To support their increasing regulatory activity, bluebird bio decided to overhaul their use of Veeva Vault RIM. Previously, the company used Vault RIM to approve and store documents, but they hadn’t yet transformed how people worked or accessed information. Staff still tracked submissions with spreadsheets and other tools, which made finding the right documents or information unnecessarily time-consuming. The company wanted to improve efficiency and visibility by rolling out Vault RIM to support regulatory initiatives and processes.

Phased Optimization Approach

bluebird bio designed a two-phased implementation plan to support their vision of one platform for regulatory initiatives and processes. Prior to the implementation, bluebird bio engaged with Veeva’s RIM business process consulting team to define their future state roadmap and implementation approach. The first phase of the implementation helped bluebird bio get the right infrastructure in place to adopt the planned functionality. They also took a deep look at the system’s data fields, defining the relationships needed to connect and report on regulatory information.

In the second phase, the regulatory team partnered with training and change management experts to build a global user adoption strategy. The team created a centralized training website with work instructions, checklists, videos, how-to guides, and other resources. In addition to easing people into new ways of working, user enablement emphasized adherence to best practices, like adding metadata to documents.

Benefits for Regulatory Users

With this Vault RIM relaunch, bluebird bio’s regulatory users have more information at their fingertips. They’re able to check submission status in a real-time dashboard and quickly retrieve documents associated with a health authority commitment or interaction. Most importantly, the enhanced RIM solution enables regulatory operations to work more efficiently and effectively. bluebird plans to connect Vault RIM to other Vault applications, which will extend these benefits across the company.

“This forward-looking strategy is going to make our Veeva RIM investment an asset for regulatory and other parts of the company.” – Scott Cleve, Vice President Regulatory Operations and Compliance, bluebird bio

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