Revolutionizing validation

Fujirebio Diagnostics, Inc. (FDI)

Fujirebio Diagnostics, Inc. uses Kneat to provide CSV at scale

Applications: Computer System Validation (CSV)

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.

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A Niche Contract Organization

A Niche Contract Research Organization

Applications: Computer System Validation (CSV)

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.

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Overcoming Validation Challenges for SMBs

Overcoming Validation Challenges for SMBs

Applications:

To better understand the validation challenges of medium sized companies, we surveyed a group of pharmaceutical and biotechnology organizations in the United States and Europe to uncover their top ten validation challenges – here’s what we found.

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Merck Sharp & Dohme Corp., (MSD)

MSD Global Digital Validation Rollout

Applications: Computer System Validation (CSV), Utility and Facility Validation, Equipment Validation, Cleaning Validation, Process Validation, Analytical Instrument Validation

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.

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Digitalization: The key to sustainable validation

Digitalization: The key to sustainable validation

Applications:

By digitizing the entire validation lifecycle, through the elimination of validation on paper alone, Kneat enables companies to decrease their carbon footprint by over 1.5 tons, whilst achieving efficiencies that drive the bottom line.

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A Global Technology Partnership

Reducing Global Deployment Validation Cost by 35%

Applications: Computer System Validation (CSV)

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),

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