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Kneat Gx Compliance by Design

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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 wherecompliance and data integrity is business criticaland information is shared across a set of documents

For example

– Large project execution

– Manufacturing facility validation documentation

What is Kneat Gx

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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

Some Large Project Execution Concerns…..

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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

Typical Project Execution Outcomes

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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

Kneat Gx Paperless Approach

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Kneat Modeling Concept

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Kneat’s Powerful Leveraging of Work

These are new units created by simply cloning RE201 including all of its associated documentation, embedded relationships and model objects.

RE204 bioreactor cloned documents are at development closed status and are waiting for a document number to be assigned.

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Document Change Execution Process

Change Initiation

Auto Impact Assessment

Affected Documents

Auto Generate re-test Documents

Re-test Documents

Approved Document

A1.0

D1.0

C1.0

B1.0

Approved Documents

A1.1

B1.1

C1.1

D1.1

Change Pre-Approval

Change Execution and

re-test

Change Post-

Approval

Change Completed

All docs automatically

updated

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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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Kneat Fit in Large Project Execution

A/E Data

Automation

Integrator

Data

Equipment

Vendor

Data

Kneat

Database

Master Project

Database (MPD)

Owned by

Construction Mgr

Receipt

Verification

Process

C&Q

Process

Kneat Gx application (Owned by Operator)Construction Mgt

Import* Document

Change

Execution

Requirements

Management

Process

• User/functional requirements

• Risk assessment

• Requirements traceability

• Design verification

• FAT/SAT

• IV/FV

• Online testing / Deviation Mgt

• Acceptance Reports

• Auto-impact assessment

• Auto-retest scripts

• Auto doc updating

Operations

* Import on demand,

periodically or at milestone

Note: A/E can own the

MPD for smaller projects

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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

Kneat Benefits for Project Execution

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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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Kneat Supporting Ongoing Operations

RetirementFacility Lifecycle (20 – 30 years)

Facility

Modifications /

Upgrades

Change execution based on robust impact assessment

Lifecycle documentation is always audit ready and

easily accessed

Kneat Database

Enterprise Document Management System

Approved documents

published from Kneat

Initiation

Design

Construct

Verify

Closeout

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Kneat Fit in Site Infrastructure

EDMS

CAPAKneatGeneration/

Management of the

content of lifecycle*documents

Management of all site documents

Site Change Control System

Publishing of approved Kneat

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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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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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

Kneat Gx Infrastructure

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