Project Management

Effective Validation Testing for Regulatory Compliant Agile Software

Dina Laresch, PMP

This article covers the key challenges companies face when validating software for regulated industries using agile development. The iterative nature of agile development poses challenges different from those faced by following a linear, waterfall development method. My team initially ran into problems keeping our validation cycle within budget and on schedule. The significant challenge companies face when using non-linear development is to demonstrate traceability from requirements and functional specifications to testing. The approach we first took for traceability from a user story to a validation test did not work well, since user stories represent a very small piece of functionality. Another challenge is verifying small user stories as they relate to the validation of the larger business requirement.

We embraced automated testing and used our SDLC tools to automatically generate the traceability matrix. Automated testing plays a big part in achieving effective testing for regulatory-compliant agile software. I will be discussing successful practices using automated validation testing and the steps a team can take to reduce validation cost and time at the end of a release cycle.


1. Validation testing for regulatory-compliant software following agile development is more challenging than traditional waterfall development:
Validation is the …

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