CSA thinking is in the anvil for quite some time, with US FDA reaching out to industry veterans. FDA launched the Case for Quality initiative in 2011 for a case to promote automated solutions as opposed to prevalent and outdated software. With its roots in the Medical Device industry, FDA’s aim was to improve quality with a focus on identifying areas related to high-risk requirements and reducing or combining the non-value adding requirements. The assessment was based on software’s impact to public health, patient safety and quality system-and-data integrity. CSA is not a fad, hyperbole, or a recent quality trend but meant to be a way of life to make existing processes and efforts needed to implement those processes, simpler and less resource intensive.