Building an audit trail you would actually show a regulator

Every AI product in regulated industries claims an audit trail. Most mean a log table with a timestamp column. A regulatory reviewer knows the difference. This is what 21 CFR Part 11 actually requires for AI-generated clinical data artifacts — and the specific design choices we made to meet it in TrialNexus.

The core architectural choice is append-only storage. No record in the TrialNexus audit schema is ever updated or deleted. The full history of any artifact is recoverable by reading the append log in sequence.