Case Study: EMD Serono achieves unified risk‑based quality and issue management with Veeva Systems' Vault QMS

EMD Serono Unifies Quality Risk and Issue Management

EMD Serono, a business of Merck KGaA, needed to move its R&D Quality organization from reactive, paper-based practices to a proactive, unified approach that could identify and mitigate critical risks up-front. The team required a single modern system to manage quality issues and risks, support cross-functional collaboration, ensure data privacy compliance, and provide consolidated real-time reporting.

They implemented Veeva Vault QMS with Quality Risk Management to unify issue and risk workflows, standardize risk identification and scoring, and add a risk layer across audits, observations, changes, and corrective actions. The single-source solution improved data integration and transparency, enabled proactive mitigations and effectiveness monitoring, and increased overall compliance and patient-safety assurance.

EMD Serono