Kneat Gx Platform

A laboratory worker in a white coat studies Kneat Gx on her computer screen

ONE PLATFORM – MANY SOLUTIONS

Kneat Gx is a robust and comprehensive compliance platform that provides companies with the structure, visibility and control to manage their regulated processes globally.

Kneat Gx is focused on:

  • Increasing product throughput, quality and compliance
  • Providing management real time visibility and control
  • Driving down capital and operational costs

Whether it is Validation Lifecycle Management, Commissioning and Qualification, QMS documentation or your production record processes its ease of configuration allows you to deliver operational excellence for your unique business needs.

Configuration

Managing your regulated process can be costly and time-consuming. With Kneat Gx there is no coding required to set your process up on the platform. The Kneat Gx platform is designed to facilitate your processes with ease of use and configuration. Once on-boarding is complete your subject matter experts will be trained to set up and/or modify your own processes as your business needs change.

Designed To Enable Global Standardization

Create a centralized best practice structured process that can be instantly leveraged by any user across your global organization. The process or part of the process can be locked down and enforced across your network or it can serve as a great starting point for the various users. The process can also contain record templates for the various process stages or added from the centrally controlled library.

Real Time Collaboration

Kneat Gx is a collaborative platform, which allows you to increase productivity, reduce cycle times and provide instant global visibility into all aspects of your process. All approved users can participate in your process in real time reviewing, approving and signing off on documentation & quality records. Both serial and parallel collaboration can be accomplished throughout your process and specific to each deliverable.

Part 11 Compliance & Data Integrity

Kneat Gx is a next generation software platform designed to allow Pharmaceutical, Biotech and Medical Device manufacturers to become electronic and audit ready in real time for document intensive processes. Kneat Gx enables a best practice structure incorporating regulatory and corporate requirements. As such it has been developed to deliver a process which supports all global Good Manufacturing Practices (GMP’s) and possesses all controls necessary for compliance with FDA regulation 21.CFR.Part 11 and EU guide Annex 11. The Kneat Gx platform supports your effort to capture data accurately and maintain its integrity throughout its lifecycle. It achieves this through a robust permissions and role based access, capturing who entered and changed the data with e-signature’s, time stamp’s, reason for change.

Powerful Reporting

Kneat Gx is a feature rich fully integrated platform. All data is captured securely in a structured database that can be presented intuitively in any report/dashboard. Real time reports auto-generated based on actual work done are powerful and greatly support global compliance. For example, being able to query the completion status on any Validation project, Production Batch or document across any global site greatly helps the compliance effort.

Easy to Use, Easy to Deploy and easy to Scale

Kneat Gx is a 100% web based application. It can be loaded on any server and accessed from anywhere on any device via keypad or touch. Your process can quickly be setup on the platform, verified for purpose, UAT’d and rolled out locally or globally with both on premise and cloud options. Because of Kneat Gx’s intuitive UI all users from the shop floor to senior management find it easy to use. In addition, no coding whatsoever is needed during configuration. There is often resistance to adopting new software systems because of the level of effort required to identify, install, validate, train and support. But with Kneat’s proven next generation technology your implementation process will be seamless and user friendly for a quick turnaround. The Kneat Gx platform will allow your organization to scale by quickly creating new process templates, workflows, tasks and approval groups that will simplify any outdated solution. You will increase compliance and data integrity by leveraging a validated, Part II compliant solution that allows you to stay within the web based application at all times.