Why Many Companies Struggle with Regulatory Tracking (And How to Fix It)
- Team Hoodin
- Apr 7
- 4 min read
Regulatory compliance isn’t static—it’s a dynamic, ever-changing landscape. Yet, many companies still rely on static tracking methods, leaving themselves vulnerable to costly oversights.
In this blog, we take a closer look at the tracking methods companies are using today—ranging from manual efforts to fully automated systems.
For many teams, regulatory tracking involves subscribing to newsletters, bookmarking authority websites, setting up Google Alerts, or manually browsing national databases for updates. Many rely on spreadsheets or team-managed email accounts to collect and track regulatory updates. While these methods may seem manageable at first, they can quickly become time-consuming, error-prone, and unsustainable—especially as global regulations grow more complex.
According to a Deloitte survey, a significant number of organisations continue to depend on these manual processes for third-party risk management, creating compliance gaps that could result in audits, delays, and missed opportunities (Deloitte, 2023).
So, why do traditional compliance methods fail, and how can companies stay ahead of the curve? Let’s explore.
The False Confidence Trap
You might feel confident in your current compliance process—but even well-established systems can have hidden gaps. Many companies fall into the trap of feeling confident about their processes, only to be blindsided when audits expose critical gaps. Deloitte’s survey found that only 34% of companies have real-time monitoring of regulatory changes (Deloitte, 2023). This means many teams are taking a significant risk by not having the efficient systems in place to stay fully updated.
With the EU MDR/IVDR undergoing continuous updates—requirements evolving rapidly and standards multiplying—keeping up manually searches is nearly impossible, not to mention the serious risk it creates.
Traditional tracking methods simply can’t keep up. Add to that the rise in national deviations—such as varying country-specific regulations and labeling requirements—and the landscape becomes even harder to navigate. Many companies struggle to keep their regulatory inventories up to date, increasing the risk of compliance gaps and regulatory readiness issues.
According to Webz.io, companies lose an average of 40 hours each month due to traditional regulatory tracking methods, instead of using automation. That’s a significant amount of time and money being wasted on outdated systems and processes—time that could be better spent on strategic, high-priority activities that drive business forward. Not allocating more time to these tasks can put critical initiatives at risk and slow overall progress.
The Dangers of Manual Tracking
Research highlights the stark reality for companies still relying on static, outdated manual tracking methods:
Teams using traditional tracking methods spend significantly more time on compliance tasks compared to those using automation.
Many companies admit their regulatory inventories become outdated quickly, impacting their ability to maintain compliance.
Companies lose 40 hours per month on manual regulatory tracking, according to Webz.io This is significant time that could be better spent on strategic, high-priority activities that drive business forward.
The hidden costs may be staggering:
Launch Delays: Industry estimates suggest that document rework and manual compliance tracking can significantly delay product launches, often by several weeks.
Audit Failures: Companies using manual tracking systems are more likely to experience audit findings, as these systems often fail to keep up with evolving regulatory requirements.
This isn’t just inefficient—it’s expensive and comes with a high-risk.
The Solution: Data-Driven Compliance
So, how are leading companies staying ahead of the game? By embracing automated regulatory intelligence. Here's what makes the difference:
Significantly reduced manual work, as shown by Deloitte’s case studies, thanks to the power of automation and daily tracking.
Fewer audit findings, thanks to proactive monitoring and real-time change alerts that ensure compliance is always up to date.
Faster market entry, without the stress of last-minute document fixes and delays.
By leveraging AI and automation, companies can track global regulatory sources like the FDA, EMA, and MHRA, along with market-specific regulations across various countries. Teams receive automated rationales for every requirement, ensuring compliance in diverse regions, while audit-ready reports are generated in minutes—not weeks.
What You Can Do Next
If your organization is still using manual tracking methods, you could be missing key opportunities to boost efficiency and mitigate risk. Companies that stick to traditional approaches to third-party risk management often face higher costs and increased compliance challenges.
Ready to Take Control of Your Compliance Journey?
Don’t let the maze of regulations slow you down. With Smart Compliance, you can confidently navigate every regulatory requirement with ease.
Start learning how to leverage the latest technology with automated processes. Our AI Compliance Mastery Program offers free training to help you harness AI effectively and efficiently in your RAQA operations. Learn practical, hands-on strategies from industry experts, develop actionable approaches, and seamlessly integrate AI into your workflow to stay ahead in this rapidly evolving field.
References:
Deloitte (2023). Third-Party Risk Management Survey. Retrieved from https://www.deloitte.com/global/en/about/press-room/deloittes-2023-global-third-party-risk-management-survey-shows-resiliency.html. Retrieved April, 2025.
Webz.io, What’s Causing Companies to Lose 40 Hours Each Month on Manual Regulatory Tracking? (2022) https://webz.io/blog/risk-intelligence/whats-causing-companies-to-lose-40-hours-each-month-on-manual-regulatory-tracking/ Retrieved April, 2025.
EU Commission (2024). MDR/IVDR Work Programme. Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, information obligation in case of interruption of supply, and transitional provisions for certain in vitro diagnostic medical devices. Retrieved from https://health.ec.europa.eu/system/files/2024-01/mdr_in-vitro-proposal.PDF. Retrieved April, 2025.
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