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I simply need to know if it is a violation of 21 CFR part 820 or any other FDA regulation for an in vitro diagnostic device software to allow patient information to be edited once it has been entered by the user (e.g. if the user realizes the patient ID# is incorrect or the name is misspelled). We are currently working woth two contract developers, both of whom claim to know FDA/ISO regulations, but who disagree on this point. One developer has no problem with it. The other says it is absolutely not allowed. Which one is correct?
Thanks in advance for your time.
Thanks in advance for your time.