Requirment Traceability Matrix

The Requirements Traceability Matrix (RTM) is a document that links requirements throughout the validation process. The purpose of the Requirements Traceability Matrix is to ensure that all requirements defined for a system are tested in the test protocols. The traceability matrix is a tool both for the validation team, to ensure that requirements are not lost during the validation project, and for auditors, to review the validation documentation.

The requirements traceability matrix is usually developed in concurrence with the initial list of requirements (either the User Requirements Specification or Functional Requirements Specification). As the Design Specifications and Test Protocols are developed, the traceability matrix is updated to include the updated documents. Ideally, requirements should be traced to the specific test step in the testing protocol in which they are tested.

Requirements Traceability Matrix Example

The traceability matrix can either reference the requirement identifiers (unique numbers for each requirement)  or the actual requirement itself.  In the example shown below, requirements are traced between a Functional Requirements Specification, Design Specification, and Operational Qualification.

Functional Requirements	Design Specifications	Test Cases
The program will have a functional audit trail.	Each form will use fxn_Audit_Trail in the OnUpdate event procedure.	OQ, Test Case 3, Step 52: Audit Trail Verification

In more complicated systems, the traceability matrix may include references to additional documentation, including user requirements, risk assessments, etc.

The traceability matrix can be created and maintained in an automated tool, in an Excel spreadsheet, or MS Word table.

Acronyms

The following terms or abbreviations are sometimes used: Traceability Matrix, Trace Matrix, RTM, TM