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Insights from Veeva’s Conference on Quality Management

There was a great deal of excitement at the Veeva 2016 Global Summit on clinical, quality, and regulatory. Sessions on ways to incorporate contract manufacturers and suppliers into quality processes attracted a lot of interest from the audience, as companies that have externalized manufacturing functions are struggling with manual processes. With many small organizations starting out as virtual entities and large pharmas continuing to increase outsourcing, challenges with externalization resonated with everyone.

We heard from large and small pharma companies that are leveraging the Vault Quality Suite to bring regiment and efficiency around interchanges with contract manufacturers and partners. “Modern cloud technology enables our organization to seamlessly incorporate vital manufacturing partners into our quality processes, and link processes to relevant documentation for improved compliance,” said Maria Conklin, quality control manager at Karyopharm, a small virtual company focused on treatments for cancer and other major diseases. Vault Quality is also used to gain control over processes with partners for drug stability studies, technology transfer, and contractor manuals, as discussed by a large industry-leading pharma. Even though getting contract manufacturing organizations to leverage partner solutions isn’t always easy, many attendees were enthusiastic to implement these new learnings, as it would significantly benefit both parties.

With the launch of Vault QMS earlier this year, companies also shared plans to move beyond just controlling the interchange of content with partners to incorporating external parties into quality management processes. Furthermore, customers that have implemented both Vault QualityDocs and Vault QMS will gain significant efficiencies in processes like change control, where previously it was fragmented across disparate legacy applications.

This year also had a record number of enterprise companies presenting in the quality track. It was impressive to see the speed at which these large organizations deployed and adopted a cloud-base quality solution. One company transitioned more than 20,000 internal and external users, from quality assurance to manufacturing operations, to Vault QualityDocs in just six months. And, another enterprise company instilled best practices and harmonized quality content operations in more than 60 countries and 15 languages within 12 months.

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