How do 21 CFR Part 11 e-signatures work on grading decisions in Burna AI?

A grade becomes a record when a qualified investigator signs it. At the moment of signing, Burna AI asks the signer to re-authenticate with their password, passkey or one-time code, so the signature is tied to that person at that time. The signature records the signer, the date and time and the meaning of the signature, and a SHA-256 hash computed over the signed content is stored with it. If the content changes after signing, the hash no longer matches, and the same check stops an EDC or chart filing whose content differs from what was signed. The signed record carries what the clinician accepted, what they overrode and the citation set as signed, and each signature writes an audit row. These controls follow 21 CFR Part 11 sections 11.50, on signature manifestations, and 11.200, on signature components.