Navigating the EU AI Act: A Compliance Roadmap for Life Sciences Quality and Regulatory Teams

Amie Harpe is a strategic consultant, IT leader, and founder of Sakara Digital, with 20+ years of experience delivering global quality, compliance, and digital transformation initiatives across pharma, biotech, medical device, and consumer health. She specializes in GxP compliance, AI governance and adoption, document management systems (including Veeva QMS), program management, and operational optimization — with a proven track record of leading complex, high-impact initiatives (often with budgets exceeding $40M) and managing cross-functional, multicultural teams. Through Sakara Digital, Amie helps organizations navigate digital transformation with clarity, flexibility, and purpose, delivering senior-level fractional consulting directly to clients and through strategic partnerships with consulting firms and software providers. She currently serves as Strategic Partner to IntuitionLabs on GxP compliance and AI-enabled transformation for pharmaceutical and life sciences clients. Amie is also the founder of Peacefully Proven (peacefullyproven.com), a wellness brand focused on intentional, peaceful living.