---
title: "FDA 21 CFR Part 11 Compliance — Definition & Engineering Context"
description: "FDA 21 CFR Part 11 is a United States Food and Drug Administration regulation establishing criteria under which electronic records and electronic signatures are considered trustworthy and equivalent to paper records."
canonical: https://erpstack.io/glossary/fda-part-11
markdown_url: https://erpstack.io/glossary/fda-part-11.md
publisher: ERPStack
---

# FDA 21 CFR Part 11 Compliance

> **Definition:** FDA 21 CFR Part 11 is a United States Food and Drug Administration regulation establishing criteria under which electronic records and electronic signatures are considered trustworthy and equivalent to paper records.

## In depth

Part 11 compliance is mandatory for software systems used in clinical trials and medical device manufacturing. The regulation requires implementing dual-signature verification, automated session timeout limits, and detailed, cryptographically hashed database log tables.

## How ERPStack applies this

We build clinical trial software with dual-signature validation flows, MFA confirmations, and tamper-evident audit logs to satisfy FDA auditors.

## Related reading

- [HIPAA Compliance](https://erpstack.io/glossary/hipaa)
- [Audit Trail](https://erpstack.io/glossary/audit-trail)