Traceability Matrix
Requirements Traceability Matrix · rtm · trace matrix · requirements traceability matrix
The grid that maps every URS requirement to the FS, DS, test script and test result that proves it works — your single audit defence.
The Requirements Traceability Matrix (RTM) is a grid with one row per URS requirement and columns showing where it is specified (FS, DS), where it is tested (IQ / OQ / PQ test script ID), and the test outcome. It is the document an inspector asks for first, because it proves coverage without reading every artefact.
Maintained in Excel, the RTM is almost always stale. V5 auto-generates the RTM from the validation pack: each test script is tagged to one or more URS requirements, each execution records pass/fail/N/A, and the RTM regenerates on demand showing live coverage plus open gaps. Customers ship the RTM as part of the validation evidence package.
- GAMP 5
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