Good Clinical Practice Guide
Results 1 to 2 of 2

Thread: Is it acceptable to have the FRS as a stand along document without a URS document?

  1. #1
    Forum Member
    Join Date
    Oct 2018
    Posts
    1

    Is it acceptable to have the FRS as a stand along document without a URS document?

    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?

  2. #2
    Forum Member
    Join Date
    Sep 2016
    Posts
    11
    Dear Aron,
    as my point of you is not a best practice. but i do agree it's done in common practice. URS is intended to capture around a business process all regulatory and criticla business needs to perform their business without focus on "a specific system" where the FS comes with a system solution to address some of those needs whereas other URS will be address by process or manual mitigation controls. if we mix both there is a risk to omit some requirements from process view and to focus on operating software capabilities.

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •