Cleaning validation
Validate and document cleaning processes to ensure removal of residues, contaminants, and microorganisms to maintain product safety and quality.
Solutions for Medical Device
Medical Device
Assure QSR compliance and accelerate medical device validation with Kneat
Book a demoCustomer Success
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
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
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
Trusted By
Design validation
Ensuring a medical device meets user needs and intended uses through design validation is critical, as flaws impact patient safety. Kneat centralizes, automates validation, and streamlines technology transfer for efficient compliance and innovation.
Software validation
Medical devices and manufacturing equipment often incorporate software components. Validating software to ensure it performs reliably under all intended conditions is a complex task requiring specialized expertise. Kneat ensures traceable, repeatable testing processes.
Quality system regulations
Adhering to regulations such as the FDA's QSR, which governs the design and manufacturing processes of medical devices, requires meticulous validation of all quality-related aspects. Kneat automatically tracks and documents compliance and enables seamless, controlled auditor access.
Suppliers & components
Ensuring suppliers’ components meet specifications is critical, as variability in materials or processes can impact device quality. Kneat streamlines supplier validation by centralizing supplier audit, material inspections, and verification testing, minimizing the risk of failure or recall.
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
Download case studyChallenges
Compliant, safe devices & software
Design reliability, software validation, and QSR compliance are key hurdles. Ensuring devices meet safety and user needs requires robust testing. Validation is crucial to ensuring the safety and effectiveness of life-critical devices.
THE SOLUTION
The complete digital validation platform
Kneat is designed for and trusted by the Medical Device 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
Faster, compliant design & software validation
Kneat assures QSR compliance and accelerates medical device validation, improving right-first-time outcomes from design testing to software validation. With Kneat, medical device manufacturers can streamline validation whilst confidently meeting global safety standards to deliver life-saving devices faster.
- Cut your cycle times by over 50%
- Streamline test protocol cycle times by 60%
- Reduce changeover time by 85%
Featured use cases
Computer system validation (CSV)
Ensure computer systems are validated, tested, and maintained in compliance with requirements. Guaranteeing efficiency and effectiveness throughout their lifecycle.
Audit readiness
Maintain a state of continuous compliance and documentation accuracy to ensure preparedness for regulatory inspections and all forms of audits.
Contract Manufacturing
Accelerate release to production and ensure customer confidence with more efficient, transparent documentation. Perform technology transfer and meet deadlines faster and easier.
Biotechnology
Overcome complexity across process, analytical method, equipment, cleaning, computer system, assay, sterilization, and facility validations.
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.
Pharma
Our expert team and industry-leading solution help pharma quality assurance and validation teams overcome compliance and operational challenges every day.
Featured resources
CSV vs CSA: Key GAMP Tips
CSV or CSA? Some companies are still debating which approach is right for them. Kneat’s CSV expert, Amy Wilhite explains....
60 minutes
Amy Wilhite
Digitalizing CQV
See how to get more out of your CQV program with Kneat.
60 minutes
Liam Coffey
Revolutionize your validation
Digitalize validation your way, with the validation platform trusted by the world’s leading life sciences companies.
Book a demo