CSA Gap Assessment

As FDA guidance on Computer Software Assurance (CSA) reshapes validation expectations in regulated life sciences environments, organizations are rethinking how they approach compliance, testing, and digital transformation. This presentation explores the industry-wide transition from traditional Computer System Validation (CSV) to a modern, risk-based CSA methodology. Based on real-world implementation experience, the session explores how pharmaceutical and medical device companies can align validation practices with evolving FDA expectations, reduce unnecessary documentation, and accelerate system deployment timelines.

Industry experts from Sikich and Sunrise Solutions Consulting discuss practical strategies for adopting CSA. The presentation also highlights the growing role of validation lifecycle management platforms, automated testing tools, and AI-enabled technologies in supporting scalable compliance programs. Attendees gain actionable guidance for modernizing validation programs while maintaining compliance across GxP, HIPAA, GDPR, SOX, and FDA-regulated environments.