Newer means in remote pharmacovigilance audits and inspections
Newer means in remote pharmacovigilance audits and inspections
- August 7, 2023
- Posted by: Manoj Swaminathan
Although remote audits and inspections have become a norm after the onset of the COVID-19 pandemic, the limitations of remote auditing remain! There is no doubt that remote audits cannot take precedence over on-site or face-to-face audits. Hence, a middle path is needed, primarily when the whole industry evaluates using Artificial Intelligence (AI), Machine Learning (ML), and drones for various activities.
Following are some tools that can be considered for remote audits and inspections. If you are aware of any other means, then make sure to include them in the comments section.
- Metaverse
- Virtual Reality
- Drones
- Robot-Auditor
- Quantum Computing
Metaverse
Imagine if your global team could avoid travel and meet with the auditor on the Metaverse! Yes – I am talking about Metaverse as the site or location of the audit/inspection. The auditor could even conduct interviews on Metaverse. Besides, we can even have auditors and auditees from different geographies sitting together, forming a round table. However, please note that the pharma company or the regulatory agency must own a site on Metaverse to undertake this audit. This investment will undoubtedly be worth it, as one can save on travel and hotel costs. If owning a site on Metaverse is not possible, one could consider renting it.
Virtual Reality (VR)
VR is another good option for conducting remote interviews. Besides, the auditor could consider using VR for taking the site tour.
Drones
This option is suitable for auditing large manufacturing sites. The aerial drones can provide a bird’s eye view of the unit. However, we could even have indoor drones that could examine the facility, the safety parameters, hygiene and even the storage and archival facilities.
Robot-Auditor
Using deep learning techniques, one can consider designing an expert robot. This robot could provide support with compliance activities. One could consider utilizing this robot for audits and inspections if this works. The robot could scan your safety database and identify errors in a fraction of a second. You never know; the robot could even remember the auditees’ facial expressions and body language and determine potential lapses in the Quality system!
Combination Methods
This is by far the most realistic one, where the traditional on-site or remote audit can be clubbed with one of the above means. The auditor may even take the support of a drone during the on-site audit. Besides, emerging concepts like quantum computing are gaining relevance in this field.
Most companies and regulators are utilizing traditional methods for audits and inspections. It may be the right time for innovation in this area!
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