Validation

Validation in the pharmaceutical and medical device industry is defined as the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the qualification of systems and equipment. It is a requirement for Good Manufacturing Practices and other regulatory requirements. Since a wide variety of procedures, processes, and activities need to be validated, the activity of qualifying systems and equipment is divided into a number of subsections including the following:

• Design qualification (DQ)
• Component qualification (CQ)
• Installation qualification (IQ)
• Operational qualification (OQ)
• Process qualification (PQ)

We offer different levels of validation packages depending on the requirement of the customer. We however always work according to the V-model, building all our systems based on the customer requirement specification (URS) from which we compose a Project and resource plan. This plan will refer to the URS and in detail explain the exact scope of delivery.  

Hence, whatever the validation need we meet the requirement of the customer.