User Requirements Specification - URS

What is a URS?

The User Requirements Specification (URS) is a document created before any computer system is being chosen.

The validation of any computer system requires that the user has documented what the system is supposed to do, and subsequently test that the system actually is capable of doing so. In order to test this, the requirements must be stated before purchase in a URS. The URS is the important background document for choosing the system.

Why write the URS?

The process of writing the URS is also important as the persons writing this are working through what the real needs are, instead of what they think they are. A thorough process is the single most important piece of work to ensure that the the new system is a success.

What is included?

Traditionally the URS includes the technical requirements that the users have for the new system. But with a new system there might be changes in the way we work, so a good URS also includes description of what they think the new work process looks like. This may of course be regarded as a "Catch 22": How can we know the processes when we do not know what the system is going to look like? However, it is possible to start explaining what the current work processes are, and how we vision that they may look like. That will leave it open to the vendor to suggest how their system may help us fulfilling the visions we have.

When working in a regulated industry, like pharmaceutical, medical devices, and accredited or certified industries, there are often requirements for validating the system. The System Development Life Cycle validation also includes what has happened to the system before it was bought. A further requirement in the URS should also be that the purchaser can audit the vendor to check this out, as well as several specified requirements regarding the built-in quality of the system.

Want to know more?

Publications:

Segalstad: The User Requirements Specification - The most Important Tool in the Validation, Scientific Computing and Instrumentation, Fall 2000 (24-25)

Segalstad: Development Qualification: Selecting the right LIMS vendor, European Pharmaceutical Review, Vol. 5 Issue 4 (2000) 58-61 Also published in: American Pharmaceutical Review, Vol. 3, Issue 4 Winter 2000-2001 (84-87)