What the checklist covers
The workbook has two tabs. An Instructions tab explains the Pass / Gap / N-A scoring and how to read your result. The checklist tab walks all 17 Annex 11 clauses — each stated in plain language, with a Status dropdown and columns for the evidence you would show an inspector and the owner responsible.
Totals count themselves: the workbook tallies your Pass, Gap, and N/A counts automatically, so you can see your readiness at a glance and re-run it periodically or after a major system change.
- General clauses 1–3 — risk management, personnel, and suppliers/service providers (including cloud and hosting)
- Project clause 4 — validation and a maintained inventory of GMP computerised systems
- Operational clauses 5–17 — data, accuracy checks, storage and back-up, printouts, audit trails, change management, periodic evaluation, security, incident management, electronic signature, batch release, business continuity, and archiving
- A Pass / Gap / N-A dropdown, plus evidence and owner columns, on every clause
- Automatic Pass / Gap / N-A totals
Why an Annex 11 self-check matters now
Annex 11 is the EU GMP standard for computerised systems, and it is being revised — the draft revision closed consultation in 2025, with a final version expected in 2026 that sharpens expectations on audit trails, electronic signatures, cybersecurity, and the link to the ICH Q10 quality system. Teams that already run a clean Annex 11 baseline will absorb the update far more easily than those discovering gaps under it.
As with any inspection, the findings cluster in the same clauses — validation that is not risk-based, audit trails that are not reviewed, access that is not truly restricted. Working the checklist surfaces those gaps while you can still fix them, and builds the evidence habit: for each clause, can you actually produce the record that proves it?
From a checklist to a governed computerised system
A checklist shows where the gaps are; a validated system closes them. Complere is built to satisfy the Annex 11 clauses that live in the quality system: a secure, time-stamped audit trail of GMP-relevant changes (clause 9); role-based access and identity controls that record who entered or confirmed critical data (clause 12); electronic signatures that are permanently linked to their record and carry the date, time, and meaning (clause 14); controlled change management (clause 10); and incidents that drive corrective and preventive action (clause 13) — all on a validated platform (clause 4).
Infrastructure clauses such as back-up (7) and business continuity (16) sit with your hosting and IT; the records that prove your control system works are where Complere helps, and they are one export away.
