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Data Integrity USP part 21cfr

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Data Integrity USP part 21cfr

Postby Guest » Tue Apr 17, 2007 4:57 pm

As part of a FDA USP ISO and so on regulated facility, data integrity is of the highest order. Is your software that monitors and reports data from the loggers, etc. compliant with such standards? As to say, once the data is stored into the computer, it can not be changed or otherwise manipulated. If it is what standard does the software align itself to?

Postby ziko » Wed Apr 18, 2007 12:02 pm

Hi and thank you for your post.

Currently this is not implemented in our software. I have forwarded your query to the relevant people to see if it may be an addition to our new data logging software, which is currently under development. If you could provide more information regarding this I would be more then happy to pass these details on.

Kind regards

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