Brainpower

As engineers we offer a highly specialized expertise: The knowledge of production-automatization in certain sectors.

This expertise has a method, it requires us to work consequently systematic. The "V-Model" is our compass. With its comparative dynamic of Draft-, Realization- and Trial-Phases it basically becomes our working hypothesis for highly specialized Engineering solutions.

Qualification/Validation

You have to be able to do it! In order to obtain the best- possible efficiency and clarity, we have to go meticulously into detail while qualifying facility and computer, because not only the concepts are different for every facility respectively application, but also every customer has its own requirements for qualification and validation. We have a basic pattern to which we refer to, but above all we have the competence to relieve you from all your concerns on this topic.

What we do:

Preparation of qualification plans according to GAMP5
Preparation of quality and project plans
Preparation of operation and hardware specifications
Preparation of test plans and test documentation
Implementation of supplier audits
Implementation of functional failure analysis according to FMEA, with risk-based definition of the test scope.
Implementation of assessments according to 21CFR Part 11
Coordination of test phases in the project
Coordination of Change Management (ITSM) in the project