Learning Opportunities from the Data-Driven Manufacturing Excellence Solutions Track
See how Eli Lilly and Company leverages virtual reality (VR), AI, and “release by exception” strategies to improve aseptic training, reduce human error, and accelerate cycle times, in their session, “Digital Innovation to Enable Operational Excellence.”
Why it matters: Engineers gain practical examples of using digital tools to reduce variability and enhance compliance.
“I’m especially excited about Roberto Faucitano’s session on VR in aseptic practices—training innovation is a direct way to boost safety and performance and to lower the cost of training,” shares Christan Wölbeling, Executive Industry Advisor, Körber Pharma Software GmbH
“New ways of learning tackle labor and skill shortage. They offer high engagement with efficient transportation of hands-on knowledge,” notes Vinzenz Zauner, Zauner Consulting.
Learn from PiSA® Farmacéutica’s enterprise-wide transformation, shifting from paper-based to digital-first with agile teams delivering measurable return on investments.
Why it matters: This shows how manufacturing strategy can align with business transformation, not just technology upgrades.
“The PiSA case study resonates with me; it’s refreshing to see digital transformation measured not just by systems installed but by ROI and cultural change even in high volume manufacturing environments,” according to Wölbeling.
“Many leaders face challenges in communicating the ROI to top management. Efforts where digitalization is pushed only for the sake of digitalization lack business commitment—so here we see a session on how to motivate for transformation,” said Zauner.
Explore new ISPE-developed MES templates designed to simplify and de-risk MES rollouts across modalities.
Why it matters: Faster, standardized MES implementations mean engineers can reduce project delays, costs, and risks.
“I am impressed how the ISPE Pharma 4.0 Community of Practice’s Special Interest Group MES develops approaches, how to accelerate digital transformation by providing methodologies for structured, best practices-based master batch record BR development for digitalizing shop floor operations,” said Wölbeling.
“By definition, every project is unique. But with the power of the community, ISPE collected the similarities and abstract patters of MES projects to guide and benefit the industry,” shared Zauner.
Discover how quality has evolved into a strategic driver of digital change using analytics, electronic quality management systems, and agile methods in the session, “The Role of Quality in Digital Transformation.”
Why it matters: Quality isn’t just about compliance—it leads innovation and helps scale digital adoption across the enterprise.
“As Pharma 4.0 Leaders, we selected this presentation to raise the awareness that digital transformation is benefitting our quality operations in Pharma. Quality is one of the key stakeholders in the digital transformation journeys!” shared Wölbeling.
“Quality cannot be added after the manufacturing process ends—it is a result of it. With holistic digital transformation of manufacturing towards Pharma 4.0™, we have to embed quality and unlock its force to drive success,” emphasized Zauner.
Key Takeaways
- Digital transformation is more than new tools—it’s about cultural and organizational change
- New technologies such as VR and AI can improve operator performance, defect detection, and right-first-time execution
- MES doesn’t have to be a burden: standardized templates are coming to accelerate adoption
- Quality is stepping up as a proactive partner, enabling innovation rather than acting as a gatekeeper
For manufacturing engineers, this track provides not just high-level strategy but tangible roadmaps—how to digitalize, how to justify investment, and how to embed quality and MES as enablers of Pharma 4.0.
The authors welcome attendees to join the Data-Driven Manufacturing Excellence Solutions track at the 2025 ISPE Pharma 4.0™ Conference. They look forward to inspirational insights on data and digital transformation, as well as vivid discussions on how to drive manufacturing excellence.
The 2025 ISPE Pharma 4.0™ Conference takes place 9–10 December in Barcelona, Spain, and virtually.
Learn more and register for the 2025 ISPE Pharma 4.0™ Conference.
