Vaccine monitoring solutions for compliance and quality control
Temperature sensors for ambient, freezer and refrigeration storage
Ensure regulatory compliance
Product safety and quality
Enhance operational efficiency
Comprehensive software and hardware solutions for vaccine regulatory monitoring requirements
Our systems deliver real‑time, 24/7 monitoring with programmable data rates for alarms and logged data, designed to satisfy any specific government or customer requirement. Each monitoring location includes data displays and audible alarms. The modular design for RTD and thermocouple temperature probes simplifies sensor calibration and NIST certification.
Paragon’s Enterprise software provides a multi‑user environment with administrative privileges and user‑auditing features. Our data‑logging and analysis suite offers measurement dashboards, data‑analysis charting, automated and custom‑period reports, and alarm history with custom annotations.
Paragon’s Enterprise software provides a multi‑user environment with administrative privileges and user‑auditing features. Our data‑logging and analysis suite offers measurement dashboards, data‑analysis charting, automated and custom‑period reports, and alarm history with custom annotations.
Meet regulatory compliance and reporting
Enterprise software delivers cost‑effective solutions to meet strict reporting requirements from the Centers for Disease Control and Prevention (CDC), the Vaccines for Children (VFC) program, the Food and Drug Administration (FDA), and other pharmaceutical regulatory bodies. Our systems are designed to comply with 21 CFR Part 11.
Maintain product safety and quality
Optimize vaccine and medicinal storage conditions with continuous temperature monitoring. The system features immediate notifications of cooling failures or critical storage conditions.
Improve operations and work efficiency
Reduce manual tasks and labor‑intensive reporting with an automated 24/7 monitoring system and compliant software.
System features
- Designed to meet FDA 21 CFR Part 11 and CDC, VFC, and pharmaceutical regulations, including auditing and reporting requirements.
- 24/7 real‑time system monitoring with data collection.
- Local measurement display and audible alarms.
- Programmable alarms with email and/or text notifications.
- Battery-operated and backup local data storage on system gateway(s).
- Modular sensor design for calibration and NIST certification.
- Enterprise software supporting multiple users, administrative control, auditing, and custom reporting.
- Standard reports for data, alarms, and annotations to support compliance or audit records.
- Available installation and programming services
Monitoring in refrigerators, freezers, and cold storage
Utilize our base sensor device with an RTD input expansion module to monitor temperatures inside vaccine storage refrigerators using an RTD temperature probe. Additionally, the base device includes built‑in ambient temperature and humidity sensors to monitor room conditions.
To eliminate false alarms caused by freezer or refrigerator door openings, Paragon offers a Freezer RTD with Glycerol Bottle kit and advanced alarm‑averaging software that reduces the RTD’s response to brief temperature spikes while still protecting products from cooling system failures.
To eliminate false alarms caused by freezer or refrigerator door openings, Paragon offers a Freezer RTD with Glycerol Bottle kit and advanced alarm‑averaging software that reduces the RTD’s response to brief temperature spikes while still protecting products from cooling system failures.
United States Food and Drug Administration (FDA) 21 CFR Part 11
FDA 21 CFR Part 11 compliance establishes regulations for electronic records and signatures, requiring users of electronic systems to ensure the authenticity of electronic documents. These regulations define the conditions under which the FDA will accept electronic records in place of paper records.
For a complete guide to the requirements, please refer to the FDA’s Title 21 CFR Part 11 specifications.
For a complete guide to the requirements, please refer to the FDA’s Title 21 CFR Part 11 specifications.
Meet reporting requirements
Our temperature‑monitoring systems and Enterprise software are designed to meet core 21 CFR Part 11 requirements for electronic documentation and signature control in a multi‑user environment.
- Multiple users with administrative privileges and user assignments.
- Individual user auditing.
- ReportCreator for standard 21 CFR Part 11 reporting and custom internal quality controls.
- MessageCenter with system notifications and alarm tracking.
- Secure, encrypted data storage.
Vaccine storage case study
Eliminate costly waste and meet auditing requirements with wireless temperature‑monitoring systems.
Hospitals, pharmacies, clinics, and vaccine R&D/production facilities continually face vaccine and drug spoilage caused by improper storage conditions or undetected cooling system failures.
Hospitals, pharmacies, clinics, and vaccine R&D/production facilities continually face vaccine and drug spoilage caused by improper storage conditions or undetected cooling system failures.
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