Software Validation of an Enterpirise System

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

The guidance is 21 CFR part 11. An ERP system in a pharmaceutical environment MUST be validated (thus SAP).

Perhaps you can learn something from this course.

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Thanks will have a look.

In our experience, the URS should be completed prior to selection of a tool - usually they are already listed in the (Request for Proposal) RFP. The requirements should list what the company is expecting the tool to be able to do and therefore help to evaluate whether the tool will be sufficient enough for the User. If a product is purchased prior to an approved URS then it is possible that the tool may not handle all capabilities that are desired by the User. Assuming that the ‘draft’ URS is final may lead to mistakes as Users sometimes don’t always recall everything that is needed/desired at the time of creating the draft.

If you have any other questions don’t hesitate to reach out.

Adam T…


You are absolutely correct Salmon0904. THe URS should be in place prior to purchase. But this isn’t always the case, and is very hard to get all departments to do. Often people move too fast or aren’t aware of the requirements.

In my experience, the best thing to do is to close the gap as soon as you find it. If they have a draft URS, then that is better than nothing. Just go ahead and move that through the system.

THe URS, at this point, is useful to communicate to the internal team what to expect moving forward. You might have some user requirements that groups have, that the IT department didn’t think of. So it is a useful collaboration and communication tool, and it meets regulatory needs.

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