COMPETENCIES
- CSV & DQ/CQ/IQ/OQ/PQ
- Data Integrity & Automation
- Operational Technology
- MES/Lab Equipment
- 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 – DIRA
- ITIL v4
Our engineers are individually certified and in-depth experienced with the crucial major vendor’s devices and applications.
PLEASE CONTACT
Mohamud Dahir – Associate Vice President
at EPM Scientific of Phaidon International for Contracts worldwide – Pharmaceuticals & Biotechnology