Transforming traceability to improve risk mitigation

A top-10 biotech company wanted to eliminate paper and hybrid processes from Commissioning & Qualification (C&Q) validation and implement risk-based validation aligned with ISPE Baseline Guide 5. It evaluated paperless-validation vendors, ran a side-by-side comparison between Kneat and a competitor, and selected Kneat Gx for its reporting, automated Requirements Traceability Matrix (RTM), and user-friendliness, rolling it out in phases across 30+ global sites under centralized C&Q leadership. Results cited: 88% time saved (per an analyst-firm rating shown on the page) and 40% faster C&Q than the competing vendor. A European C&Q Lead said: 'We conducted a side-by-side comparison with Kneat and another vendor and found Kneat to be 40% more efficient for C&Q.'

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.