Thema4 Process Controller by Fedegari

In order to meet the most demanding pharmaceutical requirements, great care has been taken in designing Thema4 life cycle management: from the conception phase to components selection and definition of system architecture and project management, through the project phase in the development of software according to the FDA CFR 21, part 11, to the current operation phase and the definition of product management procedures (change control, configuration management, support, repair, maintenance, etc.) according to the GAMP guidelines.

 

Now, after continuous improvements of software and hardware components, functions and processes, Thema4 finds itself in the maturity of the operation phase and the reference guideline for its management is the GAMP 5. Several new software versions are released every year that include those developments requested or suggested by our end users.

That’s why investing in a sterilizer with a Thema4 process controller allows the buyer to capitalize on decades of cumulative experience in managing pharmaceutical manufacturing processes developed for the most demanding companies worldwide. An extensive team of experts assures that the controller is constantly innovated and manages all new developments in accordance with the end users needs and the adopted GMP standards.

 

The Thema4 main features and functions will be furtherly explained on our upcoming webinar scheduled to be aired on July 18th at 10:45 AM CST. Basically our Presenter, the newly appointed Automation Director at Fedegari, Massimo Ghelfi, will explain the process controler high performance, fully validated control system, with the highest level of flexibility and configurability to fit all end users needs COTS hardware, reliability and performances.

 

If you are interested in learning what is the process control main application and which products can be integrated into its operation, then this webinar is for you.

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