Flexible, compliant batch records
Kneat enables effortless batch record creation that adapts to your manufacturing needs, while ensuring compliance. Delivering a streamlined, reliable quality assurance process.
Assured batch data integrity
Kneat enforces ALCOA++ data integrity protections to production and other batch data. Assuring batch records are compliant, accurate, and meet both regulator and customer standards.
Improved traceability
Kneat centralizes validation and batch record data, providing clear traceability for customer and regulatory audits. Ensuring all documentation is easily accessible when needed.
Reduced errors & delays
Errors in batch records can lead to production delays, costly rework, and compliance risks. Kneat’s single solution integrates validation and batch record management. Eliminating mismatched data and manual errors.
Trusted By
Challenges
Ensuring traceability across batch processes
Batch record validation requires maintaining data integrity, ensuring traceability, and avoiding costly discrepancies across all stages of the batch manufacturing process.
Other common challenges include:
- Managing manual errors in batch documentation
- Integrating batch records with validation protocols
- Ensuring traceability for multi-site production
THE SOLUTION
Batch records, 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
Agile, efficient batch records
Kneat unifies validation and batch records. Ensuring data integrity, traceability, and compliance while reducing errors and delays — for faster, more efficient processes.
- Integrate validation and batch records for a seamless workflow
- Ensure ALCOA++ compliance with enforced data integrity controls
- Reduce errors and delays with automated, accurate documentation
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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
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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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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