Ensuring Data Integrity in Digitalized Manufacturing: Risk-Based Strategies for Achieving GxP Compliance: Poster Presented at PDA Week 2025.

The digital transformation of pharmaceutical manufacturing brings about several opportunities and challenges in ensuring data integrity, one of the foundational elements of GxP compliance. As automated systems, advanced analytics, and interoperable digital tools become intrinsic parts of the operation, so too does the risk of vulnerabilities in data. This presentation covers the overall framework for mitigating these risks using a risk-based approach to data governance and integrity management.Key topics will include building resilient data governance frameworks, leveraging automation for proactive monitoring, and ensuring data traceability throughout the product lifecycle. Practical case studies will demonstrate how risk-based strategies enhance compliance, drive operational efficiency, and align with regulatory expectations such as FDA, EMA, and global GxP standards.This session bridges the gap between compliance and digital innovation, equipping attendees with actionable strategies to protect data integrity while optimizing manufacturing processes. Whether you are involved in quality assurance, regulatory affairs, or manufacturing science, this presentation will empower you to confidently navigate the complexities of the digital age.