Facility Monitoring Systems Validation: A Practical Approach 3

At this stage, the user should require the supplier to produce a Quality Plan (QP) or Master Validation Plan (MVP) in which the supplier specifies how the project will be controlled, who will be responsible for each project stage, and the time scale for each project stage.
Once the system has been fully specified and agreed upon in the FS, the design of the system must be specified within an Overall Design Specification (DS). This specification should be a top-level document that clearly states what items are required and how mechanical and software items are to be connected together to meet the function specification requirements.
Design Qualification (DQ) is linked to the URS, FS and DS. It is essential to check that all items listed within the preceding document have been addressed (not fulfilled, but addressed). DQ prevents missing a requirement.
Next are Module Specifications (MS). A “module” may be a control panel or a program. It make no difference. If something has to be built, or programmed, the requirements of the module must be clearly defined.

The Testing Phase
The final action of the first part of the V-model is to actually build the panels, order the particle counters and associated equipment or instrumentation, then write and/or configure the software. But as this V-model shows, this is only half the project. Once all hardware has been built or delivered to the supplier’s site, and its software written and configured, the system must be connected together and tested to ensure it all works.

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