Enabling ElevateBio's industry-disrupting business model

ElevateBio, a contract manufacturing/research biotech, faced processing delays, accessibility problems and manual errors from paper-based validation. It implemented Kneat's digital validation platform for its paperless operation, scalability, user-friendly design and compliance capability, enabling rapid adoption across the organization. Results: 50% reduction in review-cycle time, a 6x increase in validation processes handled, elimination of physical document storage, better document transparency and stakeholder collaboration, remote access to digital records, and smoother audits. Laura Berberian, Manager, Quality Assurance Validation at ElevateBio, said: 'The flexibility of Kneat is huge ... if we want to onboard a new client, it's a 15-minute meeting between us, and we set it up how we want.'

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.