Commissioning and qualification
Ensure facilities, systems, and equipment are designed, installed, tested, and operated per requirements — as efficiently as possible.
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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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.
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
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
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
Download case studyRevolutionize your validation
Digitalize validation your way, with the validation platform trusted by the world’s leading life sciences companies.
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Case studies
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
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
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
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
Featured use cases
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.
Pharma
Our expert team and industry-leading solution help pharma quality assurance and validation teams overcome compliance and operational challenges every day.
Consumer Health
Get more products to market faster without compromising quality. Improve the efficiency of the entire validation lifecycle for all your consumer health products.
Biotechnology
Overcome complexity across process, analytical method, equipment, cleaning, computer system, assay, sterilization, and facility validations.
Medical Device
Transform the efficiency and compliance of design, process, software, cleaning, equipment, packaging, sterilization, and test method validations.
Featured resources
Preparing for GMP Updates
Kneat experts talk about the most significant updates to GMP guidelines in years
14:00 (60 minutes)
Breaking down the ISPE® digital validation guide
Get a practical overview of ISPE’s Digital Validation Guide by Kneat’s experts.
Kneat ranked best pharma and biotech software
G2 has ranked Kneat best pharma and biotech software in Grid report, rating Kneat as the top pick in satisfaction....