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Veeva Announces New Application to Simplify Global Postmarket Surveillance in Medical Device and Diagnostics

Vault Product Surveillance Will Speed Reporting to Health Authorities for Improved Product Quality and Patient Safety

Veeva Systems announced Veeva Vault Product Surveillance, a new cloud application for medical device and diagnostics to simplify and standardize the postmarket surveillance process. Vault Product Surveillance automates electronic health authority submissions seamlessly with proactive complaint handling for faster adverse event reporting. Now companies can better identify and resolve product issues across end-to-end quality management processes to improve patient safety and compliance.

“There’s a significant opportunity for medical device and diagnostics companies to reduce the heavy burden of postmarket surveillance with a modern, consistent global approach,” said Carl Ning, senior director of Veeva Vault Quality for medical device and diagnostics at Veeva. “Veeva Vault Product Surveillance streamlines postmarket surveillance to help companies keep pace with changing regulations and get the insights they need to drive greater innovation and product quality.”

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Highly customized, complex surveillance systems limit visibility into adverse event reporting timelines and disconnect postmarket surveillance from quality and regulatory processes. With Vault Product Surveillance, companies will now have a single application to manage complaint handling and adverse event reporting around the world.

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Vault Product Surveillance unifies critical postmarket surveillance activities such as nonconformance, CAPA, risk management, and internal audit across quality management and regulatory processes. This enables companies to proactively monitor and handle complaints, quickly adapt to regulatory changes, and drive better overall quality outcomes.

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An intelligent global reporting decision tree standardizes and consolidates the complaint reportability process for various health authorities to meet global submission timelines. Real-time, interactive dashboards provide teams visibility into processing and reporting delays so they can take immediate action to resolve issues, complete tasks, and speed submissions.

Vault Product Surveillance adds new capabilities in the Veeva Vault Quality Suite for medical devices and diagnostics to stay ahead of evolving global business and regulatory requirements. Together with Vault QMS, Vault QualityDocs, and Vault Training, companies can manage end-to-end quality processes and content with greater visibility and control.

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