Faster non-conformance resolution
Audits demand rapid non-conformance traceability and resolution. Kneat centralizes data to enable instant tracking, analysis, and resolution to make compliance faster and more efficient.
Effortless audit preparation
Preparing for audits is time-intensive. Kneat eliminates manual document recall, ensuring you’re always audit ready. With Kneat’s powerful “Collections” feature, you gain full control over when and what auditors see.
Stay ahead of regulations
Evolving regulations create uncertainty. Kneat assures up-to-date compliance by automating regulatory checks and flagging changes to keep you aligned with industry standards.
Proactive risk tracking
Unidentified risks can delay validation and compliance. Kneat’s digital validation software enables real-time risk tracking, enforcing consistent processes to mitigate issues early and assure compliance.
Trusted By
Challenges
Achieving audit readiness
Audit preparation requires maintaining complete, accurate, and traceable validation data, while ensuring compliance across all processes. Often under tight deadlines.
Other common challenges include:
- Centralizing validation data for real-time access
- Addressing findings efficiently during audits
- Keeping records updated to meet regulatory expectations
THE SOLUTION
The complete digital validation solution
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
Be audit ready, anytime
Kneat simplifies audit preparation by centralizing, automating, and ensuring compliance in validation data management — saving time and reducing risk.
- Centralize all validation data for real-time access
- Streamline audit responses with digital traceability
- Ensure compliance with automated record updates
Articles
Insight, expert opinion, and overviews on topics that matter. Stay informed, get inspired, and discover new ideas to keep you ahead.
eBooks
Comprehensive explorations of key topics. Our eBooks offer in-depth analyses and actionable strategies to enhance your knowledge and skills.
Guides
Navigate complex subjects with ease. Our step-by-step guides provide clear instructions and practical tips to help you master new concepts and tasks.
Webinars
Engage experts in live sessions. Our webinars offer interactive discussions and presentations on current topics, providing opportunities for learning and networking.
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
It’s what I really wanted, the ability to still author and execute in the traditional manner, but not having the ‘on paper’ anymore.
Manager IT Compliance, Fujirebio Diagnostics, Inc
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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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