Qualification & Validation

The Expert MedTech team provide qualification and validation services ensuring stable and safe manufacturing processes from conception through to operation.

Our team engages with clients during the product and process development phase of your automation journey, ensuring that the system design captures process critical areas. Following the GAMP 5 model, the team lead, guide, support and document the IQ, OQ, PQ pathway.

We recognise that delivering robust and repeatable performance for the entire machine life is critical, the MedTech team provides operational support services addressing change control requirements.

Our approach to the GAMP V Model is
Clarify, Quantify, Qualify, Verify.