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.