One of the world’s largest pharmaceutical companies needed to rapidly stand up two new production facilities after the success of a new compound increased global demand. At the same time, the company wanted both plants to fulfill a next-generation vision for automation-driven, paperless manufacturing with complete data availability for analytics and process improvement.
2 New production sites planned to support growing global demand
16 Week Basis of Design delivery across five solutions
40+ Subject matter experts aligned to develop the design across five solutions in 16 weeks
A major pharmaceutical manufacturer had to move quickly from product success to production readiness. The company needed two new plants built and operational by 2026, which meant defining the Digital Operations Management Basis of Design in a matter of weeks.
The complexity went beyond speed. The client’s vision called for fully digital, paperless operations; complete data integrity and availability for process analytics; Lean MES; and complementary capabilities including Historian, eLogs, and SAP integration.
The design also needed to support an automation-driven operating model with MES integrated to the Distributed Control System, full batch genealogy, recipe management across DeltaV, Syncade, LIMS, and SAP, digital exception tracking for Review-by-Exception, and a foundation for future scheduling and OEE tracking.
Build two new production sites and have both operational by 2026
Define a Basis of Design for fully digital, paperless operations within weeks
Rather than treating this as a narrow system design exercise, Stellix joined a blended partner team to help shape a practical, enterprise-aligned digital operations model for the new facilities.
Stellix consultants worked with more than 40 subject matter experts across MES, quality, data integrity, and Technical Services to define an innovative Basis of Design spanning five solutions and several complex production areas.
The team translated the client’s paperless factory vision into a high-level implementation plan for Operations Management, including PI Historian, automation-driven MES integration, recipe management, exception tracking, and the foundational architecture needed for future scale and performance improvement.
Aligned 40+ SMEs across MES, quality, data integrity, and Technical Services
Developed a Basis of Design spanning five solutions and complex production areas
Within 16 weeks, the blended team delivered a Basis of Design that complied with the company’s established policies, practices, and strategies and is now being used as the primary input for the next, more detailed phase of the program.
The work gave the customer a design that matched its next-generation manufacturing vision while also enabling the company to begin formulating estimates for the next phase of development.
Just as important, the engagement brought process engineers and automation leads together to confirm and support the MES layer design through wireframes developed by Stellix.
Delivered a compliant Basis of Design in 16 weeks
Enabled estimating and planning for the next project phase
The engagement positioned the customer to move forward on two new paperless production sites with a clearer, more robust design for digital operations.
Stellix’s blend of legacy-solution expertise and willingness to apply less-common strategies helped the client navigate a technically complex integration challenge that many MES implementers are not equipped to support.
The result was a stronger collaborative design foundation for the next phase of the program and a more confident path toward the client’s automation-driven, paperless factory vision.
Aligned process engineers and automation leads around the MES layer design
Created a stronger design foundation for the next phase of development
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