A user requirement specification (URS) collects the requirements of a user or group of users associated with a given task (or function). As part of the collection process, the URS also serves as your collective memory on cross-functional stakeholders’ needs that are relevant to your business, industry and operational requirements at the time of its creation and across the system lifecycle.
URSs are critically important to your organization. URS owners, authors, and contributors must give them the effort they deserve, not relegating them to an inconvenient afterthought. Improper URS management is a waste of your resource, not only in relation to the URS itself but also to the service or item it was intended to describe, ultimately making your business less efficient and less productive.
This paper aims to stimulate debate in the biopharmaceutical industry and work towards industry-wide alignment on the creation and use of optimized and lean URSs for equipment, facilities, utilities and systems qualification.
We analyzed the content of more than 40 URSs, reviewed industry best practices, and explored good recordkeeping practices for URS documentation. The lessons learned enabled us to design a template for the URS of the future.
The intended audience is those responsible for the qualification and validation of biopharmaceutical manufacturing plants, e.g., engineering, qualification/validation managers and those responsible for quality oversight.
Implementing lean URSs throughout the qualification lifecycle will reduce waste and time. Working together, we can start a journey toward alignment and implementation of the URS of the future. How do you use URSs in your organization?