Software as a service (SaaS)

In FDA guidance on computer software assurance, SaaS is one of the ways production and quality system software is delivered. The manufacturer still has to show the software is fit for its intended use, even though the supplier controls the infrastructure and updates.

The capability provided to the consumer is to use the provider’s applications running on a cloud infrastructure. The applications are accessible from various client devices through either a thin client interface, such as a web browser (e.g., email), or a program interface. The consumer does not manage or control the underlying cloud infrastructure including network, servers, operating systems, storage, or even individual application capabilities, with the possible exception of limited user-specific application configuration settings.

FDA guidance: Computer Software Assurance for Production and Quality Management System Software (February 2026), Section IV, Definitions