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Toxicologic Pathology
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What's this?

Society of Toxicologic Pathology Position on Histopathology Data Collection and Audit Trail: Compliance with 21 CFR Parts 58 and 11

Darrell Tuomari

Schering-Plough

Glenn Elliott

Sierra Biomedical

Barbara Kulwich

Johnsons and Johnson

John Yarrington

WIL Research

Xavier Fouillet

Bracco Research, S.A.

Frank Geoly

Pfizer

Philip Long

Pathology Associates Inc

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).

Key Words: 21 CFR • histopathology • audit • electronic signature.

Toxicologic Pathology, Vol. 32, No. 1, 122-123 (2004)
DOI: 10.1080/01926230490268710
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