Validate, anywhere
Kneat’s 100% digital platform, accessible via tablet, enables seamless validation of temperature-controlled areas across your facility and supply chain. Assuring compliance anytime, anywhere.
Safeguard the cold chain
Kneat’s data integrity controls protect the cold chain, assuring temperature records are accurate and tamper-proof. Minimize the risk of temperature and protecting against product loss.
Comply across borders
Kneat’s flexible platform empowers users to quickly adapt cold chain validation processes to meet evolving global regulations. Easily update workflows and assure compliance across dynamic supply chains.
Drive end-to-end efficiency
Documenting and validating the entire cold chain process, including storage, handling, and transport, is time-consuming and prone to errors when done manually.
Trusted By
Challenges
Safeguarding the cold chain
Cold chain validation professionals must safeguard product quality by monitoring conditions and ensuring consistent performance of temperature-controlled systems throughout the supply chain.
Other common challenges include:
- Ensuring reliable sensor calibration for monitoring
- Preventing delays caused by equipment failures
- Documenting real-time temperature fluctuations accurately
THE SOLUTION
Cold chain validation, your way
Kneat is trusted by 8 of the world's top 10 life sciences companies. Digitalize and manage any validation process your way, in one easy-to-use, end-to-end solution.
- Create, template, generate, review-approve, test-execute, and trace
- Compliant electronic signatures and audit trail
- Real-time in-document collaboration
- Comprehensive reporting
- Powerful document automation
- Audit readiness, anytime
BENEFITS
Seamless, compliant cold chain validation
Seamless, compliant cold chain validation with 100% digital documentation and test execution —ensuring accuracy, security, and efficiency across global supply chains.
- Validate temperature-controlled areas anytime, anywhere
- Ensure accurate, tamper-proof records to safeguard the cold chain
- Adapt quickly to evolving regulations across global supply chains
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Customer Success
Case studies
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
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
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
- Audit
- Computer System 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
Did we get value by implementing Kneat? ... It’s a no-brainer. We’re seeing gains in schedule and work hours, positive feedback from users, and improvements to core metrics.
- Global Engineering, C&Q, Top 10 Biopharmaceutical Company
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CYCLE TIME REDUCTION
Kneat is proven to reduce cycle time by an average of 50% or more in multiple customer authored case studies.
CSAT Score
97% of our customers rate our customer support as either ‘Very Good’ or ‘Excellent.’
PLAN TO RENEW
Customer feedback via industry analyst SoftwareReviews.
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 validation.
Contract Manufacturing
Accelerate release to production and ensure customer confidence with more efficient, transparent documentation. Perform technology transfer and meet deadlines faster and easier.
Revolutionize your validation
Digitalize validation your way, with the validation platform trusted by the world’s leading life sciences companies.
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