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MasterControl Submissions Ready™

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Data Sheet 1 Data Sheet MasterControl Submissions Ready™ MasterControl Submissions Ready™ allows organizations to accelerate the preparation and organization of submissions documents utilizing FDA- and ICH-compliant submissions templates in combination with MasterControl's unrivaled document management solution. MasterControl's integrated solution ensures that authors are using the most up-to-date version of a template and that submission documents are securely stored and organized in a logical file structure. Who Can Benefit from MasterControl Submissions Ready? • Manufacturing/Operations: Rather than wasting time rewriting internal reports for submissions, manufacturing and operations personnel can use MasterControl to reuse documents and author documentation on compliant templates at the correct level of granularity. • Medical Writers: By providing compliant templates and a correct format up front, MasterControl eliminates the need to rewrite reports and other documents for submissions purposes. MasterControl also minimizes revisions by ensuring that each document has a consistent voice. • Regulatory: MasterControl simplifies the search for and inventory of submissions documents. The system automates the routing of documents for approval and provides an easy-to-follow trail of document approvers. • Clinical: With MasterControl, clinical personnel don't have to worry about tearing apart study reports to rewrite them with correct templates. In addition, MasterControl's centralized electronic document repository eliminates the need to search paper archives for trial documentation. • Management: MasterControl can provide a comprehensive solution for any organization regardless of existing in-house capabilities. Whether the organization simply needs training on the system's functionality or requires assistance configuring the system to specific needs, Submissions Ready can be packaged with any level of service and support the organization requires. An organization lacking knowledge of particular requirements that must be addressed can have MasterControl's expert advisory team analyze the circumstances and develop and clearly map out those requirements.

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