EasyLog | EL-WiFi-21CFR-TH+

206,49 ex. tax

High-Accuracy 21CFR WiFi Temp & RH Data Logger

EL-WiFi-21CFR-TH+
EL-WiFi-21CFR-TH+ 206,49 ex. tax

This high-accuracy WiFi-enabled temperature, humidity and dew point EL-WIFI-21CFR-TH+ data logger can remotely monitor an environment over a -20 to +60°C (-4 to +140°­­F) and 0 to 100% RH measurement range. Data is uploaded periodically using a standard WiFi network without the need to physically collect and connect the unit to a PC. Data is streamed wirelessly to the EasyLog 21CFR Cloud.

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 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.

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).

Measurement Range -20 to +60°C / -4 to + 140°F
0 to 100% RH
Accuracy ±0.2°C / ±0.4°F
±1.8% RH Typical
Readings Unlimited
Logging Rate User selectable between 10 seconds and 12 hours
Battery Life 6 Months

 

Could you explain what 21CFR Part 11 is?

The US FDA (Food & Drugs Administration) Code of Federal Regulations 21 Part 11, is an extension to the existing regulations that defines which electronic records and signatures that are to be considered accurate to replace paper records for the Pharmaceutical and Medical industry. Our system has been designed to assist companies comply with these regulations.

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