Lessons Learned From Inspections and Audits During COVID-19

About This Video

The one lesson the U.S. Food and Drug Administration (FDA) wants us to learn about remote inspections is this — they don’t exist. In press releases and presentations, FDA officials have been very clear that there is no such thing as a remote inspection. There are, however, remote records reviews, remote regulatory assessments, and remote interactive evaluations. The FDA’s remote inspectional activities may be done in advance of or in lieu of inspections, but they are not considered a replacement. The FDA’s hesitation to make their inspections entirely virtual is understandable and not very unexpected. The private sector has no such hesitations and many customer and supplier audits have gone completely remote. Cloud technology enables easy document sharing, virtual tours can be conducted with a mobile device, and auditors can speak with subject matter experts (SMEs) remotely. Being forced to go remote proved that certain audit/inspection activities can just as effectively be done online as in person. In this session, MasterControl Senior Product Managers Nate Henriod and Peter Harris explain how a digital quality management system (QMS) improves outcomes in audits. They’ll show a brief demo of the document management aspects of MasterControl Quality Excellence and describe the differences between audits with and without this technology.