Risk and Regulatory Change Management - 360factors EUEC 2015 Presentation
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Regulatory Change Management Ed Sattar, CEO,
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Transcript of Risk and Regulatory Change Management - 360factors EUEC 2015 Presentation
Regulatory Change Management
Ed Sattar CEO
Page 2Regulatory Change Management
Speaker Ed SattarEd Sattar is the CEO of 360factors For more than a decade Ed has made
significant professional contributions to the regulatory compliance space across
multiple industries His experiences include extensive research and consulting to
regulatory compliance consulting firms training providers as well as state and federal
regulatory agencies During his tenure in the regulatory compliance workflow
automation and eTraining space he has identified key criteria and compliance
standards that are currently being published and implemented
Ed Sattar has been nominated for the Ernst amp Young Entrepreneur of the Year award
three times and was among the top seven finalists in 2009 360trainingcom the
parent company of 360factors has appeared on the Deloitte Fast 50 as the 6th
fastest growing company in Texas It has also been listed in Inc 5000 several times as
one of the fastest growing companies
Ed studied Electrical Engineering and Finance at the University of Texas at Austin
Page 3Regulatory Change Management
Profit
PeoplePlanet
Effective Operational Risk Management amp Three Prsquos
Page 4Regulatory Change Management
Outline
Regulatory amp Operational Risk Trends
Why Implement an Enterprise Risk and Regulatory
Change Management System
Enterprise Risk and Compliance Management
Methodology
How to Implement an Enterprise Risk and Compliance
Management System
Can Automation and Software can Increase Operational
Excellence and Reduce Risk
Regulatory Change Management
Regulatory amp Operational
Risk Trends
Page 6Regulatory Change Management
Rising Regulations and Cost
Page 7Regulatory Change Management
Source Davis Polk Dodd-Frank Infographics
Regulatory change is significantly impacting
organizations and their policies
Regulatory Change Management
More Complexity More Projects and More
Risks to Manage
Managing Your Operations
Seamlessly While Reducing
Risk
Regulatory Change Management
Why Implement an Enterprise amp
Regulatory Change Management
System
Regulatory Change Management
1 Understanding Regulations- Either Over Complying or Under
Complying-
2 Regulatory Applicability and Managing Regulatory Changes
3 Automating And Streamlining Day To Day Compliance Event And
Incident Management With Respect To Regulatory Change
Management
4 Cost Efficiency By Automating Tracking and Monitoring a Non Compliance
Items Such as Events Incidents Audits amp Investigations
Four Reasons Why Implement Regulatory Change Management
Page 11Regulatory Change Management
Four Reasons Why Implement
Regulatory Change Management
Understanding Regulations
Regulatory Change Management
Regulatory Applicability
Day to Day Compliance Tasking
Event-Driven Compliance Tasking
Incident Management and Root Cause Analysis
Predictive Risk Analysis
Corrective and Preventive Actions
Policy and Procedure
Management
Audit Management
Sustainability
Training Management
Multiple Tools to address Reg
Compliance
Other Industry Pain Points
Regulatory Change Management
Enterprise Risk and Compliance
Management Model
Regulatory Change Management
1 WHY = Regulatory change management
2 WHAT = Risk and internal controls
3 HOW = Operational excellence and workflow
4 WHERE = Location Assets
5 WHO = Defining amp Mapping Roles Key Management Functions
to Metrics amp PampL
Enterprise Risk and Compliance
Management Model ndash Five Steps
Regulatory Change Management
REGULATORYCHANGEMANAGEMENTMODEL
Regulatory Change
Management
Operational Excellence
and Workflow
Risks amp Internal Controls
Organization ndash Roles and
Key Management
Functions
Location
Assets
HOW
WHY
WHAT
WHO
WHERE
Regulatory Change Management
How to Implement an Enterprise
Risk and Compliance
Management System
Page 16Regulatory Change Management
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles and Responsibilities
