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CaseLab

Validating SaaS eQMS: a risk-based CSV/CSA approach

 

By joining this showcase, you will discover:

  • A simple, risk-based decision path to define validation scope and level of effort for your eQMS.
  • How to maintain a validated state after go-live without triggering unnecessary full revalidation.
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A practical, risk-based perspective from independent CSV expert Joseph Turton.

In this CaseLab session, independent CSV expert Joseph Turton shares a practical, risk-based approach to SaaS validation in a focused 20-minute talk followed by a discussion, helping you define the right scope, effort, and maintenance strategy with clarity and confidence.

 

 

What you'll learn in this session:

  • Why SaaS eQMS validation is often misunderstood
  • What “fit for intended use” really means in practice
  • A simple, risk-based approach to defining scope and effort
  • Shared responsibility: vendor evidence vs. customer accountability
  • How to maintain validation after go-live without unnecessary rework

 

Speakers

Angel CaseLab

Angel Buendia

Knowledge Manager
at Scilife

Laura CaseLab

Laura Gilbert

Account Executive
at Scilife

Joseph CaseLab

Joseph Turton

Validation and Data Integrity Specialist at Turton Consulting