EMA Annex 11 Compliance
Risk-based validation for GxP software and cloud platforms — URS to PQ, data integrity (ALCOA+), audit trails, e-signatures, supplier assurance.
What Is EMA Annex 11 (EU GMP)?
EMA Annex 11 is the EU GMP annex that defines expectations for computerized systems used in GxP environments — from manufacturing and laboratories to SaaS and cloud-hosted platforms supporting regulated processes.
Key topics covered by Annex 11:
Risk management and validation strategy
Data integrity and audit trail review
Role-based access, security, and e-signatures
Backup, archiving, disaster recovery, continuity
Change control, release management, and documentation
Supplier assessment, agreements, and periodic review
Annex 11 Applicability Check
If Yes to any 2+, Annex 11 is in scope:
Operates in pharma/biotech, labs, CRO/CDMO, medtech, or supplies platforms to them.
Uses or provides SaaS/cloud for regulated workflows.
Creates electronic records/e-signatures that affect quality or safety.
Requires audit trails, role-based access, or controlled data transfers/APIs.
Needs supplier qualification/SLA coverage for Annex 11 controls.
EMA Annex 11 Compliance - Computerised Systems Validation Process
Inventory & Classification
GxP criticality, category, risk
Planning & Risk Assessment
Scope, suppliers, interfaces
Specifications
URS/FRS/DS, security, data integrity, e-sign
Validation and Verification
IQ/OQ/PQ, deviations/CAPA
Release
Operational controls, training, SOPs
Operation & Periodic Review
Incidents, changes, re-validation triggers
Cross-Regulatory Alignment (EU ↔ US)
Annex 11 ↔ Part 11 Control Map
Side-by-side mapping for e-records/e-signatures, audit trails, access control, record retention, and time-stamped events to expose gaps and align controls.
Risk-Based Lifecycle
From intended use and URS → risk → IQ/OQ/PQ → report, through change control, periodic review, and decommissioning — scaled to system risk.
Cloud & Supplier Alignment
Supplier qualification, shared-responsibility matrices, SLAs, release/incident handling, and evidence for multi-tenant/validated hosting consistent with Annex 11 and CFR Part 11.
Data Integrity & Continuity
Operational ALCOA+, audit-trail review, identity/access management, backup/restore & archiving, and BC/DR to keep records inspector-ready over time.
Move from scattered records to inspection-ready Annex 11 evidence
Risk-based validation, clear traceability, and sustainable operational controls.
FAQs
Clear answers on EMA Annex 11 questions
Annex 11 is the EU GMP guideline for the use of computerised systems in GxP activities. It sets expectations for validation, data integrity (ALCOA+), security, audit trails, e-signatures, supplier assurance, and lifecycle controls. It sits alongside core EU GMP chapters and is typically implemented with a risk-based CSV approach (aligned to GAMP®5 principles) to ensure systems are fit for intended use and remain in a controlled, validated state.
Yes. Annex 11 applies to any computerised system supporting GxP processes—on-premise, hosted, or multi-tenant SaaS. Cloud deployments require:
- Supplier assurance (quality agreements, release/change transparency, certifications, SLAs).
- Validation leveraging vendor evidence where appropriate, plus customer-side verification.
- Data integrity controls (access, audit trails, backup/restore, time sync).
- Clear responsibility split between platform provider and regulated company.
- Change communication to evaluate impact of vendor releases on validated state.
Trigger re-validation based on a risk-based impact assessment. Typical triggers:
1) Functional changes affecting intended use, critical calculations, or data flows.
2) Configuration changes, new integrations/interfaces, or data migration.Infrastructure/environment moves (e.g., cloud region, OS/DB upgrades).
3) Security patches that alter behavior or controls, defect fixes with high impact.
4) Cumulative minor changes that collectively increase risk.
Enabled and tamper-evident audit trails are checked on a defined cadence and after events, confirming who/what/when/why, time synchronization, completeness, and anomalies (e.g., admin or bulk edits). Findings are documented with follow-up actions/CAPA and an independent reviewer sign-off per SOP.
A concise confirmation that the system remains in a validated, compliant state: deviations/incidents/CAPA status, change history and vendor releases, access/SoD and training checks, data-integrity health (audit trails, backup/restore), key technical controls, and a risk re-assessment to decide maintenance or targeted re-validation.