How does Burna AI handle 21 CFR Part 11 electronic records and signatures?

Burna AI is built for 21 CFR Part 11, the FDA regulation for electronic records and electronic signatures. A grade becomes a record only when a qualified investigator signs it. Signing requires the signer to re-authenticate at that moment, and the signature records who signed, when and the meaning of the signature, with a SHA-256 hash of the signed content stored alongside, so a later change to that content is detectable. The signed record carries what was accepted, what was overridden and the citation set as signed. Every governed action writes an audit row naming the user, their role, the action, the record, the previous and new value, the time and the source address, so a correction shows what it changed. Access is role-based and scoped to the organization, with SSO and SAML sign-in. The architecture a security review asks about is set out at burna.ai/it.