EU GMP Annex 11 · Computerised Systems · Evidence & Implementation Kit
Pass your GMP inspection on computerised systems, with the data integrity evidence Annex 11 requires.
Every Annex 11 requirement handed to you as an adopt-ready control, with the data-integrity nuance, the exact evidence an inspector examines, and the finding they most often raise.
Inspection-ready in a weekend, not a quarter.
Here is the honest situation. Annex 11 is where GMP inspections of computerised systems concentrate, and data integrity findings can stop a batch or a site. The hard part is producing the evidence: validation demonstrating fitness for purpose and a maintained validated state, audit trails that are configured and reviewed, permanently bound electronic signatures, supplier agreements, and the ALCOA data integrity attributes throughout. Building that from the Annex text is weeks of work, and getting it wrong is an inspection finding.
This Kit removes the build. It is the complete Annex 11 requirement set and evidence guide that you personalize in a weekend.
What you get, the moment you buy
26
Requirements as adopt-ready controls. Every Annex 11 clause across the general, project and operational phases, from risk management and validation to audit trails, electronic signatures and business continuity. Personalize and you are done.
26
Evidence-they-examine checklists. For each requirement, exactly what an inspector examines, plus the finding they most often raise, and the data integrity nuance that catches manufacturers out.
1
Annex 11 Control Matrix, pre-built. Every requirement in a working spreadsheet, ready to record your implementation, status and evidence location.
1
Gap & Readiness Assessment. Score each requirement and the workbook tells you your inspection readiness as a single percentage, and exactly what to fix next.
Built to EU GMP Annex 11, with the ALCOA data integrity attributes, the validated state, audit trail review before batch release, and electronic signatures called out. Editable Word and Excel files.
Data integrity is where inspections land
Annex 11 inspections concentrate on data integrity: ALCOA records, the validated state, audit trails and their review, and bound electronic signatures. This Kit is built around getting those right, because they are where findings, and lost batches, come from.
What one control looks like
This is clause 9, Audit Trails, the control inspectors probe hardest. All 26 are built to this depth.
9 Audit Trails OPERATIONAL PHASE
Adopt this requirement
[Manufacturer] shall configure secure, computer-generated, time-stamped audit trails on GMP-relevant computerised systems that capture the creation, change and deletion of data with the reason where appropriate, shall keep the audit trail available and convertible to an intelligible form, and shall review audit trails on a documented risk basis, including before batch release for critical data.
Evidence an inspector examines
- Audit trail configuration showing capture of who, what, when and why
- Records confirming audit trail cannot be disabled or edited by users
- Documented audit trail review procedure and completed review records
- Evidence that critical audit trails are reviewed before batch release
Common finding they raise: The audit trail is enabled but never reviewed, so no one detects the unauthorised edits it faithfully recorded.
Why this is not another template pack
- The evidence is the point. Generic IT validation ignores GMP. This tells you exactly what an inspector examines and the finding they raise, for every requirement, with data integrity throughout.
- Written for GMP. ALCOA data integrity, the validated state, audit trail review and electronic signatures are built in, not bolted on.
- Built on a mapped compliance corpus, not one person's opinion, from a graph of thousands of controls across standards.
- It compounds. Annex 11 sits with your pharmaceutical quality system and computer system validation, so your GMP and IT controls share one evidence base.
Who buys this
Pharmaceutical and medical product manufacturers and their quality, validation and IT teams, and consultants preparing sites for GMP inspection. Whether it is a new system or an inspection readiness review, you save weeks and walk in with the validation and data integrity evidence ready.
By the end of the weekend you will have
✓ A control for every Annex 11 clause
✓ A completed Annex 11 control matrix
✓ The evidence an inspector examines
✓ Your validation and audit trail review anchored
✓ An inspection readiness percentage and a fix list
✓ The common findings closed before the inspection
Common questions
Is it really editable? Yes. Word and Excel files you own and adapt. No portal, no subscription.
Does this certify me? GMP compliance is assessed by an inspectorate. The Kit gets you ready: the requirements, the matrix, and the exact evidence they examine, across every clause.
Does it cover data integrity? Yes. The ALCOA attributes, the validated state, audit trails and their review are built through the operational-phase requirements.
Does it cover electronic signatures? Yes. Electronic signatures, permanently bound to their records, are covered along with batch release and archiving.
What if it is not for me? A 30-day money-back guarantee.
Do not let a data integrity gap stop a batch.
A consultant is a heavy fee and months. The Kit is instant, and it is guaranteed.
Add it to your cart and be inspection-ready this weekend.
Instant digital download · 30-day money-back guarantee · The Art of Service Pty Ltd, GPO Box 2673, Brisbane QLD 4001 · support@theartofservice.com
