FDA 21 CFR Part 11 Compliance: Requirements Management & Electronic Signatures
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Direct Official PortalsNavigating FDA 510(k) and PMA Software Audits
Medical device software developers must prove to FDA auditors that every medical hazard analysis links directly to a software mitigation requirement and a verified unit test.
21 CFR Part 11 Mandatory Controls: - **Electronic Signatures**: Must contain the printed name of the signer, date/time, and meaning (e.g. approval, review, authorship). - **Computer-Generated Audit Trails**: System must independently record the date and time of operator entries and actions that create, modify, or delete records. - **Authority Checks**: Enforce role-based access so only authorized personnel can approve functional specifications.
Both [Jama Connect](https://www.jamasoftware.com) and [Visure](https://visuresolutions.com) provide pre-validated cloud environments with complete audit-readiness documentation.
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