Reducing Cycle Times With a Single
Global Quality System

With its cutting-edge biotechnology and 70-year heritage in drug discovery, innovation is central to one large biopharma’s mission to improve patients’ lives. As the company grew its operating footprint to 50 markets worldwide, however, it faced a dilemma: how to achieve global consistency and scale without limiting regional autonomy. By transforming its quality system infrastructure to focus on standardization, it realized that it could keep up with patients’ growing unmet needs — and fulfill its mission.

The head of global quality systems sought a system capable of supporting global quality with some regional adjustments. By bringing all quality processes onto the same platform, the company has improved the user experience, increased collaboration, and reduced cycle times.

Regions marching to the beat of their own drums

Following a period of rapid global expansion, each of the company’s regional operations had adopted distinct tools to manage quality processes and documents: some manual or paper-based, others electronic. However, having disconnected systems resulted in inconsistency across its global footprint. The head of global quality systems explains: “While everyone was doing the right thing, there was a lot of wasted time in ensuring and confirming information between regions.”

Combined with manual processes, each market opting for its own approach “didn’t fit with our vision on how to globalize going forward.” Leadership lacked end-to-end visibility into quality processes, making improvements challenging. By unifying and standardizing quality management , it will accelerate drug delivery to patients.

Finding a global solution with regional flexibility

After struggling with disjointed and siloed regional solutions for years, the team decided it was time for change. The company’s vision for digital transformation was to provide one global system with some potential for customization, to accommodate its operations in the U.S., U.K., and Japan, as well as manufacturing sites worldwide. Veeva Quality Cloud would help achieve this goal: “We had to identify the best solution to standardize and globalize our quality management system, and Veeva was our choice.”

“We had to identify the best solution to standardize and globalize our quality management system, and Veeva was the best choice.” – Head of Global Quality Systems

The aspiration was to break down regional silos and make it easier for users to collaborate within the system. Selecting and implementing one quality management platform with Veeva QMS, Veeva QualityDocs, and Veeva Training for global use has improved communication. “Working in a global system made it easier to collaborate,” the head of global quality systems explains. The teams can go beyond the basics by “ensuring compliance and also maintaining consistency across the organization.”

The company created global user communities and is now considering establishing a center of excellence. Community collaboration is a major win and end-user confidence is growing. Since all users are in the same system, teams are more willing to share best practices, reducing the time spent confirming information between regions. Eventually, the center of excellence should help maintain standardization and formalize processes that come from the user communities.

In parallel, incorporating Veeva Training makes it easier to convey updated training requirements directly to users. Once configured, Veeva Training will support compliance by ensuring training is rolled out consistently with any necessary regional specifications.

Reducing cycle times with simplified workflows

By implementing Veeva QMS, QualityDocs, and Training, the company has simplified and automated its workflows. As a result, new processes for executing quality events no longer have manual steps. End-users focus on technical demand ahead of administrative tasks, reducing cycle times for change management, document updates, and user training. “Having global employees working in one space has reduced the cycle times significantly.”

“Having global employees working in one space has reduced cycle times significantly.” – Head of Global Quality Systems

For the first time, the company is working toward a globally consistent change control process directly connecting data from Veeva Quality to Veeva RIM. Change control and variations can be created in Veeva QMS, triggering registration management on the regulatory side. Although still a work in progress, tackling this at the global level means that the team “is actually becoming more efficient with every change control that we process.”

Confident that “we’ve built a quality system that can scale up to any type of changes within the organization,” the company plans to expand its use of Veeva. This entails evaluating Veeva Batch Release for its manufacturing sites and Veeva Medical Suite to improve collaboration with medical affairs to scale as the organization grows.

Advancing proactive quality

Connecting regions on the same platform has given the company a global view of its data for the first time. Greater visibility has prompted progress in tracking and analyzing data. “The globalization of Veeva QMS has created a more data-driven culture within quality,” says the head of global quality systems. “We have a foundation for continuous improvement.”

Having the right enablers in place should help pave the way for AI and predictive analytics use cases. Trending data could be used to reduce the likelihood of specific quality events occurring. “We hope to build up enough data within the system to accurately predict any type of quality issues in the future.”

Learn why companies are making the switch to Veeva Quality Cloud.