Scope of services
Our scope of services includes extensive work on GMP-compliant and risk based qualification of your equipment and facilities, as well as GMP-compliant and risk based 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 risk based qualification and validation protocols with defined test methods and acceptance criteria. These form the basis of all qualification and validation activities. The reports contain all test results and the verification of previously defined acceptance criteria. These are prepared according to customer specifications, either separately for each qualification or validation section, or as a whole document.
The additional tracking of changes or deviations and their GMP-compliant documentation, with the associated processing within the framework of the change control procedure and deviation management, round up our qualification and validation process.
In addition to the routine application of 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 based on customer requirements.
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.
We also offer our GMP services and a comprehensive service portfolio remotely wherever possible.
You will find information about our wide range of services on the following pages. Our experts look forward to receiving your inquiries and hearing from you.
