RTM
Requirements Traceability Matrix
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
The table that maps every requirement in the URS forward to the design element that implements it and the test that verifies it, and back again. It is the artefact an inspector uses to ask "show me where this requirement was tested" and get an answer in one step.
Traceability is bidirectional by design. Forward traceability proves no requirement went untested; backward traceability proves no test exists without a requirement behind it — which is how gold-plated protocols and orphaned test scripts get found.
The RTM is not a deliverable produced at the end to satisfy a reviewer. Built during specification it is a working control; reconstructed afterwards it is documentation theatre, and it usually shows.
ISPE GAMP 5 (2nd ed., 2022) for specification-and-verification traceability; EU GMP Annex 15 (2015) §2; EU GMP Annex 11 §4 for computerised systems.
Frequently asked questions
What does RTM stand for?
RTM stands for Requirements Traceability Matrix.
What is RTM?
The table that maps every requirement in the URS forward to the design element that implements it and the test that verifies it, and back again. It is the artefact an inspector uses to ask "show me where this requirement was tested" and get an answer in one step.
Which regulations cover RTM?
ISPE GAMP 5 (2nd ed., 2022) for specification-and-verification traceability; EU GMP Annex 15 (2015) §2; EU GMP Annex 11 §4 for computerised systems.