I was just wondering if anybody could provide me with some guidance regarding the validation of an enterprise
system and when a URS should be completed. I mainly deal with equipment validation and the URS is always the first
document that is written. We have just purchased an enterprise software package but a URS has not been created. I have questioned this and have had the following response from our IM department:
As part of IT System Development Life Cycle (SDLC) process we usually have a business case or draft URS available prior to talking to vendors and even purchasing the software, not necessarily approved URS.
Is this standard practice for software validation or should the URS (even if it’s an initial draft should this be signed and approved via document control?) be in place prior to purchase.
Thanks in advance