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 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 members, 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. This experience has been captured in Peer to peer practical guidance on remote inspections and audits.
“The guidance for virtual inspections and audits responds to a concrete need elicited by the current pandemic situation to have references and examples for remote interactions with health authorities,” said Dr Maria Zanta, Head of Sanofi Pasteur Global Inspection Readiness.
While 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 inspectors and the site subject matter experts’ team. “This work describes effective best practices and recommendations linked to real experiences, benchmarking and health authority published literature,” added Zanta. “Nourished lists of examples and technical details are provided to maintain quality and compliance, as an alternative to the current established on-site inspection and auditing standards.”