How does Burna AI support 21 CFR Part 11 compliance?

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.