validation – fast and
from a single source
With Devoteam Alegri, you can achieve US FDA and EU GxP compliance of computerized systems in the company quickly and efficiently.
From centrally managed and used systems all the way to the special systems used in laboratories, production, or clinical studies – Devoteam Alegri’s risk-based and pragmatic approach provides security through audit compliance and advantages in the market. The Devoteam Alegri process model is derived from the GAMP®5 guide and ensures that the specifications of both the European (EU GMP Annex 11) and American (US FDA 21 CFR Part 11) authorities are met.