Question 1

What is FDA 21 CFR Part 11 — Electronic Records, Electronic Signatures and how does it apply to AI agents?

Accepted Answer

Electronic records integrity and signatures — tamper-evident audit chain maps directly to Part 11 audit trail requirements.

Question 2

How does AutoPIL help with FDA 21 CFR Part 11 — Electronic Records, Electronic Signatures compliance?

Accepted Answer

Hash-linked audit chain implements §11.10(e) secure, computer-generated, time-stamped audit trails Agent registry binds the AI agent identity to each electronic record action Tamper-evident chain prevents §11.10(e) 'obscuring previously recorded information'

Question 3

What are the key AI governance requirements under FDA 21 CFR Part 11 — Electronic Records, Electronic Signatures?

Accepted Answer

FDA 21 CFR Part 11 — Electronic Records, Electronic Signatures requires documented access controls, audit trails, and risk management procedures for AI systems operating against regulated data. AutoPIL's policy engine, audit chain, and agent registry address these requirements at the retrieval layer.

FDA 21 CFR Part 11 — Electronic Records, Electronic Signatures — Regulatory Reference

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