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.

A growing niche Contract Research Organization with operations in Europe and North America sought to implement a validation solution that freed its skilled team from the manual burden of a ‘hybrid’ computer system validation procedure.

Executing on its visionary Global Quality Management Systems Strategy, industry leaders Merck Sharp & Dohme (MSD) chose Kneat to digitalize seven validation work processes at 27 sites worldwide, achieving over 50% cycle time reduction and eliminating reliance on three different quality management systems.

Using Kneat Gx for all Computer Software Validation and Verifi cation (CSV) documentation activities in the global deployment of the SAP S/4 HANA 1909 ERP System for the customer, HCL Technologies achieved a cost saving of 35% ($0.81M USD),

The customer, a rapidly expanding biotechnology company with over 45,000 employees achieved an 88% time saving on URS, reducing the cycle time from 2 months to just 7 days.

Since 1996, Kneat’s solution partner, Pharmaceutical Calibrations & Instrumentation LLC. (PCI) has provided the Life Science Industry with high-quality equipment and instrument services including Validation, Calibration (Process Equipment Services, Analytical Laboratory Instrument Services, Metrology Services) and Commissioning.