EU Annex 11 Computerized Systems Alignment
Built-in compliance with Annex 11 clauses: validation lifecycle management, electronic data archiving, regular audit trail reviews, and validated system access control.
Solution · European & International GMP
EU GMP Annex 11 & UK MHRA Compliance Software for Life Sciences
Computerized systems validation, Qualified Person (QP) batch release, and European data integrity standards
Pharmaceutical manufacturers exporting to the European Union and the United Kingdom must comply with EU GMP Annex 11 and UK MHRA data integrity guidelines. Novaqis delivers a fully validated, high-availability platform engineered for European regulatory expectations and Qualified Person (QP) release workflows.
- EU Annex 11 Aligned
- UK MHRA Compliant
- WHO GMP Ready
- QP Release Support
Product preview
See it in the platform
Batch exception review and Qualified Person release workflow
Dashboard / Manufacturing
Dashboard
Recent batches
BatchProductStatusLine
Capabilities
What you get
Qualified Person (QP) Batch Disposition Support
Accelerate European market release with automated Review-by-Exception dashboards that aggregate deviation records, OOS investigations, and CoA parameters for QP sign-off.
Data Sovereignty & European Cloud/On-Prem Options
Deploy on dedicated European private cloud instances (AWS/Azure Frankfurt/Dublin) or 100% on-premises plant infrastructure under complete sovereign control.
MHRA Data Integrity Governance
Meet UK MHRA GxP data integrity standards: complete lifecycle traceability, prevention of contemporaneous data omission, and independent audit trail review tools.
Compliance & control
Built for regulated operations
Audit trails, electronic signatures, role-based access, and deployment choices designed for GxP validation, not bolted on after the fact.
CapabilityHow Novaqis delivers it
- Annex 11 Validation (§4)
Comprehensive lifecycle documentation, risk-based user requirements (URS), and validated traceability matrices.
- Audit Trails (§9)
System-generated audit records for all GMP-relevant modifications, exportable for regular QA review.
- Data Security & Backup (§7)
Encrypted automated backups, disaster recovery protocols, and verifiable data restoration testing.
Outcomes
Why teams choose Novaqis
- Streamlined QP batch disposition and European market release
- Full alignment with EU Annex 11 and UK MHRA inspection standards
- Turnkey Computerized System Validation evidence packs
- Complete operational visibility across multi-site global manufacturing plants
FAQ
Frequently asked questions
- Novaqis is architected around EU Annex 11 principles, providing automated audit trails, role-based access management, validated data backups, cryptographic e-signatures, and pre-configured GAMP 5 test packages.