Software validation, sometimes called computer system validation, is an incredibly important part of ensuring that the digital economy remains happy and healthy; in an economy that depends upon digital technology when it comes to earning and reporting profits, ensuring that the software businesses depend upon is working appropriately is of the utmost importance. Despite the fact that software validation remains an essential part of modern life, many companies have begun to divest from software validation processes which ensure the software they depend upon or sell to consumers performs as advertised.
Now more than ever, software validation remains essential. Here’s why the recent trend away from ensuring software is working properly needs to be reversed as soon as possible.
We’re in a regulated era
In this day and age, regulations are growing more common and more strictly enforced. Nevertheless, many companies are skirting their responsibilities when it comes to software validation because it can be a time-consuming and expensive process. Determining that a particular piece of software is performing its advertised functions without producing negative externalities usually demands a great level of expertise, so it’s certainly true that this can be an expensive and lengthy process. It’s nevertheless of essential importance because failing to properly validate your software could lead you to run afoul of regulations, which in turn ends up costing your company huge sums of money and legitimacy.
When you hear about computerized systems validation, then, realize that IT experts are right when they stress the importance of analyzing and validating the function of your software. There are many examples that you can explore to determine what happens when your company runs afoul of regulations; the FDA is fond of sending warning letters to companies which are incapable of properly validating their software, for instance, and they’ll eagerly slap you with a warning and potential fine or penalty should you step over the line.
Reviewing the FDA’s own general principles for software validation is thus highly advised. Medical software providers in particular need to understand that not validating their software could end up costing multiple patients their lives. For the sake of human livelihood and brand longevity alike, don’t think these are regulations which can be ignored. Be careful automating this process, as human oversight is always needed to ensure good outcomes.
Validating software, especially that which ensures medical devices work appropriately, is of the utmost importance now more than ever. Nevertheless, modern companies are avoiding their regulatory responsibilities, which will certainly come back to haunt them.