Society of Toxicologic Pathology position on histopathology data collection and audit trail: compliance with 21 CFR parts 58 and 11.
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).
Tuomari
Darrell
D
Schering-Plough.
Elliott
Glenn
G
Kulwich
Barbara
B
Yarrington
John
J
Fouillet
Xavier
X
Geoly
Frank
F
Long
Philip
P
D000818:Animals; D003625:Data Collection / Q000331:legislation & jurisprudence / Q000379:methods / Q000592:standards*; D019451:Information Management / Q000331:legislation & jurisprudence / Q000379:methods / Q000592:standards*; D008330:Management Audit / Q000379:methods / Q000592:standards*; D010336:Pathology / Q000331:legislation & jurisprudence / Q000379:methods / Q000592:standards*; D011785:Quality Assurance, Health Care / Q000458:organization & administration; D012958:Societies, Scientific; D014116:Toxicology / Q000331:legislation & jurisprudence / Q000379:methods / Q000592:standards*; D014481:United States