Validation Tip: Don’t Skimp on the Humble URS

In the excitement of a new project, it is tempting to get into the purchase and implementation of new equipment and systems in a rush to meet your tight timelines.

But…take a breath. You have already performed some sort of risk assessment. That is another topic. In any case, you know what equipment and systems will need to be validated.

I urge you to take the time to generate a User Requirements Specification (URS) for each equipment or system that requires validation. Note that this document is a specification of the requirements that the system needs to meet. That is what the equipment or system needs to do or features that are required. It is not a system specification or design specification. Those documents show how the system addresses the URS.

There is lots of guidance out there about how to write a URS (for example in ISPE guidelines). I would like to highlight a couple of additional points about writing your URS:

1. Just do it, and approve it. Even if it is one page. It will save you money and time down the line and provide you with a better system. It will serve to guide your validation and unify your group.
2. Give each requirement a number. It can be a paragraph, or a table. Whatever works best for you.
3. DON’T INCLUDE THINGS YOU DON’T CARE ABOUT. Or at least separate them into a secondary tier. Even though I have this as #3 here, I think it is really important. If you do include a requirement you don’t need, you will probably have to validate it, and if it isn’t important then you will waste money getting the requirement met. You will also possibly fail the requirement and have to write a deviation that states why it is no longer important. If it’s not important, save the resources for something that is.
4. During review of the URS, prior to approval, remove any requirements that are not actually required for you to use the equipment or system for the intended purpose.

These simple steps can save you a bunch of time and money, not to mention aggravation. It will also give your process focus.

When you receive the equipment, you can validate it, set it up on a calibration and maintenance schedule, and track its lifecycle using an asset management system, either paper files or a validated CMMS like GxPReady! Suite.

Then you are on your way!

Note that in some cases, you can work with the manufacturer to get a good URS, but there is a tendency of those URSs to be overly specific to what the manufacturer provides. Focus on what is important to YOUR project, not the manufacturer.

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