Digitalizing validation worldwide

A multinational biopharma company with $29B+ in revenue and operations in 80+ countries wanted to move from paper-based validation to a digital, standardized approach with 24/7 global-site visibility and less time spent on administrative tasks. It implemented Kneat Gx to standardize workflows, simplify protocol generation, and improve auditability across 25 sites, covering analytical instrument validation, cleaning validation, C&Q, CSV, equipment validation and method validation. Outcomes: faster validation execution, reduced administrative/non-value-add work, improved collaboration across the 25 sites, better audit experience, and faster product delivery to patients. A Project Leader said: 'Kneat Gx saves us from wasting time on routine, time-consuming administrative tasks ... we can focus more on continuous improvement.'

The customer is anonymised in Kneat’s own case study — not withheld by us.

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.