I'm validating (Computer System Validation) a vendor delivered GCLP system, and have been detailing the deliverables to be created in the Validation Plan. My understanding is that both the User Requirements Specification (URS) and Functional Requirements Specification (FRS) are created for a complex GCLP system, where the the FRS describes how the system will do the things listed by the business in the URS. However in this case, the Vendor is refusing to link the FRS and URS together, meaning I do not know which FRS section corresponds to which URS section. Is it acceptable to have the FRS as a stand along document without a URS document? At my previous company, the FRS and URS had been combined into a RS document, so that's an option as well in case we are not able to link FRS and URS together, it's better to have just one RS document. Let me know what you think?