EasyLog | EL-WiFi-21CFR-ULT21CFR-Compliant WiFi Cryogenic Vaccine Data Logger with Display
The EL-WiFi-21CFR-ULT is a 21CFR Part 11-compliant Cloud-enabled wireless ultra-low temperature data logger, with a built-in display, designed for monitoring vaccines in ultra low temperature dry ice storage. The measurement range is -100 to +100°C (-148 to +212°F) using the probe supplied with the logger. The logger automatically records data and uploads it to the EasyLog 21CFR Cloud using your standard wireless network. The device will store data internally if it loses WiFi connection and automatically uploads it to the Cloud once reconnected.
Why buy a 21CFR logger?
The 21 CFR Part 11 regulations issued by the US Food and Drug Administration (FDA) give the criteria under which electronic records can be considered by the FDA as equivalent to signed paper records. If you need to meet these regulations or have enhanced data security requirements then you should choose one of our 21CFR loggers, otherwise our standard loggers will suffice.
A 21CFR Cloud subscription delivers all of the flexibility of remote monitoring and can be installed as part of a 21CFR compliant system. Features include permission-based use, authority level sign-off, and full system audit to ensure data monitored and collected is regulated to 21CFR Part 11 standard. This device requires a subscription to our EasyLog 21CFR Cloud service.
This product complies with BS EN 12830:2018 (Temperature recorders for the transport, storage, and distribution of temperature-sensitive goods).
FAQ'sCould you explain what 21CFR Part 11 is?
Is there a document that provides troubleshooting for setting up my WiFi Sensor?
Calibration testing carried out on our products provides assurance of the ongoing accuracy of your EasyLog data logger. This is relevant for all users, but is especially important for medical, food and scientific applications, and where audit compliance needs to be demonstrated. We provide a number of standard calibration options suitable for common applications such as monitoring fridges, chilled goods and freezers, but can also provide customised calibration at whatever measurement points you need. Please contact our sales team for details.
Calibration options available for the EL-WiFi-21CFR-ULT:
- EL-CAL-T ULT - Temp Points: -70°C and 0°C
Calibration certificates are available to purchase separately traceable to appropriate international standards, depending on your location.
The EL-WiFi-21CFR-ULT wireless data logger is designed for monitoring vaccines in cryogenic dry ice storage and transit, in accordance with 21CFR Part 11 compliant data security procedures.
For application stories on our data loggers, visit our case studies section.
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