Mahboubeh Lotfinia

We critically review the qualification and validation approaches in the World Health Organization Technical Report Series (WHO TRS) 1019 Annex 3 and its applicability to spectrometer systems.

The United States Food and Drug Administration (FDA) is using Remote Interactive Evaluations (RIE) to assess regulatory compliance, review submission material, or determine the timing of future inspections. Here, we look at some of the impacts of RIE on GxP laboratories. Although RIE is voluntary, is this an offer that you cannot refuse?