Diligent’s COO, Denise Dixon, and Director of Quality & Compliance, Alena Galante, author “Virtual Medical Affairs Audits: A Viable Alternative”, recently published by Pharmaceutical Executive.
Prior to COVID-19, audits by Life Sciences companies of their Medical Affairs functions were mostly conducted in person. The pandemic forced companies to look for other ways to meet their audit obligations, and a virtual (remote) approach was generally seen as preferable to delaying the audit. The virtual approach is now firmly established as a viable alternative, even with the easing of COVID restrictions.
This article addresses:
- The inherent challenges with virtual audits and how to overcome them
- Planning for a successful virtual audit
- Sharing and storing of audit documents
We hope you find it to be of value.