By Bryan Ennis, Co-Founder & CEO, Sware
The goal of Pharma 4.0 is to reach a point where organizations leverage the full potential of digitalization to speed innovation for the benefit of patients. The main challenge that these organizations face in achieving that goal is working their way through the computer system validation process. In response to this roadblock, the International Society for Pharmaceutical Engineering (ISPE) is leading an initiative known as Validation 4.0. The idea of Validation 4.0 is to help organizations transition away from creating documentary records for compliance, “validating” absolutely everything, and ignoring previous assurance activity or related risk controls.
Learn more about how to implement Validation 4.0 and attain the benefits of computer system validation.