Managing requirements can be both challenging and time consuming. Requirements must be updated, modified, deleted, and/or added as a result of changes to systems and/or processes. Managing these changes to requirements poses a significant obstacle, as well as a compliance risk, even when tracked via a change control process. The problems are compounded when managing traceability matrices, where linking individual requirements to test functions and verifying appropriate testing levels are completed. The result is increased time requirements and unnecessarily laborious project/task management.

The Requirement Management module available in ValGenesis VLMS allows our users to modify, add, or delete requirements, and to route any changes through an approval process. Once a requirement is modified, the system automatically updates the status in the traceability matrix to ensure these changes are tested. All requirement changes are automatically version controlled. With the Change Management functionality, the entire requirement change management process is maintained as a closed-loop process with validation.

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Challenges with Requirements Management during the Computer Systems Validation Lifecycle
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