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.
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|
For more examples, see our FastVal Traceability Matrix template.
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.
Q: Are traceability matrices required by the FDA and other regulatory bodies?
A: The United States Code of Federal Regulations does not specifically require a traceability matrix, but creating a traceability matrix is recognized as a validation best practice. The FDA General Principles of Software Validation state, “Software validation includes confirmation of conformance to all software specifications and confirmation that all software requirements are traceable to the system specifications (Page 7, Section 3.2).” Traceability matrices are also mentioned in Annex 11, 4.4, which states, “User requirements should be traceable through the life-cycle.” Not having a traceability matrix should not, in itself, cause an observation from an FDA auditor, but would likely be cited as indication that a validation process did not follow recognized industry practices for validation.
Q: How does Ofni Systems create their traceability matrices?
A: We use an automated traceability matrix utility to ensure requirement traceability and generate the actual requirement traceability document. Other organizations might use Excel spreadsheets to keep a table of requirements, despite this being extremely difficult to maintain manually.
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The following terms or abbreviations are sometimes used: Traceability Matrix, Trace Matrix, RTM, TM