User:Shawndouglas/sandbox/sublevel25 - Revision history

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2023-08-16T20:23:35Z

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Shawndouglas at 23:24, 15 August 2023

2023-08-15T23:24:49Z

← Older revision		Revision as of 23:24, 15 August 2023
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	'''The QAO in the context of these three points'''		'''The QAO in the context of these three points'''

	Where does this all place the quality assurance officer in the scope of laboratory quality and information security? Whether it's managed security services, private or public cloud services, in-house networking, or a mix of all these, the modern laboratory is a technology-driven business requiring modern approaches to addressing the risks that technology carries with it. An on-site IT staff may handle many of the details associated with those efforts, but the QAO of the 2020s needs to also be familiar with how that technology works and how it impacts organizational quality initiatives. The QAO will interact with the lab's QMS, and perhaps even the ISMS if one separately exists. Ideally cybersecurity policy and procedure is already woven into the various elements of the QMS, or, worst case, the lab doesn't have much of a cybersecurity policy. This is where the QAO of today's lab must shine, "ensuring organizational quality through the regular management, monitoring, review, and auditing of documentation, record systems, data, and processes as they relate to organizational quality and compliance frameworks and initiatives." That means also understanding how managed security services and cloud services operate. It's perhaps a tall ask, but in today's competitive laboratory environment, the tech-savvy QAO is more important than ever.		Where does this all place the quality assurance officer in the scope of laboratory quality and information security? Whether it's managed security services, private or public cloud services, in-house networking, or a mix of all these, the modern laboratory is a technology-driven business requiring modern approaches to addressing the risks that technology carries with it. An on-site IT staff may handle many of the details associated with those efforts, but the QAO of the 2020s needs to also be familiar with how that technology works and how it impacts organizational quality initiatives. The QAO will interact with the lab's QMS, and perhaps even the ISMS if one separately exists. Ideally cybersecurity policy and procedure will already be woven into the various elements of the QMS, or, worst case, the lab doesn't have much of a cybersecurity policy. This is where the QAO of today's lab must shine, "ensuring organizational quality through the regular management, monitoring, review, and auditing of documentation, record systems, data, and processes as they relate to organizational quality and compliance frameworks and initiatives." That means also understanding how managed security services and cloud services operate. It's perhaps a tall ask, but in today's competitive laboratory environment, the tech-savvy QAO is more important than ever.

	====5.2.2 The shared responsibility model in the scope of security management and quality assurance====		====5.2.2 The shared responsibility model in the scope of security management and quality assurance====

Shawndouglas at 20:27, 26 July 2023

2023-07-26T20:27:45Z

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Shawndouglas at 19:35, 5 May 2022

2022-05-05T19:35:33Z

Shawndouglas at 18:04, 5 May 2022

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Shawndouglas at 18:02, 5 May 2022

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Shawndouglas at 22:50, 4 May 2022

2022-05-04T22:50:04Z

Shawndouglas at 21:22, 4 May 2022

2022-05-04T21:22:20Z

← Older revision		Revision as of 21:22, 4 May 2022
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	[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/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.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 15.8–9]

Shawndouglas at 20:57, 4 May 2022

2022-05-04T20:57:21Z

← Older revision		Revision as of 20:57, 4 May 2022
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	[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://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/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.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 15.8–9]

