Introduction In the highly regulated world of pharmaceuticals, biotechnology, and medical device manufacturing, ensuring product quality, safety, and data integrity is of utmost importance. One crucial regulation that governs electronic records and signatures is 21 CFR Part 11. This article aims to shed light on the significance of 21 CFR Part 11 in Good Manufacturing Practices (GMP) compliance. What is 21 CFR Part 11? 21 CFR Part 11, also known as Part 11, was established by the U.S. Food and Drug Administration (FDA) in 1997. It outlines the requirements for…
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