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Crisis is always a catalyst for change. The changes wrought by the COVID-19 pandemic recently prompted the U.S. Food and Drug Administration (FDA) to issue a guidance for conducting regulatory inspections remotely. Time will tell whether this signifies the agency’s intent to expand its digital or remotely conducted activities, but it does provide a glimpse into the future of auditing and oversight. As regulators and other auditors normalize remote inspections, manufacturers must prepare to meet expectations.
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