Starting point
A Canadian pharmaceutical manufacturer built a new site in Germany. The manufacturing ERP SYSPRO controls business processes from manufacturing and warehouse through QA to procurement and finance with end-to-end traceability.
Before the regulatory inspection the system had to be fully validated under EU GMP Annex 11 and GAMP 5. The classically planned effort was 1,200 hours.
Approach
cube one delivered full CSV under a risk-based GAMP 5 approach, with AI-supported documentation and test preparation while keeping the same deliverable scope.
Validation documentation and qualification
- User requirements specification plus IQ, OQ and PQ through to acceptance.
- Risk-based approach under computer system validation (CSV).
- In parallel: IT administration at the new site.
Orientation: Annex 11 Check.
AI-supported efficiency
- Same deliverable in 500 instead of 1,200 hours.
- Validation file (URS, IQ, OQ, PQ, report) complete.
- GxP-compliant go-live before inspection.
The system
SYSPRO is a powerful Enterprise Resource Planning (ERP) system for manufacturing companies and distributors. It integrates business processes such as production, warehouse management, quality assurance, purchasing and finance on a central platform and enables complete traceability of all transactions. cube one GmbH performed the full computer system validation (CSV) of the system in accordance with GAMP 5 and EU GMP Annex 11, from creating the validation documentation (URS, IQ, OQ, PQ) through to successful acceptance and GxP-compliant go-live at the customer.
Result
Inspection readiness
- Full CSV completed on time.
- SYSPRO live in GxP-compliant state; validation file inspection-ready.
- Client could approach inspection with complete file.
Effort and scope
- 500 instead of 1,200 planned hours delivered.
- URS, IQ, OQ, PQ and report remained in scope.
- Related: periodic review process control system.
Related: Annex 11 Check.