In GxP environments, the URS describes the required functions of a system and is based on a documented risk assessment, and the requirements should be traceable throughout the system's lifecycle. EU GMP Annex 11 sets this out, and GAMP 5 treats the URS as the foundation of specification and testing. Each requirement is later tested, so it has to be written in a way that can be verified.
Why it matters for labeling
For an artwork comparison or approval tool, the URS records what the team actually needs: the comparison types (text, graphics, barcode, Braille), the languages and character sets, audit trail and electronic signature requirements, user roles, reporting, and integration with existing systems. Writing it before choosing a tool keeps the choice tied to needs, and gives validation testing something concrete to trace back to. It also underpins IQ, OQ and PQ.
Common mistakes
- Written after the purchase to match the product
- Vague requirements, such as "easy to use," that can't be tested
- No ranking of requirements by risk or importance
- Never updated after a significant change