When the COVID-19 pandemic forced companies to work remotely and put a stop to travel, it required pharmaceutical companies, consultancies, and regulators to adopt virtual ways to manage critical processes.

Regulatory authorities require companies to adhere to standards with their pharmacovigilance and quality systems according to good vigilance practices. Companies must demonstrate they have clear standard operating procedures, that their documentation is complete and clear, and that their pharmacovigilance system is up to date and contains full details of all critical PV processes, procedures, and key stakeholders.

To ensure their processes conform to requirements, companies must perform regular risk-based audits of their PV and quality systems, typically carried out by an experienced external auditor. Since the pandemic, such audits have all become remote. While not without their challenges, these audits have been largely successful and well-received by companies and regulators alike.

What is a remote audit?

In almost all ways, a remote audit is the same as an in-person audit, which, simply put, is to assess the level of conformity of the system. Meetings are held using electronic tools, such as Microsoft Teams or other video conferencing apps that allow the two parties to share documents and screens.

“Well in advance, I would send the company an Outlook invitation to make sure that the date is blocked in our respective calendars,” says Laurence Richard, Senior Quality Auditor and Head of Development & Operations at ProductLife Group. “Before the meeting, I would request the company send me documentation so I can prepare. I would also send a clear hour-by-hour agenda to help the company prepare, and determine who needs to be available and when.”

As with an in-person audit, the auditor will request more documentation during the audit so it’s important that the company is ready, that those involved in the audit – safety, quality, the responsible person or qualified person for pharmacovigilance (QPPV), human resources – are ready to be interviewed. And with remote audits, companies should check their connections and make sure the audit will be carried out in the best environment possible.

Addressing the challenges

While the process itself for a remote audit is much the same as an in-person audit, there are unique challenges to virtual.

“The language barrier is greater with remote audits because face-to-face it is easier to make yourself understood,” Laurence says. “However, the biggest challenge is having access to the documentation during the audit, because in some instances the organisation hasn’t scanned the documents and ensured they are loaded onto the server, and then time is lost as they go away to scan documents. We have even had experiences where those involved in the audit tried to hold up documents to the screen rather than scan them. Obviously, that is not adequate for an audit.”

Other challenges include poor network quality, inattention by the auditees, if health authority permission for a remote audit hasn’t been documented, or if key stakeholders such as the QPPV are not involved.

“From the point of view of the auditor, geography can be a challenge,” Laurence notes. “For example, if I were conducting an audit in Australia, in the past I would have travelled there, slept the night before, and adjusted to the time zone. With a remote audit, however, I must work in the local time zone, which might be the middle of the night for me and that means being available 24 hours a day.”

Reasons for remote

Nevertheless, there are definite advantages to remote audits. Companies performing audits can carry out far more if doing these remotely, the company being audited can have their audits carried out quicker, multiple stakeholders can be brought together at the same time, and rescheduling is easier.

Furthermore, remote audits are more cost-efficient since the company requesting the audit doesn’t have to pay travel expenses. For the auditor, one benefit of remote audits is that documentation is sent in advance, giving the consulting company time to prepare.

And given more attention needs to be paid to everyone’s carbon footprint, remote audits are clearly more environmentally friendly.

“We know that the health authorities are performing remote inspections and the feedback has been positive, so remote audits are achieving their objectives,” Laurence says.

Being prepared

There are some steps that both parties can take to ensure their remote audit is handled efficiently and effectively. These include:

  • Prepare a questionnaire – this should be sent to the auditee in advance to help them assess the documentation required and to determine whether they have the information to hand or experts need to be prepared to answer more questions
  • Adapt the duration of the audit – rather than try to fit an audit into one day, half-day audits on consecutive days are feasible with remote audits. The auditor needs to assess and define the time needed for interviews and for analysing the documentation
  • Decide on the platform and technology tool for the audit in advance to ensure seamless exchange of documentation
  • Test your connection before the interview
  • Define the location of the audit, e.g. office or home, and ensure you won’t be disturbed
  • Establish deadlines for receipt of documents during the preparation phase and ensure the auditee has enough time to answer questionnaires and provide documentation
  • Decide on the language to be used for the interview and ensure everyone involved speaks that language.

ProductLife Group’s auditors have extensive experience with remote audits and have been carrying these out for clients well before the pandemic, for example, when there are cost restrictions, if the location of the audit is deemed unsafe, or if the audit has to be carried out at short notice. Our knowledge of platforms enables us to guide clients and ensure smooth communication during audits. From a data security perspective, we are established to ensure the safe exchange of data during the audit through our server, which is hosted by a certified provider for health data. Contact us to find out how we can help you with your remote audit.

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The Pros and Cons of Remote Audits