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Kneat e Validation
Kneat e Validation
Kneat e Validation
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.
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.
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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.
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
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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.
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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.
Manage 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.
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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.
Kneat Solutions’ next generation paperless validation software “Kneat Gx” digitizes the entire Instrument Validation life-cycle,
delivering compelling productivity, cycle-time and compliance improvements.
Functions
Kneat Solutions’ next generation paperless validation software “Kneat Gx” digitizes the entire
Method Validation life-cycle, delivering compelling productivity, cycle-time and compliance
improvements.
Kneat Solutions’ next generation paperless validation software “Kneat Gx” digitizes the entire
computer system validation life-cycle, delivering compelling productivity, cycle-time and
compliance improvements.
Functions
Validation Management
Process Validation is the collection and evaluation of data from the process design stage through
commercial production, which establishes scientific evidence that a process is capable of
consistently delivering a product.
Stage 1 | Process Design: The commercial manufacturing process is defined during this stage
based on knowledge gained through development and scale-up activities.
Stage 2 | Process Qualification: During this stage, the process design is evaluated to determine if
the process is capable of reproducible commercial manufacturing.
Stage 3 | Continued Process Verification: Ongoing assurance is gained during routine production
that the process remains in a state of control.
Documenting the Process Validation process on paper, can result in significant inefficiencies
including an inability to adequately enforce process requirements, non-value-added activities,
lack of data visibility, physical record retrieval and storage challenges and lengthy cycle times.
Kneat Gx | Paperless Process Validation
Kneat Solutions’ next generation paperless validation software “Kneat Gx”, digitizes the entire
Process Validation life-cycle, delivering compelling productivity, cycle-time and compliance
improvements.
Functions