Glossary

User Requirements Specification (URS)

The specification setting out the requirements a facility, equipment, utility, or system must meet to be fit for its intended use.

Source · EU GMP Annex 15, §3.2 User Requirements Specification

Related sections

EU GMP Annex 15 §§1–4 EU GMP Annex 11 §4

Related terms

Design Qualification (DQ)Validation Protocol14 casesComputerised System8 cases

Source

EU GMP Annex 15, §3.2 User Requirements Specification

GRM Regulatory Glossary

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