AstraZeneca: Preparing for Rapid Manufacturing Growth With Unified Digital Validation

With 32 manufacturing sites operating across 150 countries, AstraZeneca needed a globally consistent, real-time solution to digital validation.

An over-reliance on paper, combined with distinct, site-specific processes, had increased compliance risks, reduced visibility, and led to duplicative effort over time. “Each site was writing a user requirements specification (URS) for the same qualification activity,” recalls Anup Samantaray, AstraZeneca’s IT quality capability lead for operations IT. “If the equipment doesn’t change, the requirements shouldn’t change either.”

Given its ambitious goal to launch 23 new medicines by 2030, the global biopharma chose not to delay and selected Veeva Validation Management. By unifying digital validation with Veeva QMS and Veeva QualityDocs, AstraZeneca now benefits from:

• Integrated quality and validation processes, data, and content
• Faster cycle times
• Continuous rollout of innovation
• Improved right-first-time (RFT) metrics

The transition to unified digital processes has given AstraZeneca a paperless validation approach that improves compliance. As Samantaray notes, “We’re not printing paper and creating binders. The data integrity is high, and quality and compliance are increasing across the board.”

Pivot to paper-free validation

Having initially assessed the quality technology landscape, Samantaray’s team found an industry fraught with gaps and lacking solutions to track real-time information.

A long-standing partnership with Veeva offered the chance to address this by integrating business processes across quality and validation. When QMS, QualityDocs, and Validation Management are unified, all validation and quality activities can happen in one place. “A lot of the work in validation stems from an issue or deviation occurring, resulting in a CAPA. With our tightly coupled integration, the system triggers in the same place, providing a seamless way to go from quality management into validation management,” explains Samantaray.

Teams can now leverage a single source of truth — all data is centralized while quality events and documents are linked and can be attached to validation activities. This standardized approach ensures data reusability and consistent quality while improving audit readiness.

As Validation Management is a natural extension of the Vault Platform, users encounter a familiar interface and no longer have to switch between different systems: “The look and feel of validation is similar, which is really helpful,” says Samantaray.

While traditional on-premises software quickly becomes stagnant and requires costly ‘major-version’ upgrades every few years, AstraZeneca now benefits from three annual Veeva releases of updated features and new innovations. “One of the best features of Veeva Quality Cloud is that you’re truly in continuous improvement mode — we’re no longer creating big programs to upgrade systems every three or four years,” points out Samantaray. “It means we can be agile, keep current, and adopt innovations like AI in a fast way.”

Faster, right-first-time processes

Following a 2025 go-live at a greenfield site in China, AstraZeneca’s rest-of-world rollout continues into 2026.

The anticipated impact of Validation Management will be clear and measurable. Before the implementation, quality events connected to validation consistently rose every year, from 4000 in 2022 to over 6000 in 2025. With Validation Management, projected event figures for 2026 predict an overall decrease for the first time, driven by more efficient, right-first-time validation processes. Initial data after go-live indicates event cycle times are on track to fall by 20%.

As more sites adopt Validation Management, the team will determine program success and site-specific adoption by continuing to monitor:

• User adoption and satisfaction data
• Reduced use of paper (in line with sustainability goals)
• Cycle time and RFT metrics

In the future, Samantaray’s team plans to further optimize digital validation by focusing on:

• Risk-based validation. Reducing unnecessary testing will speed validation processes
• Agentic AI. Leveraging AI automation will make daily work, such as impact assessments and authoring, faster and easier

Samantaray adds, “Gone are the days of executing a test script with pen on paper. Everything’s electronic and generated in the system. From a manufacturing standpoint, sites will be free to do other things because of the efficiency gains.”

Discover how Veeva Validation Management streamlines validation processes and reduces cycle times.