Since the start of the pandemic when travel was limited, Lachman Consultants has been performing virtual inspections.  In fact, we have performed audits and inspections at the same rate as we did before the pandemic, only now, most of them are remote.

We have been at the forefront of implementing effective state-of-the-art solutions.  During this time, we have also learned that there is no “one size fits all” solution.  Every situation is different.

Here are just a few of our key takeaways based on our experiences:

  1. Technology is evolving by leaps and bounds and getting better all the time. Lachman has implemented AvaTour™, and this has been embraced by our clients.  It allows the remote auditor to be immersed in the shop floor by using 360o cameras and 3D glasses. The experience while touring on the shop floor, in the warehouse, and in the laboratories is immersive, and the auditor feels like they are there.
  2. No matter what technology you use, orienting the auditor to the facility is important. Using a paper map with the tour route sketched on it can help the auditor “see” where they are at all times and can make the touring more effective.
  3. Advanced planning is key. Setting up times for the auditors to meet with SMEs as if they were sitting across the table in a conference room and not sending emails back and forth allows for a rich dialogue and enhances understanding.  Using available video conferencing technology is important too.
  4. A comprehensive list of pre-audit document requests also helps to smooth the process so that the auditor is not thousands of miles away waiting for something to be uploaded.
  5. The auditor needs to be flexible in terms of the time of the audit. Sometimes, the auditors may need to audit in the middle of the night to accommodate the site schedule, depending on the geography.

 

Compliance and audit needs have not stopped during the pandemic.

The FDA may not be out there inspecting, but they certainly expect you to continue oversight of your sites and suppliers during this time. Lachman Consultants has successfully navigated the virtual inspection landscape during these challenging times.  Let us share with you the benefit of our vast experience in this area by working with you on some of your inspection needs.  To schedule a virtual inspection or find out more information, please contact Linda Evans O’Connor at l.evansoconnor@lachmanconsultants.com.