How many controls does FDA 21 CFR Part 11 have?

FDA 21 CFR Part 11 contains 24 controls organized across 5 domains.

Where does FDA 21 CFR Part 11 apply?

FDA 21 CFR Part 11 is applicable in United States. Organizations operating in or serving customers in this jurisdiction should evaluate its requirements.

What frameworks does FDA 21 CFR Part 11 map to?

FDA 21 CFR Part 11 has control-to-control mappings with 474 other compliance frameworks in our database. Use our compliance platform to explore these mappings interactively.

How do I get started with FDA 21 CFR Part 11 compliance?

Start by understanding the framework's key controls and domains. Our compliance platform provides AI-powered gap analysis and mapping tools to help you assess your current posture and build a remediation plan.

FDA 21 CFR Part 11

Electronic Records; Electronic Signatures (pharmaceutical/medical devices).

Domains

FDA 21 CFR Part 11: Organizational Requirements

FDA 21 CFR Part 11: Technical Safeguards

FDA 21 CFR Part 11: Physical Safeguards

FDA 21 CFR Part 11: Administrative Safeguards

FDA 21 CFR Part 11: Patient Data Protection

Frequently Asked Questions

Map FDA 21 CFR Part 11 to any other framework

Use our AI-powered compliance platform to find control overlaps, gaps, and build remediation plans in seconds.

Try Free on Compliance Platform