title: Society of Toxicologic Pathology position on histopathology data collection and audit trail: compliance with 21 CFR parts 58 and 11.
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).
authors.affiliation: Schering-Plough.
authors.forename: Darrell
authors.initials: D
authors.lastname: Tuomari
authors.forename: Glenn
authors.initials: G
authors.lastname: Elliott
authors.forename: Barbara
authors.initials: B
authors.lastname: Kulwich
authors.forename: John
authors.initials: J
authors.lastname: Yarrington
authors.forename: Xavier
authors.initials: X
authors.lastname: Fouillet
authors.forename: Frank
authors.initials: F
authors.lastname: Geoly
authors.forename: Philip
authors.initials: P
authors.lastname: Long
mesh_terms: 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