What is Software Validation?

What is Software Validation?

What is Software Validation?

As per US FDA’s 21 CFR Part 11 compliance requirements, software validation is a key task.
And a lot of material is available over the net on this topic.

But my take on software validation is something like this…

When any software is developed by a vendor (“the supplier”), the user (“the customer”) would want to ensure that the requirement/s on the basis of which this software was developed is met satisfactorily. Not only that, the user would want to ensure that the software satisfactorily meets for every functional and non-functional requirement.

Now, there are two words – validation and verification – Often leading to confusion!

Though both mean almost similar in English, but would be used in different context; software validation and software verification.

Software validation would be the process of evaluating the software to determine whether it is according to specified requirements.


Software verification would be the process of evaluating the software if it satisfies the requirements conceptually as represented according to vendor’s description and requirement.

When I elaborate on the difference between validation and verification – software validation would help user ensure that every functionality is as per the defined requirements, behaves consistently in the intended manner whereas software verification would involve documenting the lists which would help user ensure that the intended product is as per the “prototype” as presented conceptually and typically would involve verifying against different checklists.

On the basis of this, Verification generally comes first, done before Validation.

In a nutshell, verification would involve evaluating the documented facts and data supporting the software development whereas validation would involve evaluating the software itself for its working. The evaluation in verification would be reviews, inspections, etc. while would be actual testing in case of validation.

There is a third word that pops in my mind when I am talking about validation and verification and that word is qualification; Software qualification.

Software qualification and software validation are much similar with an overlap of the import of the purpose: documented testing that the specified specifics is ready for intended use or not while software validation is documenting of the software meeting its specifications and quality aspect.

Usually, hardware, equipments, etc. are qualified (software qualification). And, processes, etc. are validated (software validation).

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