Today’s Life Sciences Manufacturers are under relentless pressure to implement Operational Excellence initiatives, such as Lean, Six Sigma, and Electronic Batch Records (eBR), that help reduce costs, increase customer service levels via on-time and accurate deliveries, improve yield, reduce scrap, and improve product quality while maintaining stringent regulatory compliance.
Additionally, as the paradigm is shifting to more patient focused medications and with the upcoming patent expirations for many “blockbuster” medications, Life Science Manufacturers are searching for ways to scale innovation in their R&D and Clinical Trials processes to improve time to market for new products.
They require innovative solutions that leverage existing investments in both their core enterprise business systems as well as the IT infrastructure. How can they extend the control and visibility that exist within the enterprise to the effort that takes place on the plant floor?
Defined as “Production Execution”, the work-steps and events taken on the shop floor, isn’t robust functionality that resides within the traditional ERP system. Until now, organizations have been forced to work with traditional MES solutions to fill this gap. Thus requiring a much higher Total Cost of Ownership (TCO) with too much functional overlap and integration challenges between the existing back-end ERP, Laboratory Information Systems (LIMS) and Process Historians.