Development and Management of User Requirements Specifications (URS)

What this document is for

The User Requirements Specification (URS) serves as the foundational architectural document within the system lifecycle, establishing the definitive baseline against which all subsequent design, development, and verification efforts are measured.

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Grounded in

FDA 21 CFR 210/211 and Part 11, EU GMP (EudraLex Volume 4, including Annex 1 and Annex 11), ICH Q7–Q12, and WHO GMP. Supplied in 13 languages.

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