Cloud computing

When quality or production systems run in the cloud, the provider is part of the system. Computer software assurance and supplier controls then have to cover what the provider does, not only the software the company configures.

Cloud computing is a model for enabling ubiquitous, convenient, on-demand network access to a shared pool of configurable computing resources (e.g., networks, servers, storage, applications, and services) that can be rapidly provisioned and released with minimal management effort or service provider interaction. This cloud model is composed of five essential characteristics: on-demand self-service, broad network access, resource pooling, rapid elasticity, and measured service. The cloud is composed of three service models: software as a service (SaaS), platform as a service (PaaS), and infrastructure as a service (IaaS). The cloud model is also composed of four deployment models: private cloud, community cloud, public cloud, and hybrid cloud.

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