Is the K-7400S osmometer and its software EuroOsmo 7400 compliant with the 21 CFR part 11?

The software EuroOsmo 7400 is not compliant with CFR 21 Part 11.

The software offers the possibility to store sample name, sample code, and additional comments when these are entered by the user. Also the operator name is documented, if entered. A report that includes the previous mentioned information can be printed. This report lists the date and time it was printed and the date and time the result file was saved. For each measurement the sample osmolality or freezing temperature (depends on what the user selected) is given. A calibration curve cannot be printed.

An export of the measurement results is possible as .xls and .txt file and include the following information: sample name, sample code, measurement result and comments.

In the following software tutorials you find more information on the EuroOsmo 7400 software and it's functions:

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