The V-Model as the bridge between design and qualification
In cleanroom projects, the V-Model functions as the bridge between design decisions and qualification outcomes. It connects what is defined during design to what must later be demonstrated during commissioning and qualification.
The left-hand side of the V represents the progression from User Requirements to functional design and detailed engineering. At the base lies the construction phase, where the design is realised. The right-hand side covers commissioning and qualification, including Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
This structure ensures traceability throughout the project lifecycle. Requirements defined at the top of the V, often captured in a User Requirement Specification (URS), must be demonstrably met during IQ, OQ and PQ within predefined limits. Design choices are therefore not isolated decisions; they directly determine how qualification will be executed and verified.