The AI revolution in regulatory compliance

| Product Lifecycle Management | Regulatory
Posted By: Trace One

Compliance is a crucial discipline in the manufacturing space. And for large enterprises operating internationally, it can be a real challenge.

On the global stage, manufacturers need to stay up to date with continuous changes across a diverse pool of regulators. Those changes happen fast—not monthly or yearly, but daily.

If you’re responsible for regulatory compliance at your business, you’re well acquainted with the difficulties of sourcing and actioning this information. But a new technology is exploding onto the scene, and it’s poised to make your work easier and more efficient in the coming years.

That technology is AI.

Facing down the challenge of global regulatory compliance

Compliance is an information-rich discipline. Manufacturers need to keep up with the latest news, find what’s relevant to their products, supply chain, and company, then take appropriate action to avoid violations.

Just ensuring you have access to the right sources can be difficult. The enormous volume of information is daunting, especially when it spans different languages. Meanwhile, expertise is scarce, so compliance teams are spread thin. Even large companies with access to plentiful resources tend to rely on expensive consultants or local talent.

The compliance landscape has also changed over time. As organizations need to reimagine and manage their supply chain differently to ensure business continuity and growth for the future, a product’s journey from initial supplier to final customer gets more complex. Any single point of failure or compliance issue ripples across the network.

At the same time, the data collection burden has increased, so manufacturers need to collect and provide more information about substances and products than ever before. Not only is volume an issue, but compliance professionals have to collate data from different artifacts with diverse forms, structures, terminologies, languages, and even digital formats like PDFs or SDSs.

How AI can improve regulatory compliance 

Fortunately, AI does what humans do worst.

As these tools evolve, we’re learning their strengths. First, they excel at processing documentation at scale, even across different formats that may not suit conventional text scanning.

More importantly, AI’s machine learning capabilities are great at identifying and reusing the knowledge they acquire. For example, once an AI algorithm identifies synonyms for a substance—like a trade name vs. a scientific name—it can retain that knowledge and apply it correctly to regulatory frameworks moving forward.

As a result, AI is very efficient at compiling data and matching it to relevant regulations, alleviating the constant game of connect the dots that’s tedious and error-prone for humans. It’s fundamentally about capturing expert knowledge and reapplying it in different contexts.

Trace One AI solutions for regulatory compliance, now and in the future

Trace One Regulatory Compliance from Trace One already offers AI features that improve regulatory compliance and decrease risk.

  • The Food News Monitoring System scans hundreds of websites, then automatically identifies and extracts the relevant data.
  • Once Trace One Regulatory Compliance scans and parses these articles, AI assigns keywords to that data to understand how it fits into regulations or identify recalls.
  • The Classification Service assigns regulatory information to its relevant product category through automatic text classification.
  • Trace One Regulatory Compliance also offers a translation service specifically adapted to regulatory needs. The tool automatically cross-references its outputs with a technical dictionary that aligns with specific regulatory terms, producing what you might call an “expert translation.”

Organizations are already saving 10–30% of their compliance teams’ time through Trace One Regulatory Compliance’s AI tools, and the possibilities continue to advance.

The rise of generative AI has led to substantial advances in natural language processing. Simple, sentence-form queries will soon be the norm in the compliance world. At the moment, users break their research down into many different searches, but the time will come when they can simply ask, “If I sell this product in the US, can I sell it in Brazil?” Ai-enabled answer bases will match the data to the salient regulations and return the answer.

AI’s ability to whittle complex information down into plain speech is another potential time-saver for compliance professionals who often have to translate their thoughts into layperson-friendly terms. Offloading that responsibility to generative AI tools will save time and effort.

Finally, correlating product and supply data with regulatory information can help identify risks and issues that may cause product delays. The core competency is connecting disparate data pools, finding what’s relevant, and taking action.

A straightforward use case would be identifying a substance recall or the impact of a regulatory change. AI tools will soon have the power to automatically connect that information with the relevant product to determine its compliance risk, eliminating the need for constant attention from compliance professionals.


These are just a few of the potential applications for AI technology in the regulatory compliance space. The first step is ensuring that your data estate is in order, and you’re positioned to capitalize on these tools as they emerge and mature.

Find out more about Trace One Regulatory Compliance from Trace One, and learn about the AI features and PLM integrations that will help you capitalize on future-forward technologies.