Society of Toxicologic Pathology position on histopathology data collection and audit trail: compliance with 21 CFR parts 58 and 11.

Darrell Tuomari,Glenn Elliott, Barbara Kulwich,John Yarrington,Xavier Fouillet,Frank Geoly,Philip Long

TOXICOLOGIC PATHOLOGY（2004）

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摘要

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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关键词

21 CFR,histopathology,audit,electronic signature

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