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

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   | style="background-color:white;" |'''5.1''' The system shall accurately record details of a sample's final disposition.
   | style="background-color:white;" |'''5.1''' The system shall accurately record details of a sample's final disposition.
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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 2018 2A.7.7.2]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-5-2]
   | 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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Revision as of 19:13, 27 January 2021

Regulation, Specification, or Guidance Requirement
ASTM E1578-18 C-5-1
USDA Sample Processing and Analysis Procedures for PDP 5.9–10
5.1 The system shall accurately record details of a sample's final disposition.
AIHA-LAP Policies 2018 2A.7.7.2
ASTM E1578-18 C-5-2
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" and "rejected," including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.