CFR Part 11

CFR Part 11 is a regulation established by the U.S. Food and Drug Administration (FDA) that outlines the criteria for electronic records and electronic signatures to ensure they are trustworthy, reliable, and equivalent to paper records. Primarily relevant to the Life Sciences sector—including pharmaceuticals, biotechnology, and medical devices—CFR Part 11 sets the standards for systems that manage digital documents related to regulatory processes. Compliance with CFR Part 11 enables organizations to securely manage and authenticate electronic records and signatures, reducing reliance on paper documentation while meeting FDA requirements for data integrity, traceability, and accuracy.

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