Enhance compliance and efficiency
Kneat digitalizes the entire commissioning & qualification (C&Q) validation lifecycle. Delivering significant productivity improvements and assuring compliance with regulatory standards.
Implement risk-based approaches
Kneat facilitates a risk-based, lean, lifecycle approach to C&Q that is aligned with ASTM E2500 best practice methods.
Eliminate paper records
By digitalizing C&Q processes, Kneat eliminates 100% of paper records, reducing physical storage needs and associated costs, while also minimizing protocol-based GDP errors.
Gain real-time process visibility
Kneat provides instant macro and micro visibility into all aspects of the C&Q process in real time, enabling better decision-making and proactive issue resolution.
Trusted By
Challenges
Balancing timelines & compliance
Commissioning & qualification professionals face mounting pressure to meet project deadlines while adhering to stringent regulations. We understand the challenge of ensuring equipment and facility readiness efficiently.
Other common challenges include:
- Managing deviations during equipment qualification
- Ensuring seamless handovers between commissioning stages
- Aligning validation processes with evolving global standards
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
Faster C&Q, with confidence
Kneat streamlines commissioning & qualification, enhancing efficiency, compliance, and seamless project execution while reducing delays and regulatory risks.
- Automate deviations for faster issue resolution and compliance
- Ensure smooth handovers with centralized, real-time documentation
- Stay audit-ready with standardized, up-to-date validation processes
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
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
Accelerating CQV: streamlining processes for a paperless future
As part of its top-down digital strategy, a Top 10 global pharmaceutical and healthcare company implemented Kneat to digitize CQV and AIQ, to support its...
use cases
Analytical Instrument Validation
Audit- Commissioning & Qualification
How Dechra streamlined C&Q and CSV
Understand how Kneat’s partnership with global validation services provider VEQTOR enabled leading animal health company Dechra Pharmaceuticals PLC to eliminate paper from all stages of...
use cases
- Audit
- Commissioning & Qualification
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
Before, we had Veeva....We had a lot of documentation, but it did not have the level of organization and accessibility that we have with Kneat. We also couldn’t execute C&Q digitally.
- Global Director, Commissioning & Qualification
Book a demoResults
MORE EFFICIENT FOR c&Q THAN COMPETITOR
Kneat is proven to be 40% more efficient for commissioning & qualification than a leading competitor product. As found in a customer comparative pilot study.
urs approval cycle time reduction
Kneat is proven to reduce user requirements specification approval cycle time by 88%. As found in a customer authored case study.
Reduction in Review-Approval Time
Kneat is proven to reduce review-approval cycle time by 40%. As found in a customer authored case study.
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.
Talk to an expertDoes Kneat automate test script generation and execution for commissioning?
Yes. Kneat provides digital test script authoring, execution, and review workflows. This automation reduces manual effort, eliminates paper-based errors, and accelerates commissioning timelines by allowing teams to execute IQ/OQ/PQ and commissioning tests directly within the platform.
Can Kneat support the full lifecycle of qualification (IQ, OQ, PQ)?
Absolutely. Kneat supports Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols in a single, unified environment. This ensures end-to-end traceability across the entire validation lifecycle — from commissioning through ongoing qualification.
How does Kneat handle change control and deviations?
Kneat includes built-in workflows for documenting, tracking, and resolving deviations and change controls. Every action is recorded in a secure audit trail, making it simple to demonstrate compliance during inspections.
Does Kneat align with risk-based approaches like ASTM E2500 and ICH Q9?
Yes. Kneat is designed for risk-based validation strategies. It enables users to build risk assessments, link risks to protocols, and implement a science- and risk-based approach in line with ASTM E2500 and ICH Q9 expectations.
Does Kneat offer version control for validation documents?
Yes. All validation documents in Kneat are version controlled. Edits, approvals, and updates are tracked with full visibility, ensuring teams always know the current approved version.
Are there customizable templates for validation deliverables?
Yes. Kneat provides configurable templates for validation plans, protocols, traceability matrices, and reports. This avoids the need to start from scratch and ensures consistency across projects and sites.