Vault Product Surveillance (VPS) software simplifies and standardizes postmarket incident reporting management for medical devices and diagnostics, improving product safety, reliability, and quality. Seamless connection with quality and regulatory processes enables proactive complaints handling, accelerating continuous innovation throughout the product lifecycle.
Proactively identify and resolve product quality issues for greater reliability, safety, and compliance.
Meet submission timelines with an intelligent, global reportability decision tree with country-specific criteria.
Make informed business decisions with real-time visibility into submissions and complaint-handling metrics.
Standardize and consolidate the complaint reportability process for various health authorities through a global decision tree.
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.
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, VPS supports non-electronic submission for the EU manufacturer incident report (MIR), Health Canada Vigilance, and TGA Vigilance.
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.
Automate and track events with standard and configurable workflows that provide assignment, routing, email notifications, escalation, and tracking of tasks for groups or individuals.
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.