remote audits

The pandemic has changed many aspects of our lives. This is no different for those of us in the medtech space where we were pushed to rethink how we work. In the process, we learned how to find robust alternatives to important processes such as physical audits. These changes also revealed the need for greater harmonisation at a global level to overcome fragmentation between regulators. In my experience, global regulatory agencies responded positively to the challenges posed by COVID-19. Their willingness to engage with the industry was evident and the use of such things of Emergency Use Authorizations helped reduce the roadblocks to getting much-needed devices to patients. It must be also said, however, that the pandemic exposed some of the weaknesses of the various global regulatory agencies. It laid bare the fact that the various regulators aren’t as well aligned globally as they probably should be. The pandemic highlighted the need for more agility, speed, change management, and urgency—while never compromising on safety—in our current regulatory agencies. Harmonisation of remote audits The pandemic also showed that the pace at which the various regulators are driving harmonisation, though organisations such as the International Medical Device Regulators Forum (IMDRF), is simply not speedy enough. The pandemic coincided with the ten-year anniversary of the IMDRF, and the delivery of harmonisation projects has fallen behind what the global patient population requires. I have seen many examples that highlight this lack of progress on harmonisation, but let’s focus on remote audits. As you may know, a remote audit is an audit performed off-site using information and communication technology. It mirrors all the activities that are carried out during an on-site inspection. In simple terms, it is a robust alternative to a physical audit. My experience with remote audits has demonstrated to me that they...