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

doi:10.1080/01926230490268710

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

Toxicol Pathol. 2004 Jan-Feb;32(1):122-3. doi: 10.1080/01926230490268710.

Authors

Darrell Tuomari¹, Glenn Elliott, Barbara Kulwich, John Yarrington, Xavier Fouillet, Frank Geoly, Philip Long

Affiliation

¹ Schering-Plough.

PMID: 14713556
DOI: 10.1080/01926230490268710

Abstract

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).

MeSH terms

Animals
Data Collection / legislation & jurisprudence
Data Collection / methods
Data Collection / standards*
Information Management / legislation & jurisprudence
Information Management / methods
Information Management / standards*
Management Audit / methods
Management Audit / standards*
Pathology / legislation & jurisprudence
Pathology / methods
Pathology / standards*
Quality Assurance, Health Care / organization & administration
Societies, Scientific
Toxicology / legislation & jurisprudence
Toxicology / methods
Toxicology / standards*
United States