During the pandemic, each facet of our work and personal lives went remote. This virus put an end to travel and in-person work processes. Looking at pharmaceutical companies, there was a need to adopt virtual options to complete critical processes.
Pharmaceutical companies are held to specific standards set out by regulatory authorities in terms of pharmacovigilance (PV) and quality systems. At one time, companies had their operating procedures in order when there was the ability to work in-person. Companies need to set documentation that is clear to help ensure their systems are up-to-date. These include full detail of PV processes as well as procedures.
Ensuring these processes meet the aforementioned requirements there must be frequent risk-based audits of the systems each company has in place. This is often the work of an external auditor. In the age of a remote-first world, companies must rely on virtual audits to keep their processes in order. Though there are roadblocks with the use of remote audits, they are seen to be successful and valued by both companies and regulators.
Weighing the Scales: Pros and Cons of Virtual Audits
With all the positives of doing remote work, virtual audits can pose a few challenges.
First, there is the possibility of a language barrier. It is much easier to make yourself understood when working in-person. Additionally, there may be differences in time zones that affect the auditor due to the fact that they need to work in the auditor's local time zone. This could call for working through the night to complete an audit.
Working virtually forces you to take into account network connection and proper technology. Having functional connection and equipment is key to a successful audit. A lack of these puts a strain on every party involved in a remote audit.
Another challenge is the lack of physical documentation. Accessibility of all the necessary documents is integral to a seamless audit and this can pose a problem should any documents go missing. Everything in an audit needs to be documented and the health authority needs to grant permission for a virtual audit. Companies need to get all stakeholders involved, including QPPV.
The lack of physically being in a facility for a tour is another potential downside of remote audits. On-site tours are an important step in a successful audit, however, we see that the pandemic limits or withholds auditors from doing an integral step of the traditional audit process.
Remote audits can be beneficial for companies. Virtual-first audits can be completed quicker and at a higher volume. Another plus is the ability to get a large number of people gathered simultaneously and it is much easier to schedule (or reschedule).
Many of these positives are due to the lack of necessary travel time. These meetings for virtual audits can happen anytime and anywhere in the world. Virtual audits help all parties save money while saving the environment at the same time. Travel expenses are out of the question, which lowers each party’s carbon footprint.
Virtual audits save time in the fact that consulting companies can prepare in advance to the set audit because documentation comes in prior.
Evading Challenges: Key Preparation for Remote Audits
Remote audits are the same as in-person audits in the fact that both highlight the conformity level of the systems pharmaceutical companies have in place. To have a successful remote audit, there are a few steps to keep in mind.
Making sure every party involved in the audit begins with the technology platform that is used for the audit. It is important to keep all parties on the same page when selecting a video platform like Microsoft Teams or Zoom. This ensures that there will be a simple exchange of documentation.
It is equally important to give auditees a questionnaire which helps them prepare to have the proper documentation ready for the time of the audit. This eliminates confusion and allows for a proper exchange of documentation. Considering the virtual nature of remote audits, it is essential to be prepared with the proper documents at the time of the audit. In the preparation phase of the audit, it is important to give that auditor optimal time to curate the documentation necessary for the audit.
Creating deadlines for receiving the paperwork involved in an audit is a simple way to get each party organized for a successful audit. Rather than having the auditee hold up different documents to the screen, they can rather have them scanned to the auditor prior to the audit day which assists in creating a successful audit and limits confusion.
Additionally, audits can be split across multiple days. This allows for auditors to define the time of interviews and review the documents procured in the audit. The ability to split an audit across multiple days is available when doing virtual audits. Once again, determining the time frame allows for an organized and successful audit for all parties involved.
It is important to establish the connection of the technology being used for the remote audit. Having working technology allows for each party to use their time in an effective manner to get the audit completed seamlessly. Additionally, it is important to establish where the audit will be completed. Whether it be at home or in the office, the space should have limited disturbances, once again, to make sure time is being used effectively. Keeping all of this in mind can lead to extremely successful audits, even in a remote-first world. Remote audits have been well-received by companies as the pandemic continue and can even be a feasible option as the world begins to reopen.
