EU GMP Annex 11 action plan: Assessment, strategy and digital solutions for compliance

Join Stephen Ferrell, Chief Product Officer at Valkit.ai as he provides a critical analysis of one of the most significant regulatory updates to impact pharmaceutical computerized systems in over a decade. The proposed EU GMP Annex 11 revision transforms European compliance requirements from risk-based guidance to prescriptive technical specifications, introducing mandatory audit trails for all user interactions, comprehensive cybersecurity frameworks and detailed electronic signature protocols that could affect 60-80% of existing pharmaceutical systems globally.

Stephen will explore the key contradictions and implementation challenges within the proposed regulations, compare them with FDA 21 CFR Part 11 and ICH guidelines, and examine how these changes position EU requirements as the emerging global standard for pharmaceutical computerised system compliance. Drawing on his extensive experience as a GAMP 5 contributing author, he’ll provide practical insights for life science organizations helping you to develop strategic compliance roadmaps that balance regulatory adherence with operational efficiency.

This webinar will demonstrate how modern, integrated digital quality management platforms like Ideagen Quality Management can address these evolving regulatory demands while enabling pharmaceutical innovation. Attendees will gain actionable strategies for navigating the 3-5 year industry-wide implementation timeline, understanding the technical and business implications of the changes and building future-ready validation programs that accommodate regulatory evolution while maintaining competitive advantage in the global pharmaceutical market.

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