Template:LIMSpec/Sample management - Revision history

Shawndouglas: Added 2.12

2023-06-21T23:54:25Z

Added 2.12

← Older revision		Revision as of 23:54, 21 June 2023
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	[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.22–25]		[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.22–25]
	\| style="background-color:white;" \|'''2.11''' The system shall allow samples, specimens, and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, remediated testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.		\| style="background-color:white;" \|'''2.11''' The system shall allow samples, specimens, and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, remediated testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.
			\|-
			\| style="padding:5px; width:500px;" \|[https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q1ar2-stability-testing-new-drug-substances-and-products FDA Q1A(R2)]
			\| style="background-color:white; vertical-align: text-top;" \|'''2.12''' The system should allow authorized users to create projects and research studies in the system—including, e.g., stability studies—and associate samples, tests, and metadata such as recommended storage conditions, test frequencies, and container types with the project or study.
	\|-		\|-
	\|}		\|}
	\|}		\|}

Shawndouglas: 2.11

2022-12-14T22:27:41Z

2.11

← Older revision		Revision as of 22:27, 14 December 2022
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	[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.3.2]<br />		[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.3.2]<br />
	[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.5]<br />		[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.5]<br />
			[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.7.2]<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.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf NYSDOH ELAP Medical Marijuana Microbiology Guidance]<br />		[https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf NYSDOH ELAP Medical Marijuana Microbiology Guidance]<br />

Shawndouglas: Updated for food and bev update

2022-12-01T18:48:54Z

Updated for food and bev update

← Older revision		Revision as of 18:48, 1 December 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 C-2-1]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]		\| style="padding:5px; width:500px;" \|
			[https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-1]<br />
			[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]<br />
			[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf SQF FSC 9, Food Manufacturing, Part B, 2.6.2]<br />
			[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_PetFood_v3-2-Final-w-Links.pdf SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2]<br />
			[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2]
	\| style="background-color:white;" \|'''2.1''' The system shall record and maintain the chain of custody for the laboratory's standards and reagents.		\| style="background-color:white;" \|'''2.1''' The system shall record and maintain the chain of custody for the laboratory's standards and reagents.
	\|-		\|-
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	\| style="background-color:white;" \|'''2.9''' The system should provide a means to manually or automatically track sample or specimen inventory amounts and status.		\| style="background-color:white;" \|'''2.9''' The system should provide a means to manually or automatically track sample or specimen inventory amounts and status.
	\|-		\|-
	\| 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]<br />[https://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-10]		\| style="padding:5px; width:500px;" \|
			[https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1152 (d)]<br />
			[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.4]<br />[https://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-10]
	\| style="background-color:white;" \|'''2.10''' The system shall be able to link test methods and specifications to standards and reagents.		\| style="background-color:white;" \|'''2.10''' The system shall be able to link test methods and specifications to standards and reagents.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|		\| style="padding:5px; width:500px;" \|
			[https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1138]<br />
			[https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1150]<br />
			[https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1153 (c)]<br />
			[https://www.law.cornell.edu/cfr/text/21/part-111 21 CFR Part 111.315]<br />
			[https://www.law.cornell.edu/cfr/text/21/part-129 21 CFR Part 129.80 (g)]<br />
	[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84]<br />		[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84]<br />
	[https://www.law.cornell.edu/cfr/text/21/211.166 21 CFR Part 211.166–7]<br />		[https://www.law.cornell.edu/cfr/text/21/211.166 21 CFR Part 211.166–7]<br />

