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MasterControl Change Control™

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Data Sheet 1 Data Sheet MasterControl Change Control™ Just as with life in general, the only constant in quality management and business is change. In FDA and ISO environments, change control is required as a way of improving product quality and safety — and ensuring compliance. How Can MasterControl Software Solutions Help You? MasterControl Change Control ™ is designed to automate and effectively manage every step of the change control process, from submission through actual implementation, verification, and close of project. MasterControl offers a line of validation products and services addressing different levels of validation needs based on individual risk assessment. They are designed to allow "continuous validation" for FDA-regulated companies by making validation of software upgrades easier, faster, and more cost-effective Here's how MasterControl can ease some of the major challenges in change control: Challenges MasterControl Solution Disconnected Processes: Communication breakdown is likely to happen in a quality management system that consists of disconnected tools and processes. In the context of change control, this could mean lack of follow- up, late notifications, and delays in task completion. Connected: MasterControl is an integrated solution that effectively connects users, data, and processes under a centralized system. This connectivity vastly improves communication and efficiency, and helps ensure that issues don't fall through the cracks. Poor Turnaround: Timeliness is essential in change control. A manual system that relies on paper-based documents to generate necessary data, and legwork to route and track submissions is likely to have poor turnaround for change implementation. Excellent Turnaround: Integrates and streamlines the entire change control process for faster turnaround. It offers a best-practice form that incorporates priority level, as well as escalations. Plus, reports provide real- time status for all change control tasks. Challenges and Solutions

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