← Older revision		Revision as of 19:35, 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/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]		\| style="padding:5px; width:500px;" \|[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;" \|'''31.1''' System functionality should support ALCOA principles.		\| style="background-color:white;" \|'''31.1''' System functionality should support ALCOA principles.
	\|-		\|-
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	[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://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;" \|'''31.3''' The system shall securely maintain a true, readable copy of an instrument's original (raw) data for on-demand review.		\| style="background-color:white;" \|'''31.3''' The system shall securely maintain a true, readable copy of an instrument's original (raw) data for on-demand review.
	\|-		\|-
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	[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-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.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]		[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;" \|'''31.4''' 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.		\| style="background-color:white;" \|'''31.4''' 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.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[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]		\| style="padding:5px; width:500px;" \|[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;" \|'''31.5''' The system shall accurately reflect the system date and time in its use of electronic record time stamps.		\| style="background-color:white;" \|'''31.5''' The system shall accurately reflect the system date and time in its use of electronic record time stamps.
	\|-		\|-
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	[https://www.law.cornell.edu/cfr/text/40/3.2000 40 CFR Part 3.2000]<br />		[https://www.law.cornell.edu/cfr/text/40/3.2000 40 CFR Part 3.2000]<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.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]		[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-5]<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;" \|'''32.7''' 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.
	\|-		\|-
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	[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-20]<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://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)]		[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.
	\|-		\|-
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	[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, MA-4]<br />		[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, MA-4]<br />
	[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]<br />		[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]<br />
	[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.9]		[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 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, Appendix 1]
	\| style="background-color:white;" \|'''32.25''' The system shall provide initial login access using at least two unique identification components, e.g., a user identifier and password, or biometric information linked to and used by the genuine user.		\| style="background-color:white;" \|'''32.25''' The system shall provide initial login access using at least two unique identification components, e.g., a user identifier and password, or biometric information linked to and used by the genuine user.
	\|-		\|-
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	[https://www.law.cornell.edu/cfr/text/45/164.312 45 CFR Part 164.312]<br />		[https://www.law.cornell.edu/cfr/text/45/164.312 45 CFR Part 164.312]<br />
	[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]		[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14]<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;" \|'''32.36''' 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.
	\|-		\|-
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	\| style="background-color:white;" \|'''32.38''' When the system generates a complete and accurate copy of an electronically signed record, it shall also display the printed name of the signer, the date and time of signature execution, and any applicable meaning associated with the signature. This shall be applicable for both electronically displayed and printed copies of the electronic record.		\| style="background-color:white;" \|'''32.38''' When the system generates a complete and accurate copy of an electronically signed record, it shall also display the printed name of the signer, the date and time of signature execution, and any applicable meaning associated with the signature. This shall be applicable for both electronically displayed and printed copies of the electronic record.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-26]<br />[https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br />[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.8.5.3]		\| style="padding:5px; width:500px;" \|
			[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-26]<br />
			https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br />
			[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.8.5.3]<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]
	\| style="background-color:white;" \|'''32.39''' The system should provide a means to migrate static data into the system.		\| style="background-color:white;" \|'''32.39''' The system should provide a means to migrate static data into the system.
	\|-		\|-
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	[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<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 4.1]<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)]		[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/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]		\| 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.
	\|-		\|-
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	[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, PS-4 and PS-5]<br />		[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, PS-4 and PS-5]<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://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.5.1.2]		[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.5.1.2]<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, 5.4 and Appendix 1]
	\| style="background-color:white;" \|'''34.4''' The system shall support the ability to define, record, and change the level of access for individual users to system groups, roles, machines, processes, and objects based on their responsibilities, including when those responsibilities change. The system should be able to provide a list of individuals assigned to a given system group, role, machine, process, or object.		\| style="background-color:white;" \|'''34.4''' The system shall support the ability to define, record, and change the level of access for individual users to system groups, roles, machines, processes, and objects based on their responsibilities, including when those responsibilities change. The system should be able to provide a list of individuals assigned to a given system group, role, machine, process, or object.
	\|-		\|-

← Older revision		Revision as of 18:04, 5 May 2022
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	[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.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-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-~~laboratories~~-~~isl~~ WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.0]<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]		[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]
	\| style="background-color:white;" \|'''31.4''' 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.		\| style="background-color:white;" \|'''31.4''' 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.
Line 679:		Line 679:
	[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />		[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
	[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.8.3]<br />		[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.8.3]<br />
	[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-~~laboratories~~-~~isl~~ WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)]		[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) (throughout)]
	\| style="background-color:white;" \|'''36.2''' The system should be provisioned with enough security to prevent personally identifiable information in the system from being compromised.		\| style="background-color:white;" \|'''36.2''' The system should be provisioned with enough security to prevent personally identifiable information in the system from being compromised.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.law.cornell.edu/cfr/text/45/164.514 45 CFR Part 164.514]<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 C5.5]<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 />		\| style="padding:5px; width:500px;" \|[https://www.law.cornell.edu/cfr/text/45/164.514 45 CFR Part 164.514]<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 C5.5]<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.wada-ama.org/en/resources/world-anti-doping-program/international-standard-~~laboratories~~-~~isl~~ WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.3]		[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) 10.3]
	\| style="background-color:white;" \|'''36.3''' The system shall allow authorized individuals to de-identify select data in the system, including but not limited to names, geographic locations, dates, government-issued identification numbers, telephone numbers, email addresses, full-face photos, and other personal identifiers.		\| style="background-color:white;" \|'''36.3''' The system shall allow authorized individuals to de-identify select data in the system, including but not limited to names, geographic locations, dates, government-issued identification numbers, telephone numbers, email addresses, full-face photos, and other personal identifiers.
	\|-		\|-

