Editor's Note: This blog post was reviewed and updated on January 30, 2023.
The requirements traceability matrix (RTM) is a document that links requirements throughout the validation process. Its purpose is to ensure that all requirements defined for a system are tested in the test protocols. The RTM is usually developed in concurrence with the initial list of requirements. 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 trace matrix is the mortar that holds the validation bricks together; it should be used throughout the validation lifecycle.
The manual RTM process has many drawbacks
The traditional process for creating a requirements traceability matrix is inefficient. Manually tracing requirements on Microsoft Excel spreadsheets is highly error-prone and involves considerable time and effort. It's also not cost-effective due to the resources and time needed to maintain them throughout the lifecycle.
Traditionally, companies create a traceability matrix during the initial implementation but fail to maintain the matrix during the system lifecycle, creating compliance risks.
The inefficiencies and high cost associated with paper-based requirements traceability matrices are related to the following:
Inadequate cycle times
The inability to automate the process
Intensive resource commitment
Managing the RTM manually using paper-based documents significantly increases your compliance risk due to the following:
The inability to maintain traceability during the entire lifecycle
Lack of visibility of the relationship between requirements and testing during the entire lifecycle
Lost and misplaced records
The inability to track the relationship between requirements and testing during the lifecycle
The inability to meet procedures procedure requirements
Automated risk-based trace matrix generation
ValGenesis validation lifecycle management system (VLMS) eliminates the inefficiencies related to manual paper-based requirements traceability matrices. In ValGenesis, traceability matrices can be created dynamically and updated in real time to reflect the changes made to requirements and test cases. The system also allows users to view the traceability between documents for completeness before routing them for review and approval, significantly reducing authoring time.
A dynamic traceability matrix generation function expedites the generation process
Easily performs coverage analysis by viewing the relationship between related items
Requirements are linked at the test step level for efficient traceability
The system supports one-to-many, many-to-one and many-to-many relationships
ValGenesis supports forward and backward trace relationships
Trace matrices can be approved through a controlled workflow
Traceability and computer software assurance (CSA)
With the advance of the FDA's computer software assurance (CSA) guidance and the GAMP 5 E2, there is understandable apprehension and uncertainty. The ability to push a button and see an all-inclusive trace matrix with real-time data will reassure stakeholders that the organization's risk management practices are solid. This is critical because a trace matrix is an excellent tool used by auditors to assess system validation.
Manual requirements traceability matrix generation is error-prone and costly due to the resources and time required to maintain them during the validation lifecycle.
Lisa Weeks, the marketing communications director at ValGenesis, writes extensively about technology, the life sciences and other regulated environments. Her work has appeared in many industry publications, including Life Science Leader, Quality Digest, Medical Product Manufacturing NEWS (MPMN), MedTech Pulse, Risk Insights, Medical Device and Diagnostic Industry (MD+DI), Medical Product Outsourcing (MPO), MedTech Intelligence, Pharmaceutical Processing, Pharma Manufacturing, Genetic Engineering & Biotechnology News (GEN) and Pharmaceutical Technology (PharmTech).