ASQ Raleigh held its last Life Sciences Special Interest Group (SIG) meeting of 2025 at the NC Biotech Center on the evening of November 19, 2025. We had thirteen attendees representing a range of professional backgrounds, including a recent graduate, seasoned Quality professionals, and industry consultants. Four were first-time attendees of our SIG events.
Our speaker, Nathan Blazei, is an experienced life sciences leader with a background in Quality and Regulatory Affairs. He presented his perspectives on Quality 4.0, titled “Unlocking Efficiency, Consistency, and Insight: Potential Use Cases for Artificial Intelligence in Quality Assurance.”
After a brief introduction to Quality 4.0 and associated technology, Nathan presented three potential use cases and led the discussion beyond these applications.
- Event investigation
- Procedure creation
- Inspections
A common theme of the applications is automation and artificial intelligence (AI) tool’s ability to process large amounts of data. Generative AI tools can also help summarize the information from diverse data sources and answer queries quickly, saving time and improving performance.
Participants recognized that while promising, most AI systems and tools were new and in development, and few had been tested or validated in the real world. To be truly useful, the AI systems have to be integrated with the business and be trained with domain-specific data.
The fact that many AI tools are “black box” solutions was also a concern — how much can we trust the information or answers? Can we interpret it? How do we validate it? Participants seemed to agree that the tools are useful for generating the initial documents, solutions, or recommendations, which can be a time-saver, but human experts still have to fill the gaps and make the final decisions.
Despite concerns about limitations of the current technology, the participants were enthusiastic about its potential applications in Quality and Continuous Improvement, bringing up many ideas on their wish lists: pulling knowledge embedded in the organization, performing root cause analysis, creating video-based Standard Operating Procedures (SOPs), integrating skills from different experts, AI-assisted procedures, etc.
We would have continued our discussion beyond the two hours if the building security didn’t ring the bell. More is to come next year, so check our events calendar often.