Template:LIMSpec/Sample and experiment registration - Revision history

Shawndouglas: NIST tweak

2023-03-14T15:54:14Z

NIST tweak

← Older revision		Revision as of 15:54, 14 March 2023
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	[https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2]<br />		[https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2]<br />
	[https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 14.1.3]<br />		[https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 14.1.3]<br />
			[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-10(3)]<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://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://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_FoodManufacturing_v3-2-FINAL-w-links.pdf SQF FSC 9, Food Manufacturing, Part B, 2.6.2]<br />

Shawndouglas: 1.16

2022-12-14T22:12:15Z

1.16

← Older revision		Revision as of 22:12, 14 December 2022
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	[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.13]<br />		[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.13]<br />
	[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.8]<br />		[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.8]<br />
			[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.4.3]<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.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://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 />

Shawndouglas: 1.9

2022-12-14T22:01:28Z

1.9

← Older revision		Revision as of 22:01, 14 December 2022
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	[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 11.4]<br />		[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 11.4]<br />
	[https://www.iso.org/standard/56115.html ISO 15189:2012 5.7.2]<br />		[https://www.iso.org/standard/56115.html ISO 15189:2012 5.7.2]<br />
			[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.3.3]<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.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 6.1]<br />		[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 6.1]<br />
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	[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 5.1]<br />		[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 5.1]<br />
	[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.11 and 17.21]		[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.11 and 17.21]
	\| style="background-color:white;" \|'''1.9''' The system shall be able to define the collection details for registered samples or specimens, including container size and type, number of containers, collection date and time, temperature, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.		\| style="background-color:white;" \|'''1.9''' The system shall be able to define the collection and sampling details for registered samples or specimens, including container size and type, number of containers, collection date and time, temperature, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), sampling methods used, safety concerns, and retention period.
	\|-		\|-
	\| style="padding:5px; width:350px;" \|		\| style="padding:5px; width:350px;" \|

Shawndouglas: Fix

2022-12-02T15:16:38Z

Fix

← Older revision		Revision as of 15:16, 2 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:350px;" \|[https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br />[https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-1]		\| style="padding:5px; width:350px;" \|
			[https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1149]<br />
			[https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br />
			[https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br />
			[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-1]
	\| style="background-color:white;" \|'''1.1''' The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.		\| style="background-color:white;" \|'''1.1''' The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.
	\|-		\|-
	\| style="padding:5px; width:350px;" \|		\| style="padding:5px; width:350px;" \|
	~~[https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1149]<br />~~
	[https://www.law.cornell.edu/cfr/text/21/58.105 21 CFR Part 58.105 (c)]<br />		[https://www.law.cornell.edu/cfr/text/21/58.105 21 CFR Part 58.105 (c)]<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 />

