CSA vs CSV: All the Questions You’ve Been Dying to Ask
Validation of computer software can be a scary and difficult landscape to navigate these days with the emergence of the CSA draft guidance from the FDA. It is necessary, however, if you operate in a life sciences or other regulated business. With the upcoming change from Computer System Validation (CSV) to Computer Software Assurance (CSA), having a solid foundation of understanding will be critical to your success. We know it’s spooky season, but we’re here to make understanding and then validating your systems a little less terrifying.
In one hour, let our experts elucidate, compare, and contrast the CSA guidance model against the current CSV process and provide insights on these hauntingly complex topics. Join us to explore what the future of validation may hold for your organization and its enterprise systems as the change from CSV to CSA moves forward.
Key Take-Aways:
- Learn why CSA has come about
- Understand how the FDA is currently thinking about CSA and CSV
- Discover some key differences between CSA and CSV
- Dive into the timeline for the CSA draft guidance from the FDA
- Identify critical success factors for understanding CSA application to different computer software
- See examples of the differing approaches to CSA vs. CSV
- Explore the future state of the draft guidance
Who Should Attend:
- Quality Assurance, Training Management, and Production Management
- Decision Makers, Organizational Leaders, or Business Owners
