The lecture provides a detailed exploration of how AI- and LLM-based systems can effectively support quality decisions in the pharmaceutical industry – within the complex interplay of efficiency gains, regulatory compliance, and ethical responsibility. Using practical and illustrative examples, our experts demonstrate in detail how solutions compliant with Annex 22 and the EU AI Act can be successfully implemented. This goes far beyond mere theory: participants will gain valuable insights, learn about common pitfalls, and discover best practices from real-world projects.