Example: Difference between System Testing and Validation

U

ujain82

#1
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.
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Not being able to directly answer a question like this one, I was wondering if you had looked at any of the related threads linked at the bottom of this page? I clicked on the top one, and saw that it in turn referred me to yet more threads on verification vs. validation of software and systems. Please try it, you might find your question has already been answered.
 
U

ujain82

#4
Thanks Jennifer. I did try multiple threads. I am clear on the difference as people has been stating. These are too high level.
In actual practice, how should I transform these? Thats the detailed question I had earlier. I want my development team to understand it fully.
1) System testing vs Validation
2) Example to demonstrate different levels of testing.
3) I would also want to get more clarification on Verification vs validation in IEC62304. Section 1 tells that Validation and final release in not covered in the standard. Secondly, appendix talks about Software System Test to be confused with definition of Validation.

I have had several discussions but I am always in the dilemma about difference between System testing and Validation. I don't think its same but many people does.

Thanks.
 
U

ujain82

#5
Thanks Harry. I am clear till here. I understand the high level descriptions and differences. I am looking for more detailed information as I stated in the above 2 posts.
 
S

ssz102

#6
validation means double check for certain things see whether is comfomity customer requirements or international standards or not;
verification means reconfirm similar products or sector whether was implemented corresponding actions base on validation

only is my experience for above
 

yodon

Staff member
Super Moderator
#7
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.
Looks like you already answered your own question! System testing (a mechanism to test at a "black box" level) is a and the other test methodes (unit, integration, etc.) are just tools in the toolbox. You can use system testing in Verification. Typically, Validation is performed at the "system" level so whatever validation testing is done would typically be considered in the "system test" bucket.

Don't get too wrapped up in terminology. You have properly identified the intentions of both Verification and Validation testing so if you can show (through whatever means) you are meeting those intentions, you should be ok.
 
U

ujain82

#8
Thanks 'Yodon' on the clarification.
You are corrrect that I am wrapped up in terminology. I understand the difference between the two V's.
I am confused:
1) Are both V's done against requirements (SRS)? If I consider system test as Verification against SRS, what does the Validation against? How should I show the difference between System test and Validation.
2) Medical device regulation is very light so I am having issues satisfying them. My questions were the interpretation on those. Now I want to implement those in the product development.

Thanks,
Uj
 

yodon

Staff member
Super Moderator
#9
1) Are both V's done against requirements (SRS)? If I consider system test as Verification against SRS, what does the Validation against? How should I show the difference between System test and Validation.
The best example I can give is using a hierarchical set of specifications: a Product (or Customer) Requirements Specification is a 'parent' document to the System Requirements Specification. Verification is done against the System Requirements Specification and Validation is done against the Product / Customer Requirements.

You don't want to repeat tests for the sake of 'covering' Validation where Product Spec requirements trace down fully into System Spec requirements. So you have to have a good Plan to define what you will do in each test 'phase'.

2) Medical device regulation is very light so I am having issues satisfying them. My questions were the interpretation on those. Now I want to implement those in the product development.
Not sure I understand your comment about medical device regulation (being) very light. The regulations are quite clear (that there shall be both verification and validation). So be sure to do them both!
 
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