This pharmaceutical plant faced difficulties managing paper-based production reports, as reports in .pdf format were not useful for further processing. There was a need for centralized recipe management due to occasional deviations, substantial manual work and time-consuming procedures. Machine data was stored locally, with manual backups, which was problematic from a GMP compliance and data integrity standpoint. Analyzing data when deviations occurred was challenging, as it required manual data retrieval from paper documents and local storage. Additionally, there was no real-time production overview.

The MePIS PDM solution was implemented, with modules for centralized production report management, real-time production overview and analytics. The MePIS RM solution provided central recipe management with electronic approval workflows. Integration with approximately 200 different pieces of equipment (including tablet presses, coaters, solution preparation systems, CIP/WIP, mills and packaging lines) was achieved. A bidirectional interface with MES (Werum PAS-X) was successfully tested, and a go-live was planned with an MES upgrade to a newer version. Full GMP and 21 CFR Part 11 compliance was ensured.

The plant experienced significant time savings, less paperwork, fewer human errors and reduced deviations. GMP compliance improved with unified reporting and a configurable workflow for report approvals, enhancing data integrity. Recipe-handling processes became faster and more efficient, with optimized machine setup activities and less manual work. Additionally, the company gained valuable process insights through data analysis, enabling easy comparisons of process parameters and batch comparisons (golden batch). The system also enabled data exports for further analysis, reduced reaction times to potential problems and provided live status overviews of production equipment. Overall, the solution delivered an excellent ROI.