Matt Jones
Chair of the RQA Board and Founder/CEO, Digital Quality Associates
Key Points
- Regulators are increasingly focusing on risk-based methodologies
- Quality by design is becoming more important than traditional testing methods
- Risk assessments can significantly reduce validation efforts
- Vendor management is crucial for ensuring compliance and quality
- AI's role in pharma is growing, but it requires careful oversight
- Auditors should be wary of long bug lists and lack of transparency
- Data governance is essential, especially with the rise of AI
- Technology can streamline validation and compliance efforts
Tom and Matt discuss the evolving landscape of IT quality and validation in the pharmaceutical industry. They explore the importance of a risk-based approach to validation, the role of AI in drug development, and the need for effective vendor management and oversight. The conversation also highlights the significance of data governance and the red flags auditors should look for during inspections. Overall, the episode emphasises the shift towards quality by design and the integration of technology in compliance processes.
Chapters
About the Guest
Matt Jones
Chair of the RQA Board and Founder/CEO, Digital Quality Associates
Matt Jones is Chair of the RQA Board and Founder/CEO of Digital Quality Associates, bringing 25+ years of pharmaceutical leadership and cross-GxP expertise.
As an ISO 27001 lead auditor and serial technology entrepreneur, he specializes in IT compliance and computer system validation, helping life sciences organizations navigate digital transformation while maintaining regulatory compliance.
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