Eurofarma Is The First Brazilian Company To Implement Körber's PAS-X MES For Improved Data Access, Traceability, And Regulatory Compliance

Eurofarma Laboratórios has become the first Brazilian company to migrate its entire production at its main plant in Itapevi, São Paulo, to Körber's PAS-X Manufacturing Execution System. The implementation promotes the adoption of operational excellence and enables real-time data access, complete traceability, and improved regulatory compliance.

In Itapevi, Eurofarma produces a wide range of medicines, including generics, cancer drugs, over-the-counter medicines, and veterinary medicines—all products previously manufactured using manual processes. The goal was to replace the numerous manual activities, supported by thousands of paper documents, with digital workflows.

"To implement its Digital Factory of Excellence, Eurofarma chose Körber's PAS-X MES," says Daniel Bosso Gonçalves, Vice President Latin America Software, Körber Business Area Pharma. "The company is once again taking the lead in the region by managing the transition of its manufacturing processes from manual, paper-based workflows to a fully digital environment, improving quality, efficiency, and transparency, and laying the foundation for sustainable innovation."

Today, over 200 workstations are equipped with Electronic Batch Recording (EBR), covering the entire process from warehousing to packaging. Production spans five buildings and covers various manufacturing processes – including digital equipment setup, cleaning processes, and electronic logbooks.

"With the successful implementation of PAS-X MES at our plant, we are celebrating an important milestone in our digital transformation journey," says Allan Santiago, Director of Global Quality at Eurofarma. "The project marks a new era of operational excellence, enabling real-time data access, complete traceability, and improved regulatory compliance. By replacing manual processes with digital workflows, we have significantly reduced errors and increased efficiency. For our quality team, this means faster, data-driven decisions and better preparation for audits."

Eurofarma worked closely with Körber's teams, benefiting from their expertise in project management and the coordination of a multidisciplinary team. Key users from various departments—including Quality, Production, Automation, IT, and Manufacturing Excellence—were strategically involved throughout the project.

The digitalization project was carried out in several phases. The first phase focused on the implementation of PAS-X MES in the weighing and dosing areas, as well as further processing steps up to final filling and packaging for a smaller product family – including the connection to SAP. This phase was completed in just eight months from project initiation to go-live. In subsequent phases, the use of PAS-X MES was expanded to all other processes, products, and recipes, ultimately achieving complete digital integration.

As part of the MES project, more than 20,000 Master Batch Records (MBRs) were created, enabling comprehensive control of processes, equipment utilization, and material tracking. All operator interactions are now conducted digitally, ensuring compliance with FDA 21 CFR Part 11 regulations.

"We now operate a fully digitalized factory capable of producing thousands of batches per month in various forms and packaging in a harmonized and transparent manner," adds Marilene Narciso, Digital Project Manager at Eurofarma. "With PAS-X MES, we have a robust tool for our further digital transformation and the integration of Industry 4.0 and artificial intelligence."

About Körber
We are Körber – an international technology group with approximately 13,000 employees at over 100 locations worldwide and a common goal: We translate entrepreneurial thinking into customer success and shape technological change. In our Digital, Pharma, Supply Chain, and Technologies business areas, we offer inspiring products, solutions, and services. We respond quickly to customer needs, implement ideas seamlessly, and create added value for our customers with our innovations. In doing so, we increasingly build on ecosystems that solve the challenges of today and tomorrow. Körber AG is the holding company of the Körber Group.

In the Körber Business Area Pharma, we deliver the difference by supporting our customers with a holistic ecosystem approach. Our unique portfolio of end-to-end solutions ranges from machines—for aseptic processing solutions, inspection, packaging and materials, and transport systems—to consulting, services, software, and digital and AI-driven solutions that serve as integrating layers to advance pharmaceutical production.

We simplify processes, reduce risks, and accelerate time to market, ensuring seamless collaboration along the entire pharmaceutical and biotechnology value chain. With our comprehensive industry expertise, we help global clients unlock new potential. Our solutions contribute to a better quality of life for current and future generations.

For more information, visit https://www.koerber-pharma.com/