What is 21 CFR Part 11?
Regulations issued by the US Food and Drug Administration (FDA), their full name being Title 21 of the Code of Federal Regulations, Part 11. Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States; Part 11 provides the criteria for the FDA to accept submission of electronic records as equivalent to paper records.
USB 21CFR-Compatible Temperature, Humidity & Dew Point Data Logger with LCD Screen
- EasyLog 21CFR Software available as a free download
- -35 to +80°C (-31 to +176°F) and 0 to 100%RH measurement range
- Logging rates between 10 seconds and 12 hours
- High contrast LCD, with two and a half digit temperature and humidity display function
- Immediate, delayed and push-to-start logging
- Use as part of a 21CFR Part 11 compliant system
- RoHS compliant
This standalone data logger measures and stores over 16,000 temperature and humidity readings from -35 to +80°C (-31 to +176°F) and 0 to 100%RH range at a resolution of 0.5°C (1°F) and 0.5%RH.
The user can easily set up the logger and view downloaded data by plugging the data logger into a PC’s USB port and using the free EasyLog software. Data, including calculated dew point, can then be graphed, printed and exported to other applications for detailed analysis. The encrypted data has full audit tracking to comply with the requirements of 21CFR Part 11.
The high contrast LCD can show a variety of temperature and humidity information. At the touch of a button, the user can cycle between the current temperature and humidity, along with the maximum and minimum stored values for temperature and humidity.
The data logger is supplied with a lithium metal battery, giving up to 2 years’ logging life. The logger is protected against ingress from water and dust to IP67 standard when the cap is fitted.