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From Validation to Cyber Resilience: What the EMA Annex 11 Draft Means for GxP Cybersecurity

Cybersecurity in GxP is no longer just an IT concern. This article explores how the draft EMA Annex 11 aligns with cybersecurity practices, what this means for governance and system lifecycle management, and steps pharmaceutical companies can take to strengthen resilience.

Do You Know Where AI Is Already Shaping GMP Decisions in Your Organization?

AI may already be shaping GMP decisions in your organization, even within familiar tools. This article explores how to identify where AI is used, distinguish trained models from programmed logic, and understand what draft Annex 11 and Annex 22 mean for…

Join us at the October Zug Pharma Group Gathering

KVALITO Consulting Group is supporting the next Zug Pharma Group monthly gathering on 1 October at Freiruum in Zug.  Join us for an evening of conversation and connection with Zug’s life sciences community. We look forward to reconnecting with familiar faces, meeting...

KVALITO Establishes U.S. Presence to Deepen Client Partnerships and Support Global Growth

New U.S. entity will bring KVALITO closer to life sciences clients and support the continued growth of its Applied Technology and Innovation, Quality and Compliance, and transformation services. BASEL, Switzerland, July 20, 2026: KVALITO Consulting Group has...
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