Locations and Assets
COMPONENTS OF REQUIREMENTS KNOWLEDGE BASE
1 Regulatory Standards Requirements
and Objectives library management
2 Translate regulatory requirements into
action evidence subject frequency
3 Monitor regulatory change
4 Regulations in effect to proposed
5 Mapping- regulatory requirements
mapped to CAPA policy procedures and
evidence
6 Regulation Applicability
Step 1- Requirements Knowledge
Base amp Taxonomy
WHY
Page 17Regulatory Change Management
Step 2- Risk amp Internal Controls1 What is impacted
Environmental Risk
Financial Risk
Legal Risk
Reputational Risk
Operational Risk
2 Define internal controls
Process
Procedures
Risk Assessments
tasks
training
3 Define risk levels
Which details impacting
factors
Is based on a systematic
process allowing the
organization to prioritize more
efficiently
Effectively assesses issues
requiring immediate action
Requirements Knowledge Based amp
Taxonomy
Operational Excellence and
Workflow
Risk and Internal Controls
Reporting ndashRoles and Key management
Functions
Location Assets
WHAT
Page 18Regulatory Change Management
Step 2- Risk amp Internal Controls
Requirements Knowledge Based amp
Taxonomy
Roles and Responsibility
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
Small Workforce Large Workforce
Hig
h R
isk
Lo
w R
isk
Page 19Regulatory Change Management
Weak Technology
bull Documentsamp spreadsheets
bull Email for workflow amp tasks
bull No audit trail or accountability
Moderate Technology
bull Basic workflow amp task management
bull No regulatory content feeds
bull Audit trail for accountability
Strong Technology
bull Enterprise workflow
bull Integrated and actionable regulatory content with policy management
bull Closed loop process ndash everything integrated into one platform
bull Indexing of regulations to other policies
Small Workforce Large Workforce
Hig
h C
om
ple
xity
Low
Co
mp
lexity
Step 2 - Risk amp Internal Controls
Page 20Regulatory Change Management
1 How
2 Compliance process around
sites assets events
3 Process automation and cost
4 Manual VS automation
Step 3- Business Processes
Requirements Knowledge Based amp
Taxonomy
Operational Excellence
and Business Processes
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 21Regulatory Change Management
Automate Corrective Action to Increase Speed Eliminate Waste and Cut Costs
Automate Scheduling Tasking and Tracking
Embed Transparency and Accountability
Automate Management of Change
PROCESSESS THAT CAN BE AUTOMATED
PROCESSESS THAT CANrsquoT BE AUTOMATED
Translation of Requirements
Subject Matter Expertise
Step 3- Business Process
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 22Regulatory Change Management
1 Where is compliance
done
2Compliance done at the
site and asset level
Step 4 Location amp Assets
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHERE
Page 23Regulatory Change Management
1 It is important to define the
roles and responsibilities
before you create an EHS
Regulatory Compliance
Framework
2 So what are the barriers to
creating a Regulatory
Compliance Framework
3 Is there a specific role and
responsibility structure or
can it vary from organization
and industries
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHO
Page 24Regulatory Change Management
1 Key Roles and Structure
2 Key Functions
3 Key Actions
4 Outcome Results
COMPONENTS OF ROLES AND RESPONSIBILITES
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
Regulatory Change Management
Can Automation and Software
Increase Operational Excellence
and Reduce Risks
Page 26Regulatory Change Management
1 Is Technology perceived
as a catalyst for growth and
performance
2 Are people or technology
barriers to Regulatory
Compliance Automation
Automate Regulatory
Compliance Through Software
Requirements
Regulations
Standards
Business Requirements
Business Process
Risks amp Controls
Organization
Location
Assets
Page 27Regulatory Change Management
Source Global survey by KPMG Inc
BENEFITS OF AN INTEGRATED MANAGEMENT SYSTEM
Automate Regulatory
Compliance Through Software
Regulatory Change Management
Predict360 REGULATORYCOMPLIANCEARCHITECTURE
Page 29Regulatory Change Management
People Planet and Profit
