21CFR Thermocouple Temperature Data Logger
WHAT IS 21 CFR PART 11?
Normally when using environmental recorders consisting of hardware, sensors and software, the data is collected and stored in various means. To comply with 21 CFR Part11 the entire data processing has to be validated to make sure that there is no data corruption through the entire process.
21 CFR Part 11 is confirming the instruments information / data digital signature. To ensure that data generated by a software and/or recording devices have not been voluntarily or involuntarily altered/modified. It details several points that a organizations must implement before stating its solution is 21 CFR Part 11 compliant by generating a PDF file that cannot be modified, certify that data are encrypted, software must have an ID and password to login, audit trail and the instrumented and sensors are validated/certified/traceable.
This standard is usually known and requested in the life science industry. If you want to rely on loggers to certify that pharmaceutical products are correctly maintained within their proper range of temperature, you have to make sure that data generated is reliable.
The purpose of 21 CFR part 11 is basically to ensure that the data read and stored by a software and environmental instruments are entirely accurate.
|Temperature Sensing Range:||-328°F ~ 2,462°F (-200°C ~ 1,350°C )|
|Temperature Accuracy:||+/- 2°F (+/- 1°C) typical|
|Temperature Scale:||°F and °C|
|Dimensions:||4.64 x 1.06 x 1.06”|
|Calibration Available:||Yes (purchased separately)|
|Shelf Life:||12 Months|
|Recording Rate:||between 1 second to 12 hours|
|Software Type:||Windows 10, 8, 7 (32-bit and 64-Bit Versions)|
- 21CFR Temperature Logger
- K-type Thermocouple Probe
- Software ( Free Download )
- Wall Mount Bracket
- Quick Start Guide
How To Set Up 21CFR Software
How To Set Up 21CFR Logger
How To Stop/Download 21CFR Logger