Harmonization that works

Fresenius Kabi, operating worldwide, found its localized, site-by-site validation processes hard to manage at scale and needed a standardized approach that could still flex to different regulatory requirements. It implemented Kneat's digital validation platform, which offered 21 CFR Part 11/Annex 11 compliance and global review/approval, harmonizing global process while accommodating site-specific needs. The platform was deployed across 27 sites, with cycle times decreasing and audit readiness strengthened; expansion to more locations was underway. Deanna Vona, Supervisor, Tech Transfer at Fresenius Kabi, said: 'It's very important to have flexibility...to adapt to what we need. We have different regulatory requirements, different procedures at different sites.' Fresenius Kabi has been a Kneat customer since 2023.

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.