Tag Archives: OTS Software

OTS/SOUP Software Validation Strategies

My last discussion of Off-The-Shelf software validation only considered the high-level regulatory requirements.  What I want to do now is dig deeper into the strategies for answering question #5: How do you know it works? This is the tough one. … Continue reading

Posted in FDA, Software Quality | Tagged , | 8 Comments

Validation of Off-The-Shelf Software Development Tools

A reader asked me about OTS software tool validation. He says: It seems to me that the editor and any other tool used to create the software is exactly that, a productivity tool. The end result (compiled binary installed on a … Continue reading

Posted in FDA | Tagged , | 12 Comments