Concepts Service

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.