Many of our pharmaceutical, biotechnology and medical devices customers request work to the ISPE GAMP®5 Guide for Qualification/Validation of Automated Systems – guidelines which have become de facto standard for Good Automated Manufacturing Practice in the healthcare industries.
We have a long history of projects successfully validated to ISPE GAMP®5 guidelines including many which are now operating in cGMP regulated environments (FDA, EMA,…).
To minimize your Costs and the Risks on Qualification/Validation we developped
. Built in function to keep the application at the lowest Category of ISPE GAMP®5 guidelines (Our Recorder solution stay at Cat3, Our Environemental Monitoring System EMS stay at Cat4,…)
. We produced a full set of ”State of the Art” Template document associated with the ”V” model of the ISPE GAMP®5 guidelines.