Page 30Regulatory Change Management
Page 2Regulatory Change Management
Speaker Ed SattarEd Sattar is the CEO of 360factors For more than a decade Ed has made
significant professional contributions to the regulatory compliance space across
multiple industries His experiences include extensive research and consulting to
regulatory compliance consulting firms training providers as well as state and federal
regulatory agencies During his tenure in the regulatory compliance workflow
automation and eTraining space he has identified key criteria and compliance
standards that are currently being published and implemented
Ed Sattar has been nominated for the Ernst amp Young Entrepreneur of the Year award
three times and was among the top seven finalists in 2009 360trainingcom the
parent company of 360factors has appeared on the Deloitte Fast 50 as the 6th
fastest growing company in Texas It has also been listed in Inc 5000 several times as
one of the fastest growing companies
Ed studied Electrical Engineering and Finance at the University of Texas at Austin
Page 3Regulatory Change Management
Profit
PeoplePlanet
Effective Operational Risk Management amp Three Prsquos
Page 4Regulatory Change Management
Outline
Regulatory amp Operational Risk Trends
Why Implement an Enterprise Risk and Regulatory
Change Management System
Enterprise Risk and Compliance Management
Methodology
How to Implement an Enterprise Risk and Compliance
Management System
Can Automation and Software can Increase Operational
Excellence and Reduce Risk
Regulatory Change Management
Regulatory amp Operational
Risk Trends
Page 6Regulatory Change Management
Rising Regulations and Cost
Page 7Regulatory Change Management
Source Davis Polk Dodd-Frank Infographics
Regulatory change is significantly impacting
organizations and their policies
Regulatory Change Management
More Complexity More Projects and More
Risks to Manage
Managing Your Operations
Seamlessly While Reducing
Risk
Regulatory Change Management
Why Implement an Enterprise amp
Regulatory Change Management
System
Regulatory Change Management
1 Understanding Regulations- Either Over Complying or Under
Complying-
2 Regulatory Applicability and Managing Regulatory Changes
3 Automating And Streamlining Day To Day Compliance Event And
Incident Management With Respect To Regulatory Change
Management
4 Cost Efficiency By Automating Tracking and Monitoring a Non Compliance
Items Such as Events Incidents Audits amp Investigations
Four Reasons Why Implement Regulatory Change Management
Page 11Regulatory Change Management
Four Reasons Why Implement
Regulatory Change Management
Understanding Regulations
Regulatory Change Management
Regulatory Applicability
Day to Day Compliance Tasking
Event-Driven Compliance Tasking
Incident Management and Root Cause Analysis
Predictive Risk Analysis
Corrective and Preventive Actions
Policy and Procedure
Management
Audit Management
Sustainability
Training Management
Multiple Tools to address Reg
Compliance
Other Industry Pain Points
Regulatory Change Management
Enterprise Risk and Compliance
Management Model
Regulatory Change Management
1 WHY = Regulatory change management
2 WHAT = Risk and internal controls
3 HOW = Operational excellence and workflow
4 WHERE = Location Assets
5 WHO = Defining amp Mapping Roles Key Management Functions
to Metrics amp PampL
Enterprise Risk and Compliance
Management Model ndash Five Steps
Regulatory Change Management
REGULATORYCHANGEMANAGEMENTMODEL
Regulatory Change
Management
Operational Excellence
and Workflow
Risks amp Internal Controls
Organization ndash Roles and
Key Management
Functions
Location
Assets
HOW
WHY
WHAT
WHO
WHERE
Regulatory Change Management
How to Implement an Enterprise
Risk and Compliance
Management System
Page 16Regulatory Change Management
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles and Responsibilities
Locations and Assets
COMPONENTS OF REQUIREMENTS KNOWLEDGE BASE
1 Regulatory Standards Requirements
and Objectives library management
2 Translate regulatory requirements into
action evidence subject frequency
3 Monitor regulatory change
4 Regulations in effect to proposed
5 Mapping- regulatory requirements
