Markets in the modern era move at light speed. Small mistakes can snowball into big problems, so it’s important to ensure your products are registered in the right places at the right time. Regulatory Intelligence is the art of taking guidance from large amounts of regulatory information, both inside and outside your company. But what is Digital Thread, and how can it help your regulatory intelligence strategy?
The concept of Digital Thread benefits is simple, but powerful. Centralizing product data in one system (or a set of integrated systems) allows you to reference, update, analyze, and respond to that data in real-time. It’s applicable to any number of business functions, but it can be especially useful for Regulatory affairs. Here are 7 key ways that Digital Thread technology can help you build Regulatory Intelligence.
1) Keep Track of Product Registration
If your product data spreads across multiple systems, things can get complicated fast. Imagine multiple product registrations across multiple countries, all requiring specific information and with different regulatory requirements. This could mean thousands of documents holding millions of data points. Leverage the digital thread to centralize the product information and create an authoritative source for the product’s information. You’ll never have to wonder where your products are registered again.
2) Traceable Data Flow
You reference and maintain many pieces of information throughout a product’s development. One example is GTINs. Engineers select Global Trade Item Numbers, design them in labeling, and apply them to the product in manufacturing. If there’s any slip up in communication between those functions, the wrong number might end up on the product. However, ensuring there’s only one source for your data eliminates the need to keep double-checking throughout the product’s lifecycle. All you have to do is look up the product on your Digital Thread.
3) Inform Research and Development (R&D)
With so many regulations on products, it can be challenging to keep your R&D team in the loop. They might change something as small as the color of a wire, unknowingly breaking registrations in three separate countries. It could be weeks later when Regulatory finally hears about the change. Digital Thread components allow you to create and expedite ‘change impact assessments,’ which communicate ideas to all relevant parties. Consequently, this saves both work and time without forcing your engineer to earn a law degree.
4) Create Automated Processes Around Your Data
Automation is another simple idea with powerful implications. Most products follow similar lifecycles. A Digital Thread system allows you to create processes to manage and track lifecycles automatically. For example, say there is a product registration in Germany due to expire in six months. The system monitors the date and sends a notification to Regulatory Affairs to prepare and renew the country registration. Or another example – Regulatory Affairs noticed that a proposed change to an existing product would violate regulations in Italy. They can reject the change and include the reasons for a rework. The process will automatically then re-route back to Engineering for further review. With Digital Thread benefits, your product’s data and work processes are woven together.
5) Faster and Simpler Regulatory Submissions
Having one system to manage all your product’s data helps collect all the documentation necessary for registering a product. Thankfully, you can also use the system’s automated processes to ensure those submissions are in the correct order and on time.
6) Data Analytics with Machine Learning
The intersection between Machine Learning and Regulation is a deep enough topic for a blog post of its own, but the basic idea is this: there’s way too much data to handle on our own. Fortunately, we use computers to help us understand it. Another benefit of having all your data in a single space is that it becomes easier to analyze and understand. AI could be a fresh set of eyes to ensure your products are compliant. It can also be a helping hand to read through the numerous changes to worldwide regulations that happen every day.
7) Trust in your data
It’s hard to overestimate the psychological side of the business. Likewise, if you can’t trust your data, decisions become much more challenging to make. Having a system that keeps track of, understands, and empowers your data is key to confidence in the marketplace. For more tips on keeping your data organized, check out our podcast episode “Clear Unambiguous Data = Smooth Operator.”
If you’ve been finding it hard to trust your data, or you now believe leveraging the Digital Thread would help you build Regulatory Intelligence, then reach out to ArcherGrey to discuss our Digital Thread solutions. We’d be happy to help!