Articles tagged with “21-cfr-part-58”

GLP Audit Trails: A Guide to Compliant File Systems

Learn the technical requirements for GLP audit trails (updated April 2026). Covers compliant file systems, WORM storage, EU Annex 11 revision, OECD IT Security guidance, and network shares for data integrity

55 min read

11/17/2025

good laboratory practice glp audit trail data integrity 21 cfr part 58 immutable storage worm storage compliant file system

21 CFR Part 58: A Guide to Good Laboratory Practice (GLP)

Learn about 21 CFR Part 58, the FDA's Good Laboratory Practice (GLP) regulations for nonclinical studies. Updated for 2026 with recent enforcement actions, OECD IT security guidance, and New Approach Methodologies (NAMs)

45 min read

11/17/2025

21 cfr part 58 good laboratory practice glp fda regulations nonclinical studies data integrity quality assurance regulatory compliance