FDA Remote "Inspections" During The Pandemic

By Sarah Beale, MasterControl

Remote audits aren’t unique to the isolation imposed by the COVID-19 pandemic. For customer and supplier audits, much of the requirements can be met remotely. The biggest convenience with remote audits comes from the ability to quickly and easily share electronic documentation. It’s worth noting that this is only easy if the company being audited has invested in a quality management system that stores its documents, provides version control, and tracks all changes.

These same benefits apply to the U.S. Food and Drug Administration (FDA) remote inspections. We use the term “inspections” loosely here because the FDA wants to be clear that reviewing records, holding Zoom meetings with companies, and other remote oversight activities are not actual inspections. With that in mind, these activities have been vital during the pandemic and have shown the importance of going digital and investing in an electronic quality management system (eQMS).