FDA — 21 CFR Part 11 & Device Cybersecurity

Overview

FDA — 21 CFR Part 11 & Device Cybersecurity (FDA) — US FDA requirements for electronic records and signatures (21 CFR Part 11), medical device cybersecurity, and CGMP manufacturing controls. ComplAI maps this framework’s controls so your team can track implementation, evidence, and audit readiness.

13 controls available in ComplAI for this framework.

Who it's for

• Organizations that must demonstrate FDA compliance
• Security and compliance teams operating in United States
• Customers and partners that require FDA assurance

Why it matters

FDA is a recognized manufacturing framework. Activating it in ComplAI lets you manage controls, evidence, and readiness in one place.

How ComplAI helps

• Activate FDA in the Framework Library to load its control catalog
• Assign owners, track compliance status, and attach evidence per control
• Use risk register and issues workflows when controls fail or deviate
• Export readiness views for leadership and auditors

Sample controls

• 21 CFR 11.10

  Electronic record controls

  data protection

• 21 CFR 11.30

  Record retention and retrieval

  governance

• 21 CFR 11.50

  Electronic signature manifestations

  governance

• 21 CFR 11.100

  Electronic signature controls

  access control

• 21 CFR 11.200

  Signature linking

  data protection

• Cyber Guid. 1

  Cybersecurity risk management

  risk management

Getting started

1. Open Framework Library and activate FDA
2. Review the control list and prioritize high-impact domains
3. Attach policies, procedures, and technical evidence
4. Mark controls audit-ready and monitor residual gaps