1. Kneat Gx
Compliance by Design
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2. What is Kneat Gx
 Kneat Gx creates and maintains sets of product,
process or equipment lifecycle documents with
less effort and higher quality
 Kneat can be applied to any process where
compliance and data integrity is business critical
and information is shared across a set of
documents
 For example
– Large project execution
– Manufacturing facility validation documentation
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3. Some Large Project Execution Concerns…..
 Right First Time translation of requirements
 Collaboration across multiple stakeholders
 Engineering data management
– Data flow between different stakeholders
– Data integrity
– Management of change
 C&Q process
– Test plans need to be appropriate and optimised
– Test documents need to be aligned with latest design
– Management of deviations and re-work process
 Timely handover of accurate and complete data /
information to operations
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4. Typical Project Execution Outcomes
 Corrupt, inaccurate, missing data
 Test documents not aligned with design
 C&Q process delayed and over budget
 As-building exercise is a headache
 Handover to operations is problematic
 Non-optimal start up impacts company goals
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5. Kneat Gx Paperless Approach
 Document content is dynamically linked to a
database which provides structure and context
 Automated assessment of the impact of change
across all documents
 Streamlined execution of changes to documents
 Downstream life cycle documents/ test reports are
auto-generated
 Online test execution and deviation processing
 Cloning of suites of documents for new projects
maintaining embedded relationships
 Efficiency, Quality and Compliance built in
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6. Kneat Modeling Concept
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7. Kneat’s Powerful Leveraging of Work
RE204 bioreactor cloned documents are at
development closed status and are waiting for a
document number to be assigned.
These are new units created by simply cloning RE201
including all of its associated documentation,
embedded relationships and model objects.
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8. Document Change Execution Process
Affected
Documents
Approved Auto Generate re- Re-test
Document Auto Impact Documents
B1.0 test Documents
Assessment
Change
A1.0
Initiation C1.0
A1.1 D1.0
B1.1 Change Change Pre-
Change Post- Approval
Completed Approval
C1.1 All docs Change
automatically Execution and
updated re-test
D1.1
Approved
Documents
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9. Kneat Fit in Large Project Execution
 All lifecycle documents are generated, approved and executed within
Kneat
 Global collaboration
 Automated and streamlined change execution
 Just in Time release of test documents
 Online testing and deviation management
 Auto-generation of test and acceptance reports
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10. Kneat Fit in Large Project Execution
Note: A/E can own the
MPD for smaller projects • User/functional requirements
Requirements • Risk assessment
Management
• Requirements traceability
Process
A/E Data • Design verification
Master Project Import*
Automation Kneat Document
Database (MPD)
Integrator Owned by
Database Change Operations
Data Execution
Construction Mgr
• Auto-impact assessment
• Auto-retest scripts
• Auto doc updating
Equipment • FAT/SAT
Vendor
Receipt C&Q • IV/FV
Data
Verification Process • Online testing / Deviation Mgt
Process • Acceptance Reports
Construction Mgt Kneat Gx application (Owned by Operator)
* Import on demand,
periodically or at milestone
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11. Kneat Benefits for Project Execution
 Engineering specifications and verification process
can be standardised
 Global project execution through collaboration
and live management oversight
 Design and test documents always aligned
– On-line document change execution
– Auto impact assessment
– Auto updating of affected life cycle documents
– Just in Time release of test protocols
 Right first time project deliverables translates to
reduced Business Risk - Quality, Safety, Financial,
and Operational
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12. Kneat Opportunity for Operations
 Kneat can continue to provide value to operations
in a new facility
 Instant access to original requirements, design
basis and associated risk assessments
 Retention of project knowledge, practices and
templates for future projects
 Ongoing document change execution related to
facility modifications and additions
 Documentation relating to new equipment can be
cloned from similar existing equipment
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13. Kneat Supporting Ongoing Operations
Enterprise Document Management System
Approved documents
published from Kneat
Kneat Database
Initiation Closeout
Facility
Design Verify
Modifications /
Upgrades
Construct
Facility Lifecycle (20 – 30 years) Retirement
 Change execution based on robust impact assessment
 Lifecycle documentation is always audit ready and
easily accessed
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14. Kneat Fit in Site Infrastructure
Management of all
site documents
Publishing of EDMS
approved Kneat
documents
Kneat CAPA
Generation/ Site Change Control
Management of the System
content of lifecycle*
documents
Doc status and
change details
* Lifecycle documents describe a regulated process, where info is shared across
documents and compliance and data integrity are business critical. eg Facility
Qualification
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15. Kneat Benefits for Operations
 Ability to copy/clone work done on previous
projects provides significant efficiencies
 Reduced time to market for new product launches
 Optimal plant performance is achieved sooner
 Lifecycle documents are audit-ready and
maintained in a state of compliance at all times
 Lower risk of citations and warning letters
 Lower cost of compliance
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16. Kneat Gx Infrastructure
 Web application based on Microsoft’s .NET
platform
 Browser based access to secure optimized
database
 Controlled login over Secure Sockets Layer (SSL)
 Full enterprise level scalability
 Fully validated to GAMP 5 ISPE guidelines and
21CFR Part 11 regulations
 System architecture facilitates integration with
other IT applications
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