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.

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.

Abstract: 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.

Abstract: A method for substantiating a data message for use in a system includes adding discovery information to the data message related to the origin of the data message, validating the data message to comply with an industry standard, authenticating the data message to determine who transmitted the data message, and authorizing the transmission of the data message based on access rights. A method for generating a substantiated system is also described.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: A method and system of social networking is provided. A computer-readable medium including instructions for the social network is also provided. The method or system can include mutable widgets. A user decorates a room web page with the mutable widgets and can change the look and content of the widget. The widget can include tracking features and advertisements. A user can visit other rooms and copy widgets and the content of the widgets to the user's room.