Case Study

Merck move from multiple  siloed solutions to a single system with CARA

Learn how CARA helped a global life science company reduce cost and improve efficiency.


Regulatory Correspondence

Regulatory Documents



GxP records



Medical Inquiries






85,000 users

12 systems

18 million documents

21 CFR Part 11

Merck KGaA – at a Glance

The Merck Group, is a German multinational science and technology company headquartered in Darmstadt, with employees in 66 countries. The group includes around 250 companies; the main company is Merck KGaA in Germany.  It is the oldest pharmaceutical company in the world, having recently celebrated their 350th anniversary.

The problem

Merck KGaA has multiple systems managing Quality, Regulatory and Safety as well as Clinical (eTMF).

The Solution

The solution was to implement CARA across the board for these systems. This included the main Regulatory Submissions documentation system, the Quality documents, PV documents, as well as Safety Data Exchange Agreements, which then automatically generates PSMF Annexes, reducing the cycle time from 3 weeks to minutes. Additionally, Merck has implemented CARA for eTMF and also for managing Medical Inquiries. Call centre staff receive calls or emails with inquiries and can search for responses in real time, reducing the cycle time and improving the SLA achievements.

The Benefits

Users benefit from faster process times, better performance in CARA than previous systems, and a single UI that is consistent across repositories, allowing for reduced training. IT has an easier task with system maintenance and a single common infrastructure for their systems. The systems are currently in-house.

Merck is, however, moving multiple systems in the Quality area to the CARA Cloud during 2020/2021, which will provide cost savings and efficiency savings. It will also allow external companies to access the systems for collaboration.