Understanding the Differences: 21 CFR Part 11 vs. Annex 11
Understanding the Differences: 21 CFR Part 11 vs. Annex 11 Two key regulations that pharmaceutical and medical device companies need to be compliant with are 21 CFR Part 11 and Annex 11, which are crucial to ensure product quality, safety and data integrity. While both regulations are aimed at ensuring the integrity of electronic records […]