This high accuracy standalone data logger measures and stores more than
32,000 temperature readings over a -40 to +125°C (-40 to
range with a resolution of 0.1°C (0.2°F).
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 21CFR software. Data 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
The high contrast LCD can show a variety of temperature information. At the touch of a button, the user can cycle between the
current, maximum and minimum stored values for temperature.
The data logger is supplied with a lithium metal battery which typically gives two years’ logging life.
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
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.