WECUG Spring Conference Recap

by CHRISTINA WARDELL, Director, Service Operations - ViaLase I attended the QAD West Coast User Group Meeting in Carlsbad this week and wanted to share a few highlights. Based on prior user feedback, QAD adjusted the format this year. The sessions focused more on getting the most out of existing systems rather than promoting new upgrades.

QAD experts were available throughout the conference to troubleshoot issues and answer questions in real time. Those face-to-face conversations ended up being some of the most valuable parts of the trip.

I attended several sessions. These were my key takeaways:

AI Validation for Life Sciences

With AI Champions now built into QAD Adaptive, there was significant discussion around Agentic AI and its use in life sciences. The key takeaway was clear: AI cannot be a black box. It must be explainable, validated, and aligned with its intended use.

That naturally limits where we can apply it.

The most practical use cases today are in non-GMP workflows, such as monitoring purchase orders, flagging delays, and drafting vendor communications. These are straightforward ways to reduce manual effort without adding validation risk.

Project Velocity (AWS Migration)

There was also discussion around QAD’s migration from Flexential to Amazon Web Services (AWS), focused on improving system stability and reducing downtime.

This was particularly relevant for us. Our AWS migration was scheduled for this past Tuesday, 4/28, and we needed an extension. We were unable to secure one through normal channels but being onsite made a difference. I was able to connect directly with the QAD project manager and secure an extension to June 1^st.

It was a good reminder of the value of direct access and real-time problem solving.

From a broader perspective, the move to AWS is intended to improve reliability. From a user standpoint, the goal is that the change is largely invisible, which is exactly what we want.

FDA Transition to QSMR

In February, the FDA announced its transition to the Quality Management System Regulation (QMSR), including a shift from Computer Software Validation (CSV) to Computer Software Assurance (CSA). This aligns more closely with ISO 13485:2016 and emphasizes a risk-based approach to software validation.

Key elements include: 

·                     Focus testing on what matters most

·                     Prioritize patient safety

·                     Reduce excessive documentation

In other words, less time proving everything works and more time focused on proving the right things work. This is a meaningful shift and, if applied correctly, should reduce validation burden while maintaining compliance and supporting faster implementation.

If you would like any of the presentation materials, or are interested in attending a future meeting, feel free to reach out. It was a great meeting overall and I’m glad I attended. I’m happy to share what I have and help coordinate.