EasyLog EL-WiFi-21CFR-VAC WiFi Vaccine Monitoring Kit (21 CFR)

Why choose a 21CFR logger?

The 21 CFR Part 11 regulations issued by the US Food and Drug Administration (FDA) set the criteria under which the FDA can consider electronic records equivalent to paper records. If you need to meet these regulations or have enhanced data security requirements, choose one of our 21CFR loggers; otherwise, our standard loggers will suffice.

The 21CFR Cloud subscription delivers all 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, so that the data monitored and collected is regulated to the 21CFR Part 11 standard. The device is supplied with a high accuracy glycol bottle thermistor probe and requires a subscription to the EasyLog 21CFR Cloud service.

This product meets and exceeds CDC standards for vaccine monitoring.

Specifications

• 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

Applications

The EL-WiFi-21CFR-VAC suits a wide variety of applications, particularly those that require 21CFR compliant data collection and management, including:

• Vaccine storage
• Blood and 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.