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Missed the 2015 R&D Summit: Quality and Manufacturing Track? Get the Recap Here!

Over 450 people attended the 2015 Veeva R&D Summit in early November to share how cloud has quickly transformed operations by supporting agile and distributed business models. With increased outsourcing of key development and manufacturing functions, one of the hot topics was how to manage data and content for a product lifecycle when most of the information is externally generated. Top life sciences companies outlined how they are incorporating Vault QualityDocs into operational processes to support data quality, and ensure content traceability with vendors such as contract test labs and manufacturers — improving collaboration, reducing cycle times, and supporting faster decision-making.

Impax Labs discussed their global deployment of Vault QualityDocs to more than a 1,000 users, and how the application’s built-in best practices accelerated implementation. The solution supports local processes and multiple languages, while allowing Impax to gain greater control, operational efficiency, and visibility into quality processes. Other highlights include an interactive session led by Nancy Singer, who currently trains FDA investigators, and Bob Kenney on how to write records for regulatory compliance and use Vault QualityDocs to support company policies.

Many of the presentations also touched on validation. Even though the Veeva Vault applications are designed for a highly regulated industry with stringent validation requirements, it was great to hear first-hand from companies that have been through multiple releases. Customers say the validation process is much easier due to Veeva’s comprehensive validation package with each release that includes IQ and OQ tests. Veeva’s validation documentation and methodology has significantly reduced the burden for companies. You can access select presentations from the Summit here, and I look forward to another great event next year. Block October 17-19, 2016 on your calendar today.

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