Question on a LinkedIn group:
Life Science industry is using traditional V model for CSV. Should this model be changed for Agile based development, testing and validation.
I believe we should be able to use the user stories instead URS as the basis of V model. Please share your thought. Thanks
PJ Singh, PMP
Co-Founder & Director – Quality, Compliance, Validation, and Technology Integration
I’ve found out, during my tenure as Scrum PO for a GxP regulated product, that if you have a documentation resource, usually a Business Analyst, embedded in the SCRUM team, constantly making sure that there is documentation alignment between URS and User Stories, and make the documentation part of the Definition of Done, you can have a very strong alignment between V model and Agile practices.
I’m willing to propose and defend that, for implementing CSV while practicing Agile, one needs to have Documentation as a SPRINT deliverable.