Article | May 28, 2014

Improving Computerized System Quality Through Design Verification

Source: ProPharma Group, Inc.
Mike Byrd

By Mike Byrd, Director of Computer System Validation, ProPharma Group

For those of us who travel routinely, one of the most sought after treasures in the typical airport terminal is an electrical outlet. With our dependency on mobile devices and technology, access to a continuous power supply while on the move is a necessity. This is all too often realized when you get that annoying message on your smartphone that your battery is critically low and you need to connect your charger … and all available outlets in your immediate vicinity are taken by fellow travelers.

Fortunately some airlines are recognizing this growing need and providing multi-outlet charging stations for their flying customers. I was fortunate enough to locate an unoccupied charging station on a recent trip only to discover that it was inoperable. I checked behind the unit and found that it was unplugged, as the outlet could not accept a fourth plug due to outlet and cord configurations.

This situation could have been avoided with a simple design/specification verification of outlets and plugs before deploying the units to the terminals. So what does this have to do with software quality/system validation? This example hardly impacts any pharmaceutical product quality or patient safety. The fact is, similar situations often arise when reviewing validation plans and auditing system life cycle documentation.