U
Hello friends,
I have a standard question specific to medical device software product.
I am looking for specific example for System testing and Validation. I have read lots of threads which talks about differences between Verification and Validation. Also reading FDA CFR 820 requirement, its clear that validation is confirming the user requirements rather than Software requirements.
In general, Verification has - Unit, Integration and System test - whcih confirms software requirements and detailed design.
Validation is a system level activity end to end to confirm product meets intended use and user needs.
I am now in a dilemma - what is system testing? and where does it fall under Verification or Validation? Thats why i need example to see difference between these different levels of testing and also the scope in which they are used to develop new or maintain a software product. Like for a upgrade to an existing product, how should we differenciate System test and Validation.
I am looking for groups expertise to resolve my dilemma. Hope I am clear in my explanation. Let me know if any questions.
Thanks in advance.
I have a standard question specific to medical device software product.
I am looking for specific example for System testing and Validation. I have read lots of threads which talks about differences between Verification and Validation. Also reading FDA CFR 820 requirement, its clear that validation is confirming the user requirements rather than Software requirements.
In general, Verification has - Unit, Integration and System test - whcih confirms software requirements and detailed design.
Validation is a system level activity end to end to confirm product meets intended use and user needs.
I am now in a dilemma - what is system testing? and where does it fall under Verification or Validation? Thats why i need example to see difference between these different levels of testing and also the scope in which they are used to develop new or maintain a software product. Like for a upgrade to an existing product, how should we differenciate System test and Validation.
I am looking for groups expertise to resolve my dilemma. Hope I am clear in my explanation. Let me know if any questions.
Thanks in advance.