Smarter paperless validation
Purpose built for Life Sciences, Kneat’s 21 CFR Part 11/Annex 11 compliant paperless validation platform turns documents and data into tools to enhance product quality and accelerate production. Use Kneat Gx to make validation easier, faster, and smarter.
Intuitive User Interface
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.
- Search any document or drawing for unique IDs, numbers, titles, keywords, and more.
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
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, 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.
- 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 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.
- Issue a document for review, email notifications alert users.
- Real time, in-document commenting between document reviewers.
- Automated version management throughout.
- Mandatory and non-mandatory password protected signatures
- Document owner can update to new version while in-review.
- 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.
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.
Electronic Logbook Management
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 Life-cycle management in one 21 CFR Part 11/Annex 11 application
- All supporting documentation, just a click away
- Comprehensive, time-stamped, author-attributed logbook history
Reporting & Paperless Handover
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 present 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 User Administration area allows authorized 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.
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.
Document Management (Module)
The Kneat Document Management Module* delivers effective, efficient, and compliant management of non-native Kneat documents, both GxP and non-GxP, throughout their lifecycle to live alongside native Kneat documents in Kneat Gx. Users create their documents in their document generation software apps (Word, PDF, Excel); check-in to Kneat Gx for review and redlining; check-out from Kneat Gx into the relevant software app for updates; check-in updated documents to Kneat Gx for review and compliant e-signature approval.
- Controlled document check-out/check-in, with manual/bulk upload of various file types such as Word, Excel, PowerPoint, PDF, and JPEG
- Online collaborative comprehensive review of documents e., redlining with annotation
- Search for any document by number, title, project, system, etc
- Configurable access restrictions in line with business needs
- Cross reference and link non-native Kneat documents within Kneat-native documents
*Document Management Module is available as an optional ‘add-on’ to a base package of Kneat Gx.
Drawing Management (Module)
The Drawing Management Module* adds on to the Kneat Gx digital validation platform and integrates with existing CAD systems to bring drawings into your Kneat Gx Workspace. Users check-in to Kneat Gx for review and redlining; check-out from Kneat Gx into the CAD system for updates; check-in updated drawings to Kneat Gx for review and compliant e-signature approval.
Kneat’s Drawing Management module delivers effective, efficient, and compliant management of drawings throughout their life cycle.
- Elimination of paper drawings, 21 CFR Part 11/Annex 11 compliant drawing management (including e-signature) with access control, configurable workflows, version control, backup storage, and audit trails
- Online collaborative comprehensive review of drawings i.e., redlining with annotation
- Perform live walkdown markups
- Flexible search options including equipment ID, keywords, titles, and more
- Centralized repository of drawings, schematics, and diagrams alongside validation documentation
- Reference drawings in validation documentation
*Drawing Management Module is available as an optional ‘add-on’ to a base package of Kneat Gx.
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