Often, there’s considerable confusion between the term’s “verification” and “validation.”

There are several reasons for this confusion.

Used in Different Contexts

First, while the terms are defined consistently, they are used in different contexts.

Product Validation

For example, product validation focuses on showing that user needs and intended use is met.

Within product validation, there are many activities including clinical studies, usability validation, safety compliance, and so on.

Software Validation

Software validation, though, requires that the entire software life cycle is addressed.

It still confirms that “user needs and intended use” are met, though, since software is expected to change.

Thus, all the lifecycle processes need to be in place and operational to ensure that the software is managed in such a way as to continually ensure these aspects.

Process Validation

Process validation is intended to ensure that a process can consistently produce an output that meets requirements.

Again, though, this is just ensuring that user needs and intended use is met.

So, keep the phrase “user needs and intended use” in mind when thinking of validation.

Not Just Testing

And as you should be able to see, validation is not just testing.

Verification, on the other hand, is the means to demonstrate requirements are met.

That’s fairly consistent in any context.

This is generally JUST testing.

Objective Evidence

One of the themes you will hear whenever the topic of verification or validation comes up is “objective evidence.”

This means that you can provide evidence that whatever you’re claiming is backed up by real data.

We’ll talk more about that later.

Suffice to say, for now, that saying “yep” – or even a checkmark in a box – when asked if a system was confirmed to be fast, would not be considered objective evidence.