21 CFR Compliant Weighing & Labeling Solution

21 CFR Weighing and Labeling System Architecture

Project Overview

A pharmaceutical company in Hyderabad was using a standalone thermal label printer connected to a weighing balance, printing product information and weight details separately for manual affixing to cartons. Revised regulatory requirements mandating dynamic weight data along with product information on a single label made the existing system inadequate.

Project Details

Customer Challenges

Low operational efficiency due to manual intervention
Non-compliance with regulatory requirements (21 CFR)
Frequent label format changes based on customer-specific “ManufacturedBy” and “Marketed By” details for each batch
Lack of centralized monitoring and control from a PC
Limited traceability of weighing and labeling operations

Key Components

21 CFR Compliant FW6000 Weighing Scale
Integrated Label Printer
Label Design Software
Centralized PC Software
Integrated Label Printer
Label Design Software
Centralized PC Software

Solution Provided

Deployment of a 21 CFR-compliant weighing scale integrated with a label printer for real-time printing
Implementation of PC software to : • Monitor operations • Maintain audit trails • Ensure data integrity and compliance
Flexible label design system enabling operators to: • Modify label formats for each batch • Update customer-specific details easily
Centralized connectivity allowing up to 8 weighing balances to be connected to a single PC

Customer Benefits

Improved operational efficiency, reduced manual errors
Simultaneous printing of product info and weight on one label
Easy, quick modification of label formats per batch

Results Achieved

100% Traceability of weighing and labeling activities
Full 21 CFR Compliance with audit trail and secure data handling
Improved operational efficiency and reduced manual errors
Simultaneous printing of product information and weight on a single label
Easy and quick modification of label formats
Significant increase in overall productivity

Conclusion

The solution delivers a scalable, regulatory-compliant weighing and labeling platform that ensures complete traceability, audit-ready 21 CFR compliance, and centralized control across multiple weighing stations from a single PC.