Trial Oversight Spotlight #12: Barry McManus
In this episode:
Tom and Barry uncover managing technology vendors in the clinical trial sector. Barry shares his experience in quality management and computerised system validation, emphasising the importance of risk assessment, monitoring, and oversight in vendor management. Followed by some Myth Busting about validation, advocating for a balanced approach that prioritises quality and compliance while fostering collaboration between stakeholders.
Key points:
- Why clear requirements are the foundation of effective vendor management
- The critical role of risk assessment in technology vendor selection and oversight
- How validation extends far beyond initial implementation
- Key metrics that actually matter when evaluating vendor performance
- Focusing on objective evidence rather than excessive documentation
- Leveraging good software engineering practices to enhance validation efficiency
Time stamps:
- – Intro
- – Managing Technology Vendors - Best Practices
- – Compliance and Due Diligence as a Sponsor
- – Key Metrics for Vendor Management
- – Myth Busting Validation Goals
- – Computer System Assurance vs Validation Services
- – Good Software Development Practices
Guest Bio
Barry McManus
Principal Consultant at Empowerment Quality Engineering
Barry is Principal Consultant for Empowerment Quality Engineering Ltd with 27+ years in Quality Assurance, Software Engineering, and IT Administration. He leads GxP CSV compliance and IT supplier audits globally, performs software lifecycle process improvement, and conducts risk assessments for validation strategies.
Since entering the regulated industry in 2003, Barry has managed QA, QC, and CSV roles while maintaining GxP compliance and actively participates in industry organisations, including RQA's I.T. committee, IEEE, ISACA, and ISPE.
Host Bio
Tom is running the Trial Oversight Spotlight Interview Series where he meets with a variety of colleagues working in clinical research. They discuss a selection of the most important topics and decisions that are currently being navigated by all types of organisations delivering research.
Tom has spent over a decade in Clinical Trials Operations and Quality Assurance and has experienced the impact that suboptimal vendor oversight and vendor non-compliance can have on the quality of clinical trials. Mayet is the solution to fix this.