Computer Software Assurance ( CSA) comes from a multi-year collaboration between FDA and industry. It identifies common pain points. FDA’s current thinking puts patient safety and product quality at the heart of the risk assessment process.
During the webinar, we learned how CSA can be adapted to transform Software Defects and Value-added software defect handling (J&J case study).
Topics Covered:
- Who Implemented CSA?
- 5 things you need to know about CSA
- ISPE GAMP- CSA Appendix
- J&J Case Study on Software Defect Handling
- Test Defect vs. Test Incident Process
- UAT Testing