Complete MES for a new packaging center in Turda, Romania
Stada
Company
Stada
Industry
Pharmaceutical
Solution
CHALLENGES
The new plant in Turda required a modern MES to provide a digital framework for production management and achieve several key goals: paperless production, reduced manual work for operators, support for QM and regulatory compliance, a transparent view of the manufacturing process, optimized productivity and adherence to strict/short implementation deadlines. Both new and standard Stada production processes were implemented to meet these demands.
SOLUTIONS
In the packaging department at Stada, a comprehensive MePIS LS solution was implemented, encompassing material flow control, MBR/EBR, equipment management, exception management and generic MBRs. A full validation package was included to ensure compliance with GMP and 21 CFR Part 11 regulations. The system was also integrated with the company's ERP system (SAP) and the shop floor. Additionally, a digital showroom was set up to display room status in real-time, further enhancing operational transparency and efficiency.
RESULT
Stada saw improvements in GMP and regulatory compliance, with customized production report approval workflows enhancing data integrity. Paper documentation and manual work in data management were significantly reduced. Visualization and comparison of process parameters became easier, leading to optimal settings for production processes. Batch comparisons and analyses (golden batch) were also facilitated. Moreover, data exports for reporting and analytics became quicker, and responses to problems and critical alarms were much faster thanks to a real-time system status overview.
