Is your AI clinical trial tool actually 21 CFR Part 11 compliant? A checklist.

Every AI tool entering the clinical trial space claims to be 21 CFR Part 11 compliant. The phrase has become a marketing checkbox deployed without precision. The gap between what 21 CFR Part 11 actually requires for AI-generated clinical data artifacts and what most vendors implement is wide enough to constitute a compliance risk.

Part 11 requires computer-generated, time-stamped, append-only audit trails that capture every operator action — including AI inference calls. The audit trail must capture which agent made each call, which model version was used, what inputs were provided, what outputs were returned, and the exact timestamp. Human approval is required before AI output enters any clinical record, and that approval must be authenticated, attributed, and immutably logged.