Equipment validation
Ensure equipment is validated, tested, documented, and maintained to meet operational and regulatory requirements. Assuring consistent and efficient performance.
Solutions for Biotechnology
Biotechnology
Overcome your validation challenges and drive efficiency, compliance, and cost savings with Kneat
Book a demoCustomer 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
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
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
Digitalizing validation worldwide
A global biopharma leader digitalized validation with Kneat Gx across 25+ global sites and thousands of users, achieving 24/7 visibility, audit-friendly processes, and faster product...
use cases
- Analytical Instrument Validation
Cleaning Validation- Commissioning & Qualification
- Computer System Validation
- Equipment Validation
Method Validation
Trusted By
Process variability
Biotechnology processes often involve living organisms, introducing inherent variability. Validation professionals must develop strategies to control and minimize this fluctuation to ensure consistent product quality. Kneat enables best-practice controls for variability.
Analytical method complexity
Complex molecules require sophisticated analytical techniques that produce more data, increasing testing burden. Kneat’s powerful, automated data management features de-risk, simplify, and streamline method validation.
Scalable processes
Transitioning processes from laboratory scale to full-scale manufacturing without compromising product quality or efficacy requires thorough validation to address potential scale-up issues. Kneat enables efficient verification to enable the fastest possible testing during expansion.
Compliance for novel therapies
The rapid rise of therapies like gene and cell therapies often outpaces regulation. Documentation must be flexible to navigate these uncharted areas to ensure compliance with evolving frameworks. Kneat provides the flexibility to easily update templates and workflows as needs change.
The flexibility of Kneat is huge ... if we want to onboard a new client, it’s a 15-minute meeting between us, and we set it up how we want. We update our process mapping document, and we move on.
- Laura Berberian, Manager, Quality Assurance Validation, ElevateBio
Download case studyChallenges
Controlling complexity & variability
Managing variability in bio-processes, scaling operations, and validating advanced methods pose major challenges for validation professionals in the biotechnology industry. Navigating regulations for novel therapies requires process innovation and precision to ensure compliance, while maintaining accuracy and reliability in complex biotech product validations.
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
Easily manage complexity & variability
Kneat makes the complex tasks of managing variability, scaling up processes, and compliance for novel therapies easier. Overcome the unique complexity of biotechnology validation more efficiently with Kneat.
- Proven to increase speed to market by up to 20%
- Proven to reduce cycle time by over 50%
- Reduced audit preparation time by 40%
Featured use cases
Process validation
Ensure manufacturing processes are validated, controlled, and maintained to consistently produce products meeting predefined quality standards.
Audit readiness
Maintain a state of continuous compliance and documentation accuracy to ensure preparedness for regulatory inspections and all forms of audits.
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.
Featured resources
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CSV or CSA? Some companies are still debating which approach is right for them. Kneat’s CSV expert, Amy Wilhite explains....
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2025 State of Validation
Unlock exclusive insights from the 2025 State of Validation study. See what the data really means — save your spot....
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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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