A Quality Management System (QMS) in pharma is more than a regulatory checkbox—it’s a complex ecosystem composed of interconnected processes such as change control and batch release systems. A highly functioning QMS delivers strong oversight, enabling proactive prevention and reducing the risk of recalls. Technologies play a vital role by enabling targeted alerts and root cause investigations, focusing efforts where they matter most. This session will address how to strengthen the foundation of your QMS to prevent issues before they arise, ensuring quality remains a top priority and not a background task. Learn why the benefits of a strong QMS far outweigh the risks of unresolved quality problems and how to embed a culture of vigilance that keeps your operations safe and compliant. In this session, you will learn how to:

• Understand the components and critical processes that make up a robust QMS ecosystem.
• Identify how technology can enhance preventive actions and reduce noise from non-actionable alerts.
• Recognize the challenges pharma faces in maintaining QMS focus and how to elevate its priority within your organization.
• Establish a robust QMS framework that reduces errors and mitigates recall risks.

• What are the key foundational elements of an effective QMS that truly prevent recalls rather than just detect issues?
• How can we better integrate technologies to improve alert systems and focus on meaningful preventive actions?
• In what ways can organizations overcome the tendency to deprioritize QMS, ensuring it remains a core business focus?
• How do we balance regulatory compliance requirements with the need for continuous QMS improvement and innovation?
• Can you share successful examples or lessons learned where strengthening QMS foundations led to measurable quality improvements?

The moderators briefly summarize each World Café and present the key findings.