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Kneat Gx

The proven digital validation platform

Trusted by industry to improve efficiency and reduce compliance risk.

Flexible & Compliant

The only digital validation platform for any process, configurable your way

Benefits

50%

Reduce cycle times by over 50%.
As found in multiple customer case studies.

Reduce cycle times in every step of your validation lifecycle, for any process. From protocol creation to review, approval, test execution, and more.

Enjoy peace of mind with complete traceability, instant document retrieval, and audit ‘war-rooms.’ Ensuring confidence and readiness for inspection anytime.

Ensure data integrity with secure, time-stamped audit trails, role-based access controls, and automated traceability.Enhancing compliance and trust in your validation processes.

Enhance governance through harmonized validation processes across all your sites. Ensuring consistent compliance, streamlined oversight, and improved operational control.

35%

Reduce your validation costs by up to 35% through digitalization. Eliminating paper records, enhancing efficiency, and accelerating cycle times for significant savings.

Reduce cycle times in every step of your validation lifecycle, for any process. From protocol creation to review, approval, test execution, and more.

50%

Reduce cycle times by over 50%.
As found in multiple customer case studies.

35%

Reduce validation costs by over 35%.
As found in customer case study.

We were able to demonstrate over 50% cycle time reduction…and process simplification from 15 steps to 8 … because of Kneat we minimized the number of systems we used from 5 to 2.

- Global Executive Director, MSD

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Industry Solutions

Elevating validation for Life Sciences

We are built for biotechnology, pharmaceuticals, medical devices, and consumer health.

Solutions by industry

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

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

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

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

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

Merck Sharp & Dohme

Merck Sharp & Dohme (MSD) reduced validation time by 50%

MSD digitized seven validation processes globally, reducing cycle times by 50%, process steps by 46%, and replacing three QMS systems.

use cases

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

Fujirebio Diagnostics, Inc

Fujirebio Diagnostics, Inc uses Kneat to provide CSV at scale

Fujirebio Diagnostics cut CAPA change control time in half and is saving 40% on test script execution, translating to significant savings.

use cases

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

Merck Sharp & Dohme (MSD) reduced validation time by 50%

MSD digitized seven validation processes globally, reducing cycle times by...

Biogen’s lab of the future

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

Fujirebio Diagnostics, Inc uses Kneat to provide CSV at scale

Fujirebio Diagnostics cut CAPA change control time in half and...

Enabling ElevateBio’s industry-disrupting business model

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

Use Cases

For all your validation needs

A single platform for commissioning and qualification, equipment validation, computer system validation, and more.

Use case

Commissioning and qualification

Ensure facilities, systems, and equipment are designed, installed, tested, and operated per requirements — as efficiently as possible.

Use case

Computer system validation (CSV)

Ensure computer systems are validated, tested, and maintained in compliance with requirements. Guaranteeing efficiency and effectiveness throughout their lifecycle.

Use case

Equipment validation

Ensure equipment is validated, tested, documented, and maintained to meet operational and regulatory requirements. Assuring consistent and efficient performance.

Use case

Analytical instrument validation

Ensure analytical instruments are qualified, calibrated, and maintained to provide accurate, reliable, and traceable results.

Use case

Audit readiness

Maintain a state of continuous compliance and documentation accuracy to ensure preparedness for regulatory inspections and all forms of audits.

Engineering

Engineering teams choose Kneat to streamline commissioning and qualification, ensure equipment integrity,
and accelerate
delivery timelines.

Quality
Assurance

Quality assurance teams rely on Kneat to ensure data integrity, protect regulatory compliance, and enable audit readiness.

Information Technology

IT teams implement Kneat to replace multiple point solutions and integrate with their digital ecosystem.

Quality Control

Quality control teams choose Kneat to seamlessly collaborate and contribute to critical validation activities.

Efficiency

Reduce cycle time in every step of your validation lifecycle, for any process. From protocol creation to review, approval, test execution, and more.

Audit readiness

Enjoy peace of mind with complete traceability, instant document retrieval, and audit ‘war-rooms.’ Ensuring confidence and readiness for inspection anytime.

Data integrity

Ensure unparalleled data integrity with secure, time-stamped audit trails, role-based access controls, and automated traceability. Enhancing compliance and trust in your validation processes.

Ease of use

Kneat is easy to use and learn, enabling your organization to make a lasting change to digital validation faster, and more easily.

Customer Ratings

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0

G2.com

Overall rating by customers via independent industry analyst firm, g2.com.

0%

CSAT Score

97% of our Customers rate our Customer Support as either ‘Very Good’ or ‘Excellent’.

0%

PLAN TO RENEW

Customer feedback via industry analyst SoftwareReviews.com.

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

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