How Recipharm Advanced Bio transformed validation with Kneat Gx

Recipharm Advanced Bio's paper-based validation slowed approvals and made document retrieval hard, while the industry faced 180+ FDA data-integrity observations and the company needed to maintain 21 CFR Part 11/EU Annex 11 compliance across disciplines. It implemented Kneat Gx for analytical instrument qualification, commissioning & qualification, computer system validation, electronic forms, and QA electronic logbooks, using a Word-like interface to ease adoption while converting paper templates into digital workflows with access controls, search, and version comparison. Outcomes: review cycles cut from days to hours, 24/7 validation visibility, and 98% of user requirements met, with strong alignment to 21 CFR Part 11, EU Annex 11 and ALCOA++. Kailash Rathi, Director of Quality Systems & Validation, noted: 'Unlike some other platforms that focus only on data-centric, form-driven validation -- such as Veeva Vault and ValGenesis VLMS -- Kneat Gx offered flexibility and configurability.'

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.