mapped to CAPA policy procedures and
evidence
6 Regulation Applicability
Step 1- Requirements Knowledge
Base amp Taxonomy
WHY
Page 17Regulatory Change Management
Step 2- Risk amp Internal Controls1 What is impacted
Environmental Risk
Financial Risk
Legal Risk
Reputational Risk
Operational Risk
2 Define internal controls
Process
Procedures
Risk Assessments
tasks
training
3 Define risk levels
Which details impacting
factors
Is based on a systematic
process allowing the
organization to prioritize more
efficiently
Effectively assesses issues
requiring immediate action
Requirements Knowledge Based amp
Taxonomy
Operational Excellence and
Workflow
Risk and Internal Controls
Reporting ndashRoles and Key management
Functions
Location Assets
WHAT
Page 18Regulatory Change Management
Step 2- Risk amp Internal Controls
Requirements Knowledge Based amp
Taxonomy
Roles and Responsibility
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
Small Workforce Large Workforce
Hig
h R
isk
Lo
w R
isk
Page 19Regulatory Change Management
Weak Technology
bull Documentsamp spreadsheets
bull Email for workflow amp tasks
bull No audit trail or accountability
Moderate Technology
bull Basic workflow amp task management
bull No regulatory content feeds
bull Audit trail for accountability
Strong Technology
bull Enterprise workflow
bull Integrated and actionable regulatory content with policy management
bull Closed loop process ndash everything integrated into one platform
bull Indexing of regulations to other policies
Small Workforce Large Workforce
Hig
h C
om
ple
xity
Low
Co
mp
lexity
Step 2 - Risk amp Internal Controls
Page 20Regulatory Change Management
1 How
2 Compliance process around
sites assets events
3 Process automation and cost
4 Manual VS automation
Step 3- Business Processes
Requirements Knowledge Based amp
Taxonomy
Operational Excellence
and Business Processes
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 21Regulatory Change Management
Automate Corrective Action to Increase Speed Eliminate Waste and Cut Costs
Automate Scheduling Tasking and Tracking
Embed Transparency and Accountability
Automate Management of Change
PROCESSESS THAT CAN BE AUTOMATED
PROCESSESS THAT CANrsquoT BE AUTOMATED
Translation of Requirements
Subject Matter Expertise
Step 3- Business Process
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 22Regulatory Change Management
1 Where is compliance
done
2Compliance done at the
site and asset level
Step 4 Location amp Assets
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHERE
Page 23Regulatory Change Management
1 It is important to define the
roles and responsibilities
before you create an EHS
Regulatory Compliance
Framework
2 So what are the barriers to
creating a Regulatory
Compliance Framework
3 Is there a specific role and
responsibility structure or
can it vary from organization
and industries
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHO
Page 24Regulatory Change Management
1 Key Roles and Structure
2 Key Functions
3 Key Actions
4 Outcome Results
COMPONENTS OF ROLES AND RESPONSIBILITES
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
Regulatory Change Management
Can Automation and Software
Increase Operational Excellence
and Reduce Risks
Page 26Regulatory Change Management
1 Is Technology perceived
as a catalyst for growth and
performance
2 Are people or technology
barriers to Regulatory
Compliance Automation
Automate Regulatory
Compliance Through Software
Requirements
Regulations
Standards
Business Requirements
Business Process
Risks amp Controls
Organization
Location
Assets
Page 27Regulatory Change Management
Source Global survey by KPMG Inc
BENEFITS OF AN INTEGRATED MANAGEMENT SYSTEM
Automate Regulatory
Compliance Through Software
Regulatory Change Management
Predict360 REGULATORYCOMPLIANCEARCHITECTURE
Page 29Regulatory Change Management
People Planet and Profit
Page 30Regulatory Change Management
Page 3Regulatory Change Management
Profit
PeoplePlanet
Effective Operational Risk Management amp Three Prsquos
Page 4Regulatory Change Management
Outline
Regulatory amp Operational Risk Trends
Why Implement an Enterprise Risk and Regulatory
Change Management System
