Using an IQ / OQ / PQ Approach to Validating Medical Device Software
Duration: 60 Minutes
This medical device software validation training will show how you can validate software using IQ / OQ / PQ methodologies, typically employed for medical device process validation.
Objectives of the Presentation
Why Should you Attend
- Development of software test plans
- How to apply IQ / OQ and PQ techniques to software
- Risk based software testing
- How does Software Validation relate to Design Validation?
- Typical software tests
- What is the appropriate sample size for software testing?
- Software issue tracking
- How to address open issues when releasing software
Software Validation is a hot topic with the FDA because of the numerous medical device recalls related to faulty software. This webinar provides a method for performing thorough software validation using well established methods of Installation Qualification, Operational Qualification and Performance Qualification. These terms are not commonly used with software, but these processes can be successfully applied to software validation in order to reduce the likelihood of enduring a software recall.
Who can Benefit
This webinar will provide valuable assistance to medical device companies in performing verification and validation testing throughout the product lifecycle. The employees who will benefit include:
- Systems Engineers
- Software testers
- Test Engineers
- Quality System Auditors
- Engineering Managers and personnel
- Regulatory Affairs
- Software Vendors