Environmental Monitoring

Flexible Validation Concepts: Creativity is the Key

Article Posted: March 01, 2005

What do garage door openers have to do with validation of systems in the vivarium? They serve as a simple example of how to apply key validation principles.

What do garage door openers have to do with validation of systems in the vivarium? They serve as a simple example of how to apply key validation principles. In this article I’m going to use my experience of validating my garage door opener to explain the principles and give examples of how they apply to the vivarium.

There are many approaches to performing verification and validation, and each seems to have similar concepts and nomenclature. In construction, the term used for validation is often commissioning. In engineering development, they break it into distinct and detailed activities: the engineering activities are IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification). As I validated the use of my garage door, I found that I used all of these concepts.

One basic principle for all approaches to implementing a validated system is planning. In planning to validate my garage door, the first step was to determine the best approach for my application. Since I purchased my garage door opener and installation from a local specialist, there was no need to employ the more elaborate and detailed approach used when engineering a new system. This is the same approach I take when I purchase a computer system to ensure that its functionality matches my intended purpose.

Here’s an example of taking advantage of a specialist: choosing an environmental monitoring system for the vivarium. During a supplier audit of the manufacturer, the buyer reviews their design and testing methodologies. They evaluate whether the manufacturer’s design for monitoring room temperature, humidity, and lighting corresponds to the specific requirements in the vivarium. Perhaps their system is capable of monitoring a wider range of functionality than required. If so, that’s a bonus, but the basic requirements must be met. The manufacturer must also demonstrate through their rigorous testing and validation procedures that the product works in even more complex installations than the buyer’s needs require. With this confidence in the equipment design and per formance, the buyer establishes that their validation efforts need only entail the
implementation of this system in their vivarium.
Back to the garage door. Once I was satisfied that I would not have to validate the entire garage door opener design, and that I could focus just on my specific implementation, I set out to define my detailed user requirements. These were the things that I knew I wanted out of the system functionality for my specific applications.

When I first installed the opener system, I “verified” its basic operation by testing a few of its simple functions. This is very similar to basic commissioning and IQ/OQ of the methodologies mentioned earlier. The IQ is specific to the equipment being installed properly. OQ is demonstrated when the physical operation works and responds according to the program and external influences. These are the examples of the verification criteria and noted IQ/OQ references:

Related Topics: March/April 2005 ALN Environmental Monitoring