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Scilife Validation: a practical, risk-based approach

See how Events and CAPAs work together from issue to resolution.

Agenda


05:05
Scilife's approach to validation

11:05
Scilife demo

20:10
Validating a module for the first time

23:00
Shared responsibility model

29:45
Revalidation: how much to redo

38:05
Poll and questions

Validation is essential in a regulated environment, but not every change requires the same level of effort. A risk-based approach helps you focus validation where it matters most. In this Deep Dive, Catherine Kolar, Solutions Consultant and Tanu Agrawal, VP of Product QA and Release Management, and Àngel Buendía, Knowledge Manater, will explore validation throughout your Scilife journey, from initial go-live to module updates, and how intended use and risk can help determine the right level of validation effort.

You’ll learn how to:

  • How to approach initial validation based on your intended use and the Scilife functionality you use.
  • How to take a risk-based approach to revalidation following major, medium, and minor releases.
  • How to determine the right validation effort without automatically repeating a full validation.
  • Common validation questions and practical considerations across our customer community.
  • What Scilife provides to support validation and where to find the relevant documentation.