# Virtual Auditing in a Post-COVID World of Digital Compliance

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-02-18
- Length: 30m
- Episode: 180
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-18-virtual-auditing-in-a-post-covid-world-of-digital-compliance
- Listen: https://podcast.greenlight.guru/episode/virtual-auditing-in-a-post-covid-world-of-digital-compliance

## Summary

Colleen Hittle, founder of ProVeritas Partners, discusses the shift to virtual auditing and compliance in the medical device industry during the pandemic. She explains that while notified bodies adopted remote monitoring early, the FDA was slower to embrace virtual inspections, creating challenges in assessing facility context and human interaction. Hittle outlines practical workarounds, such as using video walkthroughs and pre-recorded process videos, to simulate on-site presence, and argues that virtual audits will likely remain a permanent part of the regulatory toolkit due to cost and talent retention benefits.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-18-virtual-auditing-in-a-post-covid-world-of-digital-compliance#t=0) Introduction: Colleen Hittle and ProVeritas Partners
- [3:31](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-18-virtual-auditing-in-a-post-covid-world-of-digital-compliance#t=211) Notified Bodies vs. FDA Adoption of Virtual Auditing
- [7:08](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-18-virtual-auditing-in-a-post-covid-world-of-digital-compliance#t=428) Challenges of Virtual Auditing: Context and Interaction
- [10:30](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-18-virtual-auditing-in-a-post-covid-world-of-digital-compliance#t=630) Workarounds for Manufacturing Floor Observations
- [12:42](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-18-virtual-auditing-in-a-post-covid-world-of-digital-compliance#t=762) Preparation Strategies for Companies and Auditors
- [20:51](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-18-virtual-auditing-in-a-post-covid-world-of-digital-compliance#t=1251) The Future of Virtual Auditing and Risk-Based Monitoring

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

early-stage companies

## Mentioned

- ProVeritas Partners (company)
- Green Light guru (company)
- FDA (other)
- ISO (other)
- MDSAP (other)

## Related episodes from other shows

- [253 - FDA Is Making Big Changes to Its Inspection Approach](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-07-253-fda-is-making-big-changes-to-its-inspection-approach) (Let's Combinate)
- [Ep. 15 | The Emergence of the Virtual Supply Chain in a COVID-19 World](https://hardwarepodcasts.com/podcast/moores-lobby/2020-12-17-ep-15-the-emergence-of-the-virtual-supply-chain-in-a-covid-19-world) (Moore's Lobby)
- [128 - Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadavers/Autopsies, Tales from FDA Inspections, Understanding the QMSR, and Quality Culture](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-20-128-former-fda-inspector-and-managing-consultant-vin-cafiso-cadavers-autopsies-t) (Let's Combinate)
- [188 – Certified Quality Auditor(CQA) and Audits in the Future](https://hardwarepodcasts.com/podcast/lets-combinate/2025-05-14-188-certified-quality-auditor-cqa-and-audits-in-the-future) (Let's Combinate)
- [215 - Why Aren’t Technical People Leading Drug-Device Audits?](https://hardwarepodcasts.com/podcast/lets-combinate/2025-11-26-215-why-arent-technical-people-leading-drug-device-audits) (Let's Combinate)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-18-virtual-auditing-in-a-post-covid-world-of-digital-compliance. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.