Journal
TOXICOLOGIC PATHOLOGY
Volume 32, Issue 1, Pages 122-123Publisher
TAYLOR & FRANCIS INC
DOI: 10.1080/01926230490268710
Keywords
21 CFR; histopathology; audit; electronic signature
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The purpose of this paper is to discuss the requirement of the audit trail to track changes made to the histopathology data, in order to be compliant with the Code of Federal Regulations (CFR), Volume 21, for both Part 58 (Good Laboratory Practices [GLP]) and Part 11 (Electronic Records/Signatures).
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