How does Novaqis support EU GMP Annex 11 requirements?

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.

Can Novaqis support Qualified Person (QP) release workflows?

Yes. Novaqis BRM and LIMS provide automated Review-by-Exception dashboards that compile all analytical and manufacturing parameters, enabling QPs to review and approve batch releases efficiently.

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

Book an Architecture POC Explore the Suite

Solution TelemetryGAMP 5 Cat 4

Validation Dossier:Pre-Scripted IQ/OQ

Deployment Footprint:On-Prem / Cloud Validated

Audit Architecture:SHA-256 Chained

Per-Seat Tax:$0 (Site License)

Product preview

See it in the platform

Batch exception review and Qualified Person release workflow

Dashboard / Manufacturing

Dashboard

Recent batches

BatchProductStatusLine

Technical Architecture

Governed Operational Capabilities

Each capability is built directly into our shared regulatory fabric, eliminating integration glue and validation rework.

Core Engine21 CFR §11

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.

Deterministic GxPValidated Module

Regulatory Integrity21 CFR §11

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.

Deterministic GxPValidated Module

System Architecture21 CFR §11

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.

Deterministic GxPValidated Module

System Architecture21 CFR §11

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.

Deterministic GxPValidated Module

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.

Enterprise Outcomes

Why Regulated Operations Standardize on Novaqis

Measured operational breakthroughs across quality, manufacturing, and regulatory compliance.

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.

EU GMP Annex 11 & UK MHRA Compliance Software for Life Sciences

Computerized systems validation, Qualified Person (QP) batch release, and European data integrity standards

EU Annex 11 Aligned

UK MHRA Compliant

WHO GMP Ready

QP Release Support