Medidata Solutions, Inc.

Johnlouis Petitbon

Isaac Wong

Glen De Vries

Anthony Hewer

Matthew Szenher

Andrew Newbigging

Benjamin Young

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.

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.

A method for maintaining data in a substantiated state includes executing one or more services on the data message at a first node, annotating the message header with the services executed at the first node, transmitting the data message over a data network, and receiving the annotated data message at a second node. The annotation corresponds to the services executed at the first node, and the annotated data is extractable from the header for the execution of services at the second node. A system for maintaining data in a substantiated state is also described.

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Johnlouis Petitbon