In this session, participants will explore how Computer Software Assurance (CSA) is transforming system validation within Pharmaceutical Manufacturing Execution Systems (MES). Attendees will learn about CSA’s risk-based approach, which reduces reliance on extensive documentation and simplifies processes. A case study will illustrate the transition from traditional validation methods to a more efficient model, including the shift from one MES provider to another, providing insights into the benefits, challenges, and key takeaways from a recent upgrade. In this session you will learn how to:

• Implement a risk-based approach to validation through CSA, reducing reliance on extensive documentation and simplifying processes.
• Identify the benefits and challenges associated with transitioning to CSA for more effective validation practices.
• Extract key takeaways from a recent MES system upgrade, including valuable lessons learned from the transition from Syncade to Apprentice.

• What aspects of strategic adaptation in transitioning to CSA would make for a valuable deep-dive session, particularly in regulated environments?
• What were the most impactful learnings from ElevateBio’s transition, and how could a future session focus on these lessons to benefit other organizations considering similar changes?
• How could we create a session around best practices or guidance for qualifying MES and eBRs within a CSA framework, highlighting the key differences from CSV?
• What session topics could explore the broader industry implications of moving from CSV to CSA, particularly around agility, compliance, and innovation in digital transformation?