EasyLog range

Building upon the existing EasyLog software, EasyLog21CFR extends the core software package to meet FDA requirements for the maintenance of electronic records in the pharmaceutical, biotechnology, medical device, and other FDA-regulated industries.

 Vaccines and other medicines need to be closely temperature controlled. Should they fall out of the safe temperature range at any point in their lifetime, they can no longer confidently be relied upon to treat - potentially life-threatening - conditions. As such, 21CFR Part 11 requires that all activity is traceable, accurate records are maintained, and all data is protected and tamperproof.



To ensure digital security and compliance, the new software records a full audit trail of all activities and actions taken, with individual users assigned specific permissions. Authorized users can approve comments on specific readings and the full session data. All reports include electronic signatures to verify who started, stopped, and approved the session data, with all readings collected stored in a non-editable, encrypted format.

This new software is compatible with the similarly compliant EL-21CFR-2-LCD, a USB data logger for monitoring temperature, relative humidity and dew point.