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| Regulation, Specification, or Guidance
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Requirement
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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
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5.1 The system shall accurately record details of a sample or specimen's final disposition.
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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
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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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21 CFR Part 211.160 (b)
ASTM E1578-18 C-5-3
EPA 815-R-05-004 Chap. IV, Sec. 6.1
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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.
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