Future-proofing quality: the case for TMF-QMS interoperability in the age of AI. скачать в хорошем качестве

Future-proofing quality: the case for TMF-QMS interoperability in the age of AI.

What if your TMF could do more than just store documents—what if it could think, connect insights, and prove how your processes work? This session explores the transformative impact of integrating your Quality Management System (QMS) directly into your eTMF—enhanced by the power of Artificial Intelligence (AI). By embedding Quality by Design (QbD) principles into TMF operations and leveraging AI-driven analytics, language models, and intelligent assistants, organizations can move beyond reactive compliance to build self-improving quality ecosystems. You’ll discover how AI can automatically highlight process risks, and support inspection readiness through predictive insights and natural language interpretation of quality data. This integration bridges the gap between quality frameworks and TMF documentation, transforming the TMF into a living, learning, inspection-ready system—one that evolves with every process iteration. If you’re ready to evolve from document management to intelligent quality management, this session is your starting point—bringing together QbD, eTMF, and AI innovation to redefine what “inspection ready” truly means. 0:00 - Introduction 4:10 - The importance of Quality in Clinical trials 6:50 - SOPs for Quality 8:30 - TMF and Quality : A Lifecycle Approach 13:20 - Where QMS meets TMF 20:17 - The Current Landscape 23:50 - AI and The Future of Integration 28:05 - Conclusion and Q&A