Master batch records are intended to ensure that manufacturers use the right ingredients and the right processes in the right sequence to make the product as it is designed. The key result is that product characteristics and performance are the same from batch to batch. Historically, the master batch record was generated and maintained on paper. Numerous benefits are gained by using master batch record software to create and manage an electronic master batch record: accessibility, easier version control, opportunities to enforce compliance, fewer errors and greater efficiency, to name a few. Master batch record software is part of a manufacturing execution system (MES) and is seamlessly integrated with MES workflow management. This integration streamlines batch production operations. The master batch record is created by the appropriate technical staff. MBR software enables these individuals to efficiently design, execute, review and release the master batch record for each product and batch size. As the name suggests, the master batch record (or master production record or master manufacturing formula) lays out the planned manufacture of a product. For each batch that follows the master batch record, an electronic batch record (eBR) is produced. What the master batch record lays out is what is expected to happen; the electronic batch record documents what actually happened in the production of an individual batch – what material lot, specific equipment, and operators were involved; duration of each step; sample and test results; and so on.
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