Description
Overview
This 21 CFR Part 11 compliant standalone data logger measures more than 16,000 readings over a -35 to +80°C (-31 to +176°F) and 0 to 100% relative humidity (RH) range. At the touch of a button, use the on-board display to cycle between the current, minimum and maximum logs seen during the session for both temperature and humidity.
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.
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.
Easily set up the logger and view downloaded data by plugging the unit into a PC’s USB port and using the free 21CFR Part 11 software provided. Supplied with ½ AA battery and wall mount clip.
Specification
Temperature:
Measurement range
-35°C to 80°C (-31°F to 176°F)
Internal resolution
0.5°C (1°F)
Accuracy (overall error)
0.55°C (1.04°F) typical (5 to 60°C)
Long term stability
<0.02°C (0.04°F) / year
Relative Humidity:
Measurement range
0 to 100%RH
Internal resolution
0.5%RH
Accuracy (overall error)
2.25%RH typical (20 to 80%RH)
Long term stability
<0.25%RH / year
Logging Rate
User selectable between 10 seconds and 12 hours
Battery Life
2 Years
Calibration Certificate
Available Separately
Application Info
The EL-21CFR-2-LCD has been specifically developed to meet the data security required by the FDA's 21CFR part 11 regulations. As such it is suitable for use in applications where the integrity of the data is of the highest importance.
· Vaccine Storage
· Cold Chain in the Pharma Industry
· Blood & Blood Component Storage
More detail about MOBICON-REMOTE ELECTRONIC SDN BHD
