Electronic batch record systems (EBR) are increasingly commonplace in pharmaceutical and biotechnology manufacturing environments. EBR systems are used for the automation of the execution of a batch record; they can be interfaced with many different types of systems, equipment, and instruments.
Control of the batch record uses when manufacturing pharmaceutical and biotechnology products is a regulated process of critical importance to assure product quality and patient safety.
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Therefore, the implementation strategy, validation, and ongoing control of EBR are of utmost significance and interest to regulatory authorities when they perform inspections of manufacturing facilities. This paper discusses current topics, considerations, and controls necessary for the implementation and validation of EBR.
Improvements and innovation in manufacturing execution systems through technological breakthroughs in system design have been critical to the development of systems that automate complex regulated processes in the industry. Automation of complex regulated processes provides efficiency, cost reduction, and increased compliance.
EBR systems represent one example of these technological improvements, and they are capable of a high degree of integration with different types of systems and equipment, including both manufacturing automation equipment (e.g., distributed control system, programmable logic controllers) and business systems, such as enterprise resource planning systems.
EBR systems provide critical functionality that helps ensure a high level of efficiency, consistency, and reproducibility. Because of these factors and the increased quality provided by EBR systems for pharmaceutical and biotechnology products, their use within these types of manufacturing environments is increasing.