adesso Blog

Fitting an agile development project into a waterfall-driven CSV framework and quality system can be a challenge. The first part of this series describes thorough preparation of some key topics before the start of the project to set a good foundation for this endeavor. Like the agile ceremonies and artifacts, the CSV tasks should be an integral part of the overall agile project planning. Likewise, the agile development approach is recommended to be described in the Validation Plan. This article shares best practices and observations and gives insights to some concrete activities that should be considered during the course of such a project.

Computer System Validation (CSV) in GxP-regulated industries like pharmaceutical and medical device manufacturing is the testing and documenting to see if the software is fit for its intended use, is compliant to external regulations and internal procedures, thus providing a high degree of assurance that risks to patients, product quality and data integrity are minimized. This first part of the blog describes how to plan and what to do prior commencement of the project to fit in the agile validation approach with an existing CSV V-model process.