Merck Sharp & Dohme (MSD) reduced validation time by 50%

MSD ran hybrid validation combining paper processes and outdated systems, creating manual, disconnected workflows and implementation delays; COVID-19 exposed the need for a remote-capable, fully digital solution across global operations. MSD partnered with Kneat to digitize validation across 27 sites worldwide, phasing from pilot programs to full rollout on Kneat's cloud SaaS platform for real-time data sharing and cross-site collaboration. Results: 50% reduction in validation cycle time, process steps cut 46% (from 15 to 8), and systems consolidated from 5 platforms to 2. A Global Executive Director said: 'We were able to demonstrate over 50% cycle time reduction...and process simplification from 15 steps to 8,' and that 'because of Kneat we minimized the number of systems we used from 5 to 2.'

Kneat is a paperless computer-system and process-validation platform — one of the two dominant players in digitizing the validation evidence GxP systems require before go-live.

This sits in the Ship stage of the AI use-case lifecycle: Named examples from the vendors pharma teams use to get an AI system live inside a real, regulated production workflow — validation, CRM, safety and clinical systems of record.