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 ...
A laboratory director of a nonwaived lab who holds a doctor of medicine (MD) or doctor of osteopathy (DO) degree must also be certified in anatomic pathology or clinical pathology, or both, by the ...
Have you ever wondered what happens to a vial of blood after it is drawn from your arm at the hospital? Clinical Lab Technicians are responsible for collecting biological samples such as these that ...
HHS updated its guidance on the data that should be reported by laboratories as part of the COVID-19 test results. The agency aims to obtain near real-time data with the reporting requirements to ...
Therefore, before selecting a computerized system, a laboratory must ensure that the compliance features are in place, otherwise, your digitalized workflows will be hybrid and you run the significant ...
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