PLEASANTON, Calif.--(BUSINESS WIRE)--
Alvotech, a biopharmaceutical company specializing in biosimilars,
selected cloud-based Veeva Vault QualityDocs to manage all documentation
with Good Manufacturing Practice (GMP) content.
Being a new company, Alvotech is moving quickly to establish a solid
foundation to become a leading player in the biosimilars market. This
includes construction of a state-of-the-art manufacturing facility,
currently underway in Reykjavik, Iceland, and implementation of a system
to manage procedural GMP-related documentation.
Alvotech has the unique advantage of starting fresh without any existing
legacy systems or ingrained processes. It was important, therefore, for
Alvotech to find a solution that would leverage the most current
practices to establish a lean and effective quality and compliance
system.
Alvotech selected Vault QualityDocs to streamline its quality,
manufacturing, and validation documentation. Alvotech is using Vault
QualityDocs to manage the process and documentation related to the
construction of its new manufacturing facility in Iceland, and it will
be the standard to manage GMP-related content once the company is
operational with production.
Alvotech selected Vault QualityDocs for its fast implementation,
usability, and standard GMP functionality, according to Tinna Madsen,
director, quality systems for Alvotech.
“Vault QualityDoc’s easy-to-navigate user interface and intuitive design
mean our staff across sites can easily access and collaborate on GMP
critical content,” said Madsen. “And our users can complete ‘read and
understood’ tasks directly in Vault QualityDocs to ensure consistency
and compliance with new employee onboarding.”
Alvotech successfully implemented Vault QualityDocs quickly and without
a lot of customization, which were key factors in the selection process.
“Time was of the essence for us, especially given our ambitious growth
plans,” said Gudmundur Oskarsson, Alvotech CIO. “We didn’t have much
time to spend on customization. Vault QualityDocs gives us a solution
that is purpose-built for efficiently managing GMP-related content. And
with Vault QualityDocs, we knew we could be up and running fast without
having to set up any infrastructure.”
Additional Information
For more on Veeva Vault QualityDocs, visit: veeva.com/qualitydocs
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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 375 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 www.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, 2015. 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20151209005321/en/
Source: Veeva Systems Inc.