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FDA Guidance on Computer Software Assurance (CSA) – A New Validation Paradigm?

Calling all DIA Members! Sign in and Join industry and regulatory experts in a discussion about meaningful change thresholds and ways to forge a path towards establishing digital endpoints.


This program has been developed in collaboration with the GCP & QA Community, the System Validation Working Group, and the Clinical Research Community as well as the Society of Quality Assurance (SQA).

Starting with a brief history of software validation, this webinar guides participants through the changes and opportunities brought about by the new FDA Guidance on Computer Software Assurance (CSA) released in September 2022, such as the risk framework, error-guessing, unscripted testing, repeatability testing, as well as risk analysis and adequate documentation. Panelists will discuss how the CSA implementation may decrease the cost of validation while increasing efficiency and provide participants with advice on how to implement the CSA into their validation strategy.

NOTE: This webinar is exclusive to DIA members only.


  • Meeting Designed For:

    • Executive, Leadership, and Management Professionals from Biotechnology, Pharmaceutical, Device, CRO, Regulatory Agency, and Academic Research Sponsors involved in:
      • Clinical Research
      • eClinical
      • Good Clinical Practice
      • IT/Validation
      • Quality Assurance, Control
      • Regulatory Affairs
      • Validation