Reflecting on Remote Supplier Audits
Helping the pharma industry maintain focus on quality
31 August 2021
There is a constant obligation to engage with pharma supply chain members on matters concerning quality through frequent supplier audits, however, over the past 14 months, COVID-19 related measures and travel restrictions have impacted scheduling and conducting supplier audits.
Remote or "virtual" auditing was already a possibility, but was quickly embraced as the "go-to" solution to maintain the high level of focus on quality across the pharmaceutical sector. But whilst remote audits provided a solution, they also presented new challenges for many, including issues related to executing the audit, managing the flow of information and engagement with the teams at the audit site.
To overcome these challenges, it was necessary for stakeholders in both the auditor and auditee teams to consider the audit objectives and whether these can be met with a remote audit, furthermore collaboration was necessary to decide which technology to use and the type of information or data that needs to be collated before and during the audit.
A key benefit of virtual audits is to allow auditors to receive and share information, review documentation and processes, ask questions and discuss observations with auditee teams from all over the world. A remote audit should aim to replicate a physical on-site audit and include the same activities as close as possible and even have a similar duration as on-site audit.
A virtual audit should include opportunities for document review and discussions with experts within the auditee team, however good collaboration is really important in order to not lose the direct interaction necessary for good communication. A successful audit will require the client, auditor, and auditee teams to work closely together to make the remote audit work in terms of planning, logistics, technologies, and IT considerations.
Platforms such as MS Teams or Zoom have allowed effective real-time communication between all parties allowing video, audio, chat function and live document/photograph sharing – however, optimisation of the audit benefits from checking prior to the audit that these tools work well and are suited to the logistics of the tour, particularly if there are multiple buildings involved which may not be close to each other or Wi-Fi signal is not strong in certain places.
The ability to conduct a virtual audit has become a key tool to maintain the laser-like focus on quality and compliance. It has helped to mitigate travel restrictions or challenges associated with facilities closures to visitors and social distancing measures. Looking ahead, it is likely that remote audits will become an established practice and should be considered when reviewing quality agreements and contracts between suppliers and manufacturers, particularly when considering the truly global nature of pharmaceutical supply lines.
To learn more, download our full white paper on good practice for auditor/auditee collaboration for remote audits and key considerations for success: ARTICLE | Good Practice for Remote Audits