Intuitive user interface

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.  

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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. 

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. 

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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.

 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.  

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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. 

 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.

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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 Gx | Paperless Instrument Validation

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

 Validation master plan management

 Systems Register management
 System Impact assessment
 Requirements capture and trace-ability management
 Risk assessment
 Test protocol development (FAT, SAT, IQ, OQ, PQ/UAT)
 Paperless test execution with integrated deviation management
 Validation summary final report
 Real time validation metrics
 Validation status monitoring and periodic review management
 Decommissioning

Why use Kneat Gx for Instrument Validation? 

 Reduce cycle-times by up to 60%

 Productivity improvement of up to 100%*
 21 CFR Part 11/EudraLex Annex 11 compliant
 Eliminates 100% of paper-records
 Best practice that can be leveraged over and over across projects and sites
 Paper records are eliminated – instant central access to all records online
 Records and versions cannot be misplaced – find and launch the correct record in seconds
 Potential for data integrity issues is minimized, ‘ALCOA’ principles embedded in the process with focus on the data
lifecycle
 Instant macro and micro visibility into all aspects of the process in real time
 Protocol GDP errors minimized
 Comprehensive validation register provides real time inspection preparedness
 Kneat Gx | Paperless Method Validation

Kneat Solutions’ next generation paperless validation software “Kneat Gx” digitizes the entire
Method Validation life-cycle, delivering compelling productivity, cycle-time and compliance
improvements.

 Validation master plan management

 Design review
 Requirements capture and management
 Risk assessment management
 Protocol development & management
 Document review & approval
 Paperless test execution with integrated deviation management
 Validation summary report
 Real time validation status & metrics
 Periodic review
 Change management and re-validation

Why use Kneat Gx for Method Validation?

 Facilitates best practice risk-based, lean, life-cycle approach to validation

 Eliminates 100% of paper-records
 Paperless test execution with integrated deviation management
 Productivity improvement of up to 100%*
 21 CFR Part 11/EudraLex Annex 11 compliant
 ‘ALCOA’ Data Integrity best-practice
 Instant macro and micro visibility into all aspects of the process in real time
 Protocol GDP errors minimized
 System status monitoring – validated, review due/complete, etc.
 Audit ready in real time

Kneat Gx | Paperless Computer System Validation

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

Audits and assessments 

 Computer System Vendor audit
 21 CFR Part 11/EudraLex Annex 11 assessment
 Impact assessment

Validation and Verification

 Validation master planning

 Validation project management
 Functional Specification (FS), Design Specification (DS)
 Design qualification (DQ), installation qualification (IQ), operational qualification (OQ)
 User acceptance testing (UAT)
 User Requirements Specification (URS)
 Requirements capture, traceability and life-cycle management

Validation Management

 Periodic review management

 IT System rRisk managementegister management
 Risk management
 Review, change management and re-qualification

Why use Kneat Gx for Computer System Validation and Verification? 

 Facilitates best practice risk-based, lean, life-cycle approach to validation

 Eliminates 100% of paper-records
 Paperless test execution with integrated deviation management
 Productivity improvement of up to 100%* and cycle time savings of up to 50%*
 21 CFR Part 11/EudraLex Annex 11 compliant
 Standardizes CSV processes for all project and IT system life-cycle management
 ‘ALCOA’ Data Integrity best-practice
 Instantly see why approved data was changed, when and by who
 Macro and micro visibility into all aspects of the process in real time
 Protocol GDP errors minimized
 System status monitoring – validated, review due/complete, etc.
 Audit ready in real time

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.

Process Validation is regulated by FDA  21 CFR 820.75 and 21 CFR Part

211.100, 211.110 and EudraLex Annex 15, and occurs in three main stages, Process Design,
Process Qualification and Continued Process Verification. 
  

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.

There are four key types of process validation, Prospective Validation (before

production), Concurrent Validation (during production), Retrospective Validation (after
production) and Revalidation (validation following any process change) – all of which can be
conducted in Kneat Gx.

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

 Process Design and DOE (Design of Experiment Studies)

 Process Qualification
 Continued Process Verification (maintaining a state of validation)
 Prospective Validation
 Retrospective Validation
 Concurrent Validation
 Revalidation

Why use Kneat Gx for Process Validation?

 Risk-based, lean, life-cycle approach to process validation

 Productivity improvement of up to 100%* and cycle time savings of up to 50%*
 Eliminates 100% of paper-records, physical storage and retrieval and associated costs
 Digitized test-execution with integrated deviation management
 21 CFR Part 11/EudraLex Annex 11 compliant
 ‘ALCOA’ Data Integrity best-practice
 Comprehensive audit trail with detailed, un-editable change log
 Instant macro and micro visibility into all aspects of the process in real time
 Protocol based GDP errors minimized
 System status monitoring – validated, review due/complete, etc.