Anca Niebergall

Managing temperature excursions remains one of the most complex and time-sensitive challenges in pharmaceutical distribution, with direct implications for product quality, supply continuity, and speed to market. In this use case, Astellas shares how enhancements to its TrackWise Digital system—combined with the introduction of Mean Kinetic Temperature (MKT) for assessing minor excursions—have enabled more consistent, data-driven decision-making.

• Position Quality Assurance as a strategic partner to the supply chain by enabling risk-based, data-driven decisions that protect product quality while supporting supply reliability and financial performance
• Embed continuous improvement into GDP operations by standardizing best practices and elevating the distribution network as a center of operational excellence
• Align digital innovation with global GDP requirements to accelerate product release timelines and deliver greater impact to market