Digital Process Validation for Faster Speed to Market

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

1. • 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:

1. • 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