Krka faced several challenges with its previous MES, which lacked API-specific functions, utilized regenerated products cand employed API-specific materials not controlled by SAP. Production unit and line reconfiguration occurred frequently, and tracking equipment cleanliness was a challenge. Furthermore, operators had a very poor user experience when running production far from the control room.

To address these issues, standard MePIS LS functionalities were implemented. This included synchronization between MePIS LS and SAP for the exchange of materials, MBR, work orders and material flow; equipment management and configuration; MBR management; Material Flow Control (MFC); inventory and warehouse management; equipment logbook for cleanliness; production execution; deviation management; and labeling and printing. The solution is fully compliant with GMP and 21 CFR Part 11. Additionally, API-focused MePIS LS functionalities were introduced, such as equipment management and configuration, the use of regenerated materials, integration with SCADA/DCS, and mobile device support for production execution and material flow activities. Customer benefits are still to be determined as the implementation is ongoing.