Biogen's lab of the future

Biogen's manual validation processes hindered lab operations, and the company needed to streamline workflows, harmonize asset management across sites, and centralize records for a modernized QC lab. Biogen implemented Kneat for analytical instrument validation (AIV), running a pilot starting 2017 followed by full implementation completed in six weeks. Results: over 100% productivity improvement in laboratory asset lifecycle management within three months of full implementation, a 50% cycle-time reduction, faster onboarding, improved change control, and harmonized operations across sites. A Quality Control Manager for Analytical Instrument Validation at Biogen said: 'Within only 3 months of operation since release, Biogen had achieved productivity improvements to laboratory asset lifecycle management of over 100%.'

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.