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By - SebastianFeye

Part 11 compliance is critical, Firms need to be aware of compliance with using the Cloud

21 CFR Part 11 – Electronic Records Part 11 of the Code of Federal Regulations applies to drug makers, medical device manufacturers, biotech companies, biologics developers, CROs, and other FDA-regulated industries, with some specific exceptions in regards to electronic record keeping. [1] It requires that they implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software