The V model
To the test
Where the third-party element is a standard product, the purpose of the validation is to confirm that the system meets process needs, and that the supplied version is installed and working as intended. In these instances, the documentation can be standardized; for example, the OQ test protocol could be a standard document for the product and the IQ could be a checklist generated from a generic template. The manufacturer may also request copies of generic or type approval documentation.
Automated systems, however, must be designed for purpose, and the project to supply the final system must adhere to necessary standards and generate all documentation, including system-specific specifications and test protocols. A system provider that is already familiar with these standards can add a great deal of value in helping to draw up these documents.