Computer system validation (CSV)
Ensure computer systems are validated, tested, and maintained in compliance with requirements. Guaranteeing efficiency and effectiveness throughout their lifecycle.
Solutions for Medical Device
Medical Device
Assure QSR compliance and accelerate medical device validation with Kneat
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Customer Success
How Alcon Uses Kneat as a Catalyst for Harmonization
How Alcon harmonized & accelerated validation
See Nathan Racheske, Head of Analytical Science and Technology at Alcon, as he outlines how moving from legacy paper-based processes to standardized digital workflows increased...
Featuring
Nathan Racheske
Switching validation systems
Alcon switched from its incumbent digital validation system to Kneat. Discover why Alcon made the switch—and how the team migrated documents and data between systems.
Featuring
Cesar Tavarez
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
Cleaning validation software
Validate and document cleaning processes to ensure removal of residues, contaminants, and microorganisms to maintain product safety and quality.
Audit readiness
Maintain a state of continuous compliance and documentation accuracy to ensure preparedness for regulatory inspections and all forms of audits.
Featured resources
The Cost Savings of Digital Validation
See how digital validation cuts delay to market, overhead, and compliance costs. Get the overview to build your case with....
Drawings and the digital gap
13% of organizations are fully digital, and 23% still use paper drawings. See why that gap matters.
Kneat Gx Drawing Management
One platform for drawings and validation — your way. See it in Kneat Gx.
45 Min
Ruairi McGarry
Revolutionize your validation
Digitalize validation your way, with the validation platform trusted by the world’s leading life sciences companies.
Book a demo