Smarter Digital Validation

Kneat Gx is designed to be flexible and configurable so you can upgrade your validation without extensive reworking of processes, templates, and settings your teams have become accustomed to. Quick to learn and easy-to-use, Kneat’s fast time to value makes it easy to scale up and adapt as business needs change.

• Configurable workflows to use what works from existing processes merged with Kneat’s specific enhancements.
• Configurable settings and views so Kneat Gx is perfect for specific organizations, sites, and processes.
• Expert support in designing workflows and templates to ease onboarding and speed training.

Specially designed to be mastered quickly, Kneat’s clearly identified work areas, and a logical menu layout are easy to learn for any validation professional.  Reach any document, document template, audit trail, report, administrative controls, document editor and more in just a few clicks.

• Access everything directly from your permission driven home page.
• View any system or project status report or configure and save your own customized report.
• Advanced filter and search functionality complete with preview snippets allows for easy and flexible searching of documents, drawings, files, attachments, and more.
• Use the Real-Time Requirements Traceability Matrix (RTM) to conveniently trace related requirements, tests, and documents throughout the validation lifecycle.

Use customizable Workspaces to generate documents, deviations/non-conformances, execute test scripts, and send documents for review and approval to anyone anywhere with an internet connection.

• Generate projects and documents, using pre-defined templates from the library.
• Share templates across all Workspaces – enabling process harmonization across projects, sites, and teams.
• Total collaboration between users working on the same document in the same Workspace, simultaneously.

Automatically generated Real-Time Requirements Traceability Matrix (RTM) updates in real time as changes are saved, making it quick to implement and easy to trace to requirements and sections in Test documents.

Authorized users can also define approval workflows for document types as needed, to ensure streamlined processes with flexible permissions and configurations.

• Author templates and route for review and approval within the library area.
• “Smart import” existing paper-based or digital document templates into Kneat.
• Design, approve, integrate, and analyze test case data outside documents for streamlined, future-ready testing.
• Create test executable templates with pre-approval and post-approval workflow.

Kneat’s Inbox area allows a user to view and navigate to documents they have received for Review or Approval from anywhere they can log into Kneat for near instant sign off. Quickly filter the Inbox to view documents or forms by status, ‘in progress’, ‘complete’ and more. When selecting a document from Kneat’s Inbox, the document will launch, and the user can review it or set an approval status.

Execute tests for pre-approved documents in real time. Record results, create and process any exceptions, upload evidence, apply electronic signatures, and generate summary reports without ever going to paper. Capture any subsequent changes to test data complete with e-signature, time stamp, and a reason for change — all while automatically generating a full audit trail.

• Execute testing and sign using compliant electronic signatures.
• Multiple users can test within the same protocol simultaneously.
• Attach an unlimited number of file attachments, screen shots to a test row, test section, test script etc.
• Apply a witness signature to any test step/script if required.
• View the full history of a test and all associated events.

Kneat’s Electronic Logbook Management feature, eLogbook, is included in all Kneat Gx versions, with no additional software or hardware purchases, installation or qualification required. Simply setup the electronic logbook work process in your Kneat Gx application and start logging.

• Logbook forms based on your procedures
• Real-time equipment and cleaning data and status reports from any place
• Complete lifecycle management in one 21 CFR Part 11/Annex 11 application
• All supporting documentation, just a click away
• Comprehensive, time-stamped, author-attributed logbook history Manage and Edit Documents

Run status reports for all projects, systems, and validation deliverables within Kneat Gx. Users can run an overall report, create a report using filters, save a filtered report and export the report to PDF. Paperless handover makes it easy to represent documentation outside of Kneat Gx —perfect for administrative tasks— while including a full audit trail of all activities.

• Run status reports for all projects, systems, and validation deliverables.
• Create reports using detailed filters.

The ‘Collections’ feature in Kneat allows users to send approved PDF documents to a dedicated staging area / digital room where non-standard users, such as auditors, can view, and interact with the content. This expedites audit preparation, reduces human error, and enables responses to remote audits.

Kneat automatically generates an independent detailed, un-editable audit trail in real time. See any user action, correction or change with a corresponding configured system time zone timestamp, and a range of other particulars at the click of a mouse.