This Software Verification and Validation training will help you understand and recognize the most common software V&V failings and their fixes. You will learn how to develop and use a repeatable software V&V template for all software validation projects.
This presentation focuses on the verification and validation planning and execution of software after basic developmental testing and de-bug. It includes COTS (commercial off-the-shelf) and growing "cloud"-based software. A suggested FDA model will be evaluated, implemented, with V&V documentation and test case examples.
Areas Covered in the Seminar:
- Recent industry failures.
- Tougher FDA Expectations / Requirements.
- Roles of Verification and Validation.
- An FDA "Model".
- A Typical Software V&V Protocol / Test Report.
- A Brief Overview of 21 CFR Part 11.
- Legacy, Hybrid, New and ER / ES Systems.
- Expected Regulatory Deliverables.
- Complementary Guidelines, e.g., GAMP.