How to Stay Compliant with 21 CFR Part 11 and EU Annex 11

How to Stay Compliant with 21 CFR Part 11 and EU Annex 11

Maintaining compliance with 21 CFR Part 11 and EU Annex 11 is crucial for pharmaceutical companies operating globally. This article outlines key steps to ensure regulatory compliance, data integrity, and system reliability, helping businesses avoid costly penalties and ensure smooth operations.