The Future of Audits: How Regulatory Agencies Will Use AI to Evaluate Your QMS
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Key Takeaways
- How regulators are using AI (e.g., Elsa) to prioritize and conduct inspections—and what that means for you.
- The audit implications of FDA's PCCPs and credibility expectations for AI-derived evidence.
- A list of AI-specific documentation to keep maintained in your QMS (including applications used, business purpose, human oversight strategies, and more).
- How MasterControl's AI philosophy ensures compliance while empowering users to prepare for the next generation of AI-assisted audits.
About This Event
AI is already reshaping regulatory oversight. The FDA’s internal assistant “Elsa” is speeding reviews and helping prioritize inspection targets, while new guidance is raising the bar for documentation surrounding AI (e.g., Predetermined Change Control Plans for AI-enabled devices and credibility frameworks for AI-generated evidence). The EMA’s AI initiatives and the EU AI Act will require structured AI quality management, technical documentation, logging, and human oversight—likely signaling implications for future FDA regulations and fundamentally changing how life-science organizations are audited.
This practical session provides an overview of fast-moving policy and details steps you can take now to be audit-ready across the U.S. and EU. Including how a digital and compliant QMS with specialized AI sets you up for success.
Following the presentation, our 15-minute demonstration will show these strategies in action, illustrating how MasterControl helps organize everything needed for audits even in the age of AI and how our specialized AI tools save time, improve efficiencies, and increase compliance.
Key Takeaways
- How regulators are using AI (e.g., Elsa) to prioritize and conduct inspections—and what that means for you.
- The audit implications of FDA's PCCPs and credibility expectations for AI-derived evidence.
- A list of AI-specific documentation to keep maintained in your QMS (including applications used, business purpose, human oversight strategies, and more).
- How MasterControl's AI philosophy ensures compliance while empowering users to prepare for the next generation of AI-assisted audits.
Jessica Madsen
Senior Product Marketing Manager
MasterControl
Jessica is the Sr. Product Marketing Manager over MasterControl Quality Excellence. She has an extensive marketing career spanning nearly 20 years including leadership, strategy, product marketing, customer marketing, and demand gen. Jessica excels at working across teams to bring products to market and translating tech features to customer benefits that resonate.
Dawn Irons
Principal Product Manager - Quality
MasterControl
