SES

The presentation offers examples of how technology is leveraged to enable operational excellence in one of the most important manufacturing plant of Eli Lilly OUS. It focuses on digital innovation, how it enables data-driven decisions and improves end-to-end supply resiliency. It covers examples of use of virtual reality for aseptic practices, line setup, critical interventions, aseptic operators training, reducing human error and optimizing right-first-time execution.

The presentation explores the evolving role of Quality in driving digital transformation within the pharmaceutical industry. It highlights how the Quality function; traditionally seen as a compliance-focused discipline, has progressively transformed into a strategic partner, actively supporting and embraced digital tools—such as data analytics, automation, and digital quality management systems (eQMS). This approach enables innovation, promoting digital initiatives across different business units inside our organization.

This presentation will explore how digital tools can enhance data integrity and enable real-time data capture in microbiological quality control (QC), with a concrete use case involving SmartReg (an eBR/MES platform) integrated into sterility test pumps distributed by Merck. In many microbiology labs, operators face the daily challenge of maintaining compliance and traceability while working under laminar flow hoods with limited freedom of movement.

Pharma 4.0 needs more than digital tools—it needs interoperable, trusted data spaces. This presentation introduces how Industry 4.0 building blocks like the Asset Administration Shell (AAS) and the “AAS Dataspace for Everybody” initiative provide the foundation for scalable, secure, and collaborative digital ecosystems. Backed by Germany’s Manufacturing-X program, these frameworks are driving cross-industry adoption of open, standards-based data sharing.

Takeda is actively leveraging integrating artificial intelligence (AI) within GxP-regulated environments, aiming to enhance quality, speed, and operational efficiency. This strategic approach aligns with Takeda’s commitment to innovation, ethical AI use, and strict adherence to regulatory standards. Carmen’s presentation showcases AI applications designed to standardize, simplify, and streamline operations while ensuring compliance.

Based on real-world case studies the integration of AI into pharmaceutical quality control processes will be showcased from a strategic perspective. The presentation will showcase how data governance, risk management and computer system validation principles can be integrated from a strategic perspective. Based on a case study utilizing unsupervised learning, the importance of integration of risk management and data governance will be reviewed, and a few thought-provoking impulses will be given.