21 CFR Part 11 Compliance Checklist
A comprehensive checklist covering all FDA requirements for electronic records and electronic signatures. Use this to assess your systems and prepare for audits.
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What's in the checklist
21 CFR Part 11 establishes the FDA's criteria for accepting electronic records and electronic signatures as equivalent to paper records and handwritten signatures. This checklist covers all requirements across three main areas.
Subpart B: Electronic Records
Requirements for systems that create, modify, maintain, archive, retrieve, or transmit electronic records.
Section 11.10 - Controls for Closed Systems
- Validation
System validation to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.
- Record Generation
Ability to generate accurate and complete copies of records in both human-readable and electronic form.
- Record Protection
Protection of records throughout their retention period to enable accurate and ready retrieval.
- + 8 more requirements
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Section 11.30 - Controls for Open Systems
- All Closed System Controls
Open systems must meet all requirements of closed systems (Section 11.10).
- Document Encryption
Use of document encryption to ensure record authenticity, integrity, and confidentiality.
- + Additional open system requirements
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Subpart C: Electronic Signatures
Requirements for electronic signatures to be considered legally equivalent to handwritten signatures.
Section 11.50 - Signature Manifestations
- Printed Name
Signed electronic records must contain the printed name of the signer.
- Date and Time
Date and time when the signature was executed.
- Meaning of Signature
The meaning associated with the signature (e.g., review, approval, responsibility).
Section 11.100 - General Requirements
- Unique Identification
Each electronic signature must be unique to one individual and not reused or reassigned.
- Identity Verification
Verify the identity of individuals before assigning electronic signatures.
- + More signature requirements
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Audit Trail Requirements
One of the most critical and commonly cited areas during FDA inspections.
Key Audit Trail Elements
- Computer-Generated Timestamp
Secure, computer-generated timestamps that cannot be modified by users.
- Previous Values
Record of previous values when changes are made to electronic records.
- Independent Review
Audit trail available for independent review by QA and regulatory agencies.
- + Complete audit trail checklist
Full list of audit trail requirements and assessment criteria
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The full checklist includes 40+ requirements across all sections, assessment criteria for each item, common findings from FDA inspections, and documentation guidance.