Vaccine monitoring solutions for compliance and quality control
Temperature sensors for ambient, freezer and refrigeration storage
Meet regulatory compliance
Product safety and quality
Improve work efficiency
Vaccine monitoring solutions
Swoop graphic
Comprehensive software and hardware solutions for regulatory requirements
Our systems provide real-time, 24/7 monitoring with programmable data rates for alarms and logged data, designed to meet any specific government or customer requirements. Individual monitoring locations have data displays and audible alarms. Our modular design for RTDs and thermocouple temperature probes simplifies sensor calibration and NIST traceable certification.

Paragon's Enterprise software provides a multi-user environment with administrative privileges and user auditing features. Our data logging and analysis software suite offers measurement dashboards, data analysis charting, automated and custom period reports, and alarm history with custom annotations.
regulatory compliancer
Meet regulatory compliance and reporting
Enterprise software provides cost-effective solutions to meet strict reporting requirements from the Center for Disease Control and Prevention (CDC), Vaccines For Children (VFC) program, Food and Drug Administration (FDA) and pharmaceutical boards. Our systems are designed to meet 21CFR Part 11.
critical temperature control
Maintain product safety and quality
Optimize vaccine and medicinal storage conditions with continuous temperature monitoring. Systems features immediate notification of cooling failures or critical storage conditions.
efficient pharmacy
Improve operations and work efficiency
Reduce manual operations and labor intensive reporting and documentation with automated 24/7 monitoring system and compliant software.
System features
  • Designed to meet FDA 21CFR Part 11 and CDC, VFC, and Pharmaceutical regulations , 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 with multiple users, administrative, auditing, and custom reporting.
  • Standard reports for data, alarms. and annotations for compliance or audit records.
  • Available Installation and programming services
Refrigeration sensor setup
Monitoring at refrigerators, freezers and cold storage
Utilize our base sensor device with an RTD input expansion module to monitor temperatures inside the vaccine storage refrigerator with an RTD temperature probe. In addition the base device has built in ambient temperature and humidity sensors to monitor room conditions.

In order to eliminate false alarms with freezer and refrigerator door opening or closing, Paragon offers a Freezer RTD with Glycerol Bottle kit and advanced alarm-averaging software programming by reducing the response time of the RTD to sudden temporary changes in the temperature while still protecting food products from cooling system failures.
United States Food and Drug Administration (FDA) 21CFR Part 11
The FDA 21CFR Part 11 compliance establishes regulations on electronic records and signatures, and dictates that those who use electronic systems for document and signature control must provide assurance that the electronic documents are authentic. Regulations establish requirements for the FDA to accept electronic records in lieu of paper records.

For a complete guide to the requirements, please visit the Food and Drug Administration's Title 21CFR Part 11 specifications.
Compliance. Quality. Efficiency.
Meet reporting requirements
Our temperature monitoring systems and Enterprise software are designed to meet core 21CFR Part 11 regulation 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 21CF Part 11 reporting and custom internal quality controls.
  • MessageCenter with system notifications and alarm tracking.
  • Secure encrypted data storage.
Vaccine Case Study
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 are constantly facing the issue of vaccine and drug spoilage due to improper storage conditions or cooling system failures that go undetected.

Desktop monitor background Dashboard view
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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