21 CFR Compliance

FDA 21 CFR Part 11 defines the criteria for the acceptance by the FDA of electronic records, electronic signatures and handwritten signatures executed to electronic documents. These rules apply to pharmaceutical, medical device, biotech, and biologics manufacturers, and other FDA-regulated industries. 

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Our validation and compliance experts thoroughly understand the requirements of 21 CFR Part 11. They define, document and execute procedural controls to protect computer systems data and ensure that records are authentic, durable, incorruptible and confidential as required. We can help you at any and all stages of compliance preparedness with a robust 21 CFR Part 11 compliance program.