The focus of ValserV is the validation of business processes in the Life Sciences. My expertise is on the Development, Qualification and Validation in the Pharmaceutical and Medical Device Industry.
Pragmatic and cost saving
An important goal for validation is to prevent errors in the process at an early stage of development. In that way the customer is assured of a safe quality product that meets the requirements. The manufacturer has less failure in production and saves costs on poor quality. This benefit is the result of a properly performed validation.
Process Validation in three steps
Process Validation may involve the development of a new drug or medical device or on a change in the manufacturing process. We distinguish three steps:
- Process Design: to determine the specifications for product and process
- Process Qualification: to test and document if the product/process meet the specified requirements
- Continued Process Verification: the continued monitoring and improvement of the qualified process (‘State of Control’).
Interested? Please feel free to contact me for an appointment.