Enterprise Risk and Compliance Management
Methodology
How to Implement an Enterprise Risk and Compliance
Management System
Can Automation and Software can Increase Operational
Excellence and Reduce Risk
Regulatory Change Management
Regulatory amp Operational
Risk Trends
Page 6Regulatory Change Management
Rising Regulations and Cost
Page 7Regulatory Change Management
Source Davis Polk Dodd-Frank Infographics
Regulatory change is significantly impacting
organizations and their policies
Regulatory Change Management
More Complexity More Projects and More
Risks to Manage
Managing Your Operations
Seamlessly While Reducing
Risk
Regulatory Change Management
Why Implement an Enterprise amp
Regulatory Change Management
System
Regulatory Change Management
1 Understanding Regulations- Either Over Complying or Under
Complying-
2 Regulatory Applicability and Managing Regulatory Changes
3 Automating And Streamlining Day To Day Compliance Event And
Incident Management With Respect To Regulatory Change
Management
4 Cost Efficiency By Automating Tracking and Monitoring a Non Compliance
Items Such as Events Incidents Audits amp Investigations
Four Reasons Why Implement Regulatory Change Management
Page 11Regulatory Change Management
Four Reasons Why Implement
Regulatory Change Management
Understanding Regulations
Regulatory Change Management
Regulatory Applicability
Day to Day Compliance Tasking
Event-Driven Compliance Tasking
Incident Management and Root Cause Analysis
Predictive Risk Analysis
Corrective and Preventive Actions
Policy and Procedure
Management
Audit Management
Sustainability
Training Management
Multiple Tools to address Reg
Compliance
Other Industry Pain Points
Regulatory Change Management
Enterprise Risk and Compliance
Management Model
Regulatory Change Management
1 WHY = Regulatory change management
2 WHAT = Risk and internal controls
3 HOW = Operational excellence and workflow
4 WHERE = Location Assets
5 WHO = Defining amp Mapping Roles Key Management Functions
to Metrics amp PampL
Enterprise Risk and Compliance
Management Model ndash Five Steps
Regulatory Change Management
REGULATORYCHANGEMANAGEMENTMODEL
Regulatory Change
Management
Operational Excellence
and Workflow
Risks amp Internal Controls
Organization ndash Roles and
Key Management
Functions
Location
Assets
HOW
WHY
WHAT
WHO
WHERE
Regulatory Change Management
How to Implement an Enterprise
Risk and Compliance
Management System
Page 16Regulatory Change Management
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles and Responsibilities
Locations and Assets
COMPONENTS OF REQUIREMENTS KNOWLEDGE BASE
1 Regulatory Standards Requirements
and Objectives library management
2 Translate regulatory requirements into
action evidence subject frequency
3 Monitor regulatory change
4 Regulations in effect to proposed
5 Mapping- regulatory requirements
mapped to CAPA policy procedures and
evidence
6 Regulation Applicability
Step 1- Requirements Knowledge
Base amp Taxonomy
WHY
Page 17Regulatory Change Management
Step 2- Risk amp Internal Controls1 What is impacted
Environmental Risk
Financial Risk
Legal Risk
Reputational Risk
Operational Risk
2 Define internal controls
Process
Procedures
Risk Assessments
tasks
training
3 Define risk levels
Which details impacting
factors
Is based on a systematic
process allowing the
organization to prioritize more
efficiently
Effectively assesses issues
requiring immediate action
Requirements Knowledge Based amp
Taxonomy
Operational Excellence and
Workflow
Risk and Internal Controls
Reporting ndashRoles and Key management
Functions
Location Assets
WHAT
Page 18Regulatory Change Management
Step 2- Risk amp Internal Controls
Requirements Knowledge Based amp
Taxonomy
Roles and Responsibility
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
Small Workforce Large Workforce
Hig
h R
isk
Lo
w R
isk
Page 19Regulatory Change Management
Weak Technology
bull Documentsamp spreadsheets
bull Email for workflow amp tasks
bull No audit trail or accountability
Moderate Technology
bull Basic workflow amp task management
bull No regulatory content feeds
bull Audit trail for accountability
Strong Technology
bull Enterprise workflow
