“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.”
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.
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.
Vault Product Surveillance is planned for availability by the end of 2020.
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.
In other news, Veeva announced Veeva Vault Signal, the industry’s first solution that seamlessly manages signals from identification through risk evaluation and mitigation. Vault Signal unifies signal management processes so pharmacovigilance teams can easily manage safety signals with greater visibility across the entire signal workflow. Together with Vault Safety, Vault SafetyDocs, and Vault Safety.AI, Veeva offers the only comprehensive suite of cloud applications on a single cloud platform to manage the drug safety lifecycle, from case intake to signal detection and risk management planning.
“Veeva Vault Signal is welcome news for companies looking for an efficient, one-stop solution for drug safety,” said Marc Morris, vice president, safety and pharmacovigilance at Apellis Pharmaceuticals. “Streamlining adverse reaction data, signal analysis, and action with one platform will make safety risk management simpler and faster, as well as free up my group’s resources.”
Vault Signal analyzes and segments adverse event data from customers’ safety databases and external global health authorities. Pharmacovigilance teams can more readily identify and manage signals, improving future risk mitigation. Vault Signal is easily tailored to align with every signal management process and meet the needs of any business, from large pharmaceutical companies to emerging biotechs.
“Veeva is delivering a modern approach to signal management that will speed up how pharmacovigilance teams analyze data, detect and evaluate signals, and perform risk mitigation,” said Kelly Traverso, vice president of safety strategy at Veeva. “Veeva Vault Signal will give organizations the full visibility and traceability they need to drive compliance in patient safety.”