2019 R&D Summit: Quality and Manufacturing Highlights

Check out this recap of 2019 Veeva Quality Summit to hear key takeaways from sessions with Samsung Biologics, Roche, BMS, and more.


Hi guys, this is Mike Jovanis. I’m VP of Vault Quality here at Veeva responsible for the quality solution space. I’m joined today by Kent Malmros, who’s the Senior Director of Vault Training. Last week, we held our 2019 Veeva summit, and Kent and I would like to share some key reflections from the week.

If we look at the key themes that emerged within our discussions, the first is the transformative nature of what’s being done today with these projects, that I’ll speak to more in a moment. We also had a focus on modernizing and unifying quality. And the last was unfolding training into the notion of unification and modernization, which Kent will comment on in just a moment.

The history of quality projects: they really began in the electronic form with the emergence of Part 11 back in the late nineties, and continued for 20 to 25 years during which, homegrown apps and manual processes were replaced, compliance challenges were remediated, resulting in what’s today an aging fragmented solution landscape.

And that created the driver for truly transformative projects. Drilling into a couple of them that were presented, Samsung Biologics was our keynote speaker. They’re a contract manufacturing business based out of Korea, and they have implemented the suite of Veeva quality products and modernized their manufacturing environment. BMS and Roche both presented on QMS transformation initiatives, where both of them will be consolidating multiple legacy QMS apps into a single Vault QMS.

BMS is also collapsing and harmonizing R&D quality with manufacturing quality.
Roche is a different story as they’re harmonizing and consolidating across many different lines of business that were previously separate systems. PRA Health Sciences presented on their unification and harmonization project, where they implemented both Vault QualityDocs and Vault QMS in a three-phase initiative that modernized and brought together all of those different solution spaces into a single Vault. So I’d like to hand it back to Kent who’s going to speak about we did in the training space during the week.

Yeah, thanks, Mike. And I think ending with PRA’s transformation project is a good segue into training because many of the same problems that have plagued other quality systems — document management and quality management — that’s the problem we’re looking to avoid with Vault Training. And so the discussion and the topics of conversation around improvement of GxP and quality training effectiveness are a starting point. And when we talk about the evolution of unified training management, Foamix shared their story about how the maturation of their use of the quality suite going from quality docs into a unified training system was really natural because, in their over 60 combined years within the quality team of quality training experience, they’ve gone through that process. They have had to figure out a way to eliminate training applications, eliminate integrations, and by adding Vault Training, they were able to avoid that.

Dicerna took it another step where they talked about efficiency and effectiveness around the end-to-end life cycle of creating documents and then essentially developing a training program around them in the same application and seamlessly being able to manage, for example, the review and approval of curricula in the same application where they’re delivering assignments and tracking progress on those assignments. Two other customers who joined us for a panel discussion were from Xeris and Xencor. And they shared many of the same sentiments as Foamix and Dicerna, but for them, part of the conversation was, now that we have a unified approach to training management, how can we move ahead and look at training effectiveness differently? How can we combine training outcome data with other quality event data to demonstrate the training is working?

So Mike, I think it was an overall great summit. Thanks for joining us for a few minutes and, of course, thanks for joining us at Summit. Have a good day.

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