The Food and Drug Administration (FDA) has strict requirements on what type of information must be recorded and accessible. FDA record keeping requirements under 21 CFR 211.188 include:
Electronic batch reporting (EBR) streamlines the process for manufacturers, eliminating time-consuming manual data entry and validation, and the potential for human error.
Disparate equipment and systems. Manufacturers rely on a wide range of systems for data collection and process control, including PLCs, analytical instruments, SCADA systems, MES, historians, LIMS, and more. This presents a major hurdle for manufacturers trying to digitize their batch reporting process as these systems do not provide context for manufacturing data or easily integrate with enterprise IT systems.
Logging relevant and required batch information. While required for regulatory reporting and process analysis, tracking batch data through production and packaging is challenging without a standardized model to collect and define the data.
Native connections and modeling capabilities. Manufacturers who select and deploy HighByte Intelligence Hub at the Edge can securely connect disparate devices, files, databases, and systems via open standards and native connections. Powerful modeling tools enable them to create and govern standard data payloads.
Real-time data assembly. HighByte Intelligence Hub allows users to assemble data in real time into EBR payloads prior to publishing to a unified namespace (UNS) or data lake in the Cloud. The Intelligence Hub is easily configured to publish data when batch events happen, like completion of a production step.
Information accessibility. The Intelligence Hub enables the collection and contextualization of data at much higher data resolutions from a much broader set of devices and systems than has previously been available. Regulatory and process optimization groups can quickly and easily access information to troubleshoot, optimize, and report on the production process.
Cost savings. The batch data model provides a complete view of the product environment. It can be used to catch quality issues early in batch processes, which can result in multimillion-dollar savings for batch manufacturers.
