Digitizing validation: a leap in productivity

Although the input lists this customer as an unnamed tier-one biotech, the fetched Kneat page itself explicitly names the customer as Biogen Inc. Biogen faced escalating validation demand from regulatory requirements and growth, with inefficient paper-based processes creating bottlenecks in document management, approvals, and cross-site visibility. Biogen implemented Kneat Gx globally, replacing paper systems with a scalable digital platform, standardizing processes across facilities and enabling real-time monitoring. Results: 100% productivity increase in output, 85% improvement in equipment-changeover efficiency, 60% reduction in cycle times, and up to 58% faster approval times. A Quality Assurance Engineer at Biogen said: 'Kneat eliminates frustrating clerical type paper-based activities and allows staff to apply their skills. It removes the chain that is the paper system.'

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.