Shawndouglas: Tweak

2022-05-17T18:09:40Z

Tweak

← Older revision		Revision as of 18:09, 17 May 2022
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	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-7]		\| style="padding:5px; width:500px;" \|[https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-7]
	\| style="background-color:white;" \|'''2.7''' The system shall allow logically associated samples to be grouped together based on associated metadata such as ~~sample~~ type, test method, assigned user, and status.		\| style="background-color:white;" \|'''2.7''' The system shall allow logically associated samples or specimens to be grouped together based on associated metadata such as type, test method, assigned user, and status.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-8]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2]<br />[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.4.2]		\| style="padding:5px; width:500px;" \|[https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-8]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2]<br />[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.4.2]
	\| style="background-color:white;" \|'''2.8''' The system should allow for the accurate identification of a physical sample in the system via barcode or RFID technology.		\| style="background-color:white;" \|'''2.8''' The system should allow for the accurate identification of a physical sample or specimen in the system via barcode or RFID technology.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|		\| style="padding:5px; width:500px;" \|
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	[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.7]<br />		[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.7]<br />
	[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.22–25]		[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.22–25]
	\| style="background-color:white;" \|'''2.11''' The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, remediated testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.		\| style="background-color:white;" \|'''2.11''' The system shall allow samples, specimens, and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, remediated testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.
	\|-		\|-
	\|}		\|}
	\|}		\|}

Shawndouglas: Updated for 2022.

2022-05-05T20:18:37Z

Updated for 2022.

