Why does the U.S. Food and Drug Administration (FDA) requires companies to validate any software used in design, manufacture, packaging, labeling, storage, installation and servicing of finished devices?

The U.S. Food and Drug Administration (FDA) requires companies to validate any software used in design, manufacture, packaging, labeling, storage, installation and servicing of finished devices. Companies must also use change control to ensure changes to IT systems don’t create unintended risks.

But meeting FDA requirements around software validation and change control isn’t always straightforward, particularly if you don’t have in-house experts to guide the process.

With that in mind, let’s take a closer look at what’s required for initial validation, and how to use change control to maintain a validated Quality Management System (QMS).