Virtual Quality Audits — Overcoming Pandemic Limitations And Serving Biopharma's Future

By Vladas Algirdas Bumelis, Audrius Abrutis, and Benas Petronis, Northway Biotech

While virtual quality audits sometimes took place prior to the COVID-19 pandemic, their frequency of use in the biopharmaceutical industry has skyrocketed in the past 18 months. This increased application has driven improved utilization of technology and more cohesive execution strategies, rendering virtual audits a valuable tool whose regular use will continue to provide value even when the pandemic recedes.

This is not to say virtual audits can fully replace in-person quality audits in all scenarios. Virtual audits have emerged as a practical first step in the supplier and vendor qualification/requalification process — a supplementary resource to gain initial findings and fulfill obligations that move a project along. But it remains a best practice to follow a virtual audit with an in-person site visit that confirms its findings or fills informational gaps not addressed in the virtual walk-through.