Validation Use Cases
Cleaning validation software
Enforced standards, secure compliance, digital validation makes products clean andsafe, every time.
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Challenges
Mitigating cross-contamination risk
Cleaning validation demands consistency in cleaning protocols, managing cross-contamination risks, and ensuring residue detection meets regulatory expectations.
Other common challenges include:
- Scaling protocols for multi-product facilities
- Validating new cleaning technologies or methods
- Ensuring rapid recovery from protocol deviations
Reduce contamination risks
Cross-contamination risks are high in multi-product facilities. Kneat digitalizes protocols to enforce consistent cleaning practices and significantly reduce contamination risks.
Ensure complete traceability
Manual cleaning validation records can be inconsistent and error-prone. Kneat digitalizes documentation to enhance accuracy, ensure traceability, and streamline compliance with regulatory standards.
Scalable cleaning processes
Scaling cleaning protocols often disrupts operations. Kneat simplifies scalability by automating process validation and tracking, allowing for seamless growth.
Eliminate manual errors
Manual tracking frequently leads to errors. Kneat eliminates these with automated, validated workflows that assure consistent cleaning compliance across operations.
THE SOLUTION
Cleaning validation, 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
Accelerate cleaning validation
Kneat simplifies cleaning validation, assuring consistency, compliance, and efficiency while adapting to evolving protocols and multi-product facility needs.
- Standardize and scale cleaning protocols effortlessly
- Ensure rapid, compliant recovery from deviations
- Validate new methods with confidence and ease
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Customer Success
Case studies
Advancing efficiency, control, traceability, and insight
A frustration with the complexity, inefficiency, and error strewn nature of paper-based validation led the client to explore possible solutions. What began as a commissioning...
use cases
Audit
Cleaning Validation
Commissioning & Qualification
Method 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
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
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
Book a demoResults
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.
Book a demoDoes Kneat meet 2025 lifecycle validation expectations (ALCOA⁺, 21 CFR Part 11 / Annex 11) and provide audit-ready protocol/report packs?
Kneat Gx is 21 CFR Part 11 / Annex 11 compliant and built around ALCOA++ data-integrity principles, and the product includes audit trails and a Collections feature for secure, fully digital audit handover. Kneat also makes template management easy and lets your team author IQ/OQ/PQ and other validation documents inside the platform so they’re always audit ready.
Does Kneat ship built-in, audit-ready templates (IQ/OQ/PQ, CVP, MACO calculations) and an automated change-control workflow that stays evergreen?
Kneat supports template management, preloaded template packs and automated workflows to accelerate protocol creation and approvals, and the platform allows authoring/locking of validation documents (IQ/OQ/PQ, risk assessments, change controls) within the system. Kneat also is flexible and configurable, so your validation teams can create the documents and processes they need, no matter the requirement.