Using an IQ / OQ / PQ Approach to Validating Medical Device Software (Medical DeviceTraini)
Venue: Online Event
|Event Date/Time: Oct 26, 2011||End Date/Time: Oct 26, 2011|
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. This 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.
Areas Covered in the Seminar:
- 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.