#United States #Life Sciences #Salt Lake City #MasterControl #AI Regulatory Chat

MasterControl's New AI-Powered Regulatory Chat

In the fast-evolving landscape of life sciences manufacturing, ensuring compliance with regulatory requirements can be a daunting task. Traditional methods often involve labor-intensive processes, including subscribing to multiple regulatory newsletters, conducting manual searches, and consistently reviewing guidelines to stay updated on the complex web of regulations. Recognizing these challenges, MasterControl has introduced its AI-driven Regulatory Chat, designed to enhance and simplify compliance navigation for manufacturers in this critical sector.

Streamlining Regulatory Queries with AI

Launched on August 19, 2025, MasterControl’s Regulatory Chat employs advanced generative AI technology to create a user-friendly, natural language chat interface. This allows users to pose intuitive queries related to a variety of regulatory requirements, including the U.S. Code of Federal Regulations (eCFR) and the European Union Medical Device Regulation (EU MDR). Additionally, MasterControl plans to expand the tool to incorporate regulations from other regions in future updates, broadening its utility for manufacturers with global operations.

Addressing Complex Challenges in Compliance

As noted by MasterControl's Chief Product Officer, Sue Marchant, the regulatory environment for life sciences products is increasingly intricate, involving a plethora of requirements that span multiple jurisdictions. The AI-powered Regulatory Chat seeks to democratize access to regulatory knowledge, empowering all members of an organization, not just regulatory experts. This innovation is a significant step toward helping manufacturers maintain compliance while expediting their product development and manufacturing workflows.

Key Features of Regulatory Chat

The initial features of the Regulatory Chat include:

• - Natural Language Interface: Users can engage with the system using conversational language, making it easier to ask questions and obtain relevant information.
• - Comprehensive Coverage: The tool currently provides insights into FDA and EU MDR regulations, ensuring that manufacturers can stay compliant with vital guidelines.
• - In-line Citations: Along with each response, users receive citations and references, offering them transparency and the ability to verify information.
• - Contextual Suggestions: The system offers suggestions for follow-up questions based on the initial inquiry, facilitating a more in-depth exploration of regulatory topics.
• - Upcoming Features: MasterControl intends to integrate functionality that will allow users to analyze their standard operating procedures (SOPs) against prevailing regulations to identify compliance gaps.

A Commitment to Compliance and Innovation

Developed on MasterControl's proprietary platform and adhering to the rigorous standards outlined in ISO 42001, the Regulatory Chat emphasizes high governance and control measures. This aspect sets it apart from general-purpose AI tools, which often lack industry-specific focus. MasterControl’s solution is crafted specifically for life sciences manufacturing, and the entire development and deployment process is conducted within a secure environment to ensure the safety and integrity of the regulatory data utilized.

Conclusion

MasterControl Solutions Inc. has a robust legacy as a leading provider of cloud-based management software for quality and manufacturing in regulated sectors. For over three decades, its mission has aligned with its customers' needs to expedite the launch of life-changing products. By implementing the AI-powered Regulatory Chat, MasterControl continues to empower more than 1,100 organizations globally to streamline operations, safeguard compliance, manage assets, and derive actionable insights from data in real-time. This innovative tool marks a significant advancement in navigating the complexities of regulatory compliance for life sciences manufacturers, embodying MasterControl's commitment to enhancing industry standards and efficiency.