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Solutions for Biotechnology

The Leading Biotechnology Validation Software

Overcome your validation challenges and drive efficiency, compliance, and potential cost savings up to 50% or more with Kneat. Chosen and trusted by 8 out of 10 of the world’s leading biotechnology companies for proven validation efficiency and compliance.

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Trusted By

The flexibility of Kneat is huge ... if we want to onboard a new client, it’s a 15-minute meeting between us, and we set it up how we want. We update our process mapping document, and we move on.

- Laura Berberian, Manager, Quality Assurance Validation, ElevateBio

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Revolutionize your validation

Digitalize validation your way, with the validation platform trusted by the world’s leading life sciences companies.

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Biogen Inc.

Biogen’s lab of the future

Biogen digitalized analytical instrument validation to deliver their “Lab of the Future” vision, achieving greater efficiency, data integrity, and compliance.

use cases

  • Analytical Instrument Validation Analytical Instrument Validation

A top 10 biotech leader

Transforming traceability to improve risk mitigation

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...

use cases

  • Commissioning & Qualification Commissioning & Qualification
  • Equipment Validation Equipment Validation

ElevateBio

Enabling ElevateBio’s industry-disrupting business model

ElevateBio reduced cycle times by 50%, accelerated manufacturing changeovers, and delivered top-tier quality assurance with Kneat.

use cases

  • Commissioning & Qualification Commissioning & Qualification
  • Computer System Validation Computer System Validation
  • Equipment Validation Equipment Validation

Multinational Biopharma

Digitalizing validation worldwide

A global biopharma leader digitalized validation with Kneat Gx across 25+ global sites and thousands of users, achieving 24/7 visibility, audit-friendly processes, and faster product...

use cases

  • Analytical Instrument Validation Analytical Instrument Validation
  • Cleaning Validation Cleaning Validation
  • Commissioning & Qualification Commissioning & Qualification
  • Computer System Validation Computer System Validation
  • Equipment Validation Equipment Validation
  • Method Validation Method Validation
Biogen’s lab of the future

Biogen digitalized analytical instrument validation to deliver their “Lab of...

Transforming traceability to improve risk mitigation

The customer, a rapidly expanding biotechnology company with over 45,000...

Enabling ElevateBio’s industry-disrupting business model

ElevateBio reduced cycle times by 50%, accelerated manufacturing changeovers, and...

Digitalizing validation worldwide

A global biopharma leader digitalized validation with Kneat Gx across...

Solutions by industry

Our expert team and industry-leading solution help pharma quality assurance and validation teams overcome compliance and operational challenges every day.

Get more products to market faster without compromising quality. Improve the efficiency of the entire validation lifecycle for all your consumer health products.

Overcome complexity across process, analytical method, equipment, cleaning, computer system, assay, sterilization, and facility validations.

Transform the efficiency and compliance of design, process, software, cleaning, equipment, packaging, sterilization, and test method validation.

Accelerate release to production and ensure customer confidence with more efficient, transparent documentation. Perform technology transfer and meet deadlines faster and easier.

Frequently asked questions

How does Kneat help eliminate operational bottlenecks, risk management and improve efficiency in validation activities?

Kneat’s platform is designed to significantly improve efficiency by transforming traditional paper-based or disjointed operational workflows. It helps eliminate bottlenecks caused by length delays in approvals caused by paper in your validation activities, allowing you to accelerate the lifecycles of validation projects and streamline processes from start to finish.

How does Kneat ensure data integrity and provide assurance in a highly regulated environment?

Kneat provides robust assurance of data integrity by utilizing advanced features the build ALCOA++ principles into every step, including password-protected esignatures, uneditable time stamps, complete audit trails and more. Our platform offers a comprehensive and transparent repository for all validation data, ensuring oversight and compliance with regulatory requirements.

Is Kneat a customizable platform capable of handling diverse validation needs?

Absolutely. Kneat is a highly customizable and scalable solution, offering a comprehensive set of features for any validation process including those for clinical processes. Its design allows for seamless integration, ensuring the platform adapts to your organization’s unique needs and specific requirements.

How does Kneat enable proactive and timely management of validation and compliance?

With Kneat, you can maintain proactive control over your validation lifecycle. The platform’s workflow capabilities, combined with advanced analytics, provide real-time insights, ensuring all validation processes are timely and you remain continuously audit-ready.