There are so many promises of the 4.0 world. Why has the adoption in the pharmaceutical industry been so slow relative to other industries? Is it regulations? Is it processes? Is it mindset? This session is intended to dive into some aspects related to quality and, in particular, validation. We will explore efficient, more focused ways to approach validation in a world where digital is the focus and data is fundamental. How can we demonstrate fitness for intended use in this data driven world?