Template:LIMSpec/Core laboratory testing and experiments - Revision history

Shawndouglas: Updated for food and bev update

2022-12-01T18:57:55Z

Updated for food and bev update

← Older revision		Revision as of 18:57, 1 December 2022
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			[https://www.law.cornell.edu/cfr/text/21/part-111 21 CFR Part 111.315]<br />
	[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84 (d)]<br />		[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84 (d)]<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 5.1.3.1]<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 5.1.3.1]<br />
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			[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 1.1152 (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/part-1 21 CFR Part 1.1153 (c)]<br />
			[https://www.law.cornell.edu/cfr/text/21/part-106 21 CFR Part 106.100 (c–f)]<br />
			[https://www.law.cornell.edu/cfr/text/21/part-111 21 CFR Part 111.110]<br />
			[https://www.law.cornell.edu/cfr/text/21/part-111 21 CFR Part 111.325]<br />
			[https://www.law.cornell.edu/cfr/text/21/part-112 21 CFR Part 112.161]<br />
			[https://www.law.cornell.edu/cfr/text/21/part-114 21 CFR Part 114.100 (a)]<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/21/211.194 21 CFR Part 211.194]<br />		[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
	[https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 212.60 (g)]<br />		[https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 212.60 (g)]<br />
			[https://www.law.cornell.edu/cfr/text/21/part-507 21 CFR Part 507.202]<br />
	[https://www.law.cornell.edu/cfr/text/21/606.160 21 CFR Part 606.160]<br />		[https://www.law.cornell.edu/cfr/text/21/606.160 21 CFR Part 606.160]<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 G16.1]<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 G16.1]<br />
	[https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.10]		[https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.10]
	[https://www.astm.org/e1578-18.html ASTM E1578-18 C-3-14]<br />		[https://www.astm.org/e1578-18.html ASTM E1578-18 C-3-14]<br />
			[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 5.6.1.2]<br />
			[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 9.3.1]<br />
			[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 9.3.5]<br />
	[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.1.2]<br />		[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.1.2]<br />
	[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.2.1]<br />		[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.2.1]<br />
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	[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.1–4]<br />		[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.1–4]<br />
	[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.16]<br />		[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.16]<br />
			[https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02004R0852-20210324 E.U. Commission Reg. No. 852/2004 Annex I, Section II.4.i]<br />
			[https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02004R0852-20210324 E.U. Commission Reg. No. 852/2004 Annex I, Section III.8.d]<br />
			[https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02004R0852-20210324 E.U. Commission Reg. No. 852/2004 Annex I, Section III.9.c]<br />
			[https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 4.18.3]<br />
			[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 4.18.3]<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 />
			[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf SQF FSC 9, Food Manufacturing, Part B, 2.4.4.6]<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, 2.4.4.6]<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, 2.4.4.6]<br />
	[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 5.4.2]<br />		[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 5.4.2]<br />
	[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 8.1.3]<br />		[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 8.1.3]<br />

Shawndouglas: Updated for 2022.

2022-05-05T20:20:16Z

Updated for 2022.

Shawndouglas: Updated dead urls

2021-01-27T19:01:53Z

Updated dead urls

← Older revision		Revision as of 19:01, 27 January 2021
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	\| style="background-color:white;" \|'''3.9''' The system shall support, at a minimum, the floating point/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.		\| style="background-color:white;" \|'''3.9''' The system shall support, at a minimum, the floating point/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.aihaaccreditedlabs.org/~~Policies/Pages/default.aspx~~ AIHA-LAP Policies 2018 2A.7.8.2]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-11]		\| style="padding:5px; width:500px;" \|[https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2018 2A.7.8.2]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-11]
	\| style="background-color:white;" \|'''3.10''' The system shall allow users to enter operators such as <, >, +, and - with numeric test results.		\| style="background-color:white;" \|'''3.10''' The system shall allow users to enter operators such as <, >, +, and - with numeric test results.
	\|-		\|-
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	[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 5.4.2]<br />		[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 5.4.2]<br />
	[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 8.1.3]<br />		[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 8.1.3]<br />
	[https://~~extranet~~.who.int/~~prequal~~/~~content~~/~~who-technical-report-series~~ WHO Technical Report Series, #986, Annex 2, 15.8]		[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 15.8]
	\| style="background-color:white;" \|'''3.13''' The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.		\| style="background-color:white;" \|'''3.13''' The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.
	\|-		\|-
	\|}		\|}
	\|}		\|}

Shawndouglas: Removed protection from "Template:LIMSpec/Core laboratory testing and experiments"

2019-09-19T22:17:24Z

Removed protection from "Template:LIMSpec/Core laboratory testing and experiments"

← Older revision	Revision as of 22:17, 19 September 2019
(No difference)

Shawndouglas: Protected "Template:LIMSpec/Core laboratory testing and experiments" ([Edit=Allow only administrators] (indefinite) [Move=Allow only administrators] (indefinite))

2019-09-19T21:23:47Z

Protected "Template:LIMSpec/Core laboratory testing and experiments" ([Edit=Allow only administrators] (indefinite) [Move=Allow only administrators] (indefinite))

← Older revision	Revision as of 21:23, 19 September 2019
(No difference)

Shawndouglas: Created as needed.

