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Checklist: FDA 21 CFR Part 11 Compliance

cover page for the fda 21 cfr part 11 compliance checklist

For FDA-regulated manufacturers, ensuring Part 11 Compliance can be challenging and confusing, as many different systems are often used, in conjunction with hard paper copies, to store and transmit records. For most manufacturers, relying solely paper processes is not a practical option in today’s digital age, so ensuring the digital systems they are using meet the FDA’s requirements is essential. Download this checklist of requirements that can be used to ensure your software meets FDA 21 CFR Part 11 Compliance requirements.