13 controls
76 frameworks share controls with it
United States
verified against its source document
Every control below is one this framework asks for. The right hand column counts how
many other frameworks in our corpus carry the same control, which is the difference between
doing this work once and doing it again for the next standard.
FDA 21 CFR Part 11 Evidence & Implementation Kit
13 controls is the documentation set somebody has to write. This is that set,
already written: an adopt-ready artifact for every control in policy and procedure text you
edit rather than draft, and the evidence checklist an auditor asks for against each.
See what is in it, $249
The same set every buyer of this kit receives. Nothing here is produced on request.
What you already have
Frameworks whose controls overlap this one, most first. If you run any of them, the
count is roughly what you have already evidenced.
Every control
| Code | Control | Also in |
|---|
Part11.10 | Controls for closed systems (21 CFR §11.10) | 15 |
Part11.100 | Electronic signatures - general requirements (21 CFR §11.100) | 1 |
Part11.200 | Electronic signature components and controls (21 CFR §11.200) | 1 |
Part11.30 | Controls for open systems (21 CFR §11.30) | 42 |
Part11.300 | Controls for identification codes and passwords (21 CFR §11.300) | 29 |
Part11.50_70 | Signature manifestations + signature / record linking (21 CFR §§11.50 + 11.70) | 1 |
Part11.AccessAndAuth | Access control + authority + device checks (21 CFR §11.10(d) + (f) + (g) + (h)) | 34 |
Part11.AuditTrail | Audit trail requirements - secure computer-generated time-stamped (21 CFR §11.10(e)) | 36 |
Part11.CSV | Computer system validation + risk-based approach (21 CFR §11.10(a) + 2003 FDA Scope and Application Guidance + 2023 CSA draft) | 33 |
Part11.Definitions | Definitions (21 CFR §11.3) | 0 |
Part11.RecordRetention | Record protection + retention + readiness for inspection (21 CFR §11.10(b) + (c)) | 28 |
Part11.Scope | Scope and implementation (21 CFR §§11.1-11.2) | 0 |
Part11.Status | 21 CFR Part 11 - corpus status, FDA enforcement landscape, CSA transition | 0 |
Tell me when FDA 21 CFR Part 11 files something new
One email when a public company newly discloses something this framework governs, naming the company and what our corpus says it puts in scope. Nothing else, and one click to stop.
What this page is
A control-level reference for FDA 21 CFR Part 11, drawn from our framework corpus. Control codes and
titles are references to the standard, not reproductions of it. The overlap counts and the
auditor artefacts are our own work and are the part you will not find elsewhere.
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