ELM-158-01

Software Cannot Be Pre-Validated – Understand Intended Use [Video]

Throughout this program, we’ve mentioned that there are factors that may take a validated system out of a validated state.

Validated System

Sometimes you’ll see system providers (especially for software) advertise that they can sell you a validated system.

That’s at best partially true and at worst a fabrication.

Be wary of such advertisements.

Your Environment

Remember, a system can only be validated for your intended use in YOUR environment.

If a supplier has done a validation, it’s done in their environment for their intended use.

Leverage Testing

That’s not to say that you can’t leverage any testing that the supplier has already done.

Many times, the functional verification can be used to reduce your overall test effort.

In such cases, you’ll at least have to be able to demonstrate that your requirements are equivalent to the supplier’s requirements.

Author

Don Hurd

Practical Quality & Thorough Validation The Realtime Group