COMPETENCIES
- Computerized Systems Validation
- Data Integrity
- IT/OT – MES & Lab Equipment
- Data Automation
- Project Management
- Data & App Migrations
- ITSM/Change Control
COMPLIANCE
- FDA 21 CFR Part 11 – ERES
- FDA 21 CFR Part 210/211 – cGMP
- FDA 21 CFR Part 820 – CAPA
- ISPE – GAMP5 2nd Edition
- EudraLex Vol. 4 – GMP
- WHO Annex 5 – ALCOA+
- ITIL v4
Our engineers are individually certified and in-depth experienced with the crucial major vendor’s devices and applications.
PLEASE CONTACT
Callum Quilter – Principal Consultant
at EPM Scientific of Phaidon International for Contracts worldwide – Pharmaceuticals & Biotechnology