Revolutionizing validation

ElevateBio selected Kneat to digitize all its validation processes, resulting in rapid changeover of its manufacturing suites following a 50% cycle-time reduction and a best-in-class quality assurance experience for its partners.

At Kneat we know that validation professionals are busy managing their workloads to support business goals and growth. That is why we have compiled these 10 steps to help you successfully develop, manage, and acquire budget for your digital validation project.

Computer Software Assurance (CSA) is an innovative new way to meet CSV compliance requirements, but you’ll need a robust understanding of its principles and pitfalls to implement it successfully. In this guide, you’ll learn about CSA, why it will bring your CSV programs to their next level, and how you can bring it to your validation program quickly and easily.

Our new eBook, Understanding Computer Software Assurance (CSA) will give you a foundation of understanding so you can take the first step in your CSA journey.

The customer, a global healthcare packaging company with operations in North America, Central America, Europe, and the UK, looked for a flexible digital solution to validate its SAP system and enable online collaboration—with the goal of maximizing the productivity of international validation team members over all validation processes.

The customer, an innovator in the research and development of in vivo and ex vivo gene editing therapies, with operations in the U.S. and Switzerland, sought to digitize its validation program to replace cumbersome ‘hybrid’ (a mix of paper-based and digital) validation processes.