Daniel R. Matlis is Founder and President of Axendia, an analyst firm providing trusted advice to Life-Science Executives on Business, Technology and Regulatory issues. Dan has three decades of industry experience spanning the Life-Science value chain. He is an active contributor to FDA’s Case for Quality Initiative (since 2014), is a member of FDA’s Advisory Council on Modeling, Simulation and in-Silico Clinical Trial, and has co-chaired the Product Quality Outcomes Analytics initiative with Agency officials. Dan presented Axendia’s research findings to industry executives and the FDA officials. He has also provided input to the Agency on guidance titled “Computer Software Assurance for Manufacturing, Operations, and Quality System Software.” Through this Guidance FDA intends to explicitly support and encourage the use of automation, information technology, and data solutions through a streamlined validation approach.