The factory floor is the heartbeat of any manufacturing company. It is a living, breathing, complex environment, with rapidly changing conditions that can affect every other area of the business. It also generates vast amounts of material and product data which must be collected, stored and analyzed to make informed decisions and comply with CGMP regulations. Manufacturing execution systems (MES) software tracks the flow of production data in real time and manages the activities that take place on the factory floor, serving as a crucial link in the end-to-end product lifecycle and providing access to insights that key stakeholders can use to make process improvements and increase production output.
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A manufacturing execution system is a computerized system used for real-time documentation, control and management of the manufacturing process including machines, personnel and support services. MES systems track critical production activities and resources, link administration with the shop floor, and are often integrated with other applications used for purchasing, shipping-receiving, inventory control, quality control and assurance, and maintenance and scheduling, such as material requirements planning (MRP) and enterprise resource planning (ERP) systems.
The key functions of MES software include:
The main benefits of MES software include:
The U.S. Food and Drug Administration (FDA) and other regulatory bodies mandate thorough and accurate record keeping of key manufacturing data and activities to determine if a manufacturing company – regardless of its size or budget – is in compliance with applicable regulations and directives (e.g., FDA 21 CFR Part 11), and to ensure products meet their specifications. Furthermore, production records are crucial to timely mitigation in the unfortunate event of a product recall. Some companies choose to maintain these documents manually using a paper-based or hybrid system, which can be inefficient and compromise data integrity.
Manufacturing execution system software can benefit any manufacturer that wants to streamline its record-keeping and production processes. However, despite its many benefits, the complexity of MES software means that implementation and routine validation can be too expensive for many manufacturers, a cost that can typically only be justified in large companies with heavily automated, high-volume production lines.
While an MES system collects and stores some of the critical manufacturing data that is needed to compile a compliant batch record, device history record and other required documentation, this data can be cumbersome to extract and leverage. MasterControl Manufacturing Excellence solutions are designed to integrate with MES software and use the essential production information to provide easier access to data insights and automatically generate compliant, customizable production records.
MasterControl Manufacturing Excellence software can help your company:
For more information about MasterControl Manufacturing Excellence and how it enhances manufacturing execution systems (MES) software, please contact a MasterControl representative.