Production records, including batch records, are among the many important documents that are critical to current Good Manufacturing Practice (cGMP) manufacturers. Yet many manufacturers continue to rely on paper-based processes to maintain production data and documents. Manually compiling production information and sorting through cabinets filled with binders of paperwork is a tedious, error-prone process that does not lend itself to efficiency, visibility, or collaboration.
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Manufacturers often look to shop floor management systems like manufacturing execution systems (MES) or manufacturing operations management (MOM) software as a solution to track the flow of production data and manage the activities that take place on the factory floor – all of which must be maintained in production records. However, these systems tend to be complex and limited in their ability to collect and report on data, track quality events or training, easily conduct change control, and automatically keep documents current.
A shop floor system should provide access to insights that lead to process improvements and increased production output. When looking to invest in shop floor management software, it’s important to consider the system’s ability to manage production records.
Robust shop floor software should allow manufacturers to efficiently capture and manage data inputs from many different sources and personnel throughout the manufacture of a product, and ensure that the data is complete and collected in the correct format at the time it is entered. It can also make detecting the source of deviations and responding to quality events much faster.
A shop floor management software system that automates the batch production record and master batch record process offers different advantages in the manufacture of a product:
Efficient Processes: A shop floor management system should help error-proof processes and eliminate common production mistakes such as missing or incomplete documentation. Whereas paper-based systems are often rife with illegible fields, shop floor software can enable each station to accurately and legibly capture all necessary data. A single, centralized system also makes it easier to store all relevant records of proper handling for each step in the production, packaging, and holding of every product batch.
Visibility of Production Data: An automated shop floor system should provide real-time visibility into manufacturing operations and processes – including employee activities, training, quality events, and corrective actions – at each step of production. By capturing, storing, and displaying all manufacturing information in real-time, shop floor software can provide a complete picture of operations while enforcing proper procedures.
Immediate Access to Changes: Shop floor management software can help you eliminate the inefficiency of paper travelers and gain real-time access to changes in the production process. Automating shop travelers can make this cumbersome, time-consuming process more efficient, error-proof the process, and provide real-time visibility into operations as workers perform activities. Notifications should alert you to any errors in the production process, giving you the opportunity to quickly manage shop floor operations and personnel.
Faster Response to Changes: Predictive analytics and advanced reporting capabilities help identify and prevent future bottlenecks. Shop floor management software should have real-time deviation tracking that will let you integrate deviation handling throughout the manufacturing process, and by automatically capturing real-time data across production and sounding an alert if a quality event occurs, the affected process or product can quickly be contained and a corrective can be taken.
Improvements in Collaboration: A shop floor management software system with robust collaboration tools should let many users collaborate, and even allow trusted third-parties to participate, in a secure environment, with FDA-compliant electronic signatures on records and approval routes. Using a common tool for managing real-time data, different teams working in different geographies, departments, and business units can communicate and collaborate more efficiently.
To learn more about how life science manufacturers can benefit from batch record features included with their shop floor management software, contact a MasterControl representative.