21 CFR Part 11 - Food & Drug Administration (FDA) 21 CFR Part 11 (2025)

Overview

US FDA regulation governing electronic records and electronic signatures in FDA-regulated industries.

✓Control mapping — map your controls once and reuse the evidence across every overlapping framework you fall under.
✓Gap assessment — see exactly where you stand against each requirement, with a prioritised list of what to fix first.
✓Deadline tracking — track readiness against key dates and assign owners so nothing slips.
✓Continuous monitoring — get alerted the moment a tool, vendor or control drifts out of compliance.