21 CFR Part 11 is the FDA regulation governing electronic records and electronic signatures. Burna AI is 21 CFR Part 11 aligned across four dimensions. Cryptographic signatures: all AI-generated grades and clinician approvals are signed with SHA-256, tamper-proof, and include complete provenance tracking. Audit trail: every action is logged with user, timestamp, IP, and resource, retained for 6 years. Access controls: organisation-scoped role-based access with adjudicator, grader, admin, and reviewer roles. System validation: the engine cannot produce a grade outside the defined CTCAE set or skip citation, enforced architecturally.
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