How to Survive a Regulatory Audit: 5 Common Gaps Found in Computerized System Audit Trails (and How to Fix Them)
Quick answer: Audit trail compliance means more than switching the audit trail on. Under 21 CFR 11.10(e) and EU GMP Annex 11, section 9, your audit trails must be secure, time-stamped, unable to obscure original data, retained as long as the record, and regularly reviewed. The five gaps inspectors find [...]