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.
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.
Used in conjunction with Lascar's 21CFR Part 11 software, the logger enjoys all of the core offerings of the original EasyLog software, but with additional 21CFR characteristics including user permissions, encrypted data which cannot be edited, full audit trail and electronic signatures for all activity.
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 every 10 seconds and every 12 hours until the memory is full
- 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.