Audit trail FAQ: hash chains, time-stamps and Part 11

These answers cover the record every signed-in run writes on Ivy. The mechanism is described in The audit trail of a run, and the clause-by-clause mapping is in 21 CFR Part 11.

Frequently asked questions

Is Ivy 21 CFR Part 11 compliant?

No software is Part 11 compliant on its own; compliance belongs to a regulated organization's validated system and procedures. Ivy's Part 11 readiness is in progress. Today it supplies a hash-chained, RFC 3161 time-stamped audit trail, access control and per-job exports. It does not yet supply electronic signatures, enforced retention periods or a validation package.

Does Ivy keep an audit trail of AI agent actions?

Yes, for signed-in runs. Every message, tool call, tool result and model call is written to an append-only event log in which each row carries the hash of the row before it. This covers runs from the web app, the terminal, curl and MCP. Keyless guest calls over curl or orchestrate write nothing durable.

Can the audit trail be edited?

A privileged database role can still edit rows, because the database does not refuse updates to the event log. What it cannot do is edit a row without breaking the chain: the verifier recomputes every hash and link and reports where the chain broke. The record is tamper-evident, not tamper-proof.

How do I verify a chat's record?

Signed in, open /audit/verify and pick a chat, or call GET /api/audit/chat-chain/{chatId} with your API key. For a curl, MCP or orchestrate session, call GET /api/audit/session-chain/{sessionId}. The verdict is verified, verified_partial, not_verifiable, broken or no_record, and a partial read is never reported as a pass.

What do the RFC 3161 time-stamps prove?

About every 30 minutes, each chat chain with new events is folded into a Merkle root, and that root is time-stamped by a public RFC 3161 time-stamping authority. The signed token shows the root, and every event under it, existed no later than the stamped time. It does not prove the time of each individual event, and the scheduled pass does not yet validate the token signatures against trusted roots.

Does Ivy support electronic signatures?

Not today. There is no electronic-signature workflow in production, so Part 11 §11.50 and §11.70 are not covered. Use an e-signature step outside Ivy for records that need one.

What happens to the audit trail when I request GDPR erasure?

Your data is deleted table by table. The hash-chained logs are kept for now, pending a ruling on how erasure and record retention interact, and the erasure report lists every store that was kept and why. Ivy does not crypto-shred chained records today.

Can I export the record for an inspection?

Yes, per job. GET /api/exports/glp-package?jobId=… returns a ZIP with raw inputs, parameters, the audit trail and checksums. GET /api/exports/chain-of-custody returns a JSON or HTML report for a job, compound or project.