Industry solution
Pharmaceuticals
Digitalization & compliance for EU-GMP pharma plants
Supporting pharma plants across the full journey to international standards: from EU-GMP consulting and Computer System Validation (CSV) per GAMP 5, to smart factory architecture with Data Integrity by design.
- EU-GMP / PIC/S / WHO-GMP consulting, gap assessment & audit prep
- Computer System Validation (CSV) per GAMP 5 — IQ/OQ/PQ
- EMS / BMS / MES deployment, IT/OT integration for cleanrooms
- Data Integrity (ALCOA+), Audit Trail, 21 CFR Part 11 & Annex 11