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Contradictions in Medical Device Verification vs. Validation - ISO 13485

T

tantan

#11
#11
Re: Contradictions in Verification vs. Validation

ok , now its getting a bit clearer...

The previous person had placed the validated testing documents as verification, and it just didnt seem to fit the definitions i was reading.

If anyone else has some good sofwtare examples it would be appreciated...not only for me as im sure there are many others who have/are pondering these questions!!

:)
 
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Jim Wynne

Jim Wynne

Staff member
Admin
#12
#12
Re: Contradictions in Verification vs. Validation

The confusion stems from the fact that validation requires verification, and the writers of the standards failed to anticipate the problems inherent in the definitions. It's similar to the idea that preventive action and corrective action are separate entities under the standards, but corrective action requires preventive action. :frust: :bonk:

In the case of software, you probably have some standards for coding: requirements for naming of variables, logic flow, branching, etc. If you were to undertake a review of a coded module or complete program to determine whether or not the requirements for program structure were met, that would be verification. On the other hand, the testing and debugging that's done in order to determine whether or not the program actually works as intended (i.e., whether or not design intent has been satisfied) would be validation.

If you look at your processes and see that the line between verfication and validation is blurred, it could be because your processes aren't structured the way the standards expect them to be.
 
T

tantan

#13
#13
Re: Contradictions in Verification vs. Validation

that makes so much sense what you have just said! We are a very small company...only 4 people...and I feel that standards are simply not writen for small companies. As thus it does seem to be the process where verfication and validation are blurring, that and no-one really understanding what is required of the standards....of which is now my goal.

Thanks again for what you wrote...has definately helped 'shed more light' :)
 
A

Al Rosen

Staff member
Super Moderator
#14
#14
Re: contradictions in verification v validation

Coury Ferguson said:
Let's look at the definitions:





This example, in my opinion would fall under validation. The objective evidence would be the testing of opening and closing the file.



In my opinion, when you compare any other existing software programs to see if it does what the other proven software has done, you have verified the program.

These are in my opinion, and someone else might have a better understanding of the differences.
Click to expand...
Coury, you have it reversed. I think Jim has the right idea.
 
T

tantan

#15
#15
Re: Contradictions in Verification vs. Validation

from how i read it both courys and jims points conferred...
 
A

Al Rosen

Staff member
Super Moderator
#16
#16
Re: Contradictions in Verification vs. Validation

Just because the the file opens when you command it to (verification), doesn't meet the requirement of the end user (validation).
 
T

tantan

#17
#17
Re: Contradictions in Verification vs. Validation

what would you define as validating something like that then? Would it be a validation to say the user was able to open a real file as the correct file appeared on the screen..or something liek that. This is why i am confused!
 
A

Al Rosen

Staff member
Super Moderator
#18
#18
Re: Contradictions in Verification vs. Validation

tantan said:
what would you define as validating something like that then? Would it be a validation to say the user was able to open a real file as the correct file appeared on the screen..or something liek that. This is why i am confused!
Click to expand...
Yes, or did the file need to be opened?
 
D

Doug Tropf

Quite Involved in Discussions
#19
#19
ISO/TR 14969 (Guidance on the application of 13485) does a good job of
explaining validation requiements for both the design/development stage and production processes.
 
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