Technical Glossary
FDA 21 CFR Part 11 Compliance
Exact 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.
Architectural Deep Dive
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.
The ERPStack Approach
We build clinical trial software with dual-signature validation flows, MFA confirmations, and tamper-evident audit logs to satisfy FDA auditors.