Difference between revisions of "Template:LIMSpec/Sample, experiment, and study approval and verification"

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   ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
   ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
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   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-5-1]<br />[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP 5.9–10]
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   | style="background-color:white;" |'''5.1''' The system shall accurately record details of a sample's final disposition.
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-5-1]<br />
[https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<br />
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.3.5]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP 5.9–10]<br />
[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.12.1]
   | style="background-color:white;" |'''5.1''' The system shall accurately record all details of a sample's final disposition, including, when applicable, storage container type and ID, disposal method, disposal location, person responsible for disposition, etc.
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   | style="padding:5px; width:500px;" |[https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018 2A.7.7.2]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-5-2]
   | style="padding:5px; width:500px;" |
[https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2022 2A.7.7.2]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-5-2]<br />
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.2.2]<br />
[https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers EMA Guidance on Good Manufacturing Practice and Good Distribution Practice]<br />
[https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5, 4.12]
   | style="background-color:white;" |'''5.2''' The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.
   | style="background-color:white;" |'''5.2''' The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.
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   | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (b)]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-5-3]<br />[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 6.1]
   | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (b)]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 C-5-3]<br />[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 6.1]
   | style="background-color:white;" |'''5.3''' The system should provide appropriate functions for specific sample statuses like "approved" and "rejected," including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.
   | style="background-color:white;" |'''5.3''' The system should provide appropriate functions for specific sample statuses like "approved," "rejected," and "cancelled," including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.
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Latest revision as of 00:15, 22 June 2023

Regulation, Specification, or Guidance Requirement

ASTM E1578-18 C-5-1
CAP Laboratory Accreditation Manual
CLSI QMS22 2.2.3.5
USDA Sample Processing and Analysis Procedures for PDP 5.9–10
WADA International Standard for Laboratories (ISL) 5.3.12.1

5.1 The system shall accurately record all details of a sample's final disposition, including, when applicable, storage container type and ID, disposal method, disposal location, person responsible for disposition, etc.

AIHA-LAP Policies 2022 2A.7.7.2
ASTM E1578-18 C-5-2
CLSI QMS22 2.2.2.2
EMA Guidance on Good Manufacturing Practice and Good Distribution Practice
WHO Technical Report Series, #996, Annex 5, 4.12

5.2 The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.
21 CFR Part 211.160 (b)
ASTM E1578-18 C-5-3
EPA 815-R-05-004 Chap. IV, Sec. 6.1 		5.3 The system should provide appropriate functions for specific sample statuses like "approved," "rejected," and "cancelled," including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.
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