The Requirement Traceability Matrix (RTM) is a document which formally links requirements throughout the validation process. The purpose of the requirement traceability matrix is to ensure that all requirements defined for the system are tested in the Testing Protocols.
The requirement traceability matrix is usually developed in concurrence with the initial list of requirements (either the user requirement specification or functional Specification). As the Design Specifications and Testing Protocols are developed, the traceability matrix is updated. Ideally, requirements should be traced to the specific test step in the testing protocol where they are tested.
How can Ofni Systems help you?
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At Ofni Systems, we suggest that the Traceability Matrix be informally reviewed by the System Owner and Quality Assurance, but that the document can exist as a separate report included in the Validation Package and does not need formal approval.
Acronyms
Traceability Matrix, Trace Matrix, RTM, TM
Additional Resources
Validation Document Resources
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