Articles tagged with “21-cfr-part-58”

GLP Audit Trails: A Guide to Compliant File Systems

Learn the technical requirements for GLP audit trails. This guide covers compliant file systems, immutable storage (WORM), and network shares for data integrity

50 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. This guide covers its scope, history, and key subparts

45 min read

11/17/2025

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