Precision environmental control for regulated industries
Continuous monitoring and compliance reporting for pharmaceutical, food storage, and controlled environment applications. GxP-compliant, automated CAPA triggers, and 21 CFR Part 11 electronic signature support.
Temperature and humidity excursions create compliance and safety risks without continuous monitoring
Manual logging and paper records create audit trail gaps, risking FDA or EMA non-compliance and batch rejection.
Hourly manual checks miss excursions in minutes. Cold chain breaches or humidity swings compromise product integrity.
Out-of-spec events trigger months of manual CAPA (Corrective and Preventive Action) documentation and root cause analysis.
Undetected excursions lead to costly batch holds, destroyed product, and loss of valuable inventory.
Six critical parameters for complete environmental control
Real-time tracking from -40°C to +70°C with ±0.5°C accuracy. Alerts trigger instantly on deviation.
Relative humidity monitoring from 10% to 95% RH with ±3% accuracy. Dew point tracking included.
Automatic timestamping of out-of-spec events with duration, severity, and recovery data.
Historical data visualization to identify patterns, seasonal drift, and equipment degradation.
Configurable alarm setpoints, escalation rules, and conditional logic for multi-parameter monitoring.
Built-in due date management and calibration certificate storage tied to sensor records.
From sensor deployment to compliance documentation in four steps
Install battery-powered or wired temperature and humidity probes at critical points: cold rooms, storage areas, cleanrooms, and production lines.
Sensors transmit readings every 5–15 minutes over secure 4G/LTE or local wireless network to the Controlytics hub.
Excursions trigger SMS, email, and in-app notifications. CAPA workflow is auto-generated with context and historical data.
Generate 21 CFR Part 11 compliant audit trails, batch reports, and investigative documentation on demand. Electronic signatures embedded.
Complete hardware and software stack for environmental monitoring
IP67 temp and humidity probes with long battery life and secure transmission
Local data collection with backup storage and cellular failover capability
Controlytics edge unit with local buffering and intelligent alarm triggering
Real-time dashboard and analytics engine for excursion detection and trend analysis
Automated audit trail generation and 21 CFR Part 11 compliant report creation
Secure mobile app and web portal for real-time monitoring and alert management
Pharmaceutical-grade temperature and humidity monitoring. Compliance-ready documentation. On-premise data integrity.
Rapid deployment with minimal operational disruption
Site assessment, sensor placement design, compliance mapping, and user training setup.
Hardware deployment, network configuration, system testing, and sensor validation.
IQ/OQ/PQ execution, compliance documentation, and operator training completion.
24/7 monitoring, preventive maintenance, quarterly calibration, and continuous compliance updates.
Measurable outcomes for risk reduction and operational efficiency
From hours to minutes—catch drift before batch impact
Auto-generated context and audit trails cut investigation time
21 CFR Part 11, EU Annex 11, and WHO validated out of box
Through prevented batch losses and reduced audit burden
Temperature and humidity-critical operations
API storage, finished goods, and cold chain compliance
Cold storage, transport vehicles, and display cases
Sample and biologics storage with strict temperature control
Distribution, transport, and last-mile delivery monitoring
Climate-controlled growing facilities and product storage
Environmental chambers, incubators, and sample storage