Building a Leading-Edge Digital Validation Program From the Ground Up

A Swiss biotech company launching a new aseptic services division needed to build a digital validation process from scratch, prioritizing efficiency and state-of-the-art tools. It partnered with PiQuP and Kneat, first deploying Kneat for Computer System Validation (CSV) and later expanding to Commissioning & Qualification (C&Q), over more than 4 years of use. Outcomes cited are faster cycle times, improved audit readiness, and enhanced traceability. Project Manager/Qualification Engineer Deividas Motekaitis said: 'They wanted something efficient; they wanted something state of the art. So, I said 'Let's do it in Kneat.''

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.