Pharma
 
 
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Pharma

The production of pharmaceutical ingredients and drugs is governed by strict regulations and demands a high level of quality in every single batch. Regulatory specifications require validation of process quality using measures incorporated in the production process. Consequently, testing the safety and effectiveness of drugs needs to be integrated into the production process.

Quality of a pharmaceutical product can be related to critical parameters of the product and process. These are defined as Key Performance Indicators of the production process and are monitored in line with the process. Laboratory workflows are integrated with production workflows for seamless operation and fast response. Deviations are alerted as they happen making it possible to perform corrections with least waste and delay.

Our solutions for the pharmaceutical industry cover the following areas

Audit trail
Contamination control
Electronic signature
Production process
Packaging
Quality assurance and validation
Reporting
Tracking and Tracing
Warehouse
Weighing and Dispensing
Utilities

Benefits

Manage the production process execution and monitor production process performance as it happens
Communicate on every enterprise level and synchronize production for a rapid start up of production allowing faster time to market and rapid deployment of new processes
Comply with FDA 21 CFR 11 regulations
Support traceability and Electronic Batch Reporting
Integrate with other systems on the planning, execution, quality and enterprise level, creating an integrated workflow

 
   
 
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