All About Electronic Batch Record System

Paper batch records are replaced by electronic procedure management and recordkeeping system. The application provides a complete solution with electronic signatures and audit trails.

The Electronic Batch Record (EBR) that defined by the US FDA, includes text, graphics, data, audio, pictorial or other information represented in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system. The Oracle Manufacturing Execution System (MES) for Process Manufacturing application lets you store all batch-relevant data in the database for rapid retrieval and processing.

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Zenith Technologies Case Study Electronic Batch Records

Use the Master Batch Record and Control Batch Record for Paperless Recordkeeping

The master production record is often referred to as the masterbatch record. This is the documented and approved set of instructions used to describe how to manufacture a specific product. The required elements of the masterbatch record are outlined in CFR Title 21 Part 211.186.

The OPM master batch record consists of the recipe, which includes the material requirements, equipment, resource requirements, processing instructions, sampling requirements, and various notes regarding batch processing. It is the template that is used repeatedly to manufacture a consistent product.

The intent of these records is to assure product uniformity from batch to batch. The master production and control records for each product include written procedures for batch formulation that must be followed on the shop floor, and a complete batch control record to document that each significant step in the manufacture, processing, packing, or holding of the batch is done.