Lab Software Quality: What is Validation & Why is it Important?

Software quality is a broad topic and often not well understood by clinical diagnostic laboratories, which is why we thought it might be helpful to offer a quick primer. Commonly, the “quality” of software refers only to its ability to meet a set of requirements. But meeting requirements is just one of many metrics for measuring quality and if you do a quick internet search, you won’t find much agreement about which metrics are the most important.

However, as software developers and consultants, what we can say with certainty is that quality should never be compromised. This is particularly true in regulated industries, especially the clinical lab, where every system
revolves around the delivery of patient-centered healthcare. So, let’s take a step back and look at some quality concepts, beginning with validation.

What is validation?

Validation is the process of establishing evidence that the laboratory method or software does what it’s intended to do. That sounds simple enough, but it can get confusing when it’s used in different contexts.

Laboratory method or clinical validation