EL-WiFi-21CFR-VAC - 21CFR WiFi Vaccine Monitoring Kit

Overview

The EL-WiFi-21CFR-VAC allows remote vaccine monitoring and data collection over a WiFi network. 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. Learn more about 21 CFR Part 11.

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 is supplied with a high accuracy glycol bottle thermistor probe and requires a subscription to our EasyLog 21CFR Cloud service.

This product meets and exceeds CDC standards for vaccine monitoring.

This product complies with BS EN 12830:2018 (Temperature recorders for the transport, storage, and distribution of temperature-sensitive goods).

Specification

Measurement range (probe supplied)

-40 to 60°C (-40 to 140°F)

Measurement resolution

0.01°C (32°F)

Measurement accuracy (typical)

±0.2°C (-15 to +60°C) ±0.4°F (+5 to +140°F)

Measurement accuracy (maximum)

±0.6°C (-40 to +60°C/ -40 to +140°F)

Operating temperature (module)

-20 to +60°C (-4 to +140°F)

Readings

Unlimited

Logging Rate

User selectable between 10 seconds and 12 hours

Battery Life

6 Months

Calibration Certificate

Supplied at 2 and 8°C

Resources

FAQ's

Could you explain what 21CFR Part 11 is?

Is there a document that provides troubleshooting for setting up my WiFi Sensor?

More support

Calibration

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.

The EL-WiFi-21CFR-VAC comes with a calibration certificate issued at 2 and 8°C. It typically takes around 2 weeks (Lascar UK and Asia customers) or 3 weeks (Lascar US customers) to calibrate this product, please place your order today and our sales team will then confirm the exact delivery date.

Click here to view a sample certificate.

Applications

The EL-WiFi-21CFR-VAC is suitable for a wide variety of applications particularly those which require 21CFR complaint data collection and management these include: