Competition in global life science markets is constantly increasing, customers are becoming more demanding and health reforms are putting pressure on prices. At the same time, regulatory requirements for medicine quality and safety are becoming increasingly stringent. Life science manufacturers are thus under increasing pressure to produce the highest quality products in the shortest possible time, at the lowest possible cost and safely.
For efficient medicine production that complies with all standards and regulations, classical methods no longer suffice. Utilization of advanced technologies is required to digitally support processes, ensure proper execution, secure GMP and regulatory compliance, and develop continual process improvement initiatives.
One of the decisive digital steps is the implementation of a Manufacturing Execution System (MES), which can contribute to production excellence in several areas:
Real-time production visibility. Central processing and review of production data enables real-time reactions based on performance and quality indicators and faster responses to prevent deviations.
Time savings. Integration of production systems and procedures into central software results in lower needs for manual inputs, much less paperwork and faster postproduction analyses, leading to optimized process times and faster product release to market.
Productivity and quality. Standardized production workflows lead operators through all the process steps, ensuring faster execution and minimizing human error. Proactive system management of key operational and quality parameters provides the basis for preventive action to avoid deviations before they occur, resulting in less waste and higher output.
Manufacturing flexibility. Quick adaptation to changing needs and demands requires flexible production, which allows faster introduction of new products; integration of new processes, production sites and personnel; and connection with the supply chain. Moreover, central MES enables the application of modern approaches such as review by exception/quality by design.
Compliance with regulations and standards. On-demand availability of electronic data on machines, process parameters, materials, procedures and people for every step of the production process facilitates compliance with regulatory and GMP requirements.
Tangible benefits in all these areas can be achieved with the introduction of MePIS LS, a modular MES adjusted for life science manufacturing.
For more information, request the MePIS LS brochure.