Faced with the travel uncertainties caused by the pandemic and a backlog of inspections, remotely conducted health authority inspections and affiliate audits have become a necessity. With appropriate use of technology and after ironing out any initial problems, they could become part of the toolkit of the future.
In response to this growing trend, a BioPhorum project is considering the challenges and opportunities of virtual/remote inspections and audits. The energetic collaboration has come together rapidly with 28 companies and 30 senior subject-matter experts involved.
By the end of 2020, the team plans to deliver a consensus guidance paper containing implementable best practices, packed with useful details such as document management practices and case studies on IT platforms. It will use ideas already available from member companies and health authorities and will disseminate best practices widely in the industry. As some types of inspection are more likely to require a form of on-site visit, a risk-based framework will be proposed.
The paper will help avoid delays and inefficiencies arising from virtual working, benefitting the industry and health authorities. BioPhorum will also co-ordinate with other collaborative groups and speak with one voice to engage and influence health authorities on the practicalities of virtual inspections and explore their opportunities, potentially accelerating mutual recognition agreements.
Experience of virtual inspections among member companies has been encouraging to date and remote working seems to be an adequate substitute for on-site inspections in most cases. Although it is uncertain whether health authorities will add remote inspections to their future way of working, the pandemic and its consequences are likely to persist for a year or two – so perhaps we have passed the tipping point and have already ushered in an era of remote inspections and audits. The industry must be prepared and ensure remote inspections do not cause delays in the short term.
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