21 CFR Part 11 Overview
FDA requirements governing electronic records, electronic signatures, audit trails, and validation practices within regulated environments.
What You Can Expect
Practical insights you can apply right away.
Electronic Records Must Be Trustworthy
To qualify under Part 11, electronic records must be created and maintained in systems that are validated for accuracy and reliability, protected against unauthorised access, and supported by secure, time-stamped audit trails that cannot be altered or obscured.
Electronic Signatures Have Strict Requirements
Electronic signatures must be unique to one individual, use at least two identification components such as a username and password, and be certified to the FDA as legally binding equivalents of handwritten signatures. Biometric-based signatures must be designed so they cannot be used by anyone other than their genuine owner.
Relevance to Digital Food Safety Systems
For food and beverage companies using digital platforms to manage compliance records, lab data, or HACCP documentation under FDA oversight, Part 11 compliance is essential. It defines the technical and procedural controls required to ensure digital records hold up to regulatory scrutiny.