PLEASANTON, CA — Dec. 9, 2015 — 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.
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