The pharmaceutical industry is among the most highly regulated and technologically demanding sectors. Digitalization of its processes is inevitable, yet many solutions that work successfully in other industries fall short in pharma. The key to success lies in a specialized and modular approach with deep understanding of OT environments.
Unfulfilled promises of digitalization
Although many pharmaceutical companies have already introduced an MES (Manufacturing Execution System) to digitalize production workflows and provide electronic batch records (EBR), practice shows that many users remain stuck in manual processes. Operators still enter data by hand, supervisors check it manually and QA departments manually review batch records.
Statements like “We still manually verify data that we manually entered” are, unfortunately, still a reality in many production environments. Why?
The core problem: incomplete IT/OT integration
One of the main obstacles to effective digitalization is the weak connection between information technology (IT) and operational technology (OT). It is not easy to thoroughly connect machines, process equipment and other shopfloor devices with IT systems such as ERP and some MES due to several reasons::
- different and incompatible communication protocols,
- lack of standardization,
- inconsistent reporting formats,
- complex context of edge generated data
- lack of context in data connection middleware
- high validation costs for each connection,
- old or incompatible equipment (the brownfield reality).
Moreover, IT and OT teams often differ in goals and mindset. IT tends to push for standardization and global harmonization, while OT looks for solutions that work locally and make operators’ jobs easier.
Why generic integration middleware fail?
- Most general-purpose IT/OT integration platforms are designed as universal tools for system integration across industries. Such platforms usually follow a simple “pass-through” logic and standard OPC based data acquisition mechanism and hardly handle non-standard data formats and reports, generated and contextualized at the edge at the end of the batch, which is most important data for production report completeness, data integrity and compliance.
Solution: MePIS digital platform
The solution is Metronik’s MePIS digital platform, developed specifically for the needs of pharmaceutical, biotech and API production.
MePIS platform is portfolio of software modules for smart and connected manufacturing operations management seamlessly integrated with OT layer, designed and developed for life-science industry.
Various different application scenarios can be built using MePIS modules: All-inclusive MES, light MES, OT-IT integration layer, Shop-floor recipe management, Shop-floor reporting, Shoop-floor reporting enhanced with workflows for supper light MES, Pass-through layer with contextualization etc.
The MePIS platform enables comprehensive management, monitoring and analysis of pharmaceutical production processes with a high degree of automation, traceability and regulatory compliance. It bridges OT and IT systems, supporting electronic records, quality control and recipe management in line with industry standards. In terms of OT-IT integration, MePIS provides ability to acquire and extract the highest possible value from the data generated by the shopfloor equipment through handling various data types, non-OPC data and batch data already contextualized at the edge.
Key advantages:
- Modularity: enables phased implementation of solutions and adaptation to different scenarios (e.g., “light MES,” reporting only, recipe integration, etc.).
- Specialized modules:
- MePIS WUA (Work Unit Agent): connects shopfloor equipment with IT systems, enables two-way data transfer, contextualization, recipe transfer and report capture.
- MePIS PDM (Process Data Management): enables centralized reporting, automated monitoring and analysis of data, support for the “review by exception” principle and reporting to IT system.
- MePIS RM (Recipe Management): enables centralized and version-controlled recipe management with validation support, including recipe download trigger from IT system..
- Support for complex OT integration accrpss different vendors (e.g., SKAN, Sartorius, PALL, Belimed), regardless of communication protocol or output format.
- Designed for compliance: support for GMP, GAMP5, 21 CFR Part 11, Annex 11, with validation documentation and full traceability.
Case study: biotechnology plant of a global pharmaceutical company
Metronik implemented MePIS in one of the largest biotech facilities in Central Europe, where more than 130 different equipment units needed to be connected. Challenges included integration of shopfloor with MES, need for centralized shopfloor report repository, manual recipe entry errors and difficulties in shopfloor data analysis.
Results of MePIS implementation:
- EBR is filled with shofloor data automatically
- Less manual work
- Significant reduction in errors and deviations
- Improved quality control,
- Faster review and approval of batch reports,
- Centralized recipe management with greater traceability,
- Significantly reduced batch preparation and analysis times.
Specialized approach for tangible results
True digitalization in the pharmaceutical industry is not only a technical challenge – it is also a regulatory, organizational and cultural one. Generic approaches fail because vendors often don’t understand the specific demands of the industry.
That is why MePIS is more than just a platform – it is an approach. It is the result of more than 30 years of experience in automation and digitalization of pharmaceutical production, and collaboration with experts from nearly 30 companies across more than 20 countries.
Its strength lies in connecting people, processes and technology to create real value.
For more information, please contact us at sasa.sokolic@metronik.si.
