FDA software validation takes more than proving that code works and is free of bugs. This 60-minute webinar explains how to run a software validation program that meets FDA requirements and produces a safe product.
You'll learn how software requirements drive validation, why requirements traceability matters, and the role of risk analysis. The session covers unit, integration and system testing, algorithm validation, challenging the software, and configuration management. It is not a programming course: it explains what must be done rather than how to carry out the tests.
WHY SHOULD YOU ATTEND?
Functional testing alone is not enough for FDA approval. The FDA expects additional requirements, analyses and tests aimed at preventing user injuries, developed from its analysis of many recalled medical devices.
This session suits engineers and engineering managers, software engineers, programmers, and quality assurance and regulatory professionals.
AREA COVERED
- Why software validation is more than testing
- Requirements traceability
- Risk analysis
- Unit, integration and system testing
- Algorithm validation
- Challenges to the software
- Configuration management
LEARNING OBJECTIVES
- Explain why software validation goes beyond functional testing
- Use software requirements and traceability in validation
- Apply risk analysis to software validation
- Plan unit, integration and system testing and algorithm validation
- Challenge the software and control changes through configuration management
- Set up a validation program that satisfies FDA requirements
WHO WILL BENEFIT?
- Engineer
- Engineer Management
- Software Engineer
- Programmer
- Quality Assurance
- Regulatory
Functional testing alone is not enough for FDA approval. The FDA expects additional requirements, analyses and tests aimed at preventing user injuries, developed from its analysis of many recalled medical devices.
This session suits engineers and engineering managers, software engineers, programmers, and quality assurance and regulatory professionals.
- Why software validation is more than testing
- Requirements traceability
- Risk analysis
- Unit, integration and system testing
- Algorithm validation
- Challenges to the software
- Configuration management
- Explain why software validation goes beyond functional testing
- Use software requirements and traceability in validation
- Apply risk analysis to software validation
- Plan unit, integration and system testing and algorithm validation
- Challenge the software and control changes through configuration management
- Set up a validation program that satisfies FDA requirements
- Engineer
- Engineer Management
- Software Engineer
- Programmer
- Quality Assurance
- Regulatory