Will GMP Auditing “Return to Normal” in 2021?

If you’ve been waiting around for things to “get back to normal”, you’re probably going to be waiting for quite some time. We hope you’re not still holding your breath.

As we’re now seeing firsthand, change is the only constant we can count on. In a recent interview, Bill Gates predicted that half of business travel will disappear forever in the aftermath of the pandemic.

On a shorter timeline, one can assume that the vast majority of business travel will not return in 2021. According to McKinsey & Co., business travel has been more volatile and slower to recover than leisure travel. We can look to the past to predict the future.

If compliance audits are designed to ensure safety and reliability in the supply chain, how can we assure safe medications are being manufactured and shipped in 2021, despite the current roadblocks to travel? Business as usual is not coming back anytime soon.
“During the 2008–09 global recession, international business travel from the United States declined more than 13 percent, compared with a decline of just 7 percent for international leisure travel from the United States. And although international leisure travel fully recovered in just two years, international business travel didn’t fully rebound to prerecession levels for five years.”

What about a Vaccine?

Pfizer, Moderna, Astra Zeneca, and many others have all made tremendous progress towards a vaccine, particularly in the past few months. Even though the vaccine has been approved for emergency use and has become available for public use, it will still be months before many will be able to get it.

Now that a vaccine has become publicly available for widespread use, the current problem remains: Company and travel restrictions supported by quarantine guidelines are not going away overnight, and on an international level, travel will continue to be particularly difficult, or in many cases, outright impossible.

Current Problems with Auditing

Most commonly, audit sites don’t want people from outside their company coming in and putting their staff at risk. Additionally, states continue to require lengthy quarantine periods for out-of-state travelers. These limitations make most audits at least very difficult, and at worst, impossible.

Thus, the main problem with compliance auditing in 2021 is not coronavirus itself, but all the associated restrictions from companies and government health agencies. How does a critical business function, based around travel, adapt to a world where travel is difficult or impossible?

The Future of Auditing

The in-person approach to auditing has worked just fine in the past, but due to the current situation forcing restrictions upon us, our industry is in a state of flux. Change is required. Remote auditing is the future. Even if travel restrictions were to disappear overnight, shifting towards remote auditing would still be the wise decision for our industry.

In fact, we’d go so far to say that remote auditing is the future… whether you like it or not. Why? Because remote auditing allows for a few concrete benefits that are either too costly or just unrealistic when comparing to in-person audits.

Specialized audit team

Due to costs associated with travel, audits are usually limited to one auditor: a generalist, who does a good job, but what if you could have several specialists to cover the specific details of complex systems. Remote auditing allows for multiple specialists to be involved in the audit at no extra cost.

Faster

Remote auditing removes almost all of the time delays associated with multi-day and/or multi-site audits. Because there is no travel associated, there is less interruption to the schedule from external factors. Better efficiency means better business results.

Better Experience

With a standardized approach to auditing, there are efficiencies that may reduce the potential for human error, and with the right remote auditing setup, provide a more accurate audit with security that is on par with in-person audits.

Future-Proof

Even if the current travel restrictions were to disappear tomorrow, that doesn’t guarantee that travel restrictions will never be put into place ever again. Remote auditing will allow our industry to always be able to conduct audits, regardless of circumstances, whether those circumstances be a pandemic, a natural disaster, or just simple political bickering between the leadership of two different countries. In an unpredictable world with an uncertain future, we can at least make sure that our medicine is safe.

Easier Than Ever

Before 2020, a video conference call in a professional setting was reserved for particularly tech-savvy companies with IT departments that support them. Now, even nursing home residents are on Zoom with their friends and family. Surely we can also adapt? If we can’t, we’ll get left behind. You don’t have to look far for companies that suffered due to their stubbornness in adapting to the newest technology. Check your Blackberry.

Remote auditing is the future because it just makes sense. When done correctly, there are no downsides -- only improvements.

But, as with all good things, there is a catch.

Problem: 

Specifics of Remote/Virtual Audits

GMP audits can, and do, take place remotely, but to achieve the same accuracy and completeness while maintaining the security of an in-person audit, certain hurdles must be overcome.

Right about now you may be thinking walking around with a Zoom conference on your iphone is an acceptable way to conduct a remote audit. It’s not. Not even close. For starters, the auditor will only see what the phone is pointed at, and at a resolution that relies on the phone’s ability to compress the image enough to send over the network. It’s not ideal.

There are other “gotchas” waiting for those who feel like bootstrapping a solution is a viable way to go, For example…
● Popular video streaming platforms may not be secure. Are you going to conduct an audit over YouTube, Facebook, or Twitch?
● Popular file transfer systems are not always configured to be secure. Are you going to email an important document that contains highly-sensitive information to an auditor? Or put it into a Dropbox folder, or onto Google Drive? Not the best option.
● Even some of the most popular internet conference tools (Webex, MS Teams, Zoom, etc.) are not configured to be secure and prohibit recording. Even if a combination of systems is thrown together to make everything simple and easy (very unlikely), the security concerns of such a system make it a non-starter.
● Not every auditor or audit site has the technical prowess to make this process efficient or secure, or even possible.

To overcome these hurdles and implement remote auditing capabilities, a capital investment in equipment and IT resources is required.

Or is it?

Solution: 

Secure and Easy Remote Auditing Service for 2021 and Beyond

In-person audits certainly have their merits, but every company involved in GMP auditing should be prepared to forge ahead in 2021 and beyond. 



Click here to learn more about RACK and schedule a demo for your organization.
The Remote Audit Communication Kit (RACK) is an all-in-one solution that you can use once, or as frequently as you want, to conduct secure remote audits from anywhere in the world. There is nothing to buy and RACK requires no long-term investment.

We’ve designed an easy-to-use service to provide a hassle-free experience.

● Live video transmission and document sharing is completely encrypted with ZERO recordings or artifacts left behind.
● No burden of ownership.
● No keeping pace with ever-changing technology or replacement of equipment.

Along with the RACK equipment, a dedicated tech support expert is standing by for the duration of the audit to assist with any questions that the users might encounter. Our system saves time and money and provides a consistent experience for any audit, which leads to greater efficiency and better overall results.

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