Solutions for Contract Manufacturing

Contract manufacturing validation software, built for speed

Accelerate time to market — Kneat Gx cuts cycle times by 50% and validation steps by 46%, helping CDMOs release products faster.

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Trusted By

Challenges
The Solution
Benefits

Common Validation Challenges

Solving CDMO validation challenges

For CDMOs, managing validation risk is key. Our software helps automate your operation, reduce manual effort, and streamline validation. Easily document every protocol, record each signature, and provide evidence for final approval. Ensure accuracy of data, detect issues during review and inspection, and support assurance of product quality for the market.

Challenges

Transparency, efficiency & flexibility

Meeting diverse client needs, handling technology transfers, and managing a wide variety of regulatory requirements can be challenging. Maintaining quality agreements and ensuring process integrity, while navigating the complexity of multi-product validation are essential for success.

Client requirements

Contract manufacturers serve multiple clients, each with unique validation protocols and standards, necessitating flexible and client-specific validation approaches. Kneat enables quick and easy replication of client protocol and test-case templates.

Technology transfer

Validating processes as part of tech transfer between client and CMO demands a deep understanding and precise replication of processes to ensure consistency and maintain product integrity. Kneat centralizes data, creating a clear, accessible single source of truth.

Compliance for diverse products

Manufacturing pharmaceuticals and medical devices requires compliance with various regulatory standards, adding complexity to validation process while ensuring quality across diverse products. Kneat automatically tracks compliance across varying standards.

Transparent quality

Ensuring that all validation activities align with the quality agreements established with clients is essential to meet contractual obligations and regulatory expectations. Kneat ensures process adherence with set workflows.

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THE SOLUTION

The complete digital validation platform

Kneat is designed for and trusted by the Pharma industry. Digitalize and manage any validation process your way, in one easy to use, end to end solution.

Create, template, generate, review-approve, test-execute, trace & more
Compliant electronic signatures and audit trail
Real-time in-document collaboration
Comprehensive reporting
Powerful document automation
Audit readiness, anytime

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BENEFITS

Accelerate release to production

Kneat streamlines client onboarding and tech transfers, accelerating validation to minimize delays between contracting and production. With Kneat, manufacturers achieve faster, more reliable, and fully transparent validation, ensuring seamless handovers and rapid time to value.

Reduce changeover time by 85% and get to market 20% faster
Tailor processes to client needs and generate batch records with ease
100% audit-ready transparency anytime for clients and regulators

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We are faster and more efficient with Kneat. Test cases are getting completed faster. As a Project Manager, I like that everything is in one place and easily accessible.

IT Project Manager, Leading Contract Research Company

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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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Customer Success

Case studies

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
Equipment Validation

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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

Analytical Instrument Validation
Audit
Cleaning Validation
Commissioning & Qualification
Computer System Validation
Equipment Validation
Facilities & Utilities Validation
Process Validation

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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
Computer System Validation
Equipment Validation

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Top 10 Pharma Leader

Top 10 pharma leader streamlines CQV

Pharma leader standardized C&Q with Kneat, achieving 20–25% cost savings and 30–40% reduction in validation cycle time.

use cases

Analytical Instrument Validation
Commissioning & Qualification

Read case study

Transforming traceability to improve risk mitigation

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

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

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

Enabling ElevateBio’s industry-disrupting business model

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

Top 10 pharma leader streamlines CQV

Pharma leader standardized C&Q with Kneat, achieving 20–25% cost savings...

Featured use cases

Commissioning and qualification

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

Audit readiness

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

Batch records

Ensure batch records are complete, accurate, and compliant. Providing traceability and supporting product quality assurance.

Industry Solutions

Elevating validation for Life Sciences

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

Solutions by industry

Medical Device

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.