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This article explains how data in GMP is controlled across its lifecycle, focusing on pharmaceutical data integrity, audit trail review, and electronic records compliance. It highlights regulatory expectations under ALCOA+ principles, FDA guidance, and Annex 11 requirements for inspection readiness.
In the life sciences sector, aligning with 21 CFR Part 11 isn't just good practice—it's crucial. This regulation, part of the Code of Federal Regulations, ensures the reliability of electronic records and signatures for FDA-regulated entities like pharmaceuticals, medical device