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Data Sheet 1 Data Sheet MasterControl Explorer Gateway™ The FDA's 21 CFR Part 11 allows regulatory information to be signed and submitted electronically and permits the use of electronic record-keeping systems in complying with predicate rules. While automated submission tools can cut costs and save time, they can only be as useful as the submission's content will allow. A submission tool is an advantageous conduit in the submissions process, but just as crucial is a mechanism that can ensure controlled, quality content in the regulatory submission. How Can MasterControl Help You? To guarantee submission consistency, companies in regulated environments demand that quality initiatives be integrated into the corporate culture organization-wide. The MasterControl Explorer Gateway™ responds to those demands by ensuring control in assembling and tracking documentation vital to submissions. The enhanced Explorer Gateway is specifically designed to help companies meet the requirements for good document control within the confines of FDA-regulated GxP environments, including compliance with 21 CFR Part 11. While every company preparing a submission uses its submission tool of choice, it still requires an effective means of controlling documents and maintaining shared submission-related files in a secure submission repository. MasterControl provides a centralized repository that controls the creation, sharing and documentation of submission-related files, regardless of the submission tool in use. Here's how MasterControl addresses key submission preparation challenges: Challenges MasterControl Solution Inefficient Process: FDA submissions (e.g., for a NDA or IND) can entail thousands of pages that need to be managed, compiled, published, and revised. With a paper-based system, the process can be overwhelming and is prone to error and delay. Efficient Process: MasterControl's centralized repository for all regulatory submission documents makes search and retrieval easy. A single repository also simplifies follow-up submissions and reduces potential agency questions. MasterControl integrates with a company's existing submission tool to streamline and optimize the e-submission process. Challenges and Solutions

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