This is a discussion on 21cfr part 11 - DICOM ; 21CFR Part 11 (Part 11) is the US regulation that covers electronic documents and compliance. I have found nothing on the web anywhere that says that a dicom image falls under Part 11 regulation in an FDA compliant research environment. ...
21CFR Part 11 (Part 11) is the US regulation that covers electronic
documents and compliance. I have found nothing on the web anywhere
that says that a dicom image falls under Part 11 regulation in an FDA
compliant research environment.
Does anyone know whether or not there has ever been a ruling and where
to find it?
