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6 Reasons to Automate Your Batch Record System

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Data Sheet 1 Data Sheet 6 Reasons to Automate Your Batch Record System Automating the batch record process makes an inefficient and cumbersome manual process more efficient. Pharmaceutical and medical device companies that automate their batch record process with an electronic batch record (EBR) system are better able to maintain centralized, electronic records of proper handling for every significant step in the production of each batch of a product. For quality managers, automating a paper-based batch record process with a robust and centralized EBR system offers a number of advantages that helps them successfully maintain production batch records, more readily meet FDA requirements, mitigate risk and accelerate speed to market. 1. Proper Employee Training In a disconnected paper-based or partially automated system, workers' training records often do not match batch record documentation. A centralized EBR system that automatically tracks and enforces training removes the need for the quality team to determine whether people building the product on the factory floor have been trained on each specific task. 2. Real-Time Deviation Tracking With a robust EBR system, companies are able to seamlessly integrate the recording, assessment and approval of a planned or unplanned deviation into the overall manufacturing process. And by tying deviations to the batch, the quality team will have a centralized place and easier way to release a batch and know there is no open deviation. 3. Improved Inter-Team Collaboration In most organizations, there is room for improvement in how quality teams and manufacturing teams communicate and collaborate with each another. By capturing and providing metrics, data and insights needed by both quality and manufacturing, an EBR system can satisfy both teams and help facilitate better communication and collaboration in corrections and verifications.

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