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How to Conduct Virtual Audits and Hybrid Audits in 2022?

Puthucode N. Rajamani, President, Rajamani Group LLC, Milltown, NJ, USA

Keywords: Virtual Audits, Hybrid Audits, Infrastructure Technology, Soft Skills

Industry: Food/Drug/Cosmetics

Level: Intermediate

Abstract

Since March 2020, with the COVID-19 induced pandemic crisis, most businesses have adjusted their business models to accommodate more virtual/remote work. Whether that would be working from home, minimizing personnel flows in a manufacturing facility or social distancing, and wearing face masks. Almost all were affected in one way or another. Some companies already had plans in place for an event like this and others have had to adjust as needed. Both the Regulatory Agencies and Companies worldwide were forced into following this practice.

Virtual, also known as remote audits, are performed offsite electronically, without the need for face-to-face interaction between an organization and the auditing party. All information is exchanged digitally rather than through paper forms. In 2022, both companies and Regulatory Agencies have started initiating Hybrid Audits. Hybrid audits is using a mixture of virtual tools to cut down personal exposure and time onsite. For Hybrid audits, depending upon the COVID-19 risk assessment, audits and inspections will be partially conducted onsite through plant/facility tours and assessments, and rest of the time will be devoted offsite to conducting documents and records review.

It is true, since the pandemic, we have been doing our best effort to keep up with changes in training, consulting, and auditing activities. Now that we’ve the COVID-19 vaccine widely available, soon we may be able to conduct face to face activities with our clients. However, as auditors we have learned that virtual audits are here to stay! I have been conducting virtual audits since 2020 and would like to share with you some of the positive developments for virtual audits as well as a few challenges experienced during this pandemic.

Auditors whose companies have invested in laptops, electronic work papers, and document imaging were at a clear advantage when working remotely became the norm. The more information auditors have, the more remote auditing is possible. It has been my experience that remote auditing is not only possible, but also can add a lot of value, cost savings, efficiency, and effectiveness. In remote auditing, technical infrastructure and having adequate audit information on auditor’s fingertips are essential for a productive and successful audit.

This presentation will also discuss current the current state of virtual audits/inspections conducted by Regulatory Agencies worldwide. Health authorities rely on inspections of pharmaceutical manufacturing facilities as a critical element of the drug approval process, and assurance of compliance to Good Manufacturing Practices (GMPs). However, during the COVID-19 pandemic, travel and in-person onsite audits/inspections have been restricted creating challenging scenarios for health authority inspections and creative solutions. Inspection alternatives used by the agencies include virtual inspections and document reviews in lieu of physical visits, which require a change in approach and logistics by the agencies and the companies being inspected. During this presentation, I would like to discuss some of the recent initiatives such as Hybrid inspections considered by US FDA, other Regulatory Agencies, and Companies Worldwide.
















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(*) based on previous conference attendance






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