Shawndouglas: Updated for food and bev update

2022-12-01T18:41:32Z

Updated for food and bev update

← Older revision		Revision as of 18:41, 1 December 2022
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	\|-		\|-
	\| style="padding:5px; width:350px;" \|		\| style="padding:5px; width:350px;" \|
			[https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1149]<br />
	[https://www.law.cornell.edu/cfr/text/21/58.105 21 CFR Part 58.105 (c)]<br />		[https://www.law.cornell.edu/cfr/text/21/58.105 21 CFR Part 58.105 (c)]<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 />
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	\| style="padding:5px; width:350px;" \|		\| style="padding:5px; width:350px;" \|
	[https://www.law.cornell.edu/cfr/text/7/91.19 7 CFR Part 91.19]<br />		[https://www.law.cornell.edu/cfr/text/7/91.19 7 CFR Part 91.19]<br />
			[https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1152 (a–b)]<br />
	[https://www.law.cornell.edu/cfr/text/40/262.18 40 CFR Part 262.18]<br />		[https://www.law.cornell.edu/cfr/text/40/262.18 40 CFR Part 262.18]<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 C2.1]<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 C2.1]<br />
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	[https://www.law.cornell.edu/cfr/text/7/331.17 7 CFR Part 331.17]<br />		[https://www.law.cornell.edu/cfr/text/7/331.17 7 CFR Part 331.17]<br />
	[https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17]<br />		[https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17]<br />
			[https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1149]<br />
			[https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1152 (a–b)]<br />
			[https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1152 (d)]<br />
	[https://www.law.cornell.edu/cfr/text/21/58.105 21 CFR Part 58.105 (c)]<br />		[https://www.law.cornell.edu/cfr/text/21/58.105 21 CFR Part 58.105 (c)]<br />
	[https://www.law.cornell.edu/cfr/text/21/58.105 21 CFR Part 58.195]<br />		[https://www.law.cornell.edu/cfr/text/21/58.105 21 CFR Part 58.195]<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/21/211.170 21 CFR Part 211.170]<br />		[https://www.law.cornell.edu/cfr/text/21/211.170 21 CFR Part 211.170]<br />
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	\| style="background-color:white;" \|'''1.11''' The system should support the creation of user-definable default sample registration preferences and/or input screens.		\| style="background-color:white;" \|'''1.11''' The system should support the creation of user-definable default sample registration preferences and/or input screens.
	\|-		\|-
	\| style="padding:5px; width:350px;" \|[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-11]<br />		\| style="padding:5px; width:350px;" \|
			[https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1149]<br />
			[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-11]<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://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,M2 5.8.7)]<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 5.8.7)]<br />
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	\|-		\|-
	\| style="padding:5px; width:350px;" \|		\| style="padding:5px; width:350px;" \|
			[https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1152 (d)]<br />
	[https://www.law.cornell.edu/cfr/text/21/58.107 21 CFR Part 58.107 (c)]<br />		[https://www.law.cornell.edu/cfr/text/21/58.107 21 CFR Part 58.107 (c)]<br />
	[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />		[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
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	\| style="background-color:white;" \|'''1.14''' The system shall provide a user-friendly means for tracking and acknowledging the physical reception of submitted sample or specimen material in the laboratory, including date and time of reception.		\| style="background-color:white;" \|'''1.14''' The system shall provide a user-friendly means for tracking and acknowledging the physical reception of submitted sample or specimen material in the laboratory, including date and time of reception.
	\|-		\|-
	\| style="padding:5px; width:350px;" \|[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-14]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.6]		\| style="padding:5px; width:350px;" \|
			[https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1149]<br />
			[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-14]<br />
			[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.6]
	\| style="background-color:white;" \|'''1.15''' The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.		\| style="background-color:white;" \|'''1.15''' The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.
	\|-		\|-
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	\| style="background-color:white;" \|'''1.16''' The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.		\| style="background-color:white;" \|'''1.16''' The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.
	\|-		\|-
	\| style="padding:5px; width:350px;" \|[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.7]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-16]<br />[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.2 and 2.2.3]		\| style="padding:5px; width:350px;" \|
			[https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1149]<br />
			[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.7]<br />
			[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-16]<br />
			[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.2 and 2.2.3]
	\| style="background-color:white;" \|'''1.17''' The system should provide a means to document sample preparation activities for a given sample.		\| style="background-color:white;" \|'''1.17''' The system should provide a means to document sample preparation activities for a given sample.
	\|-		\|-
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	[https://www.law.cornell.edu/cfr/text/9/121.11 9 CFR Part 121.11]<br />		[https://www.law.cornell.edu/cfr/text/9/121.11 9 CFR Part 121.11]<br />
	[https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17]<br />		[https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17]<br />
			[https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1149]<br />
			[https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1152 (d)]<br />
	[https://www.law.cornell.edu/cfr/text/42/73.11 42 CFR Part 73.11]<br />		[https://www.law.cornell.edu/cfr/text/42/73.11 42 CFR Part 73.11]<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 />
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	[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.8–9]<br />		[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.8–9]<br />
	[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.3]<br />		[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.3]<br />
			[https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1]<br />
			[https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2]<br />
			[https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 14.1.3]<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://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://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]<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 5.8.7.5 and 5.8.8)]<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 5.8.7.5 and 5.8.8)]<br />
	[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) (throughout)]		[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) (throughout)]

Shawndouglas: 1.5

2022-11-27T18:07:51Z

1.5

← Older revision		Revision as of 18:07, 27 November 2022
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	[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-4]<br />		[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-4]<br />
	[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.4.1.1.3]		[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.4.1.1.3]
	\| style="background-color:white;" \|'''1.5''' The system should permit unique metadata like lot number, patient number, family identifier, client or patient demographics, sampling point, random selection process used, and industry-specific items (like EPA identification number) to be included during registration.		\| style="background-color:white;" \|'''1.5''' The system should permit unique metadata like lot number, patient number, family identifier, client or patient demographics, sampling point, random selection process used, and industry-specific items (like EPA identification number or U.S. Customs and Border Protection number) to be included during registration.
	\|-		\|-
	\| style="padding:5px; width:350px;" \|[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-5]		\| style="padding:5px; width:350px;" \|[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-5]

