Success story
From Windows XP SCADA to 21 CFR Part 11 compliance: PIA modernizes Europharma/Gemphar monitoring with atvise®
Context
Europharma/Gemphar, a pharmaceutical company based in Bogotá, Colombia, needed to replace a legacy SCADA system that had reached the end of its useful life, running on unsupported Windows XP hardware and accessible from a single physical workstation. Beyond the operational bottleneck, migrating to a web-based platform had been formally required by the IT department, and compliance with 21 CFR Part 11, the regulatory standard governing pharmaceutical manufacturing records and data integrity, was mandatory, not optional.
The atvise® platform, combined with Vester's support at every stage, allowed us to deliver a solution that not only solved the client's technical problems but also met their regulatory requirements, and that trust translated directly into a second project.
The challenge
The project opened with five fronts at once:
- Legacy SCADA no longer supported or receiving updates, running on Windows XP hardware that needed replacing.
- Access limited to a single physical workstation, creating an operational bottleneck.
- Report generation was slow and difficult to interpret visually.
- Web-based migration formally required by the IT department.
- 21 CFR Part 11 compliance non-negotiable for pharmaceutical manufacturing, and not yet met.
The results
PIA implemented a web-based SCADA system using atvise®, connected to a control panel with a Unitronics PLC linked to 32 field sensors via OPC UA. The benefits landed on five fronts:
- Web accessibility. The system can now be accessed from any device on the company's local network, removing the dependency on a single physical computer.
- Faster, cleaner reporting. Report generation became significantly faster, with all data now compiled into a single consolidated PDF.
- Improved visualizations. Process graphics and trend charts were upgraded visually, making data easier to read and act on.
- Real-time trends in active use. Trend monitoring existed before but was rarely used due to how difficult it was to access; with atvise®, it became a practical tool operators now use regularly.
- Regulatory compliance. The system meets 21 CFR Part 11 requirements, including Audit Trail and calibration management directly from the platform.
The client's satisfaction with the outcome led to two concrete follow-on actions: Europharma expanded to a larger atvise® license, and contracted PIA for a second project on the same platform, a stability management system for pharmaceutical products.
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Partner
PIA (Proyectos de Ingeniería Aplicada S.A.S.) is a Bogotá-based engineering firm whose founders bring 15 to 16 years of industry experience; the company itself has been operating for approximately eight years.
Despite its size, PIA has built a track record working with large industrial clients, and at the time of this project was one of a small number of companies in Colombia with two years of dedicated development and training on the atvise® platform. Its knowledge of Colombian industry norms added further relevance to the project.
