Virtual validation of software systems

• US 8,266,578 B2
• Filed: 01/09/2008
• Issued: 09/11/2012
• Est. Priority Date: 01/10/2007
• Status: Active Grant

• Current Assignee: Virtual Purple LLC
• Original Assignee: Angela Bazigos, Christopher Hanson
• Inventors: Lumkin, Richard, Bazigos, Angela
• Primary Examiner(s): Wong, Don
• Assistant Examiner(s): Rivera, Anibal
• Application Number:
  US12/008,297
• Publication Number:
  US 20080178144A1
• Time in Patent Office: 1,707 Days
• Field of Search: None
• US Class Current: 717/101
• CPC Class Codes: G06F 11/3604 Software analysis for verifying properties of programs byte-code verification G06F9/44589
• CPC Class Codes: G06F 8/20 Software design

Abstract

A method for building and verifying and validating a software system that is used for regulated industry software related activities, such as FDA trials, field trials, biomedical data gathering, and similar efforts includes building the application into a virtual appliance using, for example, Vmware. The application and the supporting software are encapsulated in a single virtual file to create a virtual appliance that is independent of hardware and dependent only on virtual appliance support.

Claims

1. A method for constructing and validating a software system for a data intensive activity, including the steps of:

creating a user requirements specification for a first software system;

developing a project specific validation plan for the first software system based on the user requirements specification;

developing a functional specification based on the user requirements specification;

selecting first set of software applications to carry out the functional specification and selecting virtual appliance support software to run the selected software applications;

building the first software system by combining said software applications and said virtual appliance support software to form a virtual appliance; and

validating said first software system by validating said virtual appliance;

wherein the validating said software system by validating said virtual appliance comprises confirmation by examination and provision of objective evidence that the user requirements specification conforms to user needs and intended uses, and that requirements implemented by the software can be consistently fulfilled;

creating a second user requirements specification for a second software system;

developing a second project specific validation plan for the second software system based on the second user requirements specification;

selecting a second set of software applications including the first set of software applications including the validated virtual appliance;

building the second software system by combining said second set of software applications including the validated virtual appliance; and

validating said second software system by validating said second set of software applications including the validated virtual appliance, using previously developed knowledge of components of first set of software applications in the validated virtual appliance.

2. The method for constructing and validating a software system of claim 1, wherein said first software system is designed to operate under known operating system software, and said validating step includes verification of the virtual appliance under the known operating system software.

3. The method for constructing and validating a software system of claim 2, further including the step of entry of values for pre-populated lists through the use of automated software means.

4. The method for constructing and validating a software system of claim 2, further including the step of bypassing installation validation of the first software system through the use of validated virtual appliance installation in the known operating system software.

5. The method for constructing and validating a software system of claim 2, further including the step of validating at least one component of the software system through inferred qualification based on previously developed data regarding said at least one software component when operated within the virtual appliance.

6. The method for constructing and validating a software system of claim 2, further including the step of operating the software system in a plurality of computer environments using the known operating system software.

7. The method for constructing and validating a software system of claim 2, wherein said virtual appliance is independent of hardware and dependent only on virtual appliance support for operating under the known operating system software.

8. The method for constructing and validating a software system of claim 3, wherein said automated software means includes importing values from a database management program.

9. A method for constructing and validating a software system for a data intensive activity, including the steps of:

creating a user requirements specification for a first software system;

developing a project specific validation plan for the first software system based on the user requirements specification;

developing a functional specification based on the user requirements specification;

selecting first set of software applications to carry out the functional specification and selecting virtual machine support software to run the selected software applications;

building the first software system by combining said software applications and said virtual appliance support software to form a virtual appliance; and

validating said software system by validating said virtual appliance;

creating a second user requirements specification for a second software system;

developing a second project specific validation plan for the second software system based on the second user requirements specification;

selecting a second set of software applications including the first set of software applications including the validated virtual appliance;

building the second software system by combining said second set of software applications including the validated virtual appliance; and

validating said second software system by validating said second set of software applications including the validated virtual appliance, using previously developed knowledge of components of first set of software applications in the validated virtual appliance;

wherein said software validated by validating said virtual appliance is subject to regulatory review and approval.

10. The method for constructing and validating a software system for a data intensive activity of claim 9, wherein the regulatory review and approval comprises food and drug administration (FDA) review and approval.

11. The method for constructing and validating a software system for a data intensive activity of claim 9, wherein the regulatory review and approval comprises review and approval for field trials.

12. The method for constructing and validating a software system for a data intensive activity of claim 9, wherein the regulatory review and approval comprises review and approval for biomedical data gathering.

13. The method for constructing and validating a software system for a data intensive activity of claim 9, including providing a final validation report based on the validating said software system by validating said virtual appliance, wherein the validation includes confirmation by examination and provision of objective evidence that the user requirements specification conforms to user needs and intended uses, and that requirements implemented by the software can be consistently fulfilled.

14. A computer system comprising a validated software system for a data intensive activity, the validated software system including:

hardware;

a second software system that includes a first software system; and

a validated virtual appliance associated with the hardware the validated virtual appliance comprising software applications and virtual appliance support software;

wherein the validated virtual appliance is built by;

creating a user requirements specification for a first software system;

developing a project specific validation plan for the first software based on the user requirements specification;

developing a functional specification based on the user requirements specification;

selecting software applications to carry out the functional specification and selecting virtual machine support software to run the selected software applications;

building the first software system by combining said software applications and said virtual appliance support software to form the virtual appliance;

validating said first software system by validating said virtual appliance;

wherein the validating said software system by validating said virtual appliance comprises confirmation by examination and provision of objective evidence that the user requirements specification conforms to user needs and intended uses, and that requirements implemented by the software can be consistently fulfilled;

creating a second user requirements specification for a second software system;

developing a second project specific validation plan for the second software system based on the second user requirements specification;

selecting a second set of software applications including the first set of software applications including the validated virtual appliance;

building the second software system by combining said second set of software applications including the validated virtual appliance; and

validating said second software system by validating said second set of software applications including the validated virtual appliance, using previously developed knowledge of components of first set of software applications in the validated virtual appliance.

15. The computer system of claim 14, wherein said first software system is designed to operate under known operating system software, and said validating step includes verification of the virtual appliance under the known operating system software.

16. The computer system of claim 15, wherein the validated virtual appliance is further built by bypassing installation validation of the software system through use of validated virtual appliance installation in the known operating system software.

17. The computer system of claim 14, wherein the said software validated by validating said virtual appliance is subject to regulatory review and approval.

18. The method of claim 17 wherein the regulatory review and approval comprises Food and Drug Administration (FDA) review and approval.