User Requirements Specification (URS)
URS capturing testable functional, operational, data integrity, and regulatory requirements with unique IDs and traceability — the anchor for design, risk assessment, and qualification. Maps to ASTM E2500 and GAMP 5.
What a template is not
A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.
A specification stating, testably, what a system or piece of equipment must do — the document every later verification activity traces back to. A URS written as a wish list produces qualification that proves nothing in particular; a URS written as discrete, uniquely identified, verifiable statements produces a traceable line from requirement to test to release, which is what a risk-based verification approach depends on.
What's Inside
How to Use It
The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.
ASTM E2500-25 makes the requirements definition the basis on which verification is planned and risk is assessed, and ISPE GAMP 5 (2nd ed.) expects requirements to be traceable through specification and testing to release. EU GMP Annex 11 requires that computerised systems are validated against a specification of intended use. No standard writes your requirements or decides which are GxP-critical; that determination is the organisation's, and this template exists to record it in a form that later verification can trace to.