Automate your GMP, GDP, and 21 CFR Part 11 monitoring with our high-precision logging systems designed for the most stringent pharmaceutical environments.
A Data Logger for the pharmaceutical industry is an electronic system designed to record and store critical parameters such as temperature, humidity, pressure, and equipment status in a secure, traceable, and audit-ready format.
Secure, encrypted data that cannot be modified.
Every log is recorded with precise server time.
Role-based logins ensuring data integrity.
Full history of system interactions and logs.
Data Logger for Pharma by AIOTHUB records multiple parameters simultaneously, reducing hardware costs while delivering synchronized data, centralized monitoring, scalable expansion, precise analysis, faster decisions, and improved operational efficiency.
Our Data Logger for Pharma is engineered specifically to meet the high standards of the pharmaceutical industry, providing a reliable foundation for all your monitoring and compliance needs.
| Feature | Benefit |
|---|---|
| 21 CFR Part 11 Compliance | Audit-ready electronic records with full traceability. |
| Encrypted Data Storage | Prevents unauthorized access and data manipulation. |
| Real-Time Monitoring | Early detection of deviations to ensure safety. |
| Automated Alerts | Proactive protection for critical batches and vaccine storage. |
| Calibration Support | Guarantees continuous regulatory and standard compliance. |
| Automatic Data Backup | Ensures zero data loss during power or network outages. |
| User Access Control | Maintains absolute data integrity through role-based security. |
| Enclosure | IP65 Industrial (Cleanroom safe) |
|---|---|
| Mounting | Wall / DIN Rail |
| Connectivity | 4G LTE Cat-M, Wi-Fi, Ethernet |
| Input Voltage | 9–36 VDC with 72+ Hour Battery Backup |
| Operating Temp | −40°C to +85°C |
| Security | AES-256 Encryption, TLS 1.3, Secure Boot |
Pharmaceutical manufacturers must comply with stringent regulations, including FDA 21 CFR Part 11, Good Manufacturing Practices (GMP), and ISO 13485. Our system is engineered to exceed these requirements.
| Parameter | Specification | Why It Matters in Pharma |
|---|---|---|
| Core System | ||
| Microcontroller | 32-bit Industrial MCU | Stable long-term operation |
| RTC Accuracy | ±2 ppm with battery backup | Valid timestamps for audits |
| Time Sync | NTP | CFR-compliant time integrity |
| Watchdog & Brownout | Enabled | No missing data |
| Temperature Measurement | ||
| Sensor Type | PT100 / PT1000 / Thermocouple | Regulatory-approved sensors |
| Accuracy | ±0.1°C (PT100) | Vaccine & drug safety |
| Resolution | 0.01°C | High precision |
| Calibration | 2-point or 3-point calibration | Audit compliance |
| Humidity Measurement | ||
| Sensor Type | Digital RH or Industrial Probe | Stability testing |
| Accuracy | ±1.5 %RH | Stability & cleanroom |
| Compensation | Temperature compensated | Reliable readings |
| Analog Inputs | ||
| Resolution | 24-bit ADC | Lab-grade precision |
| Input Types | 0–10V, 4–20 mA | Pharma equipment compatibility |
| Isolation | Galvanic isolation | Prevents electrical noise |
| Digital Interfaces | ||
| RS-485 | Modbus RTU | Freezers, BMS, PLCs |
| Ethernet | Yes | Validation-ready networking |
| Data Integrity | ||
| Storage | 8–32 GB Industrial SD Card | Years of logs |
| Backup | Internal Flash | Zero data loss |
| Data Format | Encrypted CSV + JSON | Audit & cloud ready |
| Checksums | CRC + SHA256 | Tamper detection |
| Regulatory Compliance | ||
| Audit Trail | Every change logged | 21 CFR Part 11 |
| User Roles | Admin / Operator / Auditor | GMP control |
| Electronic Signature | Yes | Regulatory approval |
| Time-stamped Logs | Non-editable | Legal traceability |
| Alarms & Alerts | ||
| Limits | High / Low / Deviation | Cold-chain safety |
| Alerts | Email, SMS, Cloud | Immediate action |
| Local Alarm | Buzzer & LED | On-site warning |
| Validation Ready | ||
| IQ/OQ/PQ Support | Available | Regulatory validation |
| Calibration Certificate | NIST traceable | Audits |
| Data Export | PDF, CSV | Regulatory reports |
Manual temperature sheets, delayed data collection, and unverified records are no longer acceptable under GMP, GDP, and 21 CFR Part 11. Our system captures, secures, and reports your data automatically.
Our system is built to meet the strict data integrity and traceability requirements of regulated pharmaceutical environments.
Our system supports a wide range of industrial sensors, providing sub-degree accuracy for sensitive pharmaceutical environments.
Range: -200°C to +400°C
Range: 0% to 100% RH
Differential Pressure
Failure Alerts
Door Monitoring
Specialized Probes
Our data logging solutions are engineered for high-stakes pharmaceutical environments, ensuring total compliance and safety across every critical zone.
Extreme cold storage and sensitive biomaterial monitoring for critical inventory safety.
Validated monitoring for -80°C and standard cold-chain zones with 24/7 alert systems.
ICH compliant long-term temperature & humidity validation for precise pharmaceutical stability testing.
Critical raw material process control and environmental safety in high-stakes production zones.
Active dosage production monitoring and clean room environment tracking for full compliance.
Analytical testing areas and high-precision micro-labs requiring strict climate control.
GMP storage mapping and large-scale distribution monitoring for global cold chain integrity.
A seamless flow from environmental monitoring to audit-ready compliance reporting.
Real-time monitoring of critical pharma parameters.
Secure encryption and wireless data transfer.
Audit-ready, tamper-proof cloud storage.
Automated GMP-compliant report generation.
Instant multi-channel alerts for deviations.
Generic temperature loggers often fall short of regulatory expectations. Our system is precision-engineered to meet the zero-tolerance requirements of pharmaceutical manufacturing and storage.
Generate secure, time-stamped reports that are instantly ready for FDA, GMP, and GDP inspections without manual intervention.
Built on a foundation of data integrity (ALCOA+ principles), ensuring your records are accurate, legible, and contemporaneous.
Detect deviations in real-time. Prevent batch rejections and ensure the safety of vaccines and sensitive drugs through active monitoring.
From a single stability chamber to an entire multi-site manufacturing facility, our system scales with your operational needs.
Trusted by biotech leaders and cold-chain operators who require certified industrial-grade hardware and software solutions.
Dual-redundant storage ensures zero data loss during power outages or network failures, maintaining a continuous audit trail.
This is not a consumer-grade device. It is a certified, regulatory-compliant monitoring system specifically architected for the high-stakes pharmaceutical and life sciences industries.
Stop risking compliance with manual logs and incomplete records.
Move to a validated, automated, and secure Pharma Data Logger.