Abstract: Disclosed are systems and methods for facilitating compliance with regulatory requirements concerning systems that must be qualified prior to use. In one embodiment, a qualified system is provided. The qualified system includes a qualified server and a qualified software application. The qualified system is located in a controlled environment specified and controlled by an application service provider. A qualified workstation is provided at the point of use. The qualified workstation and qualified system are configured to communicate with each other via a public computer network. The qualified system is substantially qualified before a specific customer is identified. Other embodiments of the invention pertain to methods of facilitating regulatory compliance. An exemplary method involves qualifying a system based on a generic functional requirement specification before identifying a specific customer for the system.