Product Information

MasterControl Reference Model - eCTD JumpStartTM

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Data Sheet 1 Data Sheet MasterControl Reference Model - eCTD JumpStart™ Most companies working on submissions spend an inordinate amount of time locating and collecting documents, training new employees and coping with the complexities of various transactions such as mergers, acquisitions, and product purchases. In an effort to reduce wasted time and money, members of the DIA EDM SIAC have created the EDM Reference Model for eCTD targeted at the pharmaceutical and biologics industry – a best practices reference that helps companies provide consistent naming, metadata and collection of documentation in order to create common structure and consistency across the industry. How Can MasterControl Help Your Organization? MasterControl Reference Model JumpStarts are configuration accelerators comprised of document types, metadata, workflows, lifecycles and taxonomies based on DIA Reference Models to promote standardized document management configuration. The MasterControl Reference Model - eCTD JumpStartTM provides an industry best practice configuration designed to streamline the management of documents identified for use in submissions while facilitating and expediting the export to and/or integration with a submission publishing tool. Whether your organization has already acquired a publishing tool, is planning to acquire one, or is partnering with a regulatory submission publishing partner, MasterControl provides the tools you need to ensure a seamless transition from the management of content for submissions and the publishing of the submission. The MasterControl Reference Model - eCTD JumpStartTM provides not only complete source document management but fully functional submission archiving, which allows users to access their final submissions and utilize navigation tools such as an xml backbone, external hyperlinks, and bookmarks (i.e., eCTD), all while managing agency correspondence within a single, centralized system. The Reference Model - eCTD JumpStartTM is also an integral part of MasterControl's advanced regulatory solutions: • MasterControl Registrations for eCTD • MasterControl Regulatory Suite

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