Services [ Validation - Concepts ]
Consulting
GMP Office
Design&Construction Validation Production

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

Our Offer

Clearly structured easy to understand concepts for
  • Master Plans
  • Validation
  • Qualification
  • Change control

Our Procedure

We provide you with tried and tested basic concepts and develop these together with you to reach the validation and qualification concept that is most suitable to your needs and that reflects your understanding of validation and qualification within your specific area, division or the whole company.

We either advise during preparation and / or prepare ourselves the project-specific Master Plans required by GMP that serve to coordinate and control the individual projects and, alongside the names of the persons responsible, also list all of the validation and qualification systems.

During the implementation of feasible change control systems we support your efforts to track and trace quality-critical changes in order to maintain the qualified and validated status.

Your Result

A company specific qualification and validation concept together with a project-specific Master Plan in compliance with GMP requirements



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