Engineering & Validation Philosophy
utilization is optimised by:
- Involving validation requirements in the earliest stages of
the project to ensure regulatory compliance and optimize operational
- Integrating commissioning and validation to eliminate redundancy.
- Providing a cGMP audit and risk analysis of the critical processes
at the beginning rather then the end of the validation service.
- The Validation
Master Plan (VMP) is the cornerstone of the validation effort.
is a unique opportunity for the customer to familiarize its personal
with thte process and its critical operating parameters.
- The owner
has to ultimate responsibility for validation. This calls for
a close collaboration with Approval Engineering and the customer
throughout the validation efforts.