Computerized systems engineering, quality, compliance

We provide bespoke services in the fields of automated and computerized systems engineering, quality, GxP compliance and Data Integrity.

4 reasons to choose Pharmasys:

piluleWe are exclusively dedicated to the life sciences industries.

piluleOur services are perfectly tailored to fit your requirements.

piluleOur methods are built on ISPE guidelines.

piluleResults are guaranteed.

Health is a highly regulated sector. Our mission: to make sure you can trust and be fully in control of your computer systems so that you view regulatory obligations not only as constraints but also as profit drivers.
PHARMASYS has established itself in new practices in terms of GxP compliance based on the risk analysis approach put forward by the FDA at the end of 2003 and through the FDA’s « cGMP’s for the 21th century » initiative which has generated a whole new framework of guidelines and methods.
  • 21 CFR Part 11 New guidance, 2003
  • Annex 11 GMP
  • ICH Q9 Risk Analysis
  • GAMP 5, 2008 & ASTM E 2500
  • Data Integrity guidances : FDA, MHRA, PIC’s, WHO

Every PHARMASYS employee has expertise in 3 core areas – regulatory, methodological and operational, guaranteeing a holistic approach to your requirements.