21 CFR Part 11 Checklist
Electronic records & signatures — the essentials your CSV plan needs.
7 min read
Article
21 CFR Part 11 governs how electronic records and signatures are created, modified, maintained and transmitted in the FDA-regulated space. This checklist gives validation leads a single-page reference covering technical controls, procedural controls and signature manifestations.
Use it as a gap-assessment scorecard for any new or legacy system entering your validated estate.
Inside this article
- Technical controls: audit trail, access, time-stamping
- Procedural controls: SOPs, training, accountability
- Open vs closed system requirements
- Signature components & manifestation rules
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