Welcome back temperature sleuths and life science experts to a new week and a new thrilling topic!  This week I am going in depth into a crucial piece of quality compliance and validation documentation called a User Requirement Specification or URS for short.  Now why is this topic so important in today's pharmaceutical and life science industries?  To explain in one or two sentences would just not be possible, but it is possible to give an informative summary with real life examples that will hopefully help anyone reading make smart quality decisions.

First things first, a URS can be defined as a list of user requirements for any type of equipment, system, or software.  In simpler terms, a URS is written by a collective group within a company looking to define critical or business essential requirements for a system.  A system in this case is a piece or pieces of equipment that can be coupled with software to control, operate, and record data.  In the Life Science and Pharmaceutical industries, all systems can be combined to create a certain product for all types of patients around the world.

Once requirements are spelled out in a URS the document can be sent to vendors to make sure the vendor’s equipment can satisfy critical aspect, process, or quality requirements decided by the customer team.  The URS will have many different sections, each listed with very specific requirements.  Examples for sections can be vary from safety, general requirements, electrical requirements, software requirements, 21 CFR Part 11/security requirements, operational requirements and so on as I could rattle off a couple more depending on the system.  (In a future post, I will give an example system and write an example URS.)

So why is a URS so important?  Believe it or not, a URS is both beneficial to customers and vendors.  A URS is important to a life science or pharmaceutical company to see what type of equipment and features are available on the market.  This document can also help companies make different vendors work to satisfy each user requirement or make custom changes to win business.

A URS is not only beneficial to the group inquiring to buy the system but also the vendor who will be supplying the system.  The URS allows the vendor to explain how and why a specific system can satisfy all the requirements while saving time and money by not going back and forth on certain undefined issues.  If a vendor loses a bid, the vendor can decipher from the URS what requirements were not met and might have been deciding factor in not obtaining business which in turn can help create a better product in the future.

Now that all the pertinent information has been presented tune in next week for a real-life URS example of a system with a downloadable template for creating a robust User Requirement Specification.