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1. Assessment details
Identify the system and assessment context. These details will appear in your report.
2. Filter and track the checklist
Use the filters to focus on open gaps, higher-priority items or a particular requirement area.
3. Readiness overview
The overview reflects the checklist statuses you select. It is a planning summary, not a formal compliance score.
Not applicable items are excluded from the coverage denominator. Coverage does not establish regulatory compliance.
4. Part 11 readiness checklist
For each item, assess applicability and actual evidence. “Implemented” should be selected only when appropriate evidence has been reviewed and the relevant control is operating as intended.
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5. Generate and export your assessment
Generate a summary after reviewing the items. The report includes the assessment details, checklist status counts, high-priority gaps and recorded notes.
Readiness report
Review the findings and agree on actions with the appropriate stakeholders.
Understanding FDA 21 CFR Part 11 readiness
21 CFR Part 11 establishes criteria under which the FDA considers certain electronic records, electronic signatures and handwritten signatures executed to electronic records to be trustworthy, reliable and generally equivalent to paper records and handwritten signatures. Applicability depends on the records, signatures and underlying regulatory requirements involved.
Determine which records are in scope
Start by identifying records required by applicable FDA regulations and whether the organization relies on electronic records in place of paper records or relies on electronic records alongside paper records. Document the reasoning for each record type and intended use. Do not assume that every electronic file is automatically subject to Part 11, or that printing a record automatically removes Part 11 considerations.
Assess system controls and record integrity
Review access restrictions, authority checks, operational checks, audit-trail capabilities, record protection, record retrieval, system documentation and relevant validation evidence. The controls needed depend on system design, intended use, risk and applicable predicate rules. Assess the actual implementation and supporting evidence, rather than relying only on vendor statements.
Assess electronic signatures
Where electronic signatures are used in scope, assess identity verification, unique signature assignment, signature manifestation and linkage to the signed record. Review signature components and controls against the applicable requirements, including the relevant provisions in 21 CFR §§ 11.50, 11.70, 11.100, 11.200 and 11.300 as applicable.
Use documented, risk-based follow-up
Record gaps with an owner, due date, supporting evidence and planned corrective action. Involve quality assurance, regulatory affairs, IT, system owners and process users as appropriate. Assess interfaces and outsourced services when they form part of the regulated process. Reassess controls after relevant system changes.
Official reference materials
- 21 CFR Part 11 — Electronic Records; Electronic Signatures (eCFR)
- FDA Guidance: Part 11, Electronic Records; Electronic Signatures — Scope and Application
- FDA Guidance: Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations — Questions and Answers
FDA guidance describes the agency's current thinking and is generally nonbinding. Confirm the current regulation, applicable predicate rules and product-specific guidance for your use case.