Industry prepares for new international compliance standards, driving
accelerated shift to the cloud
SAN JOSE, Calif.--(BUSINESS WIRE)--
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.
Additional Information
For more on Veeva Vault for medical device and diagnostics, visit: veeva.com/MedDevice
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with Veeva on LinkedIn: linkedin.com/company/veeva-systems
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@veevasystems on Twitter: twitter.com/veevasystems
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Veeva on Facebook: facebook.com/veevasystems
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.
Forward-looking Statements
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 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.
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Source: Veeva Systems Inc.