ROI factors for implementing Manufacturing Execution System (MES) in Pharma.

Pharmaceutical, Life science and Health Care are few of the industries need to operate under continuous pressure to remain competitive while meeting the stringent regulatory manufacturing requirements. These manufacturing requirements include simple electronic record keeping to complex data assuring consistently the reliability of the manufacturing processes, equipment testing, peoples training, raw material quality, sampling plans, root cause-analysis, products deviations etc. The continuous up gradation of Manufacturing Execution System (MES) in Pharma industry in a row is a testimonial on its own.

MSE helps Pharma companies comply with 21CFR Part 11 electronic signatures, FDA audits, validation and confirms to US FDA cGMP requirements. Manufacturing Execution System (MES) enable the Pharmaceutical industry to reduce production cost and increase compliance with regulatory requirements significantly. This is due to the capability of an MES to optimize business processes in the production supply chain, improve product quality and ensure the safety of manufacturing processes.

A Manufacturing Execution System is an electronic interface between personnel, equipment automation, orders, logistics, equipment and processing instructions (batch records). The MES mediates between business administration (covering core functions such as sales and production planning or controlling) and the automation of the production process.

However, despite the importance of such a structured approach it cannot be denied that the decision for or against the benefits of an MES system frequently involve factors that are not measurable in economic terms.

Goals to be achieved by the implementation of an MES system are:

• Best suitable for controlling workflows, improving process safety, reliability and recognition of deviations at an early stage
• Reduction of operating costs due to a high level of integration and thus prevention of isolated solutions
• Rapid access to current data: management based on up-to-the-minute information for all critical business cases
• Visibility and transparency throughout the entire production process
• Reduction of administrative work for maintaining manufacturing documents
• Immediate documentation of process steps
• Reduction of storage costs due to reduced lead times (WIP)
• Creating and approving master batch records
• Reducing the number of lost batches
• Complete 21 CFR Part 11 compliance