FDA 21 CFR Part 11
Electronic Records; Electronic Signatures (pharmaceutical/medical devices)
Framework summaries on this platform are AI-assisted interpretations for educational and compliance planning purposes. They do not reproduce or replace the official standards. Refer to the authoritative source for the definitive text. Framework names and trademarks belong to their respective organisations.
Framework Domains (5)
FDA 21 CFR Part 11: Administrative Safeguards
Organizational security management (FDA 21 CFR Part 11)
| Code | Title |
|---|---|
| FDA-CFR11-06 | Security management process and risk analysis |
| FDA-CFR11-07 | Workforce security and clearance procedures |
| FDA-CFR11-08 | Information access management |
| FDA-CFR11-09 | Security awareness and training program |
| FDA-CFR11-10 | Contingency planning for ePHI |
| FDA-CFR11-11 | Business associate management |
FDA 21 CFR Part 11: Organizational Requirements
Policies, procedures, and documentation (FDA 21 CFR Part 11)
| Code | Title |
|---|---|
| FDA-CFR11-21 | Security and privacy policies |
| FDA-CFR11-22 | Documentation and record retention |
| FDA-CFR11-23 | Compliance evaluation and review |
| FDA-CFR11-24 | Incident reporting procedures |
FDA 21 CFR Part 11: Patient Data Protection
Safeguarding protected health information (FDA 21 CFR Part 11)
| Code | Title |
|---|---|
| FDA-CFR11-01 | ePHI access controls and authorization |
| FDA-CFR11-02 | ePHI encryption at rest and in transit |
| FDA-CFR11-03 | Minimum necessary standard enforcement |
| FDA-CFR11-04 | Patient data de-identification procedures |
| FDA-CFR11-05 | Audit trail for ePHI access |
FDA 21 CFR Part 11: Physical Safeguards
Physical security for systems with ePHI (FDA 21 CFR Part 11)
| Code | Title |
|---|---|
| FDA-CFR11-17 | Facility access controls |
| FDA-CFR11-18 | Workstation security and use policies |
| FDA-CFR11-19 | Device and media controls |
| FDA-CFR11-20 | Disposal and re-use procedures |
FDA 21 CFR Part 11: Technical Safeguards
Technical measures for ePHI protection (FDA 21 CFR Part 11)
| Code | Title |
|---|---|
| FDA-CFR11-12 | Unique user identification and authentication |
| FDA-CFR11-13 | Automatic logoff and session management |
| FDA-CFR11-14 | Audit controls and monitoring |
| FDA-CFR11-15 | Integrity controls for ePHI |
| FDA-CFR11-16 | Transmission security and encryption |
Maps to 547 other frameworks
Frequently Asked Questions
What is FDA 21 CFR Part 11?
FDA 21 CFR Part 11 is a compliance framework from United States with 5 domains and 24 controls. Electronic Records; Electronic Signatures (pharmaceutical/medical devices) It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
How many controls does FDA 21 CFR Part 11 have?
FDA 21 CFR Part 11 has 24 controls organised across 5 domains. The largest domains are FDA 21 CFR Part 11: Administrative Safeguards (6 controls), FDA 21 CFR Part 11: Patient Data Protection (5 controls), FDA 21 CFR Part 11: Technical Safeguards (5 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
What frameworks does FDA 21 CFR Part 11 map to?
FDA 21 CFR Part 11 maps to 547 other compliance frameworks. The top mapping partners are NIS2 Directive Implementing Acts (46% coverage), UK Telecommunications (Security) Act 2021 (46% coverage), US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule (46% coverage). Use our comparison tool to explore control-level mappings between frameworks.
How do I get started with FDA 21 CFR Part 11 compliance?
Start your FDA 21 CFR Part 11 compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about FDA 21 CFR Part 11 requirements, and cross-framework mapping helps you leverage existing controls from other frameworks you may already comply with. Create a free account to access all 24 controls and track your progress.
Start Your Compliance Journey
Create a free account to run self-assessments, get AI advisory, and track your compliance progress across 692 frameworks.
Get Started Free →Free forever — no credit card required