Medidata Solutions, Inc.

Isaac Wong

Glen De Vries

Matthew Szenher

Andrew Newbigging

Johnlouis Petitbon

Andrew Smith

Joseph Rugilio

Bernardo Pontes

Chad Albers

Anthony Hewer

Jay B Smith

Jay Smith

Aaron Weiner

Benjamin Young

Nolan Carroll

A system for preserving causality of audits may include an upstream service, a downstream service, and an audit service. The upstream service receives a first request including a trace ID and a first span ID, generates a first audit concerning a resource owned by the upstream service and having the trace ID and the first span ID as metadata, persists the first audit to a first database, and generates a second request including the trace ID, a parent span ID, and a second span ID. The downstream service receives the second request from the upstream service, generates a second audit concerning a resource owned by the downstream service and having the trace ID, second span ID, and parent span ID as metadata, and persists the second audit to a second database. The audit service receives and asynchronously centralizes the first and second audits. The metadata can be used to infer causality of the audits. A method for preserving causality of audits is also disclosed and claimed.

System and method for preserving causality of audits

An apparatus for executing a task includes an authenticator to identify a user, a controller that can receive data from the user, and an authorizer to ensure that the user has access to applications used to execute the task. The controller is able to register or de-register the applications and then determine which if the registered applications should be used to execute the task. The controller then converts the data from the user so that it can be used by the application to execute the task. If the user selects a second task to be executed, the controller can determine which of the registered applications is to be used to execute the second task. Methods for executing multiple tasks are also described.

Apparatus and method for executing tasks

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.

Method and system for maintaining data in a substantiated state

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Isaac Wong