Computerized Systems Validation

Computerized systems used in the pharma industry, medical devices and healthcare institutions such as hospital pharmacies, should all comply with the GxP regulations. Inspectors from different authorities focus more and more their inspections on validation of these systems. Xendo has a vast experience in the field of Computerized Systems Validation. We base our approach on the GAMP 5 guide, which is accepted around the globe. The GAMP guide deals with the entire life cycle of an automated system. This includes design, procurement, installation, configuration, validation upto and including operational maintenance. If you don’t have the expertise or the capacity in your organization to deal with these issues, we can assist or consult you on it. The brochure, in Dutch, will give you more detail; just click here.