EU Annex 11
EU GMP Annex 11 is the European Commission's GMP guideline for computerised systems used in regulated medicinal-product activities. The version in force dates from 2011; a revised draft went to public consultation in 2025 and is not yet final.
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How does EU Annex 11 apply to your shop floor?
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01What Annex 11 covers
Annex 11 applies to all computerised systems used as part of GMP-regulated activities. Its principle is that the application should be validated and IT infrastructure qualified, and that replacing a manual operation should not reduce product quality, process control or quality assurance, or increase overall risk.
It is part of EudraLex Volume 4. Manufacturers and importers in the EU must follow GMP, and inspectors use the annex as the expected standard for computerised systems.
02The clauses most people need
| Clause | What it expects (paraphrased) |
|---|---|
| 1 Risk management | Apply risk management through the lifecycle, considering patient safety, data integrity and product quality. |
| 3 Suppliers | Formal agreements with suppliers and service providers; competence assessed, for example by audit. |
| 4 Validation | Lifecycle documentation, user requirements, and evidence the system fits its intended use; risk-based approach. |
| 9 Audit trails | Based on risk, consider a system-generated record of GMP-relevant changes and deletions, with reasons documented; review regularly. |
| 11 Periodic evaluation | Evaluate systems periodically to confirm they stay validated. |
| 14 Electronic signature | Same impact as handwritten signatures within the company, permanently linked to the record, with time and date. |
| 15 Batch release | Only Qualified Persons release batches; the system should identify them, and electronic signature may be used. |
03Worked example
A tablet manufacturer in Ireland moves weighing records from paper to software. Under clause 4 it writes user requirements and tests the weighing functions against them. Under clause 9 it decides, based on risk, that changes to target weights and recorded results need an audit trail with a reason for change. Under clause 14 the reviewer's electronic signature is linked to the record and shows date and time. The Qualified Person still certifies the batch, as clause 15 and EU law require.
04Common failure modes and checks
- Quoting the 2025 consultation draft as if it were in force.
- Assuming a supplier's certificate replaces the formal agreement and assessment clause 3 expects.
- Audit trails that exist but are never reviewed.
- Treating Part 11 compliance as Annex 11 compliance; the documents differ.
05Where V5 fits
V5 provides audit history, electronic signatures, role-based access and controlled documents that a customer can assess against Annex 11. Enterprise may include IQ/OQ documentation and validation support. Supplier agreements, validation for intended use, periodic evaluation and Qualified Person decisions remain the customer's responsibility.
Frequently asked questions
Q.Is Annex 11 law?+
It is an EU GMP guideline in EudraLex Volume 4; manufacturers must comply with GMP, and inspectors apply the annex.
Q.Has Annex 11 been revised?+
A revised draft was consulted on from 7 July to 7 October 2025. Until the Commission adopts it, the 2011 version applies.
Q.Does Annex 11 require an audit trail for every system?+
Clause 9 asks companies to consider audit trails based on risk for GMP-relevant changes and deletions.
Q.Can an electronic signature be used for batch release?+
Clause 15 allows a Qualified Person to use an electronic signature to certify release.
Primary sources
Further reading
Explore this topic
EU Annex 11 sits inside this topic cluster in our glossary. Every neighbour is one click away.
Electronic records, signatures, audit trail and ALCOA+ data-integrity principles.
Want to see how EU Annex 11 could fit into your own records and workflows? Explore the related V5 pages or talk to our team about what applies to your operation.