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.

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