Veeva Systems (NYSE: VEEV) today 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.”
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.
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 today, Veeva announced Veeva Vault Signal, the industry’s first solution that seamlessly manages signals from identification through risk evaluation and mitigation. Read today’s press release to learn more.
Vault Product Surveillance is planned for availability by the end of 2020. To learn how Vault Product Surveillance will help standardize postmarket surveillance, register for an upcoming webinar on May 13 at veeva.com/SurveillanceWebinar.
For more on Veeva Vault Product Surveillance, visit: veeva.com/VaultSurveillance
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About Veeva Systems
Veeva Systems Inc. is the leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 850 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices throughout North America, Europe, Asia, and Latin America. For more information, visit veeva.com.
This release contains forward-looking statements, including the market demand for and acceptance of Veeva’s products and services, the results from use of Veeva’s products and services, and general business conditions, particularly in the life sciences industry. Any forward-looking statements contained in this press release are based upon Veeva’s historical performance and its current plans, estimates, and expectations, and are not a representation that such plans, estimates, or expectations will be achieved. These forward-looking statements represent Veeva’s expectations as of the date of this press announcement. Subsequent events may cause these expectations to change, and Veeva disclaims any obligation to update the forward-looking statements in the future. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially. Additional risks and uncertainties that could affect Veeva’s financial results are included under the captions, “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in the company’s filing on Form 10-K for the period ended January 31, 2020. This is available on the company’s website at veeva.com under the Investors section and on the SEC’s website at sec.gov. Further information on potential risks that could affect actual results will be included in other filings Veeva makes with the SEC from time to time.