EasyLog 21CFR WiFi Vaccine Monitoring Kit

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 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.

Specification

Measurement range (probe supplied): -40 to 60°C
Measurement resolution: 0.01°C
Measurement accuracy (typical): ±0.2°C (-15 to +60°C)
Measurement accuracy (maximum): ±0.6°C (-40 to +60°C)
Operating temperature (module): -20 to +60°C
Readings: Unlimited
Logging Rate: User selectable between 10 seconds and 12 hours
Battery Life: 6 Months
Calibration Certificate: Supplied at 2 and 8°C

Application

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:

Vaccine Storage
Blood & Blood Component Storage

The EL-WiFi-21CFR-VAC comes with a calibration certificate issued at 2 and 8°C. It typically takes around 3-4 weeks.