/cfr/text/9/121.11 9 CFR Part 121.11]<br />		[https://www.law.cornell.edu/cfr/text/9/121.11 9 CFR Part 121.11]<br />
	[https://www.law.cornell.edu/cfr/text/21/11.200 21 CFR Part 11.200 (a)]<br />		[https://www.law.cornell.edu/cfr/text/21/11.200 21 CFR Part 11.200 (a)]<br />
Line 197:		Line 197:
	\|-		\|-
	\| style="padding:5px; width:500px;" \|		\| style="padding:5px; width:500px;" \|
	[https://www.law.cornell.edu/cfr/text/7/~~332~~.11 7 CFR Part ~~332~~.11]<br />		[https://www.law.cornell.edu/cfr/text/7/331.11 7 CFR Part 331.11]<br />
	[https://www.law.cornell.edu/cfr/text/9/121.11 9 CFR Part 121.11]<br />		[https://www.law.cornell.edu/cfr/text/9/121.11 9 CFR Part 121.11]<br />
	[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (d)]<br />		[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (d)]<br />