Greenfield projects in the pharmaceutical industry offer strategic opportunities. Unlike brownfield environments, they are not constrained by legacy systems, entrenched paper workflows, or fragmented digital solutions. At the same time, they are exposed to intense pressure: tight timelines, regulatory scrutiny, and the need to deliver operational stability from the very first production batch.
For STADA, a broad-based global pharmaceuticals manufacturer, the construction of a new supply-chain hub in Turda, Romania, was not simply about adding capacity. It was a strategic decision to establish a new digital benchmark—one that could support long-term competitiveness, global scalability, and Pharma 4.0 ambitions.
The ambition: paperless production from day one
Rather than introducing Manufacturing Execution Systems gradually or digitizing selected paper processes, the company made a decisive choice: the new facility would operate as a Smart Paperless Plant from day one.
This ambition came with strict constraints. The facility had to reach full operational capability within a short time window to meet global supply demands. The corporate ERP system had to remain completely standard, without custom developments that could complicate future upgrades. At the same time, production execution had to be fully digital, audit-ready, and compliant from the first batch onward.
Compounding the challenge, this project represented the organization’s first-ever MES implementation—yet the solution needed to be scalable and replicable across more than a dozen additional sites worldwide.
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Balancing ERP standards with shop floor agility
One of the central challenges of the project was architectural. On one side stood a rigid, globally standardized ERP environment designed for consistency and long-term maintainability. On the other stood a dynamic shop floor that required real-time machine integration, flexible production execution, and intuitive operator guidance.
Bridging this gap required more than a traditional MES. The solution needed to function as an intelligent digital layer—capable of translating standardized ERP data into executable, compliant production processes without compromising agility.
This requirement led to the selection of MePIS LS MES.
MePIS LS MES as the digital backbone of production
MePIS LS MES was implemented as the operational core of the new supply-chain facility in Turda, Romania, connecting ERP with the shop floor and enabling fully digital production execution.
The system supports the entire lifecycle from Master Batch Records (MBR) to Electronic Batch Records (EBR), while integrating machines in real time and maintaining complete material and batch traceability. Electronic equipment logbooks replace manual documentation, ensuring data integrity and transparency throughout production.
A key enabler of efficiency and standardization was the use of generic MBR templates. Instead of redesigning batch records for each product, users adjust only specific parameters and Bills of Material through an intuitive graphical interface. This approach significantly reduces the effort required to manage batch documentation, minimizes manual entry errors, and accelerates product changeovers—while preserving strict process consistency.
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From go-live to audit success
To reduce risk and ensure operational stability, the project leveraged SOPs and IT/OT frameworks adapted from STADA’s established sites. MePIS LS MES was configured rather than customized, aligning the solution with corporate standards and long-term maintenance strategies.
Operators are guided through production using step-by-step digital instructions, with full digitalization allowing them to use tablets for real-time scanning and execution, enforcing process discipline and reducing variability. This enabled rapid onboarding of personnel and stable operations immediately after go-live.
The pilot go-live in January 2024 demonstrated that even complex greenfield MES projects can be delivered efficiently when supported by the right digital architecture. The ultimate proof came quickly: the first production batch successfully passed its first audit.
Tangible results with long-term impact
Today, the facility utilizes a fully digitalized packaging infrastructure designed for high-volume output. Production data is captured and processed in real time, providing accurate operational insight and supporting informed decision-making.
Beyond operational performance and compliance, the project delivered lasting strategic value. STADA now has a scalable digital blueprint for future sites—reducing rollout time, lowering operational risk, and supporting consistent execution across the organization.
What this project shows about Pharma 4.0
This greenfield project demonstrates that Pharma 4.0 is not a distant vision. With the right MES architecture, it is possible to combine paperless production, regulatory confidence, and ERP standardization—without compromising speed to market.
By positioning MePIS LS MES as the digital backbone of production, STADA transformed a new facility into a future-proof standard for global deployment.
Interested in building a paperless, Pharma 4.0–ready production environment? Get in touch with sasa.sokolic@metronik.si
