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.