On the 27th of April, we conducted the webinar “Practical Advice for Your Next Remote GVP Audit”. In this webinar, we shared the best practices in planning, conducting, and reporting remote audits based on our own experience, analysed how remote audits evolved through 2020, and answered the questions of the participants.
Continue reading to discover the questions from the Q&A session from the webinar.
Question: If you have access to the e-documents, for how long do you keep them?
Answer: When documents are provided through a sharing platform, we require access to them for at least 2 weeks after the interview day. When documents are provided through other means they are kept according to the provisions established by the contracts with our clients.
Question: Do you find recording a remote audit useful?
Answer: We do not record remote audits. Someone might find it useful, however, re-watching a recorded audit would be very time-consuming. We prefer to optimise the methodology for taking notes and ask for post-audit clarifications when something is not clear enough. What is more, for recording an audit you should ask the consent of the auditees who may cause confidentiality concerns.
Questions: How do you check the retention of the documents in the fireproof cabinet via remote audit?
Answer: The verification of the hard-copy (or paper-based) archive is probably the only big limitation for remote GVP audits. We typically ask questions on this topic to the auditees and review the relevant procedures for paper-based archiving. However, it is not possible to physically access the archive and verify it by yourself.
Question: What can we do in case if the auditee does not provide the requested evidence, but only shows it on the screen?
Answer: Here we must make a distinction: a refusal to provide a document requested during the audit versus a refusal to provide pre-audit documentation. In the first case, showing the requested evidence on screen is fine from the auditor’s perspective. However, it can be challenging as you have limited time to take the proper references of the document. For this reason, you must be able to take notes quickly and integrate them with post-audit clarifications when some references are missing from your notes.
If the auditee refuses to provide pre-audit documentation, like the one that you would require based on your audit checklist, your audit may result in very limited objective documental evidence. In such a case, you will have to write down this limitation on your report. When this happens, the commissioning party might consider elevating the risk level assigned to the auditee and plan a follow-up on-site audit when feasible.
Question: Is it correct to require additional documents after the remote audit and include in the report some deficiencies that were not included in the summary of the closing meeting?
Answer: if you are adopting this practice, it is important to state it during the closing meeting. In this way, you will let the auditees know that the reported observations are only preliminary and more might be identified following the review of the audit documentation.
Question: Could screenshots be a problem for confidential data/confidential procedure and data protection in some cases?
Answer: Every audit is usually covered by confidentiality agreements. As for video recording, reviewing screenshots might take additional time and require auditees’ consent.
Question: What kind of webinar system are you use and why?
Answer: If the question relates to the tool used for conducting the remote audits, we use Microsoft Teams.
Question: How should I approach remote audits if I have all the documents in paper format?
Answer: As an auditor, you should require scanned copies in your pre-audit document request. As an auditee, you can prepare scanned examples or show Word versions. However, you should give your availability to provide copies of original documents upon request.
Question: Do you foresee that once the pandemic is over, we will continue with remote audits or we will move back with on-site audits?
Answer: We believe that remote audit will continue to be used by the pharma industry especially in the GVP area due to their overall lower costs. What is more, remote audits allow to plan and execute more audits with the same auditor’s capacity.
Question: What is the FDA’s position on remote audits?
Answer: FDA recently released guidance on the topic that can be found here.
Question: What companies benefit the most from remote audits?
Answer: All the companies could benefit from conducting more remote audits. Small-size companies would benefit from the reduced costs of the audits. Medium to big-size companies could benefit additionally from the possibility to execute more audits in the same time window. What is more, they could limit the execution of the more resource-consuming and costly on-site audits only to high-risk partners.
Question: What is the AIFA position on remote audits?
Answer: AIFA has expressed its position regarding the GMP remote audits – the text (in Italian only) can be found here.
Additional positions were taken regarding the visits of clinical monitors in clinical trials with specific reference to alternative “remote” approaches to the Source Data Verification (SDV). The text (in Italian and English) can be found here (section “Related documents”).
Question: How much in advance should I set the pre-audit test call?
Answer: There is no fixed rule for this. You can set the call one day or one week prior to the planned interview days. We suggest doing it once the agenda has been established so that you can review it together with the attendees during the test call.
Question: Which part of remote audits do you find the most challenging?
Answer: The conduction of the audit interviews can be quite challenging – it requires exceptional attention to the details and concentration, as you take notes, make questions, and review documents in the same limited time window.
Question: Do you use any special tools for creating the audit checklist?
Answer: No, we normally use a Word form but also an Excel spreadsheet can be suitable.
Do you have questions about conducting or undergoing remote audits? Reach out to us for a conversation with an expert.