Ramboll creates the overall plan for the validation activities (VPL) in the initial phase of a project in order to ensure that quality is a priority from the beginning.
One of the most important documents to draw up is the User Requirement Specification (URS), where all requirements are stated.
When the engineers have finished the design of a facility, a HVAC system, a critical utility system or a process system, a design qualification (DQ) is done to ensure that all requirements have been included in the design solution.
During construction, the building process is monitored in order to ensure that the construction is done according to design and that all the needed documents are provided.
When construction is complete and the facility or system is handed over, installations are tested and qualified (IQ). When the installation has been tested (OQ) and approved, the operation and functionality is tested. Often, this has to do with the automation system, (FMS) where Ramboll ensures that the GAMP guideline is followed. Finally, after we have tested and validated the functionality, the process qualification or validation (PQ) is performed in order to ensure that the product can be produced consistently within specifications.
Ramboll can draw up all documents needed for the qualification, based either on the client’s qualification system or on Ramboll own templates.