Industry prepares for new international compliance standards, driving accelerated shift to the cloud
SAN JOSE, CA — MedTech Conference — Sept. 25, 2017 — Today at Advamed’s 2017 MedTech Conference, Veeva Systems (NYSE: VEEV) announced that Veeva Vault is helping a growing number of medical device and diagnostics companies improve quality and efficiency to meet new compliance standards. In less than one year, Veeva has seen nearly 25% growth in medical device and diagnostics customers as organizations prepare to meet rigorous compliance requirements from global health authorities and the international standards organization (ISO). Now, nine of the world’s top 15 medical device companies are implementing Veeva Vault, including leaders such BD (Becton, Dickinson and Company).
New compliance requirements are expected to significantly impact medical device and diagnostics operations. Beginning March 2019, the 2016 revision to ISO 13485 will require that risk management is incorporated into every aspect of the quality management system. Additionally, the European Commission ratified new medical device regulations for all European member states, while the U.S. Food and Drug Administration released more than a dozen new medical device guidance documents in 2016 and 2017 that set new expectations for risk assessment.
“We needed a scalable, global, and easy-to-use content management solution that would adapt to expanding business and compliance needs, and meet multiple stakeholder requirements. Veeva Vault transforms how we access and manage critical documentation,” said Orit Magyar, head of quality systems and processes at Coloplast. “We are already seeing faster document approval and tighter control. And, with real-time visibility, we can see where content stands, so bottlenecks or problems can be resolved immediately – not weeks later.”
Similar to Coloplast, companies are adopting Veeva Vault to increase collaboration, transparency, automation, and efficiency. Veeva Vault is the only platform and suite of cloud applications designed to manage regulated content and data across the product lifecycle. From discovery to product design in clinical, quality, and commercial, Veeva Vault ensures global consistency that device makers need to meet today’s challenges, stay compliant, and continuously innovate.
“Medical device and diagnostics companies recognize the urgent need to improve content and data management across functions, and are turning to Veeva as a proven cloud technology provider,” said Melonie Warfel, vice president of medical device and diagnostics at Veeva. “Customers can unify their processes from end-to-end with Veeva Vault to increase quality and efficiency while gaining valuable insights across the product lifecycle that they can build upon with each new product in development.”
To learn more about Veeva Vault, visit Veeva booth #616 at MedTech for a live demo. Also, see a presentation during the conference on Wednesday, September 27, at 10:10 a.m. in Hall 1 & 2, Solutions Showcase Stage.
About Veeva Vault for Medical Device & Diagnostics
Veeva Vault provides medical device and diagnostics companies with a flexible content and data management platform and suite of applications for clinical with Vault eTMF and Vault CTMS; quality with Vault QMS and Vault QualityDocs; and commercial with Vault PromoMats and Vault MedComms. Learn more about how Veeva Vault helps medical device and diagnostics companies ensure global consistency and speed time to market by visiting veeva.com/MedDevice.
For more on Veeva Vault for medical device and diagnostics, visit: veeva.com/MedDevice
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About Veeva Systems
Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva has more than 550 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices in 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-Q for the period ended July 31, 2017. This is available on the company’s website at www.veeva.com under the Investors section and on the SEC’s website at www.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.