The ability of the pharmaceutical industry to conduct on-site audits has been impacted by global travel restrictions imposed during the global pandemic caused by the COVID-19 disease. These essential examinations are designed to ensure, through the detection of potential gaps, that all regulated systems are operating in a state of control or, if not, to aid in the timely detection and remediation of noncompliance. Industry has quickly pivoted to the use of remote auditing tools to ensure that the requirements of health authorities and marketing authorizations are being met.

This document describes steps that can be taken to ensure an effective and efficient remote assessment. It introduces standard nomenclature to describe the types of remote audits and discusses key considerations for their scheduling, duration, planning, conduct, closing, reporting, and follow-up. This document focuses on aspects of auditing that are different in the remote setting than in on-site audits or that have a particular impact in the remote setting. It may assist entities as they work through the challenges of remote and hybrid auditing and determine the changes in practices, standard operating procedures, and quality agreements that are necessary to facilitate effective and efficient remote audits.