← Older revision		Revision as of 20:18, 5 May 2022
Line 8:		Line 8:
	! 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 C-2-1]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]		\| style="padding:5px; width:500px;" \|[https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-1]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
	\| style="background-color:white;" \|'''2.1''' The system shall record and maintain the chain of custody for the laboratory's standards and reagents.		\| style="background-color:white;" \|'''2.1''' The system shall record and maintain the chain of custody for the laboratory's standards and reagents.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.astm.org/~~Standards/E1578~~.~~htm~~ ASTM E1578-18 C-2-2]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]		\| style="padding:5px; width:500px;" \|[https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-2]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
	\| style="background-color:white;" \|'''2.2''' The system shall record the current and historical storage location for the laboratory's standards and reagents.		\| style="background-color:white;" \|'''2.2''' The system shall record the current and historical storage location for the laboratory's standards and reagents.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.astm.org/~~Standards/E1578~~.~~htm~~ ASTM E1578-18 C-2-3]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]		\| style="padding:5px; width:500px;" \|[https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-3]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
	\| style="background-color:white;" \|'''2.3''' The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.		\| style="background-color:white;" \|'''2.3''' The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.astm.org/~~Standards/E1578~~.~~htm~~ ASTM E1578-18 C-2-4]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]		\| style="padding:5px; width:500px;" \|[https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-4]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
	\| style="background-color:white;" \|'''2.4''' The system shall require the recording of a standard and reagent's first opening date.		\| style="background-color:white;" \|'''2.4''' The system shall require the recording of a standard and reagent's first opening date.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.astm.org/~~Standards/E1578~~.~~htm~~ ASTM E1578-18 C-2-5]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]		\| style="padding:5px; width:500px;" \|[https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-5]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
	\| style="background-color:white;" \|'''2.5''' The system shall allow only active standards and reagents to be shown as available for use.		\| style="background-color:white;" \|'''2.5''' The system shall allow only active standards and reagents to be shown as available for use.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.astm.org/~~Standards/E1578~~.~~htm~~ ASTM E1578-18 C-2-6]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]		\| style="padding:5px; width:500px;" \|[https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-6]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
	\| style="background-color:white;" \|'''2.6''' The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.		\| style="background-color:white;" \|'''2.6''' The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.astm.org/~~Standards/E1578~~.~~htm~~ ASTM E1578-18 C-2-7]		\| style="padding:5px; width:500px;" \|[https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-7]
	\| style="background-color:white;" \|'''2.7''' The system shall allow logically associated samples to be grouped together based on associated metadata such as sample type, test method, assigned user, and status.		\| style="background-color:white;" \|'''2.7''' The system shall allow logically associated samples to be grouped together based on associated metadata such as sample type, test method, assigned user, and status.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.astm.org/~~Standards/E1578~~.~~htm~~ ASTM E1578-18 C-2-8]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2]<br />[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.4.2]		\| style="padding:5px; width:500px;" \|[https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-8]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2]<br />[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.4.2]
	\| style="background-color:white;" \|'''2.8''' The system should allow for the accurate identification of a physical sample in the system via barcode or RFID technology.		\| style="background-color:white;" \|'''2.8''' The system should allow for the accurate identification of a physical sample in the system via barcode or RFID technology.
	\|-		\|-
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	[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84]<br />		[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84]<br />
	[https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17]<br />		[https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17]<br />
	[https://www.astm.org/~~Standards/E1492~~.~~htm~~ ASTM E1492-11 4.2.1]<br />		[https://www.astm.org/e1492-11r17.html ASTM E1492-11 4.2.1]<br />
	[https://www.astm.org/~~Standards/E1578~~.~~htm~~ ASTM E1578-18 C-2-9]		[https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-9]<br />
	\| style="background-color:white;" \|'''2.9''' The system should provide a means to manually or automatically track sample inventory amounts and status.		[https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]
			\| style="background-color:white;" \|'''2.9''' The system should provide a means to manually or automatically track sample or specimen inventory amounts and status.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[~~http~~://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1]<br />[https://www.astm.org/~~Standards/E1578~~.~~htm~~ ASTM E1578-18 C-2-10]		\| 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]<br />[https://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-10]
	\| style="background-color:white;" \|'''2.10''' The system shall be able to link test methods and specifications to standards and reagents.		\| style="background-color:white;" \|'''2.10''' The system shall be able to link test methods and specifications to standards and reagents.
	\|-		\|-
Line 55:		Line 56:
	[https://www.law.cornell.edu/cfr/text/21/606.65 21 CFR Part 606.65 (c)]<br />		[https://www.law.cornell.edu/cfr/text/21/606.65 21 CFR Part 606.65 (c)]<br />
	[https://www.law.cornell.edu/cfr/text/21/606.151 21 CFR Part 606.151]<br />		[https://www.law.cornell.edu/cfr/text/21/606.151 21 CFR Part 606.151]<br />
	[https://www.astm.org/~~Standards/E1578~~.~~htm~~ ASTM E1578-18 C-2-11]<br />		[https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.9]<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 C6.2]<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 C10–12]<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.astm.org/e1578-18.html ASTM E1578-18 C-2-11]<br />
	[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.1.2.1]<br />		[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.1.2.1]<br />
	[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.3.2]<br />		[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.3.2]<br />
	[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.3.2]<br />		[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.3.2]<br />
	[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.5]<br />		[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.5]<br />
	[https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf ~~New York Department of Health~~ ELAP Microbiology ~~Protocol~~]<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/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf NYSDOH ELAP Medical Marijuana Microbiology Guidance]<br />
			[https://www.pfp-ifss.org/ifss-resources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/ PFP Human and Animal Food Testing Laboratories Best Practices Manual]<br />
			[https://ris.dls.virginia.gov/uploads/1VAC30/dibr/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf TNI EL-V1-2016-Rev.2.1 (V1,M1 1.1)]<br />
	[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.5]<br />		[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.5]<br />
	[https://www.who.int/medicines/~~areas~~/~~quality_safety~~/~~quality_assurance~~/~~expert_committee~~/~~trs_986~~/en/ WHO Technical Report Series, #986, Annex 2, 17.7]<br />		[https://www.ams.usda.gov/sites/default/files/media/TestingGuidelinesforHemp.pdf USDA Hemp Production Program Laboratory Testing Guidelines, Testing Remediated Hemp Samples 2]<br />
	[https://~~www~~.who.int/medicines/~~areas/quality_safety/quality_assurance/expert_committee/trs_986/en/~~ WHO Technical Report Series, #986, Annex 2, 17.22–25]		[https://www.ams.usda.gov/services/lab-testing/lab-approval USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h]<br />
	\| style="background-color:white;" \|'''2.11''' The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.		[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.7]<br />
			[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #961, Annex 13, 12.1]<br />
			[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.7]<br />
			[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.22–25]
			\| style="background-color:white;" \|'''2.11''' The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, remediated testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.
	\|-		\|-
	\|}		\|}
	\|}		\|}

Shawndouglas: Fixed broken URL

2021-01-27T19:34:15Z

Fixed broken URL

← Older revision		Revision as of 19:34, 27 January 2021
Line 62:		Line 62:
	[https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf New York Department of Health ELAP Microbiology Protocol]<br />		[https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf New York Department of Health ELAP Microbiology Protocol]<br />
	[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.5]<br />		[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.5]<br />
	[https://~~extranet~~.who.int/~~prequal~~/~~content~~/~~who-technical-report-series~~ WHO Technical Report Series, #986, Annex 2, 17.7]<br />		[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 17.7]<br />
	[https://~~extranet~~.who.int/~~prequal~~/~~content~~/~~who-technical-report-series~~ WHO Technical Report Series, #986, Annex 2, 17.22–25]		[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 17.22–25]
	\| style="background-color:white;" \|'''2.11''' The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.		\| style="background-color:white;" \|'''2.11''' The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.
	\|-		\|-
	\|}		\|}
	\|}		\|}

