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Your guide to 21 CFR Part 11 compliance
Head of Product - CPO, AODocs · Sep 2, 2023 · Updated Oct 6, 2026
For life sciences companies with covered FDA records, Part 11 compliance requires an assessment of electronic records, signatures, and procedures. A cloud QMS can support controlled electronic records and signatures when configured for the intended use; software alone does not establish compliance.
21 CFR Part 11 is an FDA regulation addressing specified electronic records and electronic signatures maintained or submitted under FDA record requirements. Determine which records and signatures are in scope, including applicable exemptions and predicate rules, before selecting technical and procedural controls.
To assess your process and identify evidence gaps, we recommend using our 21 CFR Part 11 compliance checklist:
Discover our 21 CFR Part 11 checklist
Use the checklist to identify relevant controls, responsible owners, required evidence, and unresolved gaps. Completion does not certify compliance or replace intended-use validation and procedural assessment.
While operational processes within your quality program can be made much easier with automation, keeping track of the design, development, review and acknowledgment of your program policies and procedures can quickly become cumbersome. The critical features and functions of the software tools you can implement to facilitate this process can be broken down into 4 main stages:
- Validation
- Audit
- Records
- Retention
Completing the checklists for each of these categories is a great starting point for your evaluation of software and the capabilities that you would find most helpful in the implementation and validation of your Quality program processes.
At AODocs, we have used this checklist as a guide to providing a QMS application within our qualified platform to enable quality programs like yours. We also provide a path for enhancing your Quality program, with advanced learning and acknowledgements, information governance and records management, audit, corrective actions, and quality events. Each one of these can keep your QMS investment growing with your Quality program.
To learn more, download our complete checklist for the 4 stages of compliance:
If you’d like to learn more about how AODocs for Life Sciences can bring Continuous Validation to your Quality program, visit our website today and ask for a demo.
Frequently asked questions
How to prepare a compliance checklist?
Prepare a Part 11 compliance checklist by identifying the records, systems, intended uses, and applicable FDA predicate rules. Then map the relevant controls to evidence and responsible owners. A checklist designed for one regulated process may not fit another, so document its scope before assessing gaps or selecting technical controls.
What evidence should support a completed Part 11 checklist?
Each assessed control should link to relevant evidence, such as approved procedures, access records, validation results, or a tested signature and audit-trail example. Record gaps, responsible owners, and the decision on closure. A checked box or supplier statement does not demonstrate that the control operates in the organization's intended use.
Does a Part 11 checklist need review after a system change?
A system or process change should trigger an assessment of its effect on regulated records and the existing control evidence. FDA guidance supports a justified, documented, risk-based approach to validation. Determine which tests, procedures, or training need updating rather than assuming every change requires complete revalidation or no review.
Does completing a checklist certify Part 11 compliance?
No. A checklist helps organize an assessment but does not certify that a system and its use comply with Part 11. The organization must evaluate the applicable requirements, resolve relevant gaps, and maintain the technical and procedural controls over time. Keep the assessment result and its limits explicit.