Shawndouglas: Fixes

2022-09-29T19:04:09Z

Fixes

← Older revision		Revision as of 19:04, 29 September 2022
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	[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP 5.1.11]<br />		[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP 5.1.11]<br />
	[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.4.1.2.5]<br />		[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.4.1.2.5]<br />
	[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.2]</~~ref~~>		[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.2]</br>
	[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.11]		[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.11]
	\| style="background-color:white;" \|'''1.13''' The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.		\| style="background-color:white;" \|'''1.13''' The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.

Shawndouglas: Updated for 2022.

2022-05-05T20:17:40Z

Updated for 2022.

Show changes

Shawndouglas: Fixed broken URL

2021-01-27T19:29:58Z

Fixed broken URL

Shawndouglas at 21:19, 11 January 2020

2020-01-11T21:19:15Z

← Older revision		Revision as of 19:29, 27 January 2021
Line 27:		Line 27:
	[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2.2]<br />		[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2.2]<br />
	[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.3]<br />		[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.3]<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 15]<br />[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 6.1]<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 15]<br />[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 6.1]<br />
	[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.4.1.2.6]<br />		[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.4.1.2.6]<br />
	[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.11]		[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.11]
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	[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.7.1–6]<br />		[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.7.1–6]<br />
	[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.2 and 2.2.3]<br />		[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.2 and 2.2.3]<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 11.4]<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 11.4]<br />
	[https://www.iso.org/standard/56115.html ISO 15189:2012 5.7.2]<br />		[https://www.iso.org/standard/56115.html ISO 15189:2012 5.7.2]<br />
	[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 6.1]<br />		[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 6.1]<br />
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	[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.10]<br />		[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.10]<br />
	[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.3]<br />		[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.3]<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 15]<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 15]<br />
	[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.4.2]<br />		[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.4.2]<br />
	[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 6.2]<br />		[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 6.2]<br />

