In April 2021, the U.S. Food and Drug Administration (FDA) came out with its guidance on remote audits, and a goal to reduce its audit backlog. As you wait your turn, conducting a mock audit will ensure that your people, processes, and technology are prepared.
Mock audits were discussed in our Virtual Audits
and Inspections webinar. Learn more
Remote interactive evaluations (also known as remote—or virtual—audits) have become more common since the pandemic began. There remain instances where an in-person evaluation is best, especially when it comes to facilities inspections, but the FDA has approved virtual evaluations for pre-approval and pre-license inspections, post-approval inspections, surveillance inspections, and follow-up and compliance inspections.
Taming the Backlog Beast
The FDA is under pressure to reduce its backlog of more than 1,000 audits that were waylaid because of the pandemic. The U.S. Government Accountability Office (GAO) said that the FDA’s future inspection plans need to address issues presented by the COVID-19 backlog, so the FDA is using teleconferencing, livestreaming video, and screen-sharing technologies for audits that can be conducted in this manner.
If your organization has not been audited by the FDA in the past year, be prepared for an inspection. If you haven’t experienced a remote audit, mock audits and assessments are an ideal way to prepare.
Learn more about mock audits in our On-site and Remote Audit Best Practices blog, which also addresses preparation and the importance of the agenda. Read it here
If audits in general are a cause for concern, let USDM’s Audit Team share their knowledge and experience with you. We’ve also got a checklist to help you focus on the various tasks, including remote collaboration and content access.
Remote Evaluation Process
Remote evaluations can preclude the need for an on-site inspection, support some enforcement (compliance) actions, and help rank and prioritize facilities for future inspections.
Applicants for a remote evaluation must show that they can adhere to critical technical aspects, such as adequate bandwidth for video conferencing, live streaming, and document sharing. A regulated industry can deny a remote audit, but if the FDA request is denied, it can result in delayed drug approvals, among other things.
Read our Best Practices for Virtual Audits and Regulatory Inspections white paper for details about planning for a virtual audit, sharing documents online, conducting interviews and meetings, and more.
Remote collaboration and accessing documentation are two major pain points for organizations being audited, so it is important for you to have a secure and reliable content management system. The best way to test your system is with a mock audit.
Mock Audits are Worth the Effort
Mock audits prepare your team to manage an audit. Doing one virtually helps you to identify issues with equipment, bandwidth, and internal systems so that you can resolve them before they become inspection issues.
Mock audits were discussed in our Virtual Audits and Inspections webinar. One key benefit is establishing a workflow process so that all employees and the auditor have a good user experience. Be sure to include the IT team and on-site safety officers. Prepare an index of the documentation you will make available to the auditor, including standard operating procedures (SOPs).
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If you're using augmented or virtual reality in your remote audit, practice with it during your mock audit. You’ll need to be familiar with the equipment and ensure that your Wi-Fi is reliable throughout your facility to avoid interruptions and disconnections.
A Note on Medical Device Audits
A December 2020 update to the Medical Device Singe Audit Program (MDSAP) expands on the “temporary extraordinary measures” related to COVID-19 quarantine orders and travel restrictions in the U.S. In part, it says that mandatory elements of a surveillance audit that cannot be verified remotely shall be verified on-site, and that deviations to the plan will be added to the next on-site audit. The auditing organization shall adjust the audit program to ensure that required oversight is completed during the certification cycle for audits performed using alternative arrangements.
European Union medical device regulations also address exceptional circumstances in the context of the COVID-19 pandemic. In short, it states, “Calls for the possibility to take temporary extraordinary measures, including remote audits, related to notified body on-site audits under the medical devices Regulations have been made by industry as well as notified bodies.” Click here to read more about the legal requirements and considerations by the Commission.
How USDM Can Help
Do you have an approved supplier list? Do you work from checklists? Can you access your documents quickly? Are you able to present the necessary documentation to the auditors?
Our Audit Assessment services take a holistic approach to your regulatory requirements, reveal gaps and risks in your processes and systems, and deliver a report of our findings. We provide a recommendation for how to remediate any findings and prioritize them based on your business priorities, resources, technical know-how.
Contact us today to get your questions answered by our experienced team of auditors.
About the Author
Diane Gleinser is the Vice President of Life Sciences Solutions at USDM Life Sciences. She has more than three decades of experience in the life sciences industry and leads a highly skilled team of implementation and compliance engineers. Her in-depth knowledge of the regulatory landscape and unwavering passion has been instrumental in rooting USDM's focus on regulatory compliance for life sciences customers. Read more
On-demand webinar: Virtual Audits and Inspections
White paper: Best Practices for Virtual Audits and Regulatory Inspections
Blog: On-site and Remote Audit Best Practices
Checklist: Virtual Audits Checklist
Regulatory Support: USDM Audit Team