EU GMP Annex 11 Action Plan: Assessment, Strategy And Digital Solutions For Compliance

The proposed revision to EU GMP Annex 11 marks a seismic shift in how pharmaceutical companies must approach computerized system compliance. In this webinar, Stephen Ferrell, Chief Product Officer at Valkit.ai and GAMP 5 contributing author, breaks down the transition from risk-based guidance to prescriptive technical mandates, introducing mandatory audit trails, robust cybersecurity frameworks, and stringent electronic signature protocols. With potential impact on up to 80% of existing systems, Ferrell examines the contradictions and implementation hurdles, compares the EU changes with FDA 21 CFR Part 11 and ICH guidelines, and outlines how these updates may set a new global standard.

Gain practical strategies for navigating the 3–5 year implementation timeline and learn how integrated digital quality platforms can support compliance while driving innovation.