Template:LIMSpec/System validation and commission - Revision history

Shawndouglas: Updated for 2022.

2022-05-05T20:47:06Z

Updated for 2022.

← Older revision		Revision as of 20:47, 5 May 2022
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	! style="color:brown; background-color:#ffffee; width:700px;"\| Requirement		! style="color:brown; background-color:#ffffee; width:700px;"\| Requirement
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.astm.org/~~Standards/E1578~~.~~htm~~ ASTM E1578-18 S-2-1]<br />[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy Appendix G.8]<br />[https://~~nvlpubs~~.nist.gov/~~nistpubs~~/~~SpecialPublications~~/~~NIST.SP.~~800-~~53r4.pdf~~ NIST 800-53, Rev. 4, SA-4(3)]		\| style="padding:5px; width:500px;" \|[https://www.astm.org/e1578-18.html ASTM E1578-18 S-2-1]<br />[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy Appendix G.8]<br />[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, SA-4(3)]
	\| style="background-color:white;" \|'''33.1''' The vendor should be able to demonstrate the use of software development standards, secure coding practices, formal change control, and software revision control within its development practices. The vendor should also document its staff's skills and certifications.		\| style="background-color:white;" \|'''33.1''' The vendor should be able to demonstrate the use of software development standards, secure coding practices, formal change control, and software revision control within its development practices. The vendor should also document its staff's skills and certifications.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.astm.org/~~Standards/E1578~~.~~htm~~ ASTM E1578-18 S-2-2]<br />[https://~~nvlpubs~~.nist.gov/~~nistpubs~~/~~SpecialPublications~~/~~NIST.SP.~~800-~~53r4.pdf~~ NIST 800-53, Rev. 4, SA-4(2)]		\| style="padding:5px; width:500px;" \|[https://www.astm.org/e1578-18.html ASTM E1578-18 S-2-2]<br />[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, SA-4(2)]
	\| style="background-color:white;" \|'''33.2''' The vendor should be willing to provide access to source code through a suitable escrow.		\| style="background-color:white;" \|'''33.2''' The vendor should be willing to provide access to source code through a suitable escrow.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.astm.org/~~Standards/E1578~~.~~htm~~ ASTM E1578-18 S-2-3]		\| style="padding:5px; width:500px;" \|[https://www.astm.org/e1578-18.html ASTM E1578-18 S-2-3]
	\| style="background-color:white;" \|'''33.3''' The system should be able to document a summary and evaluation of enterprise performance markers and processes.		\| style="background-color:white;" \|'''33.3''' The system should be able to document a summary and evaluation of enterprise performance markers and processes.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.astm.org/~~Standards/E1578~~.~~htm~~ ASTM E1578-18 S-2-4]<br />[https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]<br />[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.11.5]<br />[https://~~nvlpubs~~.nist.gov/~~nistpubs~~/~~SpecialPublications~~/~~NIST.SP.~~800-~~53r4.pdf~~ NIST 800-53, Rev. 4, SA-4(1), SA-4(2), and SA-5]		\| style="padding:5px; width:500px;" \|
			[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.4.7.2]<br />
			[https://www.astm.org/e1578-18.html ASTM E1578-18 S-2-4]<br />
			[https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]<br />
			[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.11.5]<br />
			[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, SA-4(1), SA-4(2), and SA-5]
	\| style="background-color:white;" \|'''33.4''' The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.		\| style="background-color:white;" \|'''33.4''' The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.
	\|-		\|-
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	[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (a)]<br />		[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (a)]<br />
	[https://www.law.cornell.edu/cfr/text/21/820.70 21 CFR Part 820.70 (i)]<br />		[https://www.law.cornell.edu/cfr/text/21/820.70 21 CFR Part 820.70 (i)]<br />
			[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.4.7.2]<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 C5.7]<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://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.5]<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://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-11]<br />		[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-11]<br />
	[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 8.6]<br />		[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 8.6]<br />
	[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. VI, Sec. 8.6]<br />		[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. VI, Sec. 8.6]<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://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://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.11.2]<br />		[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.11.2]<br />
	[~~http~~://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 4.1]		[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 4.1]<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 5.4.7.2)]<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, 10.2]
	\| style="background-color:white;" \|'''33.5''' The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.		\| style="background-color:white;" \|'''33.5''' The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.astm.org/~~Standards/E1578~~.~~htm~~ ASTM E1578-18 S-2-2]<br />[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-4]		\| style="padding:5px; width:500px;" \|[https://www.astm.org/e1578-18.html ASTM E1578-18 S-2-2]<br />[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.5]<br />[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-4]<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, 10.3–7]
	\| style="background-color:white;" \|'''33.6''' The documentation associated with system validation shall discuss all applicable steps of the life cycle, justify applied methods and standards, and include change control records and observed deviations during validation, if applicable.		\| style="background-color:white;" \|'''33.6''' The documentation associated with system validation shall discuss all applicable steps of the life cycle, justify applied methods and standards, and include change control records and observed deviations during validation, if applicable.
	\|-		\|-
	\|}		\|}
	\|}		\|}

