Case Study: a global gene therapy company streamlines validation and reduces time and effort with Kneat Solutions

Streamlining Validation for Gene Therapy Commercialization

A growing global gene therapy company was facing the challenge of modernizing its cumbersome hybrid validation processes, which used a combination of paper-based, DocuSign, and database systems. As it moved toward commercialization, the company sought a single digital solution to ensure data integrity, harmonize workflows, and support functional efficiency in a remote work environment. They selected Kneat Solutions to implement their Kneat digital validation platform.

Kneat Solutions implemented its platform to manage the entire computer system validation lifecycle and later expanded it to include commissioning, qualification, and equipment validation. The solution provided a user-friendly interface that eliminated manual execution, giving teams full transparency and the ability to work remotely. The customer reported that Kneat reduced the time and effort required for validation executions by an estimated 50%.