Remote quality audits (sometimes called “virtual audits” or “e-audits”) are replacing the in-person quality audits that have long been an integral part of selecting a life science Contract Manufacturing Organization (CMO) or Contract Development and Manufacturing Organization (CDMO). Choosing the right manufacturing partner means going beyond just technical specs. Having the opportunity to see facility layouts and condition are critical. However, with COVID-19 changing how we think about travel, will the in-person audit become a thing of the past? The FDA has issued an extension and expansion of temporary Medical Device Single Audit Programs (MDSAP). This extension is currently limited to where “travel restrictions or social/physical distancing as a result of the pandemic prevent on site audits from occurring.” With social distancing looking to be required over the next half-year or more, there is the possibility the extension could become permanent. However, GMP does not require on-site audits and the benefits offered by touring online could spell the end of CMO facility visits for good. Now is the time to begin familiarizing yourself with the remote audit process.
Remote audits can be scheduled faster, are more convenient, and have far less cost.
Like on-site audits, remote auditing requires good coordination between the players so that key materials are quickly accessed. However, a remote audit brings in the added complexity of conferencing and video technologies. Settling on a common communications platform is the first step and with a wide range of platforms (e.g. GoToMeeting, Zoom) to choose from, it may not be as easy as it seems due to differences in company policies. Time zone differences can also present a challenge.
With all minor inconveniences resolved, remote audits offer several benefits to both teams while maintaining the core features of an in-person visit. Auditors are able to evaluate more CMOs within the same timeframe, as travel time between sites is eliminated. This not only speeds the decision process, it also returns significant travel cost savings to the budget.
Remote audits are a fact of life for anyone evaluating a CMO in the near term
Whether you are selecting a CMO to produce next gen sequencing kits, diagnostic cartridges or a pharmaceutical product, seeing the facility and meeting the team is always a critical step in the decision process. While traditionally this has been achieved via in-person visits to the CMO’s facility, COVID-19 has complicated matters. Many facilities are closed to outside personnel with no reopening dates projected, and auditors may be wary of travel even if visits are allowed.
Interestingly, COVID-19 has actually increased the demand for contract manufacturing as supplier’s race to quickly scale up their production of related diagnostics, vaccines, and therapeutics. With these critical projects demanding that companies move fast, teams have already been utilizing remote audits to accelerate projects.
What should I expect from a remote audit?
A remote audit contains many familiar aspects of the in-person audit. Participants from both sides will join a teleconference call rather than meet in a conference room, which still allows teams to gather and ask questions as usual. This portion of the audit does not vary significantly from the traditional in-person meeting. Remote audits can be easier to schedule in comparison to aligning multiple travel plans. The teleconferences can also take place in a few shorter sections, compared to a full day. Staging serial teleconferences can also allow better follow-on questions.
The “tour” is the most different component of a remote audit. Rather than walking through the facility yourself, the CMO can supply a narrated video or photo walkthrough of key areas. Conveniently, this video can be replayed after the audit if you need to revisit a certain section. Requests can also be made to showcase specific areas that are important to your company’s decision.
Remote audits at Argonaut
To summarize, remote audits may be with us to stay. While requiring small adjustments compared to in-person audits, they can be scheduled faster, are more convenient, and have far less cost. Remote audits also allow you to view or screen more potential CMOs, and the virtual tour can be viewed by more team members than would normally audit a facility in-person. Remote audits are safer for all personnel in these current times of social distancing. You can also ask for your virtual tour to be customized specifically to areas of your concern.
Argonaut has successfully performed remote audits for both life science and pharma-industry customers, and is ready to support your e-visit. Guided video tours are available to take you through the facility, highlighting critical areas and process flow. If you are interested in auditing Argonaut as a potential CMO, please contact us to discuss your project.
Remote audits are a fact of life for anyone evaluating a CMO in the near term. Even as facilities reopen and travel resumes, the benefits of a remote audit may influence companies to continue them in the future.