Crisis is always a catalyst for change. The changes wrought by the COVID-19 pandemic recently prompted the U.S. Food and Drug Administration (FDA) to issue a guidance for conducting regulatory inspections remotely. Time will tell whether this signifies the agency’s intent to expand its digital or remotely conducted activities, but it does provide a glimpse into the future of auditing and oversight. As regulators and other auditors normalize remote inspections, manufacturers must prepare to meet expectations.
To gain insight into the impact of remote processes and regulatory inspections, two experts from intelligent manufacturing and quality management system (QMS) software provider MasterControl, Chief Product Officer Matt Lowe and Managing Director of APAC Sara Bresee, to share their perspectives on the new era of auditing.
Although the FDA’s new guidance stemmed from current pandemic conditions, could it signal the emergence of a larger trend?
Matt Lowe: COVID has fundamentally changed the way we’re going to work going forward, and the FDA is certainly not immune to that. There’s a new view on how much can we do without incurring travel costs.
Sara Bresee: The Zoom culture proved work can be done in a COVID-like environment remotely. Why would anyone want to incur the expense of sending auditors to India, China, or anywhere else if it’s possible to get the same quality level of inspection remotely?
What role will technology play in meeting new provisions that the FDA must be able to “remotely review, observe, examine and evaluate the information requested”?
Matt Lowe: It’s impossible to do any of those things without a digital quality management system. Taking pictures, scanning documents and transmitting them back and forth to an auditor just isn’t realistic.
Thinking back to FDA audits in which I was involved, you know auditors will pull a few production records — whether they’re batch records at a pharma company or device history records at a medical device company — and you dread it. The auditor goes through with a fine-tooth comb and asks for the training records of everyone who has initialed them. And that’s usually a recipe for disaster.
Electronic systems don’t just enable people to do that remotely, they allow them to do it with greater confidence that everything’s in order. Our customers have been effectively conducting audits digitally for years. Although the FDA auditor may be there in the room with them, the audit is driven from a cloud-based system. There’s no printing of papers unless specifically requested by the auditor.
Sara Bresee: Bringing online the last piece of that paperless solution — the electronic batch record — gives you the trifecta. Aligning the quality group, the regulating authority and the manufacturing team to the batch record gives everyone access to a document that is digital, clear and in a system of record. And they can easily do that remotely. That’s a massive leap forward.
How will the role of digital systems change as technology advances?
Sara Bresee: The regulatory schema has evolved from collections of paper to sets of data. There’s now a distinction between reams of paper — even if it is oriented in a digital system — and the specific data regulators want. In terms of audits, there has to be a similar shift in manufacturing.
Matt Lowe: Agreed, and I think you’ll see that reflected more in standards, reference models and all the structures that require manufacturers to organize data in a way that lets the FDA easily consume it. If the FDA goes to a primarily remote method, the government may mandate digital systems. Already there are areas within the FDA where digitization isn’t optional. But I think you’ll see digitization mandated more.
What are the advantages of digitizing and integrating quality and manufacturing processes?
Matt Lowe: Even if they’re electronic, you rarely see manufacturing and quality data in the same place. Combining the two data sets brings huge benefits. It gives you incredible insights and lets you identify problems that are very difficult otherwise to see. The processing power and the human capital required to do those things without an integrated system are just unrealistic.
Sara Bresee: It also lets you use your peoples’ knowledge effectively to improve quality, as opposed to having well-paid resources review things that aren’t a good use of their time. The company gets better value on a human basis, which even extends into the pure value of ensuring operators are trained to perform tasks well. A digital system provides immediate training and gets operators back to being productive.
Digitization obviously has value, but is it too costly and/or time consuming an option for some?
Matt Lowe: If you seriously evaluate the cost and the time wasted by not digitizing, it’s immediately apparent that you can’t afford not to. That particularly holds true on the manufacturing side. Paper seems cheap and infinitely flexible, but the accompanying problems take a toll on the organization and workforce. People just don’t recognize it.
Sara Bresee: Whenever I see an Iron Mountain box I think, “How is it a viable business model to continue to pay to store paper?” The amount of money spent on storing paper is crazy. We don’t need paper in a modern manufacturing environment.
What steps can manufacturers take to prepare for the way audits might be conducted in the future?
Matt Lowe: Don’t wait to digitize, and don’t be afraid. The systems have come a long way in the last 10 to 20 years. They are purpose-built and come off the shelf with years of industry knowledge, so you don’t have to worry that it’s going to be too hard, costly or time consuming.
Sara Bresee: It starts with the people and the process. We must always ask ourselves if we’re using the most streamlined process and if the data we capture is driving action, decision-making or insight. No amazing change can happen unless the combination of people and processes results in data that’s useful for decision-making. If we get that part right, then a good system can provide great insights.
What are some competitive advantages you’ve seen companies gain by implementing a digital platform that integrates quality and manufacturing activities and data?
Matt Lowe: The contract space — contract development, manufacturing, and research — is a sector that sees very direct returns by utilizing digital systems. We’ve talked about regulatory bodies like the FDA doing audits, but these types of companies are audited by their customers dozens if not hundreds of times a year. Making that a much more efficient process and garnering the confidence and trust of their clients, that’s a very real competitive advantage. But, for any company, the heart of it all is getting your product to market faster.
Sara Bresee: You’re also seeing the evolution of medicine. What was once science fiction is now the stuff of reality. As medicine makes transformative leaps and bounds, the ability to ensure the same level of quality for a mass-manufactured pharmaceutical product that you can for a batch of one is the standard we have to hold ourselves to. And that is enabled through platform technology.
How do digital systems facilitate the risk management approach the FDA says it will apply to determine when a remote evaluation will be requested?
Matt Lowe: The biggest thing a digital systems approach does for manufacturers whose products are regulated by bodies like the FDA is that it will keep you off their radar. Ultimately, you want to make sure your house is in order so that they don’t have a reason to do an audit, remote or otherwise. Ensuring compliance and efficiency — and improving outcomes and product quality — are what electronic systems are built for. They dramatically lower your risk of being flagged for an audit.
Sara Bresee: The risk-based approach brings manufacturing and quality together. It lets individuals spend their valuable time only reviewing the batch record areas where their specific level of expertise is needed, or where there truly is a deviation, labelling issue, or risk.
What kinds of returns can a company expect to get from investing in a paperless system?
Matt Lowe: It keeps your risk profile low. But it also brings greater value to the manufacturing process and improves product quality. If you consider the review-by-exception process in particular, it gets product to customers much faster. And it drives down the working capital required to maintain inventory. Plus, it reduces deviations and scrap.
Sara Bresee: Employee engagement also goes up. Employees today expect to use tablets and touch screens in the workplace. So, when companies are trying to attract and retain operators when talent is scarce, engagement goes up the more employees can use modern tools in the workplace. That intangible human benefit shouldn’t be discounted.