Shawndouglas: Fixed broken URL

2021-01-27T21:53:32Z

Fixed broken URL

← Older revision		Revision as of 21:53, 27 January 2021
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	[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 8.6]<br />		[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 8.6]<br />
	[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. VI, Sec. 8.6]<br />		[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. VI, Sec. 8.6]<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://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.11.2]<br />		[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.11.2]<br />

Shawndouglas: Added NIST 800-53 to various items

2019-11-15T21:17:00Z

Added NIST 800-53 to various items

← Older revision		Revision as of 21:17, 15 November 2019
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	! style="color:brown; background-color:#ffffee; width:700px;"\| Requirement		! style="color:brown; background-color:#ffffee; width:700px;"\| Requirement
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 S-2-1]<br />[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy Appendix G.8]		\| style="padding:5px; width:500px;" \|[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 S-2-1]<br />[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy Appendix G.8]<br />[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, SA-4(3)]
	\| style="background-color:white;" \|'''33.1''' The vendor should be able to demonstrate the use of software development standards, secure coding practices, formal change control, and software revision control within its development practices. The vendor should also document its staff's skills and certifications.		\| style="background-color:white;" \|'''33.1''' The vendor should be able to demonstrate the use of software development standards, secure coding practices, formal change control, and software revision control within its development practices. The vendor should also document its staff's skills and certifications.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 S-2-2]		\| style="padding:5px; width:500px;" \|[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 S-2-2]<br />[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, SA-4(2)]
	\| style="background-color:white;" \|'''33.2''' The vendor should be willing to provide access to source code through a suitable escrow.		\| style="background-color:white;" \|'''33.2''' The vendor should be willing to provide access to source code through a suitable escrow.
	\|-		\|-
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	\| style="background-color:white;" \|'''33.3''' The system should be able to document a summary and evaluation of enterprise performance markers and processes.		\| style="background-color:white;" \|'''33.3''' The system should be able to document a summary and evaluation of enterprise performance markers and processes.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 S-2-4]<br />[https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]<br />[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.11.5]		\| style="padding:5px; width:500px;" \|[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 S-2-4]<br />[https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]<br />[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.11.5]<br />[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, SA-4(1), SA-4(2), and SA-5]
	\| style="background-color:white;" \|'''33.4''' The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.		\| style="background-color:white;" \|'''33.4''' The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.
	\|-		\|-

Shawndouglas: Created as needed.

2019-09-19T23:24:44Z

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.astm.org/Standards/E1578.htm ASTM E1578-18 S-2-1] [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy Appendix G.8]
| style="background-color:white;" |'''33.1''' The vendor should be able to demonstrate the use of software development standards, secure coding practices, formal change control, and software revision control within its development practices. The vendor should also document its staff's skills and certifications.
|-
| style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 S-2-2]
| style="background-color:white;" |'''33.2''' The vendor should be willing to provide access to source code through a suitable escrow.
|-
| style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 S-2-3]
| style="background-color:white;" |'''33.3''' The system should be able to document a summary and evaluation of enterprise performance markers and processes.
|-
| style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 S-2-4] [https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3] [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.11.5]
| style="background-color:white;" |'''33.4''' The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.
|-
| style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (a)] 
[https://www.law.cornell.edu/cfr/text/21/820.70 21 CFR Part 820.70 (i)] 
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-11] 
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 8.6] 
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. VI, Sec. 8.6] 
[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] 
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3] 
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.11.2] 
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 4.1]
| style="background-color:white;" |'''33.5''' The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.
|-
| style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 S-2-2] [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-4]
| style="background-color:white;" |'''33.6''' The documentation associated with system validation shall discuss all applicable steps of the life cycle, justify applied methods and standards, and include change control records and observed deviations during validation, if applicable.
|-
|}
|}