EasyLog | EL-WiFi-21CFR-DULT

288,99 ex. tax

21CFR-Compliant Dual Channel WiFi Cryogenic Vaccine Data Logger with Display

EL-WiFi-21CFR-DULT
EL-WiFi-21CFR-DULT 288,99 ex. tax

The EL-WiFi-21CFR-DULT is a dual channel 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 probes 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).

Measurement Range -100 to +100°C (-148 to +212°F)
Accuracy ±2.5°C (±4.5°F) typical
Logging Rate User selectable between 10 seconds and 12 hours
Storage Capacity Unlimited
Dimensions (logger) 82 x 70 x 36mm (3.22 x 2.75 x 1.41”)
Dimensions (probe) 300 x Ø1.5mm x 1m cable (11.8 x Ø0.06″ x 39.4″ cable)
Battery Rechargeable Battery / 6 Months Battery Life / Mains Powered Option

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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.

Would the 21CFR Cloud product be suitable for my company?

The product has been designed for companies which want to use electronic means to securely replace their paper records to comply with 21 CFR Part 11 regulations for the Pharmaceutical and medical industries. Also if you work within, and want to be compatible with, the US Pharmaceutical and medical industry and to streamline your record-taking accordingly, initiating a 21 CFR Cloud would be advantageous.

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