Annex 11 of the EU GMP guidelines applies to all computerised systems used as part of GMP-regulated activities. Its principle is that using a computerised system should not reduce product quality, process control or quality assurance compared with the manual system it replaces, and that there should be no increase in the overall risk of the process.
The annex covers risk management throughout the lifecycle, personnel and suppliers, validation (including user requirements and traceability), data and accuracy checks, data storage and printouts, audit trails, change and configuration management, periodic evaluation, security, incident management, electronic signatures, batch release, business continuity and archiving. The same text is used in the PIC/S GMP Guide and applies in the UK.
Why it matters in GMP
For manufacturers supplying the EU, UK or other PIC/S markets, Annex 11 is the reference inspectors use when they review a LIMS, eQMS or eBMR. Annex 11 and Part 11 overlap heavily but are not identical — Annex 11, for example, expects the reason for a change to be recorded and audit trails to be regularly reviewed, and addresses batch release by a Qualified Person through computerised systems.
- Base validation and audit trail scope on documented risk assessment.
- Record who changed what, when and why.
- Allow only authorised people to certify and release batches in the system.
How Swat iQua Suite handles it
Swat iQua Suite is designed to comply with EU GMP Annex 11: a mandatory reason for every change in the audit trail, periodic risk-based audit trail review, role-based and site-scoped access, e-signatures with re-authentication, server-enforced segregation of duties and an e-signed, evidence-based batch release. Our CSA traceability register and implementation team support your validation.