- Over 200 qualified projects
- Harmonized documentation across the North American, European and Asian markets.
- Provided documents follow the GAMP, EU GMP, ICH and FDA guidelines and regulations
- Qualification package can be adapted to customer’s needs
Benefits of our validated standard platforms
- Risk mitigation: many functions are already covered by the standard platform qualification
- Quality: the standard doesn’t need to be qualified on each project
- Time optimization: the Mikron team is focused on customer specific processes