Novartis Mengeš faced the challenge of manually transcribing all production data from SCADA systems into paper production reports. Data analysis and comparisons of batch performance were limited, and resolving deviations was inefficient due to the time-consuming data retrieval process from SCADA systems. Storing data locally on individual SCADA systems posed compliance and data integrity challenges without a central SQL and Historian. Moreover, a comprehensive real-time process control and overview were lacking.

The MePIS PDM solution for centralized data management was implemented, offering data analysis, data contextualization and a real-time production overview, along with production reports and process analytics. Add-on modules were upgraded with a comprehensive report builder (EBR/MBR), allowing the option of manual entry of the start and end of individual operations. Integration with approximately 70 SCADA systems was achieved, with implementation finalized on about 70% of them. Full compliance with GMP and 21 CFR Part 11 was established.

GMP and regulatory compliance were significantly improved, with customized production report approval workflows enhancing data integrity. Paper documentation and manual data management were reduced, while visualizing and comparing different process parameters became much easier. This facilitated batch comparisons and analyses (golden batch). Quick data exports enabled faster reporting and analytics, and a real-time system status overview helped speed up responses to problems and critical alarms.