Your Remote Audit Questions Answered

Virtual audits are taking the place of in-person inspections as the COVID-19 pandemic continues to disrupt standard business practices. Preparing for a virtual audit requires a specific set of skills and expertise.

NSF Vice President Sanjay Shetgar recently hosted a webinar on the issue of remote audits, where we received many questions from attendees. We have compiled the most frequently asked questions and provided answers for them below.

If you would like our assistance in preparing for a remote audit or any other issue within the pharmaceutical sector, contact us by using the form below.

Question: Are videos contrary to data protection and privacy laws?

Answer: You are right; that is possibly why the FDA is not issuing a formal closeout as it happens in on-site audits. If the situation persists, then the required amendments in privacy laws could be upgraded to meet the end objective of patient safety.

Question: Do you think regulators expect that audit frequency will need to increase if remote audits are used rather than on-site audits? If so, this suggests they believe the remote audit process is in some way less rigorous.

Answer: In my opinion, remote audits will assess the risk and reduce the number of on-site days. Much of what will happen depends on the trajectory of the pandemic itself. It appears that the FDA is confident that this phase will pass.

Question: Is there a different timeline for submission of documents for auditor review with a remote audit?

Answer: The timeline is no different from any other on-site audit. However, I always recommend keeping the inspectors updated when documents are ready and waiting to upload or have already been uploaded.

Question: With remote audits being new for both the auditors and the hosts, are you seeing more requests for extended audits of facilities?

Answer: You are right; remote auditing is a relatively new issue for everyone. Inspectors typically want to complete the audit within the timeframe given. However, the document request and queries could continue for some time.

Question: Do I need to scan all records for the remote inspection (e.g., presiding year logbooks and ongoing logbooks)?

Answer: A logbook is typically not requested. If an inspector does ask for it, it would likely be in response to missing information on an existing batch record. That said, it is an indicator for companies to start moving to automation/digitization where possible.

Question: We are performing virtual audits but are having difficulties making every area accessible. We’ve experienced network issues and struggled with camera positioning in overseas audits. What would you suggest?

Answer: This is a common challenge for companies. You could consider improving connectivity with wifi extenders. It might also be worth carrying out risk analysis and recording the operation or steps not visible separately. These recordings could then be provided to the inspector upfront.