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MasterControl Process™

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Data Sheet 2 MasterControl Process™ Challenges MasterControl Solution Inefficient System: A paper-based forms process can be plagued with inefficiency caused by such issues as filling out the wrong form, misplaced forms, having to send the form to one person at a time, and sending the form to the wrong person. Efficient System: Users' ability to launch processes is rights based, reducing the potential for mistakes. Electronic tracking indicates where any task is within a process. Configurable workflows automate routing to appropriate participants and can escalate the task if timelines are not met. Tasks can be processed concurrently by multiple users or even groups. These features taken together achieve the most efficient turnaround possible. Poor Data Capture: With paper forms, the onus lies with the operator to input accurate and complete information on a form. Accurate Data Capture: Companies can use a variety of field formats along with field validation for accurate and accelerated data collection. With the click of a mouse, a user can select from a number of pre-configured options. For ease of administration, these pre-configured options can be stored centrally and used across multiple processes. Poor Data Access: In order to analyze data across multiple paper forms, an analyst must manually and accurately transfer this information to a spreadsheet or other analysis tool. This is a slow, error-prone process that is unlikely to be used widely. Real-time Data Access: MasterControl's Analytics module contains user-configurable reports that always show the latest data at the click of a button. Disconnected Processes: In manual systems, every form is an independent entity that has to be completely and accurately filled out. The relationships between forms cannot be easily navigated, such as when a Complaint triggers a CAPA, because these forms might be stored in different locations. Getting the big picture is difficult because data analysis is a tedious manual process. Connected Processes: MasterControl processes are connected to other related processes, controlled documents, external data repositories, and internal data structures. For example, a Change Control can be launched directly from a CAPA, connecting one process to the next and allowing for easy navigation between the two. Relevant information is automatically passed to the new process, reducing data entry and avoiding mistakes common in manual transfer of information. Product information can be pulled from an ERP system, documents can be attached to a Change Control, and Error Codes for Complaints, Deviations, OOS and other quality processes can be administered from a single internal location. Challenges and Solutions

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