Pharmaceutical and Life science are few of the early adopters of information technology for quality compliance, process optimization, reducing errors, involving the supply chain and increasing profit.
According to a report published by Gartner in 2010, there is a huge need of integrated IT manufacturing technologies, supported by the fact that the increase in corporate IT budgets from 19 % in 2007 to 25% in 2015. The Pharmaceutical industry has adopted this strategic initiative of integrating manufacturing IT and is benefiting through improved quality and production efficiencies. The key to a successful MES implementation is applying the right level of IT to maximize Return on Investment (ROI).
IT is playing a major role to streamline, automate and expedite various process involves at all levels of manufacturing operations. Technologies like manufacturing execution system (MES) has enabled IT in manufacturing to shift from being data centric to process centric. By not restricting technology at the manufacturing operations management level, activities such as Electronic Batch Records (EBR), real-time reporting, Enterprise Resource Planning (ERP) and equipment integration all have allowed pharmaceutical companies to maximize return on IT investment, improve quality, provide a platform for continuous improvement and ultimately increase profits.
Manufacturing Execution System (MES) as a technology has been successfully deployed within the pharmaceutical industry since the Food and Drug Administration (FDA) declared the final 21 Part 11 regulations on 21 March 1997. According to this electronic records and electronic signatures are equivalent to handwritten records and signature. In these 16 years technologies associated with Manufacturing Execution System (MES) has upgraded lot and became best practice in Pharma industry.
The amount of IT included to an MES project is dependent on the customers’ business need. The basic version of Manufacturing Execution System (MES) should include replacement of paper batch records with an EBR, automated material weigh & dispense and integration with legacy ERP system to achieve optimization in inventory and production. Manufacturing Execution System (MES) can also be integrated at the factory level, for gaining complete control over the entire enterprise. This level of control helps ensure ‘right-first-time’ manufacturing and total enterprise visibility. The MES acts as a central system with effective integrations with other manufacturing systems and departments such as operations, quality, maintenance and inventory control. The MES not only facilitates regulatory compliance, but also supports drug makers to ensure high quality in their manufacturing processes.