This division performs the integral validation project management of existing, remodelled or new plants.
For this purpose, the Validation Master Plan (VMP) is developed as the project΄s master document, divided into the following steps:
preparation of the User Requirements Specifications (URS); Design Qualifications (DQ); verification of the compliance with the specifications or requirements in factory and on site (FAT) and (SAT); Installation Qualification, Operational Qualification (OQ) and Performance Qualification (PQ).
The scope of these projects includes the qualification of facilities, utilities such as purified water plants (PW), water for injections plants (WFI), pure steam generation and distribution systems (PV), pharmaceutical compressed air and air-conditioning systems (HVAC), and the qualification of process equipment, analytical instruments, etc.