Revolutionizing validation

A Global Life Sciences Company

Efficiency, control, traceability and insight

Applications: Commissioning and Qualification, Method Validation, Cleaning Validation

A frustration with the complexity, inefficiency, and error strewn nature of paper-based validation led the client to explore possible solutions. What began as a commissioning and qualification validation project, has led to rolling out Kneat’s solution to many more validation processes.

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A Leading Molecular Diagnostics Company

Meeting increased productivity and compliance demands

Applications: Computer System Validation (CSV)

The client, a leading molecular diagnostic company, is dedicated to saving and improving lives by discovering and delivering tests across major diseases. They produce their own proprietary software which requires validation and FDA compliance and have been successfully using Kneat for Computer System Validation since 2014.

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Tier One Biotech

Digitizing the entire validation life cycle: A productivity leap

Applications: Utility and Facility Validation, Equipment Validation, Commissioning and Qualification

The client, a US headquartered tier one biotech with multiple facilities in the US and the EU, achieved productivity improvements of 100% after digitizing validation on the Kneat platform.

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Biogen Inc.

Biogen's Lab of the Future

Applications: Analytical Instrument Validation

The client, Biogen Inc., contracted Kneat to deliver their vision for the future of laboratory operations. Biogen Inc. (previously known as Biogen Idec) is an American multinational biotechnology company specializing in the discovery, development, and delivery of therapies for the treatment of neurodegenerative, hematologic, and autoimmune diseases.

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A Validation Service Provider

Driving Temperature Profiling Productivity

Applications: Commissioning and Qualification, Equipment Validation

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.

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A Risk Focused Global Biotech

Transforming Traceability: From Prohibitive to Productive Risk Mitigation

Applications: Commissioning and Qualification, Equipment Validation

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.

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