Regulations in pharma and medical devices don’t stand still. They change as new technologies come in, as authorities learn from past challenges, and as the industry itself evolves. Companies that don’t keep up face the risk of delays in product launches, product recalls, customs clearance hurdles, supply chain issues — and, most importantly, risks to product quality and patient safety.
For regulatory teams, this is easier said than done. They are already stretched with new product rollouts and making sure marketed products stay compliant. On top of that, they must constantly track new laws, guidance, and updates. The task is rarely simple: finding information across multiple sources, checking what matters, confirming accuracy, and then working out how it affects products, quality systems, documentation, and the organization as a whole.
Using AI to Track Regulatory Changes
Manufacturers can leverage artificial intelligence to deploy tools and technologies to streamline this function. This ensures there is a steady stream of updates captured in real time, structuring the data using metadata, analyzing context using natural language processing (NLP) and storing the data in predefined database formats relevant to different functions and end users within the organization.
Metadata-based storage is key for structured storage and retrieval of data during search by the end users. It also enables the system to interact with other systems, such as document management systems (DMS), quality management systems (QMS) or regulatory information management systems (RIMS) to identify products, sites, documents, standard operating procedures that may be impacted by the update.
AI can also take large documents — a new guideline in PDF or Word, for example — and create short summaries. Some tools even allow teams to “chat” with the document. Still, companies usually don’t rely on automation alone. A regulatory expert is often needed to look at the change and judge what it really means. The best approach is a mix: let AI do the heavy lifting, and let experts make sure the insights are practical and reliable.
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Combining Internal Expertise with External Support
Depending on organization size, implementing such process and system requires considerable assessment of cross-department organization requirement for regulatory intelligence, potential cost versus benefit analysis, timelines for implementation and deploying resources.
- Larger, multi-national, broad portfolio companies often have complex structures and require strategic assessment to identify, assess, develop and deploy such solutions.
- Change management, communication management stakeholder engagement are key for success of such initiatives, that require large investments and long term commitment.
- Smaller companies, with limited products and markets in scope, can scale down the scope of implementation in terms of time and cost, yet it can be considerable commitment.
- RSS feeds from health authority website and other relevant sources can be leverage to build lean solutions that may require relatively less budget and time.
- Coupled with fractional deployment of regulatory team’s time can deliver desired results.
- AI based cloud solutions that capture, analyze and structure the RSS feeds can be used to develop such solutions.
Also Read: Artificial Intelligence in Medical Device Regulatory Affairs
There are specialized solutions available that offer off the shelf cloud solutions for tracking and monitoring regulatory updates. Such solutions are a viable options large, medium and small companies alike since they offer comprehensive global coverage considering their focus and variety of analytical functions that can be used for decision-making.
These tools can also be integrated with existing systems within the company to leverage real time updates for impact assessment. Integration, however, requires strategic assessment, IT system compatibility, data security, implementation, change management, cost and other considerations.
Also Read: Artificial Intelligence in pharmaceutical Regulatory Affairs
In summary, companies can leverage artificial intelligence-based solutions to meet their regulatory intelligence and updates monitoring needs. Depending on organization needs, return on investment and impact on organization, select approach can be adapted.
Artixio provides regulatory updates monitoring solutions and services through its regulatory intelligence platform and experienced regulatory teams based in key markets worldwide. Write to us at info@artixio.com to learn more about our regulatory intelligence solutions and services.
