Hi All,
I am new in the forum and I would like to understand the main differences between the URS and the FS, also would like to understand which information should be included in each, also I am not sure if someone can share some examples.
Thanks a lot for your help
URS are are given by user to developers.
FRS means the sequence of operations to be followed on every single process.
It is always developed by developers and engineers.It deals with requirements given by client.
URS-User requirement specification (This document describes what user need as per cGMP requirement and inhouse specification)
This document mainly include:
Purpose
Scope
Responsibility
Technical specification, location
UR
MOC
Required docs
Compatability & support.
Utelity requirement
FDS -Functional design specification-this document specify complete, precise, the requirement design, characteristic of component and system, for determining the provision have been met.
FDS is manufacturer/supplier interpretation of URS
once FDS is approved any change will go through CC.