Method and apparatus for producing regulatory-compliant software
US9767001B2 · kind B2 · utility
Assignee
Inventors
Key dates
| Filing date | Mar 7, 2016 |
| Grant date | Sep 19, 2017 |
| Priority date | — |
| Expiry date | Apr 26, 2036 |
Classification
- Technology area (CPC G)Physics
- CPC primaryG06Q30/018
- WIPO fieldComputer technology
- WIPO sectorElectrical engineering
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 eviden…
Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.