White Paper: Digital and AI-Enabled GMP Systems: Enhancing Compliance, Data Integrity, and Operational Efficiency
Published By VTI Life Sciences
Introduction
The pharmaceutical industry is undergoing a significant transformation driven by digitization and artificial intelligence (AI). As regulatory expectations from agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) continue to emphasize data integrity, traceability, and compliance, Good Manufacturing Practice (GMP) systems must evolve accordingly. Digital and AI-enabled GMP systems have emerged as powerful tools to ensure regulatory compliance while simultaneously increasing operational efficiency and reducing the risk of human error and data manipulation.