gempex GmbH services

Adapted to individual targets, individual requirements and the scope of the project

To define what is really important and critical and to reduce the amount of effort to a minimum. Our Offer Preparation, moderation and documentation of risk analyses according to: HACCP, HAZOP, FMEA, Failure Tree Analysis, And others. A risk analysis is a very important instrument in reducing the amount of work in qualification and validation processes to a minimum and directing new or re-construction activities towards the given target in accordance with given requirements.

`Documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.`

As documented evidence that computer-supported systems were correctly specified under consideration of the regulatory requirements, were correctly implemented and installed according to their specification and fulfil all requirements for their productive operation.