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US 8,266,578 B2Granted
Virtual validation of software systems
AssigneesAngela Bazigos, Christopher Hanson
InventorsAngela Bazigos, Richard Lumkin
Life of this patent
Estimating the term…
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.
Claims18
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.
11 more elements
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.
11 more elements
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 more elements
Dependencies are inferred from the claim text.