I am a new validation manager in medical device ind. who has an extensive experience with IT Software but not with plant manufacturing. I was recently, asked why should we focus on Software validation when our devices are class 1 device and we have process validation in place. If we put materials and get an expected product then why should we waste time in Software validation. I reminded them about the regulatory requirements and its important because software is constantly changing but other than that, i did not have a solid answer.
Any thoughts!
Any thoughts!