Global pharmaceutical company meets 21 CFR Part 11 compliance standard requirements for RM dispensing and FG dispatch using mobivue

About the client

The client started their business in 1961 at White Sulphur Springs, West Virginia. U.S. Today they are one of the largest pharmaceutical company with its presence
in 165 countries in the world. They market 7500 products to 7 billion people with a global workforce of 35000.

Challenges

With increasing competition and FDA compliances getting stringent by the day, the client realized that they had to up their data management game to meet audit trail compliance and stay ahead in the business.

The client had to produce data trails to the auditor for the operations carried out in their manufacturing. The paper-based, manual data entry at RM/PM stores and plant operations raised questions on the authenticity and accuracy of recorded data. The data trails could be easily accessed by everyone making them vulnerable to tampering and manipulation. It also did not provide any real-time validation of the floor operations against set SOPs. The system's inability to track material expiry caused in inventory loss and increased production cost.

Why mobivue manufacturing operations management

BCI did an in-depth analysis of the data capturing and management process followed at the client’s manufacturing plant and devised a barcode-enabled mobivue manufacturing operations management solution. The solution complied with FDA 21 CFR Part 11 norm and generated accurate information on every floor transaction. The solution’s ability to integrate with their machinery and devices with the existing ERP (SAP) to capture and upload real-time data on 4Ms made the client choose mobivue BCI’s track record of creating successful supply chain solutions across the industries added confidence in their choice.