← Older revision		Revision as of 18:02, 5 May 2022
Line 131:		Line 131:
	[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.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-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-laboratories-isl 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]		[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]
	\| style="background-color:white;" \|'''31.4''' 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.		\| style="background-color:white;" \|'''31.4''' 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.
Line 677:		Line 678:
	[https://ichgcp.net/ ICH GCP 2.11]<br />		[https://ichgcp.net/ ICH GCP 2.11]<br />
	[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />		[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
	[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.8.3]		[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.8.3]<br />
			[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)]
	\| style="background-color:white;" \|'''36.2''' The system should be provisioned with enough security to prevent personally identifiable information in the system from being compromised.		\| style="background-color:white;" \|'''36.2''' The system should be provisioned with enough security to prevent personally identifiable information in the system from being compromised.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.law.cornell.edu/cfr/text/45/164.514 45 CFR Part 164.514]<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 C5.5]<br />[https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]		\| style="padding:5px; width:500px;" \|[https://www.law.cornell.edu/cfr/text/45/164.514 45 CFR Part 164.514]<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 C5.5]<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.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.3]
	\| style="background-color:white;" \|'''36.3''' The system shall allow authorized individuals to de-identify select data in the system, including but not limited to names, geographic locations, dates, government-issued identification numbers, telephone numbers, email addresses, full-face photos, and other personal identifiers.		\| style="background-color:white;" \|'''36.3''' The system shall allow authorized individuals to de-identify select data in the system, including but not limited to names, geographic locations, dates, government-issued identification numbers, telephone numbers, email addresses, full-face photos, and other personal identifiers.
	\|-		\|-

← Older revision		Revision as of 22:50, 4 May 2022
Line 130:		Line 130:
	[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/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.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.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.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 15.8–9]
	\| style="background-color:white;" \|'''31.4''' 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.		\| style="background-color:white;" \|'''31.4''' 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.
Line 271:		Line 272:
	[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 4.13.1.4]<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 4.13.1.4]<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://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.2.3.5]<br />
	[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 15.9]		[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 299:		Line 301:
	[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8]<br />		[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8]<br />
	[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, MA-4]<br />		[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, MA-4]<br />
			[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]<br />
	[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.9]		[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.9]
	\| style="background-color:white;" \|'''32.25''' The system shall provide initial login access using at least two unique identification components, e.g., a user identifier and password, or biometric information linked to and used by the genuine user.		\| style="background-color:white;" \|'''32.25''' The system shall provide initial login access using at least two unique identification components, e.g., a user identifier and password, or biometric information linked to and used by the genuine user.
Line 345:		Line 348:
	[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://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, 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 />
			[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]<br />
	[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ 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, unauthorized logins, and electronic signings.		\| style="background-color:white;" \|'''32.31''' The system shall keep an accurate audit trail of login activities, including failed login attempts, unauthorized logins, and electronic signings.
Line 672:		Line 676:
	[https://www.astm.org/e1578-18.html ASTM E1578-18 S-5-2]<br />		[https://www.astm.org/e1578-18.html ASTM E1578-18 S-5-2]<br />
	[https://ichgcp.net/ ICH GCP 2.11]<br />		[https://ichgcp.net/ ICH GCP 2.11]<br />
	[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]		[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
			[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.8.3]
	\| style="background-color:white;" \|'''36.2''' The system should be provisioned with enough security to prevent personally identifiable information in the system from being compromised.		\| style="background-color:white;" \|'''36.2''' The system should be provisioned with enough security to prevent personally identifiable information in the system from being compromised.
	\|-		\|-

User:Shawndouglas/sandbox/sublevel25 - Revision history

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Shawndouglas at 23:24, 15 August 2023

Shawndouglas at 20:27, 26 July 2023

Shawndouglas: Blanked the page

Shawndouglas at 19:35, 5 May 2022

Shawndouglas at 18:04, 5 May 2022

Shawndouglas at 18:02, 5 May 2022

Shawndouglas at 22:50, 4 May 2022

Shawndouglas at 21:22, 4 May 2022

Shawndouglas at 20:57, 4 May 2022

Shawndouglas: Replaced content with "
TOC
{{ombox | type = notice | style = width: 960px; | text = This is sublevel25 of my sandbox, where I play with features and..."