21 CFR Part 11 Compliance Checklist
A section-by-section checklist of every requirement in FDA 21 CFR Part 11 for electronic records and electronic signatures. 34 items covering Subpart B and Subpart C, each mapped to its specific CFR section.
Why Organizations Need a Part 11 Checklist
FDA 21 CFR Part 11 defines over 30 distinct requirements spread across seven regulatory sections. The regulation covers everything from system validation and audit trail retention to two-factor authentication and password management controls. Missing even a single requirement can result in a Form 483 observation or a warning letter, both of which create real operational disruption and reputational risk.
The challenge is that Part 11 was written as regulatory text, not as an implementation guide. Subpart B (Electronic Records) and Subpart C (Electronic Signatures) each contain requirements that interact with each other but are structured by regulatory logic rather than by implementation order. A checklist that maps every requirement to its specific CFR section gives QA teams, IT departments, and compliance officers a concrete way to verify coverage without re-reading the regulation every time.
This checklist is designed for three use cases: evaluating a new e-signature vendor against Part 11 requirements, conducting internal compliance audits of existing systems, and preparing documentation before an FDA inspection. It covers all items from Section 11.10 through Section 11.300, organized by subpart and section for easy reference.
What the Checklist Covers
34 individual requirements organized by Part 11 section, each referencing the specific CFR subsection.
Controls for Closed Systems
11.10Validation, audit trails, access controls, authority checks, device checks, personnel qualifications, accountability, and document controls.
14 items
Controls for Open Systems
11.30Additional encryption and digital signature measures beyond closed system controls.
2 items
Signature Manifestations
11.50Printed name, date/time, and meaning (approval, review, authorship) displayed on signed records.
4 items
Signature/Record Linking
11.70Signatures linked to records so they cannot be excised, copied, or transferred.
1 item
General Requirements
11.100Unique signatures, identity verification, and FDA certification of electronic signature intent.
4 items
Components and Controls
11.200Two-factor authentication requirements, continuous session rules, and biometric controls.
4 items
Identification Codes/Passwords
11.300Uniqueness, periodic review, loss management, transaction safeguards, and device testing.
5 items
Related Part 11 Guides
Go deeper on specific Part 11 topics with these guides from the Certivo blog.
Built for Part 11 Compliance
Certivo is a purpose-built e-signature platform for life sciences organizations that need FDA 21 CFR Part 11 compliance without the overhead of configuring a general-purpose tool. SHA-256 hash chain audit trails, 2FA at every signing event, and validation documentation included.