01
Pharma and API CDMO
Rules we work under
- GMP
- CSV
- Data integrity
- FDA
Systems we connect
- SAP
- LIMS
- eBR / MES
- QMS
- Document management
- Access control
Inspection-ready systems for plants that cannot stop. We design GMP processes lean, validate as we go and keep quality and production on the same data.
- A long-standing partnership with a European API CDMO: more than five years of programs and initiatives across its five plants
- Complete, validated information system for a new API factory in 12 months
- Brownfield SAP S/4HANA rollout in two Indian plants, live in 11 months for under €1M
- Data integrity and audit-trail review method, validated by a major US pharma customer
- SAP greenfield under FDA validation while the site grew from 150 to 350 employees
- Changeover times on packaging lines at a UK site cut from 16 to 11 hours