Case Study: Top 10 Biotech Company transforms C&Q traceability and cuts approval times with Kneat Solutions

Transforming Traceability Prohibitive to Productive Risk Mitigation

A rapidly expanding top 10 biotech company sought a paperless validation system to manage its complex commissioning and qualification (C&Q) processes, which were "painful" and "onerous" to maintain manually. Their specific challenge involved the prohibitive labor required to trace risks, ensure compliance, and handle documentation using a combination of paper and Excel, all while adhering to stringent regulatory standards.

Kneat implemented its SaaS platform, Kneat Gx, which provided efficient risk-traceability functionality and automated reporting. The solution dramatically improved efficiency, resulting in an 88% reduction in user-requirements-specification approval cycle time (from 60 days to 7) and cutting site-acceptance-test execution time in half. Kneat's user-friendly platform enabled a successful global deployment, which is now scaling to over 30 sites.