Power that’s easy to use

Purpose built for Life Sciences, Kneat’s feature rich platform and easy to use interface makes any validation easier, faster and smarter.

Intuitive dashboard design

Clearly identified work areas and a logical menu layout let new Kneat users learn quickly.  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.

Manage validation by site, process or project with Workspaces

The ‘Workspace’ area of Kneat is where most users will spend their time. Workspaces are customisable, and can be organized by site, process or project. Within a Workspace, a user can generate documents, deviations/non-conformances execute test scripts, and send documents for review and approval.

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

 

 

Template building and document generation

Kneat’s templates area allows authorized users to create document templates that can be used to generate documents, protocols and reports in the Workspace.  Authorized users can also define approval workflows for document types as needed.

  • Author templates and route for review and approval within the library area. 
  • Create new templates quickly by copying an existing template. 
  • Create test executable templates with pre-approval and post-approval workflow. 

Review and approval

Kneat’s Inbox area allows a user to view and navigate to documents they have received for Review or Approval. 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.

Review 

  • Issue a document for review, email notifications alert users.  
  • Real time, in-document commenting between document reviewers.  
  • Automated version management throughout.  
  • Document owner can update to new version while in-review. 

Approve

  • Issue a document for approval to users, email notifications alert users.
  • Approve with 21 CFR Part 11 / Annex 11 compliant electronic signature.
  • Approvers can review all document information, including any document changes complete with reviewer comments.
  • Reject a document and provide comment.
  • Re-open an approved document for modification and version management is auto applied. 

Test execution

When a test document has been pre-approved, it may then be issued for execution. Testers can enter recorded 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.  

Reporting

Within the reports area the user can run status reports for all projects, systems and validation deliverables. The user can run an overall report, create a report using filters, save a filtered report and export the report to PDF. 

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

Managing users

The User Administration area allows authorised administrators to create, edit and deactivate role based user accounts. All users, user permissions, and the creation of user groups to suit processes are managed in this area of Kneat. 

  • Assign and manage user permissions from one centrally controlled panel. 
  • Assign user privileges as needed. 

Manage and edit documents

Kneat’s Editor allows you to create a document based on an approved template, author a document from scratch or import a word document.  You can define document types associated with stages in a process or project and arrange them into any specified order. 

  • Manage folders and documents with unique identifiers.
  • Import Word documents to quickly create a Kneat smart document or template.
  • Add re-usable content to a document from a library e.g. test cases.
  • Import data from Excel.
  • Export to a locked down and non-editable format.
  • Insert a reference or hyperlink within a document to any other document within the system.
  • Upload any attachment file type into a document such as evidence during testing.

Audit trail

Kneat automatically generates an independent detailed, un-editable audit trail in real time.  See any user action, correction or change with a corresponding timestamp, and a range of other particulars at the click of a mouse.  Filter and re-order any audit trail to pinpoint any desired information during audit, including:    

  • Revision history for any document either in review, pre-approval, or test execution.  
  • Document events such as document creation or deletion, or issued for approval.
  • Document template events such as a document template being issued for approval.  
  • Template dispositioned by signatory.  
  • Test execution events such as saved, or modified test data. 
  • Administration events such as login, create user, or edit user details.  
  • Security events such as failed login. 

 

SaaS or on-premise

Kneat is a standalone enterprise platform available as SaaS or on-premise. We can deploy quickly in our secure cloud or implement on your infrastructure, whatever is your preference. Kneat’s SaaS front and back-end, as well as its IT infrastructure undergo annual independent pen-tests. This is in addition to Amazon Web Services’ (AWS) own independent tests, periodic internal tests, and 24/7 monitoring of security-related events.

  • Most extensive compliance standards.
  • Amazon’s top-tier secure cloud services.
  • Full disaster recovery.

System architecture

  • Kneat is a Microsoft ASP.NET based web application that is hosted on Microsoft’s Internet Information Services (IIS) and is compatible with Google Chrome and Internet Explorer browsers. The client does not require any additional software; only a browser is needed.
  • Compatible with the HTML 5 standard.
  • AJAX for asynchronous communications between client and server.

We were very gratified when we reviewed the new e-Val system with the regulatory agencies and received positive feedback on our ability to document, manage, retrieve and track validation data as well as our commitment to best-in-class GxP processes.

- Director, Quality, Leading Molecular Diagnostics Company
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