Abstract: A user (e.g., a CMC scientist) identifies a change in CMC data for a regulated product, service, or system provided by an organization. A change assessment engine provides a recommendation for regulatory impact reporting. The recommendation may include a rationale and supporting evidence. The recommendation may identify the markets where the product, service, or system is registered, an indication of potential reportability in that market, specific health authority regulations that apply, and direct linkages into an internal regulatory knowledge repository of the organization. The change assessment engine may drive a user interface that guides users through the process in a consistent and repeatable manner.

Abstract: A dossier change control management system periodically ingests data regarding a regulated product from multiple data stores. The dossier change control management system updates dossier data describing a dossier history for the regulated product using the received data. The dossier includes multiple documents in a standardized format and is updated based on a data mapping indicating correspondence between fields of the documents and portions of the received data. An out-of-expectation scenario for the dossier is identified based on regulatory requirements and an alert generated. A report with information about the out-of-expectation scenario is provided for display at a client device based on the alert.