2019-09-19T21:23:42Z

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.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84 (d)] [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 5.1.3.1] [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-1] [https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.2.7]
| style="background-color:white;" |'''3.1''' The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.
|-
| style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84 (e)] [https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252 (d)] [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-2]
| style="background-color:white;" |'''3.2''' The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.
|-
| style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252 (d)] [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-3]
| style="background-color:white;" |'''3.3''' The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.
|-
| style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-4]
| style="background-color:white;" |'''3.4''' The system shall be able to check physical, control, and specification limits for an instrument sample.
|-
| style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-6]
| style="background-color:white;" |'''3.5''' The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.
|-
| style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-7]
| style="background-color:white;" |'''3.6''' The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.
|-
| style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-8]
| style="background-color:white;" |'''3.7''' The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.
|-
| style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-9]
| style="background-color:white;" |'''3.8''' The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.
|-
| style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-10]
| style="background-color:white;" |'''3.9''' The system shall support, at a minimum, the floating point/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.
|-
| style="padding:5px; width:500px;" |[https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018 2A.7.8.2] [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-11]
| style="background-color:white;" |'''3.10''' The system shall allow users to enter operators such as <, >, +, and - with numeric test results.
|-
| style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-12]
| style="background-color:white;" |'''3.11''' The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.
|-
| style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241] [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-13] [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]
| style="background-color:white;" |'''3.12''' The system should effectively alert users upon entry of out-of-specification test results.
|-
| style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194] 
[https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 212.60 (g)] 
[https://www.law.cornell.edu/cfr/text/21/606.160 21 CFR Part 606.160] 
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-14] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.1.2.3–4] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.3.4] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.1–4] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.16] 
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 5.4.2] 
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 8.1.3] 
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.8]
| style="background-color:white;" |'''3.13''' The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.
|-
|}
|}