bull Integrated and actionable regulatory content with policy management
bull Closed loop process ndash everything integrated into one platform
bull Indexing of regulations to other policies
Small Workforce Large Workforce
Hig
h C
om
ple
xity
Low
Co
mp
lexity
Step 2 - Risk amp Internal Controls
Page 20Regulatory Change Management
1 How
2 Compliance process around
sites assets events
3 Process automation and cost
4 Manual VS automation
Step 3- Business Processes
Requirements Knowledge Based amp
Taxonomy
Operational Excellence
and Business Processes
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 21Regulatory Change Management
Automate Corrective Action to Increase Speed Eliminate Waste and Cut Costs
Automate Scheduling Tasking and Tracking
Embed Transparency and Accountability
Automate Management of Change
PROCESSESS THAT CAN BE AUTOMATED
PROCESSESS THAT CANrsquoT BE AUTOMATED
Translation of Requirements
Subject Matter Expertise
Step 3- Business Process
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 22Regulatory Change Management
1 Where is compliance
done
2Compliance done at the
site and asset level
Step 4 Location amp Assets
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHERE
Page 23Regulatory Change Management
1 It is important to define the
roles and responsibilities
before you create an EHS
Regulatory Compliance
Framework
2 So what are the barriers to
creating a Regulatory
Compliance Framework
3 Is there a specific role and
responsibility structure or
can it vary from organization
and industries
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHO
Page 24Regulatory Change Management
1 Key Roles and Structure
2 Key Functions
3 Key Actions
4 Outcome Results
COMPONENTS OF ROLES AND RESPONSIBILITES
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
Regulatory Change Management
Can Automation and Software
Increase Operational Excellence
and Reduce Risks
Page 26Regulatory Change Management
1 Is Technology perceived
as a catalyst for growth and
performance
2 Are people or technology
barriers to Regulatory
Compliance Automation
Automate Regulatory
Compliance Through Software
Requirements
Regulations
Standards
Business Requirements
Business Process
Risks amp Controls
Organization
Location
Assets
Page 27Regulatory Change Management
Source Global survey by KPMG Inc
BENEFITS OF AN INTEGRATED MANAGEMENT SYSTEM
Automate Regulatory
Compliance Through Software
Regulatory Change Management
Predict360 REGULATORYCOMPLIANCEARCHITECTURE
Page 29Regulatory Change Management
People Planet and Profit
Page 30Regulatory Change Management
Page 4Regulatory Change Management
Outline
Regulatory amp Operational Risk Trends
Why Implement an Enterprise Risk and Regulatory
Change Management System
Enterprise Risk and Compliance Management
Methodology
How to Implement an Enterprise Risk and Compliance
Management System
Can Automation and Software can Increase Operational
Excellence and Reduce Risk
Regulatory Change Management
Regulatory amp Operational
Risk Trends
Page 6Regulatory Change Management
Rising Regulations and Cost
Page 7Regulatory Change Management
Source Davis Polk Dodd-Frank Infographics
Regulatory change is significantly impacting
organizations and their policies
Regulatory Change Management
More Complexity More Projects and More
Risks to Manage
Managing Your Operations
Seamlessly While Reducing
Risk
Regulatory Change Management
Why Implement an Enterprise amp
Regulatory Change Management
System
Regulatory Change Management
1 Understanding Regulations- Either Over Complying or Under
Complying-
2 Regulatory Applicability and Managing Regulatory Changes
3 Automating And Streamlining Day To Day Compliance Event And
Incident Management With Respect To Regulatory Change
Management
4 Cost Efficiency By Automating Tracking and Monitoring a Non Compliance
Items Such as Events Incidents Audits amp Investigations
Four Reasons Why Implement Regulatory Change Management
Page 11Regulatory Change Management
Four Reasons Why Implement
Regulatory Change Management
Understanding Regulations
Regulatory Change Management
Regulatory Applicability
Day to Day Compliance Tasking
Event-Driven Compliance Tasking
