Veeva Vault Product Surveillance
Vault Product Surveillance simplifies and standardizes postmarket surveillance for medical devices, improving product safety, reliability, and quality. Fully automated electronic health authority submissions and non-electronic submission outputs ensure timely adverse event reporting. Seamless connection with quality and regulatory processes enables proactive complaints handling, accelerating continuous innovation throughout the product lifecycle.
Benefits
Improve Product Quality and Patient Safety
Proactively identify and resolve product quality issues for greater reliability, safety, and compliance.
Ensure Submission Timeliness
Meet submission timelines with an intelligent, global reportability decision tree with country-specific criteria
Real-time Visibility and End-to-end Control
Make informed business decisions with real-time visibility into submissions and complaint-handling metrics.
Features
Global Reportability Decision Tree
Standardize and consolidate the complaint reportability process for various health authorities through a global decision tree.
Reporting Timeline Management
Efficiently manage event-specific reporting timelines to ensure compliance and timeliness across various health authorities. Enable quality and regulatory teams to allocate resources and prioritize submissions effectively.
Automated Adverse Event Reporting
Built-in XML payload generation and electronic data interchange (EDI) gateway provide a fully automated electronic submission for the FDA electronic medical device reporting (eMDR). Additionally, supports non-electronic submission for the EU manufacturer incident report (MIR).
Interactive Dashboards and Reports
Real-time, interactive dashboards provide clear visibility into inefficiencies and bottlenecks that cause processing and reporting delays. Take action directly from reports to resolve issues and complete tasks to speed the submission process.
Configurable Event Management Workflows
Automate and track events with standard and configurable workflows that provide assignment, routing, email notifications, escalation, and tracking of tasks for groups or individuals.
Part of Veeva Vault Quality Suite
Seamless connection to Vault Quality Suite enables end-to-end quality management improving product quality and patient safety. Unification with core quality processes, such as CAPA management and content management, eliminates the need to build and maintain complex cross-system integrations.
Resources for Vault Product Surveillance