← Older revision		Revision as of 20:20, 5 May 2022
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	! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"\|		! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"\|
	\|-		\|-fequip
	! style="color:brown; background-color:#ffffee; width:500px;"\| Regulation, Specification, or Guidance		! style="color:brown; background-color:#ffffee; width:500px;"\| Regulation, Specification, or Guidance
	! style="color:brown; background-color:#ffffee; width:700px;"\| Requirement		! style="color:brown; background-color:#ffffee; width:700px;"\| Requirement
	\|-		\|-
	\| style="padding:5px; width:500px;" \|		\| style="padding:5px; width:500px;" \|
	[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84 (d)]<br />[~~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 5.1.3.1]<br />[https://www.astm.org/~~Standards/E1578~~.~~htm~~ ASTM E1578-18 C-3-1]<br />[https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.2.7]		[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84 (d)]<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 5.1.3.1]<br />
			[https://www.astm.org/e1578-18.html ASTM E1578-18 C-3-1]<br />
			[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.2.1]<br />
			[https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.2.7]<br />
			[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.2.7]
	\| style="background-color:white;" \|'''3.1''' The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.		\| style="background-color:white;" \|'''3.1''' The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84 (e)]<br />[https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252 (d)]<br />[https://www.astm.org/~~Standards/E1578~~.~~htm~~ ASTM E1578-18 C-3-2]		\| style="padding:5px; width:500px;" \|
			[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84 (e)]<br />
			[https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252 (d)]<br />
			[https://www.astm.org/e1578-18.html ASTM E1578-18 C-3-2]<br />
			[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.2.7]
	\| style="background-color:white;" \|'''3.2''' The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.		\| style="background-color:white;" \|'''3.2''' The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252 (d)]<br />[https://www.astm.org/~~Standards/E1578~~.~~htm~~ ASTM E1578-18 C-3-3]		\| style="padding:5px; width:500px;" \|[https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252 (d)]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 C-3-3]
	\| style="background-color:white;" \|'''3.3''' The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.		\| style="background-color:white;" \|'''3.3''' The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.astm.org/~~Standards/E1578~~.~~htm~~ ASTM E1578-18 C-3-4]		\| style="padding:5px; width:500px;" \|[https://www.astm.org/e1578-18.html ASTM E1578-18 C-3-4]
	\| style="background-color:white;" \|'''3.4''' The system shall be able to check physical, control, and specification limits for an instrument sample.		\| style="background-color:white;" \|'''3.4''' The system shall be able to check physical, control, and specification limits for an instrument sample.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.astm.org/~~Standards/E1578~~.~~htm~~ ASTM E1578-18 C-3-6]		\| style="padding:5px; width:500px;" \|[https://www.astm.org/e1578-18.html ASTM E1578-18 C-3-6]
	\| style="background-color:white;" \|'''3.5''' The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.		\| style="background-color:white;" \|'''3.5''' The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.astm.org/~~Standards/E1578~~.~~htm~~ ASTM E1578-18 C-3-7]		\| style="padding:5px; width:500px;" \|[https://www.astm.org/e1578-18.html ASTM E1578-18 C-3-7]
	\| style="background-color:white;" \|'''3.6''' The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.		\| style="background-color:white;" \|'''3.6''' The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.astm.org/~~Standards/E1578~~.~~htm~~ ASTM E1578-18 C-3-8]		\| style="padding:5px; width:500px;" \|[https://www.astm.org/e1578-18.html ASTM E1578-18 C-3-8]
	\| style="background-color:white;" \|'''3.7''' The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.		\| style="background-color:white;" \|'''3.7''' The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.astm.org/~~Standards/E1578~~.~~htm~~ ASTM E1578-18 C-3-9]		\| style="padding:5px; width:500px;" \|[https://www.astm.org/e1578-18.html ASTM E1578-18 C-3-9]
	\| style="background-color:white;" \|'''3.8''' The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.		\| style="background-color:white;" \|'''3.8''' The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.astm.org/~~Standards/E1578~~.~~htm~~ ASTM E1578-18 C-3-10]		\| style="padding:5px; width:500px;" \|[https://www.astm.org/e1578-18.html ASTM E1578-18 C-3-10]
	\| style="background-color:white;" \|'''3.9''' The system shall support, at a minimum, the floating point/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.		\| style="background-color:white;" \|'''3.9''' The system shall support, at a minimum, the floating point/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies ~~2018~~ 2A.7.8.2]<br />[https://www.astm.org/~~Standards/E1578~~.~~htm~~ ASTM E1578-18 C-3-11]		\| style="padding:5px; width:500px;" \|[https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2022 2A.7.8.2]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 C-3-11]
	\| style="background-color:white;" \|'''3.10''' The system shall allow users to enter operators such as <, >, +, and - with numeric test results.		\| style="background-color:white;" \|'''3.10''' The system shall allow users to enter operators such as <, >, +, and - with numeric test results.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.astm.org/~~Standards/E1578~~.~~htm~~ ASTM E1578-18 C-3-12]		\| style="padding:5px; width:500px;" \|[https://www.astm.org/e1578-18.html ASTM E1578-18 C-3-12]
	\| style="background-color:white;" \|'''3.11''' The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.		\| style="background-color:white;" \|'''3.11''' The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.
	\|-		\|-
	\| 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-3-13]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]		\| 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/e1578-18.html ASTM E1578-18 C-3-13]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]
	\| style="background-color:white;" \|'''3.12''' The system should effectively alert users upon entry of out-of-specification test results.		\| style="background-color:white;" \|'''3.12''' The system should effectively alert users upon entry of out-of-specification test results.
	\|-		\|-
Line 49:		Line 58:
	[https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 212.60 (g)]<br />		[https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 212.60 (g)]<br />
	[https://www.law.cornell.edu/cfr/text/21/606.160 21 CFR Part 606.160]<br />		[https://www.law.cornell.edu/cfr/text/21/606.160 21 CFR Part 606.160]<br />
	[https://www.astm.org/~~Standards/E1578~~.~~htm~~ ASTM E1578-18 C-3-14]<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 G16.1]<br />
			[https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.10]
			[https://www.astm.org/e1578-18.html ASTM E1578-18 C-3-14]<br />
			[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.1.2]<br />
			[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.2.1]<br />
	[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.1.2.3–4]<br />		[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.1.2.3–4]<br />
	[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2]<br />		[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2]<br />
Line 55:		Line 68:
	[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.1–4]<br />		[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.1–4]<br />
	[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.16]<br />		[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.16]<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.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 5.4.2]<br />		[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 5.4.2]<br />
	[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 8.1.3]<br />		[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 8.1.3]<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]		[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.8]
	\| style="background-color:white;" \|'''3.13''' The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.		\| style="background-color:white;" \|'''3.13''' The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.
			\|-
			\| style="padding:5px; width:500px;" \|[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 1.2]
			\| style="background-color:white;" \|'''3.14''' The system shall allow users to link samples, specimens, and tests to a specific accreditation approval status (e.g., World Anti-Doping Agency accreditation) so as to ensure that only the appropriate accreditation labels are included on resulting test reports and related documentation.
	\|-		\|-
	\|}		\|}
	\|}		\|}