Pharma Digital Transformation with 21 CFR Part 11 Compliant ControlX SCADA Integration

Customer Focus

A leading pharmaceutical manufacturer operating granulation, coating, and compression lines required higher data integrity and audit readiness. With increasing regulatory pressure and complex batch processes, the focus shifted toward digital traceability, centralized visibility, and secure data management. The objective was to strengthen compliance while improving process transparency and operational control across the plant.

Requirement

The customer needed a centralized SCADA platform to connect existing PLC based machines and enable plant wide monitoring. The system had to support secure data logging, batch wise recording, audit trails, and automated reporting. User authentication, role based access, and electronic signatures were essential to meet regulatory compliance and ensure reliable process documentation.

Operations relied on isolated HMI systems, limiting real time visibility and decision making. Manual logbooks created risks in data accuracy and traceability. Absence of audit trails and centralized records made regulatory audits complex and time consuming. Data silos across machines reduced process efficiency and increased dependency on manual intervention.

Key Challenges

• No centralized monitoring or control
• Manual data recording and audit risks
• Lack of compliance ready digital infrastructure

Lubi Electronics deployed ControlX SCADA integrated with existing PLC systems through industrial communication protocols. The solution enabled real time monitoring, secure historian database, and batch wise data logging. Advanced features like audit trails, role based access, and electronic signatures ensured compliance readiness while improving visibility, control, and decision making across operations.

Solution Highlights :

• Centralized SCADA with real time data acquisition
• 21 CFR Part 11 compliant audit trail and security
• Automated reporting and batch data management