Shawndouglas: Added ELAP

2020-12-23T21:15:52Z

Added ELAP

← Older revision		Revision as of 21:15, 23 December 2020
Line 60:		Line 60:
	[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.3.2]<br />		[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.3.2]<br />
	[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.5]<br />		[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.5]<br />
			[https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf New York Department of Health ELAP Microbiology Protocol]<br />
	[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.5]<br />		[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.5]<br />
	[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.7]<br />		[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.7]<br />

Shawndouglas: Removed protection from "Template:LIMSpec/Sample management"

2019-09-19T22:17:13Z

Removed protection from "Template:LIMSpec/Sample management"

← Older revision

Revision as of 22:17, 19 September 2019

Shawndouglas: Protected "Template:LIMSpec/Sample management" ([Edit=Allow only administrators] (indefinite) [Move=Allow only administrators] (indefinite))

2019-09-19T21:21:28Z

Protected "Template:LIMSpec/Sample management" ([Edit=Allow only administrators] (indefinite) [Move=Allow only administrators] (indefinite))

← Older revision

Revision as of 21:21, 19 September 2019

Shawndouglas: Created as needed.

2019-09-19T21:21:20Z

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 C-2-1] [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
| style="background-color:white;" |'''2.1''' The system shall record and maintain the chain of custody for the laboratory's standards and reagents.
|-
| style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-2] [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
| style="background-color:white;" |'''2.2''' The system shall record the current and historical storage location for the laboratory's standards and reagents.
|-
| style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-3] [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
| style="background-color:white;" |'''2.3''' The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.
|-
| style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-4] [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
| style="background-color:white;" |'''2.4''' The system shall require the recording of a standard and reagent's first opening date.
|-
| style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-5] [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
| style="background-color:white;" |'''2.5''' The system shall allow only active standards and reagents to be shown as available for use.
|-
| style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-6] [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
| style="background-color:white;" |'''2.6''' The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.
|-
| style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-7]
| style="background-color:white;" |'''2.7''' The system shall allow logically associated samples to be grouped together based on associated metadata such as sample type, test method, assigned user, and status.
|-
| style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-8] [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2] [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.4.2]
| style="background-color:white;" |'''2.8''' The system should allow for the accurate identification of a physical sample in the system via barcode or RFID technology.
|-
| 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/21/211.84 21 CFR Part 211.84] 
[https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17] 
[https://www.astm.org/Standards/E1492.htm ASTM E1492-11 4.2.1] 
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-9]
| style="background-color:white;" |'''2.9''' The system should provide a means to manually or automatically track sample inventory amounts and status.
|-
| style="padding:5px; width:500px;" |[http://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1] [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-10]
| style="background-color:white;" |'''2.10''' The system shall be able to link test methods and specifications to standards and reagents.
|-
| style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84] 
[https://www.law.cornell.edu/cfr/text/21/211.166 21 CFR Part 211.166–7] 
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194 (e)] 
[https://www.law.cornell.edu/cfr/text/21/212.40 21 CFR Part 212.40 (c)] 
[https://www.law.cornell.edu/cfr/text/21/212.61 21 CFR Part 212.61] 
[https://www.law.cornell.edu/cfr/text/21/212.70 21 CFR Part 212.70 (e)] 
[https://www.law.cornell.edu/cfr/text/21/225.58 21 CFR Part 225.58] 
[https://www.law.cornell.edu/cfr/text/21/226.58 21 CFR Part 226.58] 
[https://www.law.cornell.edu/cfr/text/21/606.65 21 CFR Part 606.65 (c)] 
[https://www.law.cornell.edu/cfr/text/21/606.151 21 CFR Part 606.151] 
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-11] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.1.2.1] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.3.2] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.3.2] 
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.5] 
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.5] 
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.7] 
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.22–25]
| style="background-color:white;" |'''2.11''' The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.
|-
|}
|}