Method and apparatus for producing regulatory-compliant software

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United States of America Patent

PATENT NO 9767001
SERIAL NO

15063485

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Abstract

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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.

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Patent Owner(s)

Patent OwnerAddress
MEDIDATA SOLUTIONS INC79 FIFTH AVENUE 8TH FLOOR NEW YORK NY 10003

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Inventor(s)

Inventor Name Address # of filed Patents Total Citations
de, Vries Glen New York, US 14 70
Hewer, Anthony Canterbury, GB 2 18
Petitbon, Johnlouis Brooklyn, US 5 34
Wong, Isaac New York, US 11 216

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