How to Ace Your SaaS-based EDC System Validation for Sponsors and CROs

Sep 28, 2016 | Webinar

Recorded September 28, 2016

The mounting popularity of Software-as-a-Service (SaaS)-based eClinical technologies has shifted the paradigm of computer system validation in clinical trials. International regulatory authorities, including FDA, acknowledge the need to perform an intended use validation across various industry guidance documents. However, intended use validation is seldom implemented by CROs and Sponsors utilizing eClinical platforms in a SaaS model.
This webinar describes best practices for Sponsors and CROs validating SaaS-based EDC systems, highlighting the importance of intended use validation and a case study example of SDC’s validation of SaaS-based EDC system, iMedNet eClinical.

Watch this webinar to learn:

  • What auditors want to see in your EDC validation documentation
  • Understanding intended use validation requirements
  • Best practices for implementing EDC intended use validation
  • Key takeaways to ace your EDC validation audit

Presented by:

  • Quan Doan, Associate Director, EDC Solutions at SDC
  • Chris Wubbolt, Principal at QACV Consulting

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