MSD Global Digital Validation Rollout

Merck Sharp & Dohme (MSD) adopted Kneat Gx to digitize its global validation processes across 27 manufacturing sites, replacing hybrid systems with a streamlined digital platform. This initiative, part of MSD’s Global Quality Management Systems Strategy, resulted in significant efficiency gains, reducing validation cycle times by over 50% and simplifying workflows from 15 to 8 steps. Additionally, Kneat Gx consolidated multiple quality management systems into one, lowering operational complexity and costs.

The deployment of Kneat Gx followed a phased approach, starting with a single pilot site, followed by early adopter sites, and concluding with a global rollout. This strategy allowed MSD to refine and standardize processes while incorporating feedback from diverse site stakeholders. The platform’s intuitive interface and robust capabilities earned strong user adoption and demonstrated significant return on investment.

During the COVID-19 pandemic, Kneat Gx’s SaaS-based solution enabled seamless remote work, further emphasizing its value. MSD’s leadership highlighted the platform’s benefits in enhancing data integrity, real-time collaboration, and compliance with regulatory standards, including 21 CFR Part 11.

Kneat Gx has become a foundational system within MSD’s quality management framework, supporting validation needs across various processes, including equipment qualification, process validation, and supplier qualification. Beyond validation, MSD plans to expand Kneat’s use into other areas, leveraging its scalability and efficiency.

This partnership underscores Kneat’s capability to transform validation processes, reduce costs, and drive innovation, making it a trusted solution for leading Life Sciences companies.