21 CFR Part 11 checklist
Device QMS teams inherit PDF checklists; this free 21 CFR Part 11 checklist is a working self-score for closed electronic-record systems used in device quality before CSV/validation planning. Predicate-rule records only; validation still required.
When Part 11 applies to device quality e-records (predicate rule)
Part 11 matters when electronic records or signatures are used to meet FDA predicate-rule requirements in the device quality system (for example design history, CAPA, complaints, or production records kept electronically). This tool helps QMS and CSV owners build a first-pass gap list for closed systems — not a legal determination.
How to use this 12-control self-score
Mark each control present in the system you are assessing. Your percentage and “n of 12” drive the gap list for validation planning. Continue from the free tools hub, or compare QMS posture with ISO 13485 gap self-score and pathway context via FDA pathway picker. For SaMD change-envelope planning (not Part 11), see the SaMD PCCP checklist as related change planning only.
What your % means (gaps → validation / assessment, not a slide)
Gaps belong in validation / Part 11 assessment work — SOPs, system design, and evidence — not in a marketing slide. Predicate-rule records only; validation still required.
Checklist
0%
0 of 12 controls marked present. Gaps belong in the validation / Part 11 assessment, not in a marketing slide.
Need help closing Part 11 gaps in validation?
Self-score done — open controls need validation evidence, SOP updates, or system design changes. Book a Consultation with our clinical / regulatory engineering team to turn Part 11 gaps into a prioritized CSV and QMS remediation plan.
Book a ConsultationFAQ
- What is 21 CFR Part 11 in plain language for medical device QMS?
- 21 CFR Part 11 sets FDA expectations for electronic records and electronic signatures when records are required by predicate rules (for example device quality system records). In practice, device QMS teams use it to judge whether closed electronic systems provide trustworthy, attributable, and inspectable records.
- Do open vs closed systems change the control set?
- Yes in emphasis. Closed systems are under the organization’s control end-to-end; open systems typically need additional controls such as encryption or digital signatures because access paths are broader. This checklist focuses on closed-system controls and flags open-system extras as a separate item.
- Are electronic signatures and audit trails both required?
- Where Part 11 applies to signed electronic records, signature manifestations (printed name, date/time, meaning) and secure, computer-generated, time-stamped audit trails of create/modify/delete are core expectations. Exact applicability still depends on how your predicate-rule records are created and maintained.
- Does a high self-score replace system validation?
- No. A high percentage is only a self-assessment signal. Validation evidence, SOPs, and system design still required — this tool does not constitute a Part 11 assessment or CSV package.
- How should Part 11 gaps feed CAPA or change control?
- Treat open controls as inputs to validation / Part 11 assessment planning, then route systemic gaps through change control or CAPA with owners, due dates, and effectiveness checks — not as marketing claims about “compliance.”
Educational only. Not medical advice, not a regulatory determination, and not a substitute for qualified RA/QA, legal, clinical, or statistical counsel. 21 CFR Part 11 checklist does not submit to FDA, Notified Bodies, or IRBs. Validation still required — a self-score is not a Part 11 assessment or CSV package.
Related QMS / pathway tools
Need help closing Part 11 gaps in validation?
Self-score done — open controls need validation evidence, SOP updates, or system design changes. Book a Consultation with our clinical / regulatory engineering team to turn Part 11 gaps into a prioritized CSV and QMS remediation plan.
Book a Consultation