In response to the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) announced in March 2020 that it was scaling back foreign and domestic surveillance facility inspections and relying on other measures like reviewing records remotely. This authority is granted in Sec. 706, Records for Inspection, of the FDA Safety and Innovation Act (FDASIA).
Virtual audits are the definition of “pivot” for companies that want to qualify vendors and suppliers or gather information required for agency submissions and certifications during the global pandemic. The pivot has involved moving to virtual tours, implementing pre-audit documentation reviews, and having records accessible for the auditor. As virtual audits and assessments become commonplace, technology for such occasions has also evolved.
USDM Life Sciences and Box shared best practices for cloud content management. Watch this demo to learn how Box can get you ready for virtual audits.
This discussion included:
- Differences between on-site and virtual or remote audits
- What auditors want to see in virtual audits
- How Box can simplify virtual audits
- USDM's Assurance Report and how it provides audit-ready evidence to the FDA
- Forward-thinking ideas about how virtual audits will evolve in the next few years
Here's a preview. Click Watch Now to access the full-length on-demand webinar.
Click Watch Now to access the full-length on-demand webinar.
About the Presenters
Vice President of Cloud Compliance David is an accomplished life sciences regulatory and IS compliance professional with more than 25 years of experience in the pharma, medical device, biotech, and blood management industries, specifically in the fields of computer systems validation, risk management, quality assurance, software development, product life cycle management, and compliance roadmap development.
Managing Director, Life Sciences at Box Manu is the global lead for life sciences and go-to-market strategies for Cloud Content Management at Box.com. With two decades of deploying ECM solutions in a regulated industry, he supports life sciences companies riding the digital transformation wave to fully leverage the micro content services provided by Box.