Medical Devices 2011 - Using an IQ / OQ / PQ Approach to Validating Medical Device Software

This Medical Device Software Validation training will show how you can validate software, using IQ / OQ / PQ methodologies typically employed for process validation.

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.