QA/RA teams are under pressure to use AI, but validating non-deterministic tools is unclear. This session provides a risk-based framework to define scope, generate audit-ready evidence, and maintain compliance w/o delay.
Quality and regulatory teams are under increasing pressure to use AI to scale their impact and support faster, AI-assisted development. As non-product software is used in regulated environments, the tools must be appropriately controlled and validated.
The problem is that most validation approaches were designed for deterministic software. Teams are left unsure what actually needs to be validated, how to evaluate non-deterministic outputs, and what evidence will hold up in an audit. The result is manual reviews, screenshots, and gaps in evidence. This session gives QA/RA professionals a structured, risk-based framework for validating AI tools used within their organization, so you can maintain control and inspection readiness without slowing your team down.
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].



Delivery and Success, Ketryx
James works in Delivery and Success at Ketryx, spanning solution design, customer success, and ensuring customers achieve the outcomes they signed up for. Before Ketryx, he honed his expertise in implementation consulting at PwC, where he learned how large enterprises adopt technology. James holds a BAS from the University of Notre Dame.
Director of Client Operations, Ketryx
Richard serves as Director of Client Operations at Ketryx, leading the teams that help medical device companies automate quality and compliance workflows. He brings 20 years of experience in healthcare technology, with a background spanning Faro Health and deep expertise in the Veeva/Vault ecosystem. Known for clear vision and relentless execution, Richard specializes in solving complex operational challenges in highly regulated industries and helping clients realize the full potential of their digital investments.