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IP6 Electronic Manufacturing Guide and Electronic Batch Record

Efficient Electronic Management of Manufacturing Orders in Pharmaceuticals

IP6-eBR, Electronic Manufacturing Guide and Batch Record manages electronic guidance and execution of manufacturing orders in a pharmaceutical facility. It allows the design and parameterization of the phases and activities to be carried out in manufacturing orders. It is a validable system that provides complete process traceability with an unalterable record of data and batches. It automatically generates production dashboard, reports, and audit logs.

Professional Female Engineer, Male Machinery Operator Use Industrial Digital Tablet Computer to Work and Program Robot Arm for Production Line.

The Ip6-eBR module is the ideal tool to digitize production orders in the regulated industry, facilitating automatic compliance of the GMP guidelines and Part 11 of FDA 21 CFR. Ip6 integrates in a single solution the real-time management of warehouse movements integrated with supplies and management of manufacturing orders through electronic guidance and obtaining batch records.

Features

  • Manages the whole cycle of production workflow by linking the recipe with the execution of the procedure until the produced batch is released.
  • Set up of the master recipes for a product, production line or facility.
  • Scheduling and management of production orders and resources for execution.
  • Executes the order according to the previously designed and approved electronic guide.
  • Generates a batch record that ensures data integrity.
  • Management of in-process controls, line clearance and cleaning.
  • Full traceability of materials, resources, and operations.
  • Direct communication with equipment.
  • Management of deviations, alarms, and corrections.
  • Audit Trail.

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