17 controls
316 frameworks share controls with it
European Union (EMA/EC)
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.
EU GMP Annex 11 Computerised Systems Evidence & Implementation Kit
17 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 |
|---|
Clause 1 | Risk management | 189 |
Clause 10 | Change and configuration management | 185 |
Clause 11 | Periodic evaluation | 1 |
Clause 12 | Security | 120 |
Clause 13 | Incident management | 131 |
Clause 14 | Electronic signatures | 1 |
Clause 15 | Batch release | 1 |
Clause 16 | Business continuity | 33 |
Clause 17 | Archiving | 2 |
Clause 2 | Personnel | 156 |
Clause 3 | Suppliers and service providers | 194 |
Clause 4 | Validation | 3 |
Clause 5 | Data | 6 |
Clause 6 | Accuracy checks | 1 |
Clause 7 | Data storage | 3 |
Clause 8 | Printouts | 1 |
Clause 9 | Audit trails | 61 |
Tell me when Annex 11 to EU GMP 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 an auditor will ask you to produce
The artefacts named on the failure modes this framework speaks to.
- Configuration baselines for IT/OT assets
- Change-management process and records
- Review of changes for cybersecurity impact
- Change control records for the computerised system
- Documented configuration and change management processes
- Software release and problem management records
How programmes fail on this
Failure modes named by this framework and others. Each opens the full record.
What this page is
A control-level reference for Annex 11 to EU GMP, 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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