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MasterControl eMDR™ Enhanced Forms

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Data Sheet 1 Data Sheet MasterControl eMDR™ Enhanced Forms The U.S. Food and Drug Administration's (FDA) medical device reporting (MDR) regulation 21 CFR Part 803 requires device manufacturers to report any deaths or serious injuries as well as certain malfunctions associated with their devices. While critical, this reporting process can be both time and resource intensive, especially when it's managed using paper-based or disconnected systems. MasterControl eMDR™ enables you to digitize your adverse event reporting process and integrate it with your quality management system. The best practice solution is designed to meet the requirements for digital forms processes within FDA-regulated and GxP environments, including compliance with 21 CFR Part 11. This means events are appropriately documented and digitally maintained in a centralized, secure repository which not only improves compliance and audit-readiness, but also saves you valuable time and resources. Built using data structures, the solution is easily configured by toggling features on and off to support the business needs and processes of any med device company. Development Clinical Regulatory Quality Supplier Manufacturing Postmarket Cx Rx Qx Sx Mx Px Dx

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