In the diagram below it can readily be seen that the URS, along with the regulatory requirements as detailed in GAMP 5, and the details of computer validation (CSV) requirements as given in the VMP, come together to form a document package consisting of the DQ, IQ, OQ and PQ from which the vendor can develop a fully legal and compliant product.
Computer validation (CSV) activities are grouped in two colours (orange and blue). The blue colour is the requirement for standard computer validation (CSV).
The regulators have decreed that software used in a manner that can affect the quality of the product, without leaving visible evidence, that damaged has occurred, must be deemed as critical to the quality of that product.
The regulators have further mandated that all such software be identified as such - and subjected from concept to actual use, to Full Life Cycle Validation (FLCV) requirements. This additional validation is represent in the diagram in orange.
The vendor therefore (be they in, or out, of house), must produce a Quality Plan that ensures the software development will follow a validation evolution similar to that shown in the diagram. Your actual diagram must be planned and justified for the software system that you are proposing.
It is of paramount importance that your decision on software criticality is documented, and that your QP is reviewed and approved by QA, and the client or their representative, prior to initiation of the design process. Since these documents all form part of the computer validation (CSV) process, you must expect the regulators to want to review them.
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