Digital Process Validation for Faster Speed to Market
Kneat Gx | Paperless Validation
Why Kneat
Use Proven Technology and Validation Industry Expertise to Support Your Process Validation Program
- Risk-based, lean, lifecycle approach to process validation.
- Productivity improvement of up to 100% and cycle time savings of up to 50%.*
- Eliminates 100% of paper-records, physical storage, retrieval, and associated costs.
- Digitalized test execution with integrated deviation management.
- 21 CFR Part 11/EudraLex Annex 11 compliant.
- ALCOA+ data integrity best practice.
- Comprehensive audit trail with detailed, un-editable change log.
- Instant macro and micro visibility into all aspects of the process in real time.
- Protocol-based GDP errors minimized.
- System status monitoring: validated, review due/complete, etc.
*As found by multiple independent customer benchmarking studies.
Our partnership with Kneat was one of the critical factors for success. The minute we started our collaboration we felt so comfortable with each other…with Kneat it was very apparent. Based on our learnings from other systems deployments, we see how important it is, not just to have a robust relationship with the vendor – but to have a robust vendor.
Benefits of Kneat Gx for Process Validation
Kneat Gx digitalizes every step of process validation, accelerating production by reducing cycle times, enhancing data integrity and compliance, and streamlining analysis so validation can be easily managed from anywhere.
Kneat Gx allows you to manage all your products’ lifecycle starting with Critical Quality Attributes and Critical Process Parameters through to Validation Final Reports in one easy-to-use platform.
The Kneat Gx platform’s built-in validated features and functions support all types of documentation and can be easily set up to meet your company’s specific requirements without the need to purchase additional software or modify the application.
Sample Document Types
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- Validation Master Plan
- Design Documents (Process Control Strategy)
- Risk Assessment
- Test protocols (PV)
- Validation Summary Report
- Validation Final Report
- Operational Forms
- Decommissioning
Documentation generation is simplified in Kneat Gx by pre-approved templates and dynamic data sharing, which reduces time required to generate a document and human errors by auto-populating relevant data in templates and using unique IDs across document packs to enable quick referencing to documents.
Paperless execution reduces GDP errors and improves data integrity by providing standard functionality that supports ALCOA+ principles. In addition, Kneat Gx supports global harmonization and standardization to further reduce time required to deploy a new instrument or the time out of service for changes or upgrades. Such standardization can be done on a large scale, or more focused, so as to fit your needs.
Additional efficiencies are gained since the Kneat Gx work process does not require the transporting of physical documents and these documents cannot be lost or damaged.
Kneat Gx Validated Features
Changes to deployed work processes or addition of new work processes to Kneat Gx can be performed by a trained user within your organization simply by using Kneat Gx’s standard validated features. These changes can be performed with minimal verification without introducing risk to your program.
Standard Kneat Gx features and functionality include:
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- Critical Requirements and Parameter Management
- Requirements Traceability Matrixing
- Dynamic Data Sharing
- Real-Time Documentation Metrics
- Status Monitoring and Periodic Review Management
- Template Management and Approval
- Work Process Management
- System Register Management
Other Applications
Use Kneat to manage any validation, commissioning or qualification process.
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