Requirements Traceability Matrix is a regulatory requirement for the life science industry. 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 requirements traceability matrix is usually developed in concurrence with the initial list of requirements and 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 Requirements Traceability Matrix is required to be maintained during the lifecycle including when changes are performed to the system.

The traditional process for creating a Requirements Traceability Matrix is a paper-based inefficient manual process that requires a significant amount of resources to maintain traceability manually during the lifecycle. Unfortunately, the manual process required for creating a Requirements Traceability Matrix is very time consuming, inefficient and not cost effective due to the amount of resources and time required to maintain them during the lifecycle. Traditionally companies create a traceability matrix during the initial implementation but fail to maintain the matrix during the system lifecycle which creates a compliance risk during audits by regulatory agencies. This also creates the challenge that during the lifecycle it is very challenging to view and understand the traceability and whether changes have been validated.

The inefficiencies and high cost associated with paper-based Requirements Traceability Matrix are related to the following:

  • Inadequate cycle times
  • Inability to automate the process
  • Resource commitment

Managing the Requirements Traceability Matrix manually using paper-based documents create a significant amount of compliance risk such as the following:

  • Inability to maintain traceability during the entire lifecycle
  • Lack of visibility to the relationship between requirements and testing during the entire lifecycle
  • Lost and misplaced records
  • Inability to track the relationship between requirements and testing during the lifecycle
  • Inability to meet procedures procedure requirements

ValGenesis validation lifecycle management system provide the industry top solution that eliminates all the inefficiencies related to manual paper-based Requirements Traceability Matrix. In ValGenesis, traceability matrices can be created dynamically and updated in real time to reflect the changes made to requirements and test cases. The ValGenesis system also allows users to view the traceability between documents for completeness before routing them for review and approval, therefore significantly reducing the overall time for authoring.

ValGenesis Requirements Traceability Matrix provides the following advantages:

  • 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

About the Author

cloud-sun Ivan Soto is the Director Client Engagement and Product Strategy, he is responsible for managing the product lifecycle, strategy and overall client experience. Ivan Soto has been in the industry for over 20 years, and held several technical and management positions at different Pharmaceuticals companies in the areas of Validation, IT Compliance, Quality Control and Quality Assurance. In his previous role under his leadership, his team successfully implemented a lean validation program. He is an active speaker at conferences related to validation cost reduction and efficiency improvements. He is also a contributing editor for the Journal of GxP Compliance and Validation Technology. He has a (B.S) in Chemistry from the Catholic University of Puerto Rico.
Electronic Traceability Matrix Life Science Industries Requirements Traceability Matrix RTM

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