Do new requirements always need a validation?



[FONT=&quot]Hi All,

I googled inside Elsmar to find answer to my question but I did not find anything, so I try to launch this thread that is causing me a big headache [/FONT][FONT=&quot].

My questions are the following:
1. (background) We inserted a new localization on our clinical data management system, a Fareast asian language in particular. This requirement was requested by Marketing so it's part of our User Requirement document:

Is it required to validate (I do not refer to verification, we do verification of the new GUI, in order to avoid cropped text or malfunctioning in data insertion)?

2. In general: is it correct to say that when we introduce a new User Requirement, we need to add validation related to this requirement?

I really thank you in advace for the support you can provide.[/FONT]


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The "validation" may be as simple as checking whether the language is available; so it would be done as part of the verification.
But you can extend the validation to ensure that the text has been properly translated. Translation validation may already be a part of a separate process/procedure.


Super Moderator
Agree with mihzago but would like to extend a bit. Translation can be a tricky thing. Native speakers may tend to use colloquialisms that may not be appropriate for a medical device setting / professional. Always good to get the translation validated, IMO.


Hi yodon and mihzago,

first of all thanks both for your precious answers! They helped me to clarify the topic related to the validation of localization.

Furthermore I would ask you or whoever, about my second question, that is:

is it correct to say that when we introduce a new User Requirement, we need to add validation related to this requirement?

In particular, just to do an example, let?s assume that I insert a new filter for searching data inside a table, input coming from Marketing. This is a new requirement, consequently would you do a validation or not?
I do not refer to verification that should be done in any case.

Just to avoid misunderstanding I quote a definition of Verification and Validation from Wikipedia ?In other words, software verification is ensuring that the product has been built according to the requirements and design specifications, while software validation ensures that the product actually meets the user's needs, and that the specifications were correct in the first place. Software verification ensures that "you built it right". Software validation ensures that "you built the right thing". Software validation confirms that the product, as provided, will fulfill its intended use.?

Thanks again


Involved In Discussions
Hi Nikolaos,

I would say that you could answer your second question using the definitions you found in Wikipedia:

If the new requirement impacts your definition of the what is the "right thing" then you should a validate it. After adding the new requirement you have to demonstrate that you are still building "the right thing".


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I think you're getting too hanged up on terms and definitions.
What does it mean "to add validation" or "do validation"? Isn't checking whether you have the language enough of a validation? You can specifically check whether the language you translated to is the one that's used in the particular country.
Validation does not have to be some kind of an elaborate process.

Also, in some cases the verification and validation can be the same, especially in software.
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