Qualification and Validation
In the pharmaceutical industry, product safety requirements are constantly increasing. In order to be able to ensuer them comprehensively, a holistic approach is necessary which begins long before the actual production. It must be proven that the rooms, facilities and processes used for production and quality control are suitable for their intended use. And this is precisely the task of qualification and validation.
And this is precisely where CAT Clean Air Technology GmbH comes in: Our Qualification & Validation department consists of a team of trained specialists who guarantee the implementation of the constantly changing requirements, always at the highest level, always up to date. And all this according to the guidelines of GMP, VDA or FDA.
From consulting to the development of individual qualification steps to the implementation of the complete qualification according to the V-model of validation – we support you in the exact scope you need. The joint definition of a qualification strategy is just as much a part of our tasks as the creation of a clear qualification structure with the individual documentation steps.
Whether in clean rooms, HVAC systems, media supplies or process plants: Our qualification team intensively deals with the requirements of the customer, the legislator, the guidelines and the standards and thus creates the basis for choosing the right direction at the decisive points.