The pandemic led us to conduct more audits remotely due to hygiene measures and risks to health. We gained experience in remote audits with the ongoing situation and want to share the differences we discovered.
February 3, 2021
Since we are still living the "new normal" with Covid, we will have to keep conducting distant assessments in some cases. At Qualifyze, we discovered several differences to on-site audits we want to share with you. They might help you prepare your audits.
While preparing a remote audit, some questions have to be kept in mind. It is essential to talk about the experience in remote audits of all stakeholders to get an idea of the support needed. Further, it is vital to ask the supplier how the audit will be conducted. How is the facilities tour replaced? There are different scenarios for this. It could be a virtual tour, videos, or photos and layouts, for example. How is the Document Management System set up? A manual DMS might need more preparation than an electronic one. How will the supplier share documents? There might be the possibility to share some documents in advance for the auditor to review. Lastly, the stakeholders agree on a tool to be used during the audit. To ensure the audit's smooth conduction, a test run of the technology and connection should be planned a few days before the audit. The supplier sends an invitation for the test run as well as for the actual audit. This procedure ensures the tool used is accepted in the company and does not interfere with confidentiality.
When the employees are taking the auditor on the facility tour remotely, the internet connection can be unstable at some point. Losing the connection can be time-consuming. It might take several minutes until the connection is up and running again. This should be taken into consideration when planning the audit and setting up the audit agenda. A bad connection can also affect the quality of the video the auditor gets. Further, to ensure the facility tour is not interrupted, the supplier's mobile device should be fully charged. An additional charging device can be of fair use. This will make sure the facility tour can be conducted as planned.
When not conducting the tour live, the supplier needs to plan some time to take photos or videos. This can be time-consuming since the videos or photos taken by the supplier have to be very detailed, explaining every step throughout the process and the people working on it.
The review of a paper-based documentation system is very challenging, and its transposition to a digital form can be laborious and cost much time. Even though much documentation is requested in advance, there might be additional documentation the auditor will ask for. When the supplier is working with a paper-based system, all documents must be scanned for the remote audit. This can cause much work for the supplier during the audit. The auditor also needs to go back and forth between different topics. In this case, an eDMS could help save time during the audit and make documentation available in a shorter time. Besides that, the documentation review is very similar to an on-site audit.
Suppose an audit can be conducted remotely or not has to be decided case by case based on risks and the GMP/GDP guidelines' requirements. When a remote audit is in planning, there are a few things to keep in mind while preparing and conducting the audit. A test run of technology and connection should be considered with a remote audit to ensure that the auditor can conduct the audit. While the facility tour can be very different, it does not lack in detail. The experienced auditor knows what to look and ask for. Overall, the facility tour is the point most affected by doing an audit remotely.
The documentation review can be time costly when the supplier works with a paper-based document management system. An eDMS would be beneficial to save time during the audit. However, this is not a requirement but a recommendation for the efficient conduction of an audit.
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