Blog Posts

10 Myths about Agile and the FDA

Blog: Pathfinder Development

1. Myth: Verification and Validation should only start after all development is complete. 

Truth:  In traditional waterfall, verification and validation activities often commence at the tail end of a project, after all development is complete.  This diverges from the FDA’s recommendations:

“[The FDA] does recommend that software validation and verification activities be conducted throughout the entire software lifecycle.”[n]

In Agile, verification and validation start at the user story level, providing traceability from user story to code, code to unit test, and user story to

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