Revolutionizing validation

In-vitro diagnostics industry leader Fujirebio Diagnostics, Inc. (FDI), selected Kneat to digitize its global Computer System Validation (CSV) process with the aim of enabling its limited IT Compliance Team to deliver a large volume of complex computer-system projects, including the implementation and re-validation of systems at multiple manufacturing sites across five divisions.

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.