MasterControl, a leading provider of quality management and manufacturing software solutions, announced the general availability release of its AI-powered Regulatory Chat, an innovative tool designed to help life sciences manufacturers easily navigate complex global regulatory requirements.
Today, many life sciences professionals must subscribe to multiple newsletters for regulatory updates, perform a manual search, and/or manually review regulations regularly to keep up with changes or updates to global regulatory information. This is time-consuming, but critical to ensure their products and processes adhere to the latest guidance.
Regulatory Chat from MasterControl provides a natural language chat interface for intuitive regulatory inquiries related to regulatory corpuses, including U.S. Code of Federal Regulations (eCFR) and European Union Medical Device Regulation (EU MDR), with additional global regulations being added in future releases. This innovative tool addresses a critical challenge in the life sciences industry, where understanding and maintaining compliance with various regulatory frameworks can be both complex and resource intensive.
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“Life sciences manufacturers face an increasingly complex regulatory landscape for the products they manufacture, with requirements that span multiple countries and jurisdictions,” said Sue Marchant, Chief Product Officer at MasterControl. “Our AI-powered Regulatory Chat democratizes regulatory knowledge, making it accessible to upskill everyone in an organization, not just regulatory experts. This tool represents our commitment to helping manufacturers maintain compliance while accelerating their product development and manufacturing processes.”
Key features of the Regulatory Chat today include:
- Natural language chat interface for intuitive regulatory queries
- Comprehensive coverage of FDA and EU MDR regulations
- In-line citations and references for complete transparency
- Contextual suggestions for follow-up questions
- Architecture that lays the groundwork for upcoming functionality to analyze standard operating procedures (SOPs) against regulations to identify gaps to fill to ensure compliance
Developed on MasterControl‘s proprietary platform in compliance with the rigorous standards specified in ISO 42001, Regulatory Chat leverages advanced generative AI technology while maintaining strict governance and control. Unlike general-purpose AI tools, MasterControl’s solution is specialized for life sciences manufacturing, with all AI development and deployment contained within MasterControl’s secure environment.
Source: PRNewswire
