After 38+ years in pharmaceutical engineering, the lesson is unchanged: skipping the URS is the single most reliable way to waste money, miss deadlines, and end up with equipment that doesn’t fit the room.
“Do you have a URS?”
A URS — User Requirements Specification — is the document that defines what the user actually needs. Very often, I get answers like:
“…We already contacted several vendors for quotes.”
And I ask: So what exactly did you ask them for? Did all vendors receive the same request? Where is the written requirement?
“…We already have a layout for the suite; we just want you to continue from here.”
And I ask: Based on what did you design it? How did you determine room connections and sizes?
“…It’s just a waste of time. We know what we need. We’re under pressure to move forward.”
My response: I’m sure you know — but does everyone involved know what is expected from them in their area?
Am I the party pooper?
Maybe. But without this essential foundation, a lot of money can be wasted — or you reach a point where the machine doesn’t fit in the room, the regulator won’t approve production, or what was ordered doesn’t match what anyone actually needed (even though everyone assumed they were aligned).
So no — the URS is not unnecessary. It is the first milestone of every project.
The hidden skill: extracting requirements from stakeholders
One of the most important skills in preparing a URS is the ability to extract information from all stakeholders and understand their needs — something I learned years ago in my systems-analysis training.
Gathering requirements doesn’t happen instantly. Most stakeholders cannot provide answers on the spot without stepping away from daily tasks and thinking deeply about what they truly expect the project to deliver. There is no substitute for this stage.
When people “remember later,” it’s usually already too late — there’s no time or ability to add the requirement, or the entire project becomes delayed and more expensive.
How to start
Step 1: Free expression
Let each function freely express their needs and wishes. At this stage the URS may look like a wish list. Classify items as Must-Have and Nice-to-Have.
Step 2: Vendor quotations and evaluation
Obtain vendor quotations and begin evaluations. Some non-essential requirements will naturally drop off — but sometimes you discover that valuable features are actually reasonably priced.
In theory, a URS should describe the what and not the how, leaving the how to the vendor. In practice the two often mix, because clients frequently have knowledge or preferences about the how. Still, leave vendors enough room to be creative and propose their own solutions.
Step 3: Stakeholder sign-off
Once the URS is complete, have all stakeholders sign it. This is crucial — it ensures accountability and confirms involvement. (Some see it as “covering themselves” — that’s important too.) The signed URS then goes to vendors so they can confirm their ability to meet the requirements and price them accordingly. At this stage the client and vendor review each item together until they reach agreement on scope, price, and delivery time.
Step 4: Final update
Update the URS based on the final agreement. These requirements will later serve as the basis for the Functional Specification (FS) and for validation protocols.
In summary
Take it from 38+ years in the pharmaceutical industry: never skip the URS. You’ll thank yourself later.
