This post can also be read on the MWA Consulting, Inc.’s website.
The COVID-19 pandemic created unprecedented challenges for quality and compliance professionals in the pharmaceutical, biotech, and medical device industries. Staying on course toward product approval and audit schedules is dependent on maintaining a robust compliance roadmap, which includes sponsoring GxP audits.
While remote audits have always been an option, the pandemic forced quality units to take a fresh look at how to use them effectively and in a manner that ensures reliable results.
Here are three key takeaways from what the past year has taught us about successful remote quality audits:
If your audit schedule depends on contracting external auditors, do not rely on them to determine if a site has the capacity to host a remote audit. The site needs to know in advance of receiving the audit agenda that they will be expected to share critical documents, provide a virtual tour, and ensure appropriate data security and IT support while the remote audit is in progress. If the site has agreed to a remote audit, but lacks adequate IT infrastructure, or has policies preventing virtual viewing of their facility and documentation, you may need to adjust the audit scope, or consider scheduling an onsite audit in the future instead.
Remote audits have the potential to save time and money, especially if a site is in a remote location that requires multiple modes of transportation to get there. However, things can get bogged down quickly when an audit plan fails to factor in time for delays due to technology glitches, language differences, and challenges in coordinating the participation of people in different locations – and in different time zones.
Make sure the audit agenda is specific with respect to who needs to be online when, and that the site has made arrangements for IT support during live audit activities. Ask the site to prepare their personnel for the remote audit, and address concerns in advance, so that the auditor can expect full cooperation.
If the site is using an electronic document management system, it will make this part of the process much easier and more efficient for both the auditor and auditee.
There is little difference between agendas for remote and onsite audits. However, you’ll want to make sure a remote audit is right for your situation:
Deciding when and how to schedule remote audits will depend on the readiness of the auditee, the skill of the auditor, and the scope of the audit. If you determine that remote auditing can play a role in meeting your audit program objectives, you’ll likely discover greater efficiencies in time and budget management along the way.
On April 21, 2021, MWA Consulting, Inc. is hosting a webinar titled, “Remote Auditing: Best Practices and Practical Suggestions.” More information is available here.
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