Life is on logo

Welcome to the AU Website

We have detected that you may prefer the US site. Please use the language dropdown above to change your selection if required.

Stay in this territory

Eurotherm can offer Project Management and Engineering with Qualification/Validation activities throughout your project life cycle.

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 developed 

  • Built in function to keep the application at the lowest Category of ISPE GAMP®5 guidelines (Our Recorder solution stay at Cat3, Our Environmental 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.

Contact Us