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MasterControl Field-Based Solutions (FBS) Event Report™

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Data Sheet 2 MasterControl Field-Based Solutions (FBS) Event Report™ MasterControl FBS Event Report Features and Benefits at a Glance: • Real-time capture of quality events. Upon launch, the initial form workspace allows you to record the essential details about an event (e.g., product- related information, dates, event data, etc.), as well as any immediate containment or correction actions taken. • Configurable processes. Depending on the needs of your company, you can configure the solution to provide quality personnel with the option to address quality events by: - Correcting and documenting; - Classifying and launching another quality event form (e.g., MasterControl FBS Customer Complaint, Deviation, OOS/OOT, etc.); - Proceeding straight to issue review or; - Performing an investigation. • Risk-based disposition. When configured for an investigation, the built-in risk assessment provides quality personnel with consistent and objective guidance on when to escalate to CAPA – based on your business policies and pre-determined criteria. • Automatic communication tracking. FBS Event Report allows you to compile a record of all email correspondence – both internal and external – related to a form and stores it in an easily accessible Communications Log, which is automatically included as part of the audit trail. • Dynamic routing. MasterControl FBS technology allows you to easily configure the system to route quality event forms by location/site, event type, or a combination of the two by setting up and assigning the relevant roles. About MasterControl MasterControl Inc. creates software solutions that enable life science and other regulated companies to deliver life-improving products to more people sooner. MasterControl's integrated solutions accelerate ROI and increase efficiencies by automating and securely managing critical business processes throughout the entire product lifecycle. More than 1,000 companies worldwide, ranging in size from five employees to tens of thousands, rely on MasterControl cloud solutions to automate processes for new product development, clinical, regulatory, quality management, supplier management, manufacturing and postmarket surveillance. MasterControl solutions are well-known for being scalable, easy to implement, easy to validate and easy to use. For more information, visit © 2019 MasterControl Inc. All rights reserved. DSDVXX0USENLT-01/19

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