FDA Validated Solutions
IoT-Driven Precision for Pharmaceutical Manufacturing
GMP-compliant monitoring systems that ensure product quality, regulatory compliance, and operational excellence in pharmaceutical manufacturing.
Why Choose Our Pharma IoT Solutions?
FDA 21 CFR Part 11 Compliant
Fully validated systems meeting FDA electronic records requirements with audit trails, digital signatures, and data integrity controls.
GMP Compliance
Designed for Good Manufacturing Practices with continuous monitoring, deviation management, and automated compliance reporting.
Real-time Analytics
Advanced analytics with trend analysis, predictive maintenance, and automated alerts for critical parameter deviations.
Comprehensive Pharmaceutical Monitoring
Cleanroom Environmental Monitoring
ISO 14644 compliant monitoring for sterile manufacturing environments
Monitored Parameters:
- Particle count (0.5μm, 5.0μm)
- Temperature & Humidity
- Differential pressure
- Air velocity & flow
- Viable particle monitoring
Key Features:
- ISO 14644 classification
- Real-time alerts
- Automated reports
- Multi-user access control
Cold Chain & Storage Monitoring
Temperature mapping and continuous monitoring for pharmaceutical storage
Monitored Parameters:
- Refrigerated storage (2-8°C)
- Freezer monitoring (-20°C)
- Ultra-low freezers (-80°C)
- Controlled room temperature
- Controlled room temperature
Key Features:
- WHO GDP compliance
- Temperature mapping studies
- Data integrity assurance
- 24/7 monitoring & alerts
Production Process Monitoring
Real-time monitoring of critical manufacturing processes
Monitored Parameters:
- Reactor temperature & pressure
- pH and conductivity
- Flow rates and volumes
- Mixing speed and time
- Sterilization parameters
Key Features:
- Batch record integration
- Electronic signatures
- Deviation management
- Statistical process control
Quality Control Laboratory
Automated monitoring for QC labs and analytical instruments
Monitored Parameters:
- HPLC/GC instrument monitoring
- Stability chamber conditions
- Incubator temperature control
- Balance room environment
- Sample storage conditions
Key Features:
- LIMS integration
- Data integrity controls
- Calibration management
- Trend analysis & reporting
Proven ROI in Pharmaceutical Manufacturing
Our clients see measurable returns within 6-12 months of implementation
95%
Reduction in compliance violations
40%
Decrease in product recalls
60%
Faster regulatory approvals
₹2.5Cr
Average annual savings