Validation Online's GMP compliant computer validation (CSV) documentation and protocols start with our unique three level User Requirements Specification document (URS). Since most documents, post the URS, will either fully, or partially, base their contents on the URS, it is essential that this document clearly, concisely and in a manner that is testable, specifies the exactrequirements of the end user. It is also essential that these exact testable requirements remain attributable through the development of the Functional Specification (FS) Design Specification (DS) to the actual lines or groups of lines of code that enable them.
The Validation Master Plan - VMP, must be specific about this and all GMP requirements, and instruct all personnel involved in the qualification program, of the importance of maintaining this traceability through the Installation Qualification - IQ - Operational Qualification - OQ - Performance Qualification - PQ.
Traceabilty of URS functionality, to lines of code is an essential element in computer validation (CSV). Once this traceability is establish future maintenace and modification of software is made much simpler and more manageable.

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