Method and apparatus for producing regulatory-compliant software

Patent metadata

Field	Value
Publication number	US-9767001-B2
Application number	US-201615063485-A
Country	US
Kind code	B2
Filing date	Mar 7, 2016
Priority date	Mar 1, 2013
Publication date	Sep 19, 2017
Grant date	Sep 19, 2017

Abstract

A system for producing a clinical trial software application includes a processor, comprising a validation service and an audit service, and a platform, configured to prove-in an infrastructure on which the software application operates. The software application operating on the infrastructure is the same as the software application previously validated in a validation portal. The proving-in of the infrastructure comprises receiving infrastructure requirements from a software application supplier, building the software application supplier's instances, logging an installation report to the validation portal, and comparing the log to the frozen, validated software in the validation portal. The validation service is configured to validate the software application, freeze the validated software application in the validation portal, and generate documentation that satisfies compliance rules for the clinical trial software application. The validation service receives software code, testable requirements, and test results from a software application supplier and generates documentation regarding the validation of the software application. The audit service is configured to provide evidence of operational change management for a regulatory agency according to compliance rules of the regulatory agency. A method for producing regulatory-compliant software is also described and claimed.

First claim

The invention claimed is:

1. A system for producing a clinical trial software application, comprising:
a processor comprising a validation service and an audit service; and
a platform configured to prove-in an infrastructure on which the software application operates, wherein the software application operating on said infrastructure is the same as the software application previously validated in a validation portal, wherein the proving-in of the infrastructure comprises:
receiving infrastructure requirements from a software application supplier;
building the software application supplier's instances;
logging an installation report to the validation portal; and
comparing the log to the frozen, validated software in the validation portal, wherein the validation service:
is configured to validate the software application, freeze the validated software application in said validation portal, and generate documentation that satisfies compliance rules for said clinical trial software application;
receives software code, testable requirements, and test results from a software application supplier; and
generates documentation regarding the validation of the software application; and

wherein the audit service is configured to provide evidence of operational change management for a regulatory agency according to compliance rules of the regulatory agency.

2. The system of claim 1 , wherein the validation service continuously monitors the validated status of the software application.

3. The system of claim 1 , wherein the validated software application is hosted on a network.

4. The system of claim 1 , wherein the infrastructure comprises a language that runs the software application, number of end-users served by the software application, the types of databases used by the software application, and whether the software application is web-based or deployed in a standalone mode.

5. The system of claim 1 , wherein the infrastructure comprises the existence of load balancing by the software application.

6. A method for producing regulatory-compliant software, comprising:
validating a software application and freezing the validated software application in a validation portal;
proving-in an infrastructure on which the software application operates, wherein the software application operating on said infrastructure is the same as the software application previously validated in said validation portal, wherein the proving-in of the infrastructure comprises:
receiving infrastructure requirements from a software application supplier;
building the software application supplier's instances;
logging an installation report to the validation portal; and
comparing the log to the frozen, validated software in the validation portal; and

providing evidence of operational change management for a regulatory agency, said evidence comprising documentation that satisfies compliance rules of the regulatory agency,
wherein validating the software application comprises:
receiving software code, testable requirements, and test results from a software application supplier; and
generating documentation regarding the validation of the software application.

7. The method of claim 6 , further comprising continuously monitoring the validated status of the software application.

8. The method of claim 6 , wherein the software code and testable requirements include an electronic signature from the software application supplier.

9. The method of claim 6 , wherein a recipe deployment tool is used to build the software application supplier's instances.

10. The method of claim 6 , wherein evidence of operational change management comprises an audit trail.

11. The method of claim 6 , wherein the validated software application is used in a clinical trial.

12. The method of claim 6 , wherein the validated software application is used in a toxicology trial.

13. The method of claim 6 , wherein the validated software application is hosted on a network.

14. The method of claim 6 , wherein the validated software application is used on standalone computers.

15. The method of claim 6 , wherein the regulatory agency is a standard-setting organization.

16. The method of claim 6 , wherein the infrastructure comprises a language that runs the software application, the number of end-users served by the software application, the types of databases used by the software application, the existence of caching, and whether the software application is web-based or deployed in a standalone mode.

17. A non-transitory computer readable storage medium, comprising computer executable instructions embodied therein, to be executed by a computer, for:
validating a software application and freezing the validated software application in a validation portal;
proving-in an infrastructure on which the software application operates, wherein the software application operating on said infrastructure is the same as the software application previously validated in said validation portal, wherein the proving-in of the infrastructure comprises:
receiving infrastructure requirements from a software application supplier;
building the software application supplier's instances;
logging an installation report to the validation portal; and
comparing the log to the frozen, validated software in the validation portal; and

providing evidence of operational change management for a regulatory agency, said evidence comprising documentation that satisfies compliance rules of the regulatory agency;
wherein validating the software application comprises:
receiving software code, testable requirements, and test results from a software application supplier; and
generating documentation regarding the validation of the software application.

18. The non-transitory computer readable storage medium of claim 17 , further comprising computer executable instructions embodied therein, to be executed by a computer, for continuously monitoring the validated status of the software application.

19. The non-transitory computer readable storage medium of claim 17 , wherein the infrastructure comprises a language that runs the software application, number of end-users served by the software application, the types of databases used by the software application, the existence of caching, whether the software application is web-based or deployed in a standalone mode.

20. The non-transitory computer readable storage medium of claim 17 , wherein the infrastructure comprises the existence of load balancing by the software application.

Assignees

• Medidata Solutions Inc

Inventors

• Wong Isaac
• Hewer Anthony
• Petitbon Johnlouis
• De Vries Glen

Classifications

• G06F11/3608 Primary

  using formal methods, e.g. model checking, abstract interpretation (theorem proving G06N5/013) · CPC title

• G06Q30/018

  Certifying business or products · CPC title

• G06F8/73

  Program documentation · CPC title

• G06F11/3664

  Physics · mapped topic

• G06F11/3698 Primary

  Environments for analysis, debugging or testing of software · CPC title