Greetings All,
I would appreciate opinions on the following:
Issue: A requirement has been raised to measure small distances in the range of 0.1 to 1.5 mm on a finished drug product. The microscope (a Hirox system) can accomplish this but has no Part 11 functionality. The easiest approach I think is to print the jpeg file from the scope which contains the measurements and consider this the raw data. The jpeg would not be saved and therefore Part 11 is not an issue. Agreed? If stakeholders prefer to save the jpeg files we need to a manual work around perhaps involving a second person to witness conversion of the jpeg to a pdf and e-signing the file to insure no manipulation took place.
Any thoughts would be appreciated.
Regards,
Socrates