Agile in GxP CSV Environments: The Concept

Are you skeptical or convinced about the compatibility of agile IT system implementation and Computerized System Validation (CSV)? You didn’t make up your mind yet? Or are you just hungry for information? In any case, if you are looking for an opinion about when and how to apply an agile approach (or Scrum – used interchangeably) on regulated projects, keep reading. To make the most out of this article however, you should have basic project management, agile and GxP or CSV knowledge. 

In this article, I show how to apply Scrum on projects where the technical solution must undergo CSV (see the “How to Scrum?” section). As such, I touch on how Scrum artefacts do match to the validation documentation. Before talking about how to apply Scrum however, I start by sharing my thoughts on when to apply Scrum (see the “When to Scrum?” section). This agile framework is so much more than a way of working. It is also a way of thinking. Understanding this is key to agile implementations. 

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