At a glance

• 3,000+ — Tags Monitored
• 18+ — Data Source Collections
• 75% — Audit Prep Time Reduced

About Merck Life Science Private Limited

Merck Life Science Private Limited, Bangalore, India — incorporated in 1986 as a JV with Millipore Corporation (USA), became a 100% Millipore subsidiary in 2009, which was then acquired by Merck Chemicals in March 2010.

Headquarters: Bangalore, India · Industry: Pharmaceutical Manufacturing · Size: Enterprise

Introduction

Merck Life Science Private Limited, partnered with Itanta Analytics to revolutionize their pharmaceutical manufacturing reporting and analytics capabilities to standardize and automate critical batch manufacturing processes across multiple facilities.

Merck required a robust, scalable solution that could handle complex pharmaceutical batch reporting while maintaining strict regulatory compliance. The implementation resulted in dramatically improved operational efficiency, enhanced data visibility, and streamlined compliance reporting across their downstream manufacturing operations.

Challenges Faced by Merck

• Regulatory Compliance and Standardization Pressures: Need for standardized reporting templates, comprehensive audit trails for FDA inspections, and 21 CFR Part 11 compliance with automated backup capabilities.
• Fragmented Reporting Systems: Fragmented data collection from SCADA systems created time-consuming processes, inconsistent formats, and limited real-time visibility with poor audit trail maintenance.
• Complex Multi-System Integration: Multiple systems, various pharmaceutical processes, and different equipment required seamless integration across WinCC SCADA, PLCs, and OPC UA systems.
• Data Visibility and Decision-Making Limitations: Lack of real-time process visibility and unmanageable historical data analysis prevented optimization opportunities and proactive decision-making.
• Scalability and Resource Constraints: Manual processes couldn't scale across global facilities, wasting engineering resources on routine tasks instead of value-added activities.
• Technology Integration and Modernization Needs: Required bridging legacy SCADA with modern analytics while supporting digital transformation without disrupting critical manufacturing operations.

Highlights

• 3,000+ tags across 18 data source collections with centralized access
• Built-in 21 CFR Part 11 compliance with electronic signatures and audit trails
• Real-time monitoring with 1-second updates via OPC UA connectivity
• Automated batch reporting with two-level digital approval workflow
• HTML5 web interface with customizable dashboards and trend analysis
• Scalable architecture supporting future expansion with minimal effort

Merck Life Science Private Limited

Pharmaceutical Manufacturing Excellence

• Global pharmaceutical manufacturer requiring strict regulatory compliance
• Multiple downstream manufacturing facilities with complex batch processes
• Infrastructure includes WinCC SCADA, Siemens PLCs, and OPC UA systems
• Three Inline Buffer Dilution Machines feeding real-time manufacturing data
• Requires 21 CFR Part 11 compliance with comprehensive audit trails

Itanta System Architecture

Data Acquisition

The data acquisition process begins with three Inline Buffer Dilution Machines, feeding real-time manufacturing data to Siemens PLCs.

• These controllers continuously capture critical parameters including pressure, temperature, valve positioning, and cycle codes, providing comprehensive operational data from the manufacturing floor level.

Data Aggregation

Data flows from individual PLCs through an Industrial Ethernet Switch to the IBD WinCC RT SCADA system, which serves as the central aggregation point.

• The SCADA system consolidates data streams from all three buffer dilution systems, converting raw sensor data into structured manufacturing information while maintaining real-time synchronization across connected systems.

Data Visualization

The Itanta platform transforms aggregated SCADA data into intuitive web-based dashboards accessible through standard browsers.

• This layer provides real-time monitoring with 1-second updates, historical trend analysis, user configurable views, and comprehensive alarm management with visual alerts for immediate process visibility.

Data Distribution

The system automatically generates standardized batch reports for pharmaceutical processes and delivers information through multiple formats including PDF exports and direct printing.

• This lets all your factories access the same system, while keeping a full record of every action to meet regulatory requirements.

How Itanta Solved These Challenges

• Comprehensive Data Integration Architecture: Multi-connector approach with OPC UA (1-second intervals), SQLite (10-second intervals), and Mongo-to-Mongo connectivity handled 3,000+ tags across 18 data source collections with centralized access.
• Automated Batch Reporting System: Built-in 21 CFR Part 11 compliance with electronic signatures and comprehensive audit trails. Implemented two-level digital approval workflow: Operators mark batches "Done" and Supervisors/Engineers provide "Review".
• Redundant Engineering Station Setup: A central server monitors all three buffer dilution systems with high availability, same-domain network setup, and a scalable design that supports future expansion with minimal effort.
• Advanced Dashboard and Analytics Features: Deployed an HTML5 web interface with customizable dashboards showing real-time trends for pressure, temperature, and valve positions, along with detailed alarms, event logs, and flexible data display options for deeper insights.
• User Experience and Operational Tools: Developed IA Launcher application for dedicated SCADA integration, page selection printing functionality, direct printer integration, configurable PDF download paths, and pre-login functionality with SCADA user credentials for seamless workflow.
• Scalable and Future Ready Architecture: Centralized monitoring of multiple systems with flexible templates, built-in redundancy for high availability, and API-ready integration for future growth.

Snapshots of Reports

• 1. Alarm Data Report:
• 2. Events Data Report:
• 3. Trends Data Report:

Conclusion

The Merck-Itanta success story demonstrates that with the right technology partner and strategic approach, even the most complex manufacturing environments can achieve rapid digital transformation while maintaining the highest standards of quality, compliance, and operational excellence; the real-time visibility into critical process parameters, standardized reporting across multiple facilities and comprehensive audit capabilities have positioned end-users to make more informed decisions and respond proactively to process variations.

The scalable architecture ensures that this digital foundation can support future growth and technological evolution.

Ready to Transform Your Manufacturing Data?

Merck's success story shows how the right no-code analytics platform can revolutionize pharmaceutical manufacturing data while maintaining strict regulatory compliance. Your organization can achieve similar operational excellence and efficiency gains with Itanta Analytics.