Method and apparatus for producing regulatory-compliant software
A method for producing regulatory-compliant software includes validating a software application and freezing the validated software application in a validation portal, proving-in an infrastructure on which the software application operates, and providing evidence of operational change management for a regulatory agency, which evidence comprises documentation that satisfies the agency's compliance rules. A regulatory-compliant software package is also described.
1. 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 proving-in of the infrastructure on which the software application operates 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 and testable requirements from a software application supplier;
testing the software code to ensure that the testable requirements operate correctly; and
generating documentation regarding the validation of the software application; and
wherein proving-in an infrastructure comprises confirming that the software application operating on said infrastructure is the same as the validated software.
2. The method of claim 1 , further comprising continuously monitoring the validated status of the software application.
3. The method of claim 1 , wherein the software code and testable requirements include an electronic signature from the software application supplier.
4. The method of claim 1 , wherein a recipe deployment tool is used to build the software application supplier's instances.
5. The method of claim 1 , wherein evidence of operational change management comprises an audit trail.
6. The method of claim 1 , wherein the validated software application is used in a clinical trial.
7. The method of claim 1 , wherein the validated software application is used in a toxicology trial.
8. The method of claim 1 , wherein the validated software application is hosted on a network.
9. The method of claim 1 , wherein the validated software application is used on standalone computers.
10. The method of claim 1 , wherein the regulatory agency is a standard-setting organization.
11. The method of claim 1 , 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, the existence of load balancing by the software application, and whether the software application is web-based or deployed in a standalone mode.
12. A computer-implemented system for producing clinical trial software, 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 on which the software application operates 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 a software application, freeze the validated software application in said validation portal, and generate documentation that satisfies compliance rules for said clinical trial software;
receives software code and testable requirements from a software application supplier;
tests the software code to ensure that the testable requirements operate correctly; 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.
13. The computer-implemented system of claim 12 , wherein the validation service continuously monitors the validated status of the software application.
14. The computer-implemented system of claim 12 , wherein the validated software application is hosted on a network.
15. The computer-implemented system of claim 12 , 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, the existence of load balancing by the software application, and whether the software application is web-based or deployed in a standalone mode.
16. 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 on which the software application operates 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 and testable requirements from a software application supplier;
testing the software code to ensure that the testable requirements operate correctly; and
generating documentation regarding the validation of the software application.
17. The non-transitory computer readable storage medium of claim 16 , further comprising computer executable instructions embodied therein, to be executed by a computer, for continuously monitoring the validated status of the software application.
18. The non-transitory computer readable storage medium of claim 16 , 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, the existence of load balancing by the software application, and whether the software application is web-based or deployed in a standalone mode.