Electronic Batch Record System - K2Pharma

Project Planning to build an Electronic Batch Record

 

An Electronic Batch Record System never can be "plug and play" but typically should be customized according to the specific process requirements. K2C solution for EBRS is a Module of K2Pharma that can be fully integrated with other system features, such as change control, corrective and preventive actions etc., therefore improving the interaction between the Production Department and others (Quality Assurance, Engineering, Quality Control etc.).

The module has the following main features:

       Equipment/plant mapping and system Inventory

       Management of Production Procedures and associated workflows

       Manufacturing Execution (step by step execution and control of manufacturing operations)

       Management of alerts/reminders

       Risk assessments tools

       Management of Layouts and Drawings, with the possibility to interactively display thee status of the process

       Tools to easily enable interfaces with other information  systems, without coding

The module includes all required features to comply with Electronic Record and Signature Regulation (21 CFR part 11).

   Contact us for more information or to request for a demo.

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