Peer to peer practical guidance on remote inspections and audits

In normal conditions, regulatory inspections and audits are conducted on-site, with inspectors viewing operations, talking to staff and reviewing documents to ensure they meet requirements.

However, travel and social restrictions due to the Covid-19 pandemic have forced regulatory inspections and audits of affiliates to be conducted remotely. This is a very different way of working as it is much more difficult to view and explain the process steps remotely and respond to in-the-moment requests for information.

This is why a multi-company collaboration, comprising subject matter experts from 29 BioPhorum member companies, has shared case-studies and discussed the factors that make remote inspections and audits effective; learning from post-inspection feedback from inspectors has also been shared.

Whilst, experience shows that remote inspections can be facilitated effectively, there are challenges and limits, and companies and the inspectorates have had to adapt rapidly. What is clear is that a successful inspection depends on additional planning and organization that take account of the nuances of remote working in intricate detail; for example, using IT tools in the most effective way.

Drawing on their real-world experiences, this group of experts has provided guidance on the detailed working methods that support a successful remote inspection or audit; for example, how to manage information flows between the inspectors and the site subject matter experts’ team. With the impact of Covid-19 likely to be seen for the foreseeable future, virtual inspections may be required for some time. This BioPhorum guidance will help all stakeholders prepare and to avoid the potential problems of remote inspections and audits.

 

 

 

 

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Practical guidance on remote inspections and audits January 2021.pdfDownload 
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  • Create Date 22nd January 2021
  • DOI https://doi.org/10.46220/2020FF004
  • Last Updated