The life sciences landscape is undergoing a digital transformation, and the pharmaceutical, medical device, and healthcare industries have already begun embracing digital technology to improve quality, boost efficiency, and, most importantly, improve data integrity, product quality and patient outcomes. While the Computer System Validation (CSV) approach has been the go-to method for ensuring compliance and software reliability in the life sciences industry for decades, the current life sciences landscape in the digital era demands a more flexible, risk-based, and modern approach that puts system performance, product quality and patient safety first over excessive documentation.
Because of this, Computer Software Assurance (CSA), a new risk-driven and critical-thinking-centered approach first introduced by the FDA in September of 2022, has become the go-to method for ensuring software quality while reducing unnecessary documentation and focusing on real patient safety risks via augmented Risk Assessments and Critical Thinking. In this article, we will contrast the CSA approach with the legacy CSV model most of you in the industry are familiar with and illustrate why life sciences companies that want to gain a competitive advantage in today's digitally driven healthcare environment need Computer Software Assurance.