Validation Lifecycle Management
End-to-end Equipment Validation, Computer System Validation etc. Make the Validation process structured, easier to perform and easier to manage. Configure a streamlined, paperless and transparent process for all Validation types – Equipment, Instrument, Computer, Cleaning, Process, Method, etc.
The Kneat E-Val Solution
The Kneat e-Val solution enables business process innovation, delivering compelling productivity, cycle time and compliance improvements. All your validation process can be set up on the system making it structured, controlled, compliant, centrally managed and paper free.
The result of using Kneat Gx is best practice processes that can be leveraged over and over globally across your company:
- Enabling users to be more productive and compliant as they do their work.
- Providing management unprecedented visibility and control of all areas of the process.
- Providing a real tool to drive down capital and operational costs, minimize compliance risk and ensure audit readiness.
INCREASE PRODUCTIVITY AND REDUCE CYCLE TIMES USING KNEAT E-VALIDATION.
• Manufacturing Equipment, Systems, Utilities Validation
• Computer System Validation
• Laboratory Equipment Validation
• Process Validation
• Cleaning Validation
• Cleaning Monitoring
• Method Validation
• Periodic Review management – alerts and instant visibility
• System Status Monitoring – Includes Validated, Periodic Review Due/Complete
We Are Passionate About Maintaining Your Processes, Facilities and Systems In a State of Control
• Shorter time to peak facility performance
• Faster time to market
• Higher quality
• Make Compliance effort easier
• Audit readiness
KNEAT GX OVERCOMES VALIDATION PROCESS CHALLENGES
The Kneat e-platform enables a robust structured templated process that can be leveraged over and over. Finally, standardization can be the norm where best practice can be centrally created and leveraged globally. Some of the Challenges that Kneat Gx can help to overcome are:• Removing paper records
• Designing and embedding a Lean process is difficult when using a paper/hybrid process
• Very difficult to standardize and leverage best practice across projects/ sites and also allow for controlled flexibility where it may be needed
• Record handling, management and storage is time-consuming and requires significant coordination. Records get misplaced.
• Review and Approval is cumbersome even in good document management systems
• Inefficient and GDP error-prone test execution and summary reporting
• Metrics not readily available leading to more difficulty for management
• Difficult to access the right data quickly
• Difficult to search for and retrieve Information
• Poor Management visibility into the process at site/ multi-site level
• Data integrity concerns i.e. adhering to ‘ALCOA’ principles
• Meeting critical path system lifecycle activities
An e-Validation process can be easily and quickly configured on the platform and no coding is needed. Our customers are reporting compelling ROIs based on real productivity, cycle time improvements leading to greater product throughput and to a higher compliance standard.
Our software is allowing them to optimize their Validation and GxP testing globally and to become totally paperless.
Kneat Gx is proven to deliver business value and to scale efficiently across global sites.
Key feedback from our customers is Kneat Gx’s ease of use, its ease of deployment and its ease of scalability to new processes and to new global sites.