← Older revision		Revision as of 21:19, 11 January 2020
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.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-1]		\| style="padding:5px; width:350px;" \|[https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-1]
	\| style="background-color:white;" \|'''1.1''' The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.		\| style="background-color:white;" \|'''1.1''' The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.
	\|-		\|-
	\| style="padding:5px; width:~~500px~~;" \|		\| style="padding:5px; width:350px;" \|
	[https://www.law.cornell.edu/cfr/text/21/58.105 21 CFR Part 58.105 (c)]<br />		[https://www.law.cornell.edu/cfr/text/21/58.105 21 CFR Part 58.105 (c)]<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 />
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	\| style="background-color:white;" \|'''1.2''' The system should allow for creation and use of pre-configured (e.g., for basic clinical samples) and customizable (e.g., for regulated activities such as blood collection and storage) sample labels, with barcode support.		\| style="background-color:white;" \|'''1.2''' The system should allow for creation and use of pre-configured (e.g., for basic clinical samples) and customizable (e.g., for regulated activities such as blood collection and storage) sample labels, with barcode support.
	\|-		\|-
	\| style="padding:5px; width:~~500px~~;" \|[https://www.law.cornell.edu/cfr/text/45/162.410 45 CFR Part 162.410]<br />[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.6.1]		\| style="padding:5px; width:350px;" \|[https://www.law.cornell.edu/cfr/text/45/162.410 45 CFR Part 162.410]<br />[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.6.1]
	\| style="background-color:white;" \|'''1.3''' The system shall provide a means to assign unique identifiers such as a National Provider Identifier (NPI) or Originating Agency Identifier (ORI) to the enacting entity and any subcontracted entity. The unique identifier should be able to appear on necessary records, documents, and reports referencing those entities.		\| style="background-color:white;" \|'''1.3''' The system shall provide a means to assign unique identifiers such as a National Provider Identifier (NPI) or Originating Agency Identifier (ORI) to the enacting entity and any subcontracted entity. The unique identifier should be able to appear on necessary records, documents, and reports referencing those entities.
	\|-		\|-
	\| style="padding:5px; width:~~500px~~;" \|[https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-3]		\| style="padding:5px; width:350px;" \|[https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-3]
	\| style="background-color:white;" \|'''1.4''' The system should provide a means for automatically registering samples in the system using any number of triggers such as dates, times, web requests, and intra-system methods like APIs and web services.		\| style="background-color:white;" \|'''1.4''' The system should provide a means for automatically registering samples in the system using any number of triggers such as dates, times, web requests, and intra-system methods like APIs and web services.
	\|-		\|-
	\| style="padding:5px; width:~~500px~~;" \|[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-4]<br />[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.4.1.1.3]		\| style="padding:5px; width:350px;" \|[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-4]<br />[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.4.1.1.3]
	\| style="background-color:white;" \|'''1.5''' The system should permit metadata like lot number, client demographics, sampling point, random selection process used, and industry-specific items to be included during registration.		\| style="background-color:white;" \|'''1.5''' The system should permit metadata like lot number, client demographics, sampling point, random selection process used, and industry-specific items to be included during registration.
	\|-		\|-
	\| style="padding:5px; width:~~500px~~;" \|[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-5]		\| style="padding:5px; width:350px;" \|[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-5]
	\| style="background-color:white;" \|'''1.6''' The system shall allow for the addition, modification, and removal of new, pre-defined, and custom analytical tests.		\| style="background-color:white;" \|'''1.6''' The system shall allow for the addition, modification, and removal of new, pre-defined, and custom analytical tests.
	\|-		\|-
	\| style="padding:5px; width:~~500px~~;" \|[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-6]		\| style="padding:5px; width:350px;" \|[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-6]
	\| style="background-color:white;" \|'''1.7''' The system should offer safety information related to a submitted sample upon registration that is relevant to the lab's location and industry.		\| style="background-color:white;" \|'''1.7''' The system should offer safety information related to a submitted sample upon registration that is relevant to the lab's location and industry.
	\|-		\|-
	\| style="padding:5px; width:~~500px~~;" \|[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-7]		\| style="padding:5px; width:350px;" \|[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-7]
	\| style="background-color:white;" \|'''1.8''' The system should support the creation and use of predefined metadata templates, as well as ad-hoc, single, and multiple samples.		\| style="background-color:white;" \|'''1.8''' The system should support the creation and use of predefined metadata templates, as well as ad-hoc, single, and multiple samples.
	\|-		\|-
	\| style="padding:5px; width:~~500px~~;" \|		\| style="padding:5px; width:350px;" \|
	[https://www.law.cornell.edu/cfr/text/7/331.17 7 CFR Part 331.17]<br />		[https://www.law.cornell.edu/cfr/text/7/331.17 7 CFR Part 331.17]<br />
	[https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17]<br />		[https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17]<br />
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	\| style="background-color:white;" \|'''1.9''' The system shall be able to define the sample collection details for registered samples, including container size and type, number of containers, collection date and time, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.		\| style="background-color:white;" \|'''1.9''' The system shall be able to define the sample collection details for registered samples, including container size and type, number of containers, collection date and time, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.
	\|-		\|-
	\| style="padding:5px; width:~~500px~~;" \|[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-9]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2.1]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.5]		\| style="padding:5px; width:350px;" \|[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-9]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2.1]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.5]
