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Jon Speer

FDA Compliance

Closed-Loop Traceability for FDA Compliance

How to do it in real time

Published: Wednesday, June 2, 2021 - 12:01

Demonstrating identification and traceability in all quality system processes is a must for medical device companies to comply with FDA regulations. To satisfy this compliance need, companies will need to connect related processes within their quality system to close the loop between related pre- and post-market activities and processes. That’s what’s known as closed-loop traceability (CLT).

With a global regulatory emphasis on CLT, it’s up to medical device companies to ensure their systems can keep pace with this expectation. More devices of increasing complexity are hitting the market, challenging companies to maintain clear documentation and traceability in real time. Failing to do so hampers a company’s overall efficiency—not to mention exposes it to penalties, fines, and operational disruptions.

Fortunately, medical device companies have access to modern QMS solutions that increase the accuracy and speed of demonstrating CLT, creating opportunities not only to stay compliant but also improve their operations and competitive edge in the market.

More complexity and speed means more potential mistakes

Companies looking to champion true quality must drive more efficiency in their products and processes, and CLT is a crucial piece of the efficiency puzzle. Our latest industry report found that, despite the importance of CLT, companies are struggling to manage it effectively:
• 25 percent of respondents said documenting CLT requires substantial effort
• 31 percent say it takes two days or more to update their traceability matrices
• 13 percent can do so in less than 1 hour—and on average, companies needed 144 hours to produce a design history file

Every design change or process update made to this increasing number of complex devices must be documented and audit-ready. But when the process to update design-control matrices or build design-history files is cumbersome and complex, those responsible for overseeing CLT activities end up overwhelmed when using legacy tools. Leaving it to humans to operate using manual processes is a recipe for failure.

What’s more, legacy systems like spreadsheets and paper-based quality management tools can’t manage the complex web of interconnected relationships between products and processes, and neither can they keep pace with the required speed. Without unified and clear documentation management, companies are more likely to miss gaps due to human error.

Although quality managers strive to catch errors, some errors will slip through the cracks. The cost of each mistake can mount quickly: Should an FDA inspector discover a noncompliant process during an inspection, you could receive a 483 form observation; without fast remediation, it can escalate to a warning letter, and subsequent fines could leap into the millions of dollars—along with the potential for product recalls and legal woes.

Medical device QMS and automation bring value beyond compliance

CLT is a keystone of both compliance and quality, but doing it well requires more than legacy tools can offer. To better control it, companies can turn to a specialized medical device QMS. This purpose-built tool is built to manage the intricate connections and relationships that quality managers need to achieve closed-loop traceability. And a medical device QMS accomplishes this in real time and at scale, which is increasingly important during later stages of the device life cycle.

Rather than slogging through seemingly endless spreadsheets, quality managers can deploy this modern QMS solution to automatically sort and manage documentation across multiple locations into an easily visualized system. These documents are then fully traceable for users to understand connections and relationships, and automatically update that network in real time. Quality managers then have an explorable, easy-to-understand way to monitor and improve products and processes.

For example, a medical device QMS can automate updates to a traceability matrix, design-history file, and other related documentation. Instead of scrambling to manage disparate documents, teams can monitor overall CLT and address potential points of error. They can even use the relationship network to pinpoint and fix root causes of errors, improving overall operations and reducing risk.

This kind of visibility gives quality managers the power to spot issues further upstream and downstream in the product life cycle. A medical device QMS that offers better CLT cuts down on document management and allows teams to engage with more value-added activities. By visualizing connections and transforming them into actionable insights, quality managers can contribute toward companywide improvements. They move from merely serving compliance to driving efficiencies and demonstrating true quality.

Having a medical device QMS that can demonstrate CLT is a true marker of efficiency and is essential to outperforming the legacy tools that hold manufacturers back. Rely on the real-time automation capability of a medical device QMS to close loops, go beyond baseline compliance, and ensure true quality throughout the entire life cycle of a medical device.


About The Author

Jon Speer’s picture

Jon Speer

Jon Speer is the founder and vice president of quality assurance and regulatory affairs at Greenlight Guru, a software company that produces the only medical device quality management software solution. Device makers in more than 50 countries use Greenlight Guru to get safer products to market faster. Speer has served more than 20 years in the medical device industry and helped dozens of devices get to market. As a thought leader and speaker, he regularly contributes to numerous industry publications. He is also the host of Global Medical Device Podcast.