SES

As part of its digital transformation, Sanofi has implemented a mobile and web-based tool to support quality decision-making through real-time, interactive dashboards. This platform consolidates data from Finance, Market, Manufacturing, Supply Chain, QA, Regulatory, HR, Clinical Operations, R&D, and Procurement, offering a 360° view of operations. Powered by AI, it delivers actionable insights to guide informed decisions.

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.

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.

The biopharma industry is evolving rapidly—driven by accelerated drug approvals and scaled manufacturing. But this progress has also exposed deep inefficiencies: manual workflows, fragmented systems, and limited scalability. This session presents a bold vision for the Lab of the Future—a biopharma lab reimagined through digital twins and AI. We’ll explore how paperless operations, no-touch planning, and fully integrated systems can boost efficiency, agility, and resilience across development and manufacturing.

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.