Enhance production recipe management
Novartis / Alcon
Novartis / Alcon
To improve efficiency of recipe management process, avoid unnecessary deviations and more easily meet regulatory requirements, Novartis decided to introduce MePIS RM software for central recipe management in its production site in Puurs, Belgium. With MePIS RM, Novartis can centrally store production recipes and create workflows that lead all main stakeholders through the whole recipe lifecycle, supported by electronic signatures and push notifications. Moreover, the software enables electronic downloads, full asset-based security (access to assets based on user permissions) and complete audit trail, as well as multiple simultaneous downloads (class-based recipes). The system follows GMP recommendations and is compliant with 21 CFR Part 11. Since it is web-based, it does not require any installation and allows users to speed up preparing, approving, and downloading recipes to the selected process systems, wherever, whenever, while using their favorite device (computer, tablet, mobile). MePIS RM was introduced in Novartis Puurs site in cooperation with local system integrator – De Roeve Industrial IT.
MePIS RM enabled Novartis to speed up their recipe-handling processes while reducing errors and improving recipe data integrity as well as GMP compliance. Due to introduction of the software and consequent process optimizations, Novartis is now able to perform recipe life-cycle actions and machine setups faster. At the same time, it is able to minimize manual work and paper-based documentation for recipe management process. As a result, Novartis decreased the number of production deviations caused by incorrect (manual) parameter entries and reduced associated costs. MePIS RM also allowed Novartis to increase product quality and safety by decreasing probability for (human) mistakes and minimizing amount of bad products. Finally, with central recipe storage, full asset-based security and complete audit trail, Novartis’s recipe data integrity and GMP compliance significantly improved.