Systems and methods for regulatory compliance with qualified systems

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 ASP. 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 majority of the system is 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. After the customer is identified, additional qualification may be performed to customize the system to the customer's specific needs.

What is claimed is: 
     
         1 . A method of facilitating compliance with regulatory requirements for the use of a qualified system, the method comprising:
 qualifying a majority of a software application, wherein qualifying comprises:
 defining and documenting a set of requirements for a software application, wherein said set of requirements is at least partly defined based on regulatory requirements; 
 documenting and testing the software application to demonstrate that the software application, as installed at the location where the software application resides when it is accessed during its intended ordinary use, meets said set of requirements; and 
   granting to a customer access to the software application via a public computer network.   
     
     
         2 . The method of claim  0 , wherein qualifying the software application further comprises determining said set of requirements before a specific customer for the software application is identified. 
     
     
         3 . The method of claim  0 , wherein documenting and testing the software application is done before a specific customer for the software application is identified. 
     
     
         4 . The method of claim  0 , wherein qualifying the software application further comprises qualifying more than 50% of the software application a site other than the customer location. 
     
     
         5 . The method of claim  0 , further comprising performing a review to ensure that the customer meets certain requirements to use the software application such that the software application is used subsequently in a qualified state by the customer. 
     
     
         6 . A computer system for facilitating compliance with regulatory requirements for the use of a qualified system, the computer system comprising:
 an application server operated by an application service provider (ASP);   more than fifty-percent of a software application, said more than fifty-percent of a software application residing in the application server;   a workstation connected to the application server via a public computer network, the workstation configured to allow a customer of the ASP to access the software application; and   documentation that shows that the software application, as installed in the application server, meets with one or more regulatory requirements applicable to the customer.   
     
     
         7 . The computer system of  claim 6 , wherein more than 50% of said documentation is produced without the involvement of the customer. 
     
     
         8 . The computer system of  claim 6 , the customer is not directly involved in generating the documentation. 
     
     
         9 . The computer system of  claim 6 , the customer is not directly involved in developing the software application. 
     
     
         10 . The computer system of  claim 6 , the customer is not directly involved in specifying and/or operating the application server. 
     
     
         11 . A method of complying with regulatory requirements for a qualified software application, the method comprising:
 engaging an application service provider (ASP) to gain access to a software application;   relying on the ASP for more than fifty-percent of a qualification of the software application, wherein said qualification comprises:
 defining and documenting a set of requirements for the software application, wherein said set of requirements is at least partly defined based on regulatory requirements; and 
 documenting and testing the software application to demonstrate that the software application, as installed at the location where the software application resides when it is accessed during its intended ordinary use, meets said set of requirements; and 
   accessing the software application via a public computer network.   
     
     
         12 . The method of  claim 11 , wherein accessing the software application comprises using a workstation, and wherein said workstation has been tested, and documentation produced thereupon, to demonstrate that the workstation, as installed at the location where the workstation resides during its intended ordinary use, performs its purpose as expected. 
     
     
         13 . The method of  claim 11 , wherein accessing the software application comprises accessing an application server operated by the ASP, and wherein said application server has been tested, and documentation produced thereupon, to demonstrate that the application server, as configured at the location where the application server resides during its intended ordinary use, performs its purpose as expected. 
     
     
         14 . The method of  claim 13 , wherein the application server is located a site other than the customer's site. 
     
     
         15 . The method of  claim 12 , wherein the workstation is located at the customer's site. 
     
     
         16 . A system for facilitating compliance with regulations requiring the use of a qualified system, the system comprising:
 an application server managed by an application service provider (ASP);   a software application installed in said application server;   wherein at least 50-percent of a qualification of the software application is completed before a customer of the ASP engages the services of the ASP for the customer subsequently to be able to access the software application, thereby facilitating the customer's compliance with said regulations; and   wherein said qualification comprises:
 defining and documenting a set of requirements for the software application, wherein said set of requirements is at least partly defined based on regulatory requirements; 
 documenting and testing the software application to demonstrate that the software application, as installed at the location where the software application resides when it is accessed, meets said set of requirements. 
   
     
     
         17 . The system of  claim 16 , further comprising monitoring software operated by the ASP to detect whether the customer accesses the software application with a workstation that is in a qualified state. 
     
     
         18 . The system  claim 16 , wherein said application server has been tested, and documentation produced thereupon, to demonstrate that the application server, as configured at the location where the application server resides during its intended ordinary use, performs its purpose as expected. 
     
     
         19 . The system  claim 16 , wherein said set of requirements is defined without the involvement of the customer. 
     
     
         20 . The system  claim 16 , further comprising a workstation, wherein said workstation has been tested, and documentation produced thereupon, to demonstrate that the workstation, as configured at the location where the workstation resides during its intended ordinary use, performs its purpose as expected.