	\| style="background-color:white;" \|'''1.10''' The system should allow for the addition of observations and descriptions to registered samples in the form of free text.		\| style="background-color:white;" \|'''1.10''' The system should allow for the addition of observations and descriptions to registered samples in the form of free text.
	\|-		\|-
	\| style="padding:5px; width:~~500px~~;" \|[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-10]		\| style="padding:5px; width:350px;" \|[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-10]
	\| style="background-color:white;" \|'''1.11''' The system should support the creation of user-definable default sample registration preferences and/or input screens.		\| style="background-color:white;" \|'''1.11''' The system should support the creation of user-definable default sample registration preferences and/or input screens.
	\|-		\|-
	\| style="padding:5px; width:~~500px~~;" \|[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-11]		\| style="padding:5px; width:350px;" \|[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-11]
	\| style="background-color:white;" \|'''1.12''' The system should allow for the recording of sample delivery details such as deliverer, location, and date and time for a preregistered sample.		\| style="background-color:white;" \|'''1.12''' The system should allow for the recording of sample delivery details such as deliverer, location, and date and time for a preregistered sample.
	\|-		\|-
	\| style="padding:5px; width:~~500px~~;" \|		\| style="padding:5px; width:350px;" \|
	[https://www.law.cornell.edu/cfr/text/21/58.107 21 CFR Part 58.107 (c)]<br />		[https://www.law.cornell.edu/cfr/text/21/58.107 21 CFR Part 58.107 (c)]<br />
	[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />		[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
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	\| style="background-color:white;" \|'''1.13''' The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.		\| style="background-color:white;" \|'''1.13''' The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.
	\|-		\|-
	\| style="padding:5px; width:~~500px~~;" \|		\| style="padding:5px; width:350px;" \|
	[https://www.law.cornell.edu/cfr/text/7/331.17 7 CFR Part 331.17]<br />		[https://www.law.cornell.edu/cfr/text/7/331.17 7 CFR Part 331.17]<br />
	[https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17]<br />		[https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17]<br />
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	\| style="background-color:white;" \|'''1.14''' The system shall provide a user-friendly means for acknowledging the physical reception of sample material in the laboratory, including date and time of reception.		\| style="background-color:white;" \|'''1.14''' The system shall provide a user-friendly means for acknowledging the physical reception of sample material in the laboratory, including date and time of reception.
	\|-		\|-
	\| style="padding:5px; width:~~500px~~;" \|[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-14]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.6]		\| style="padding:5px; width:350px;" \|[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-14]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.6]
	\| style="background-color:white;" \|'''1.15''' The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.		\| style="background-color:white;" \|'''1.15''' The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.
	\|-		\|-
	\| style="padding:5px; width:~~500px~~;" \|		\| style="padding:5px; width:350px;" \|
	[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.8.3]<br />		[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.8.3]<br />
	[https://www.astm.org/Standards/E1492.htm ASTM E1492-11 4.1.1.5]<br />		[https://www.astm.org/Standards/E1492.htm ASTM E1492-11 4.1.1.5]<br />
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	\| style="background-color:white;" \|'''1.16''' The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.		\| style="background-color:white;" \|'''1.16''' The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.
	\|-		\|-
	\| style="padding:5px; width:~~500px~~;" \|[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-16]<br />[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.2 and 2.2.3]		\| style="padding:5px; width:350px;" \|[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-16]<br />[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.2 and 2.2.3]
	\| style="background-color:white;" \|'''1.17''' The system should provide a means to document sample preparation activities for a given sample.		\| style="background-color:white;" \|'''1.17''' The system should provide a means to document sample preparation activities for a given sample.
	\|-		\|-
	\| style="padding:5px; width:~~500px~~;" \|		\| style="padding:5px; width:350px;" \|
	[https://www.law.cornell.edu/cfr/text/7/331.11 7 CFR Part 331.11]<br />		[https://www.law.cornell.edu/cfr/text/7/331.11 7 CFR Part 331.11]<br />
	[https://www.law.cornell.edu/cfr/text/7/331.11 7 CFR Part 331.17]<br />		[https://www.law.cornell.edu/cfr/text/7/331.11 7 CFR Part 331.17]<br />
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	\| style="background-color:white;" \|'''1.18''' The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel—including details such as unique identifier, name, location, date, and time—while the sample is in the laboratory’s possession.		\| style="background-color:white;" \|'''1.18''' The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel—including details such as unique identifier, name, location, date, and time—while the sample is in the laboratory’s possession.
	\|-		\|-
	\| style="padding:5px; width:~~500px~~;" \|[https://www.law.cornell.edu/cfr/text/7/331.16 7 CFR Part 331.16]<br />[https://www.law.cornell.edu/cfr/text/9/121.16 9 CFR Part 121.16]<br />[https://www.law.cornell.edu/cfr/text/42/73.16 42 CFR Part 73.16]		\| style="padding:5px; width:350px;" \|[https://www.law.cornell.edu/cfr/text/7/331.16 7 CFR Part 331.16]<br />[https://www.law.cornell.edu/cfr/text/9/121.16 9 CFR Part 121.16]<br />[https://www.law.cornell.edu/cfr/text/42/73.16 42 CFR Part 73.16]
	\| style="background-color:white;" \|'''1.19''' In the case of regulated samples (e.g., select agent or toxin, cannabis, etc.), the system shall also allow for the recording of transfers to other entities outside the laboratory, including details such as personnel involved, their certification numbers (if applicable), dates, times, and any other required information.		\| style="background-color:white;" \|'''1.19''' In the case of regulated samples (e.g., select agent or toxin, cannabis, etc.), the system shall also allow for the recording of transfers to other entities outside the laboratory, including details such as personnel involved, their certification numbers (if applicable), dates, times, and any other required information.
	\|-		\|-
	\|}		\|}
	\|}		\|}