The endgame of any Commissioning, Qualification, and Validation (CQV) effort is to deliver a fully validated facility, utilities, HVAC, and process systems, as per GMP requirements.
This process can be lengthy and onerous, and a product cannot be manufactured until it is completed. In an expedited EPCMV project in the US, there are several key elements to ensure the timely and robust delivery of the CQV effort.
The most important point is to involve the validation experts as early in the project as possible. This allows them to verify requirements, understand or help develop a CQV strategy and project approach, and establish an on-site presence that will expedite downstream execution efforts.
There is a multitude of CQV guidance available, and every approach is a little different. The sooner an approach can be developed and implemented via a validation master plan (VMP) the better. The EPCMV validation team can develop the approach and VMP. Having been involved from the start, the validation team will have stronger systems knowledge and be able to generate better protocols, reducing review and approval times.
A good rapport and familiarity built with the client, the construction team, and vendors:
• Expedites the CQV process
• Allows smoother execution
• Results in fewer discrepancies and retests
• Provides a better understanding of the CQV quality needs, allowing for greater leveraging of vendor test documentation
Involving validation as part of the EPCMV team early and often in the project is the key to success, especially in the case of an expedited project. It allows for greater CQV planning earlier and this results in time-saving activity later in the process.
