The recent discovery trend in medical malpractice litigation is to not only request a copy of the patient's medical record, but to also request the defendant's electronic medical record (EMR) “audit ...

Digital transformation of analytical processes requires suppliers to design and implement audit trail(s) (AT) that are fit for intended use in a regulated laboratory. In addition, second person review ...

For example, chromatographic data should be saved to durable media upon completion of each step or injection (e.g., peak integration or processing steps; finished, incomplete, or aborted injections) ...