Vaccine monitoring solutions for compliance and quality control
Temperature sensors for ambient, freezer and refrigeration storage
Ensure regulatory compliance
Ensure product safety and quality
Enhance operational efficiency
Comprehensive software and hardware solutions for regulatory requirements
Our systems deliver real‑time, 24/7 monitoring with programmable data rates for alarms and logged data, engineered to satisfy any specific government or customer requirement. Each monitoring location includes a data display and audible alarm. The modular design for RTD and thermocouple probes simplifies sensor calibration and NIST‑traceable certification.
Paragon’s Enterprise software offers a multi‑user environment with administrative privileges and user‑audit capabilities. The data‑logging and analysis suite provides measurement dashboards, analytical charting, automated and custom‑period reports, and alarm history with custom annotations.
Paragon’s Enterprise software offers a multi‑user environment with administrative privileges and user‑audit capabilities. The data‑logging and analysis suite provides measurement dashboards, analytical charting, automated and custom‑period reports, and alarm history with custom annotations.
Meet regulatory compliance and reporting
Enterprise software delivers cost‑effective solutions to satisfy stringent reporting requirements from the Centers for Disease Control and Prevention (CDC), the Vaccines for Children (VFC) program, the Food and Drug Administration (FDA), and pharmaceutical boards. Our systems are built to comply with 21 CFR Part 11.
Maintain product safety and quality
Optimize vaccine and medication storage with continuous temperature monitoring. The system provides immediate alerts for 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 21CFR Part 11 and CDC, VFC, and pharmaceutical regulations, as well as 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 sensor calibration and NIST certification.
- Enterprise software supports multiple users, administrative privileges, auditing, and custom reporting.
- Standard reports for data, alarms, and annotations for compliance or audit records.
- Installation and programming services available
Monitoring at refrigerators, freezers and cold storage
Use our base sensor device with an RTD input expansion module to monitor temperatures inside vaccine storage refrigerators using an RTD probe. In addition, the base unit includes built‑in ambient temperature and humidity sensors to track room conditions.
To prevent false alarms when freezer or refrigerator doors are opened, Paragon offers a Freezer RTD with a glycerol‑filled 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 prevent false alarms when freezer or refrigerator doors are opened, Paragon offers a Freezer RTD with a glycerol‑filled 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.
Temperature mapping and validation services
Temperature mapping is essential for validating and documenting temperature distribution within storage or process areas and equipment such as coolers, autoclaves, and other systems that require consistent temperatures. Mapping the environment helps you identify hot or cold spots that could affect your processes or products.
Paragon offers a full range of temperature‑mapping products and services to satisfy regulatory or customer requirements. Monitoring systems are available for purchase or rental for customers who wish to conduct their own mapping.
Our cGxP‑qualified staff can perform comprehensive on‑site temperature‑mapping studies and complete all required validation documentation.
Paragon offers a full range of temperature‑mapping products and services to satisfy regulatory or customer requirements. Monitoring systems are available for purchase or rental for customers who wish to conduct their own mapping.
Our cGxP‑qualified staff can perform comprehensive on‑site temperature‑mapping studies and complete all required validation documentation.
United States Food and Drug Administration (FDA) 21CFR Part 11
FDA 21 CFR Part 11 establishes regulations for electronic records and signatures, requiring that users of electronic document‑control systems assure the authenticity of electronic documents. These regulations define the criteria for FDA acceptance of electronic records in place of paper records.
For a complete guide to the requirements, please consult the FDA’s Title 21 CFR Part 11 specifications.
For a complete guide to the requirements, please consult the FDA’s Title 21 CFR Part 11 specifications.
Meet reporting requirements
Our temperature‑monitoring systems and Enterprise software are built to satisfy 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 audit requirements with wireless temperature‑monitoring systems.
Hospitals, pharmacies, clinics, and vaccine R&D/production facilities constantly face vaccine and drug spoilage caused by improper storage conditions or undetected cooling‑system failures.
Hospitals, pharmacies, clinics, and vaccine R&D/production facilities constantly face vaccine and drug spoilage caused by improper storage conditions or undetected cooling‑system failures.
Customized sensor dashboard interface, charting analysis and system modeling
Quickly set up and customize your monitoring system using an intuitive dashboard interface with DataRecorder our innovative LaunchPad software applications. All software is browser-based and runs on any type of device or operating system.
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