Scope of services
The scope of our services includes GMP-compliant qualification of your equipment and facilities, as well as GMP-compliant validation of systems and processes.
The goal of our services is to ensure the reproducibility of your manufacturing processes (process validation), cleaning procedures (cleaning validation), analytical methods (method validation), and computerized systems (computer system validation).
Our experts prepare qualification and validation protocols with defined test methods and acceptance criteria. They form the basis of all qualification and validation activities. The reports contain the results of the tests and the verification of the previously defined acceptance criteria. They are prepared according to customer specifications, either separately for each qualification or validation part, or as an overall document.
Our qualification and validation process is completed by following up changes or deviations and their GMP-compliant documentation within the scope of the change control procedure and deviation management.
In addition to the routine application of the globally applicable GMP guidelines, including Annex 15 of the EU GMP Guideline, we apply the ECA Foundation's good practice guide on Integrated Qualification and Validation on your request.
Since Valicare experts were involved in the preparation of the ECA guide, they know exactly how to perform the qualification and validation process in a time-saving, cost-effective manner through an efficient cooperation between manufacturer and supplier.
These GMP services and a comprehensive service portfolio are also available remotely.
You can find further information on the individual services on the following pages or just contact us, we are pleased to answer and advise you.
