Insights

Digital Transformation of the Vein to Vein Process for ATMPs: Why integrated data flows and risk based validation matter for patients and pharmaceutical companies

Moving from initial AI initiatives to a scalable management organization: exploring how Finance & Controlling can drive the successful integration of AI into processes, governance, and corporate steering.

AI validation in GxP requires a shift from static CSV to a lifecycle-based approach with continuous monitoring. This is essential to ensure quality, safety, and compliance in non-deterministic systems.

SAP Enable Now is approaching end of support – along with years of built-up training libraries. The shift to WalkMe Learning Arc goes beyond a simple tool change, reshaping how knowledge is created, delivered, and used.

This milestone marks an important step in strengthening our collaboration with SAP and underlines our commitment to combining deep industry expertise with strong SAP capabilities to support our clients in complex transformation initiatives.

NIS2 makes resilience in the pharmaceutical industry a strategic leadership priority, requiring an integrated operating model that harmonizes compliance, cybersecurity, and business continuity.

Organizations succeed by applying established validation principles pragmatically and focusing on end-to-end data integrity.

Getting a researched-based pharmaceutical and biotech company ready for the FDA.