Articles tagged with “glp”

FDA BIMO Inspection Trends, FY2015-FY2024: Data Atlas

A 2026 data atlas of FDA BIMO inspections by fiscal year, inspected party and classification, with source-deck revisions, denominator rules, observation families and control priorities.

21 min read

9/24/2026

fda bimo inspection trends bioresearch monitoring fda inspections clinical investigator sponsor cro irb glp bioequivalence inspection classifications

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

GLP-Compliant Audit Trail on macOS: A Technical Guide

A technical guide to creating a GLP-compliant audit trail on macOS (Sequoia 15 / Tahoe 26). Learn to meet data integrity rules (21 CFR Part 11, FDA CSA 2025) using APFS, FSEvents & Endpoint Security

35 min read

11/16/2025

glp audit trail macos data integrity 21 cfr part 11 regulatory compliance apfs endpoint security framework