Merck KGaA: Driving Quality Transformation Across the Enterprise

With diverse global operations in more than 66 countries, quality management across Merck KGaA’s three business sectors had become complex. The company’s quality processes and technology were disparate and did not address the need for corporate oversight. This led to a frustrating user experience, long cycle times, and high maintenance costs.

In 2024, Merck KGaA launched its business transformation program (Falcon) focused on simplifying quality management for 20,000 users. Since introducing Veeva QMS, Merck KGaA has:

• Standardized quality process framework across the life sciences, electronics, and healthcare business units
• Increased efficiency by significantly reducing process steps and redundancies
• Delivered a simplified site experience
• Implemented a scalable interface architecture

As Dalia Aydin, program lead at Merck KGaA, explains: “It’s more than just implementing a new system or new technology. It’s about enabling people to embrace a new way of working.”

From on-premises to digital-first

Before deciding to switch, Merck KGaA gathered survey feedback from users and stakeholders on the performance of its on-premises quality management system. The results showed that the legacy solution was not delivering sufficient value and there was a strong appetite for change.

Knowing that this system would reach end of life soon, the team developed a business case to migrate quality management to the cloud over a three-year timeframe. The program goals were to simplify and speed up processes while delivering a consistent experience across all sites.

After completing a market assessment, Merck KGaA decided to partner with Veeva to support its ambition to modernise the quality systems landscape. “Our multi-year, cross-functional business transformation program replaces our legacy quality system with a modern, unified Veeva Vault Platform,” says Aydin.

Distinct phases to quality modernization

A three-phase implementation of Veeva QMS ensured alignment with pressing business priorities:

• Phase one focused on modernizing supplier quality management and audit/CAPA (Corrective and Preventive Action). After going live in February 2025, this launch impacted 9,000 users
• Phase two is currently underway and incorporates deviations, continuous improvements, and complaints, while introducing an additional 5,000 users
• Phase three is due to complete in late 2026 and is the most complex phase, involving integrating change controls, for the remaining set of users

Merck KGaA intends to align its internal release schedule with the three annual Veeva releases so it can benefit from ongoing enhancements, and focus on fixes and backlog management.

Empowered teams embrace change

Successful transformation across the enterprise requires leaders to clearly communicate the shared purpose and right behaviors. Merck KGaA tackled these challenges by making sure that key stakeholders had a voice during each stage of the project.

The Falcon program’s success is underpinned by continuous feedback and reflection, allowing the team to gain insights and make necessary changes before moving into the next phases of business transformation. This included:

• Gathering insights from senior management, business sector peers, and functions (including IT) to identify pain points in legacy processes and systems
• Securing executive alignment and creating a team of sponsors from core business areas to advise on Falcon’s strategic fit
• Collaborating to define program scope and sequencing based on urgency and need for modernization, resulting in a phased approach
• Creating an engagement strategy that defined roles, developing a communication plan, and establishing an advisory board, so business and IT were aligned as new processes were introduced.

Discover how Veeva QMS streamlines quality processes for global biopharmas