Incident Management and Root Cause Analysis
Predictive Risk Analysis
Corrective and Preventive Actions
Policy and Procedure
Management
Audit Management
Sustainability
Training Management
Multiple Tools to address Reg
Compliance
Other Industry Pain Points
Regulatory Change Management
Enterprise Risk and Compliance
Management Model
Regulatory Change Management
1 WHY = Regulatory change management
2 WHAT = Risk and internal controls
3 HOW = Operational excellence and workflow
4 WHERE = Location Assets
5 WHO = Defining amp Mapping Roles Key Management Functions
to Metrics amp PampL
Enterprise Risk and Compliance
Management Model ndash Five Steps
Regulatory Change Management
REGULATORYCHANGEMANAGEMENTMODEL
Regulatory Change
Management
Operational Excellence
and Workflow
Risks amp Internal Controls
Organization ndash Roles and
Key Management
Functions
Location
Assets
HOW
WHY
WHAT
WHO
WHERE
Regulatory Change Management
How to Implement an Enterprise
Risk and Compliance
Management System
Page 16Regulatory Change Management
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles and Responsibilities
Locations and Assets
COMPONENTS OF REQUIREMENTS KNOWLEDGE BASE
1 Regulatory Standards Requirements
and Objectives library management
2 Translate regulatory requirements into
action evidence subject frequency
3 Monitor regulatory change
4 Regulations in effect to proposed
5 Mapping- regulatory requirements
mapped to CAPA policy procedures and
evidence
6 Regulation Applicability
Step 1- Requirements Knowledge
Base amp Taxonomy
WHY
Page 17Regulatory Change Management
Step 2- Risk amp Internal Controls1 What is impacted
Environmental Risk
Financial Risk
Legal Risk
Reputational Risk
Operational Risk
2 Define internal controls
Process
Procedures
Risk Assessments
tasks
training
3 Define risk levels
Which details impacting
factors
Is based on a systematic
process allowing the
organization to prioritize more
efficiently
Effectively assesses issues
requiring immediate action
Requirements Knowledge Based amp
Taxonomy
Operational Excellence and
Workflow
Risk and Internal Controls
Reporting ndashRoles and Key management
Functions
Location Assets
WHAT
Page 18Regulatory Change Management
Step 2- Risk amp Internal Controls
Requirements Knowledge Based amp
Taxonomy
Roles and Responsibility
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
Small Workforce Large Workforce
Hig
h R
isk
Lo
w R
isk
Page 19Regulatory Change Management
Weak Technology
bull Documentsamp spreadsheets
bull Email for workflow amp tasks
bull No audit trail or accountability
Moderate Technology
bull Basic workflow amp task management
bull No regulatory content feeds
bull Audit trail for accountability
Strong Technology
bull Enterprise workflow
bull Integrated and actionable regulatory content with policy management
bull Closed loop process ndash everything integrated into one platform
bull Indexing of regulations to other policies
Small Workforce Large Workforce
Hig
h C
om
ple
xity
Low
Co
mp
lexity
Step 2 - Risk amp Internal Controls
Page 20Regulatory Change Management
1 How
2 Compliance process around
sites assets events
3 Process automation and cost
4 Manual VS automation
Step 3- Business Processes
Requirements Knowledge Based amp
Taxonomy
Operational Excellence
and Business Processes
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 21Regulatory Change Management
Automate Corrective Action to Increase Speed Eliminate Waste and Cut Costs
Automate Scheduling Tasking and Tracking
Embed Transparency and Accountability
Automate Management of Change
PROCESSESS THAT CAN BE AUTOMATED
PROCESSESS THAT CANrsquoT BE AUTOMATED
Translation of Requirements
Subject Matter Expertise
Step 3- Business Process
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 22Regulatory Change Management
1 Where is compliance
done
2Compliance done at the
site and asset level
Step 4 Location amp Assets
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHERE
Page 23Regulatory Change Management
1 It is important to define the
roles and responsibilities
before you create an EHS
Regulatory Compliance
Framework
2 So what are the barriers to
creating a Regulatory
Compliance Framework
3 Is there a specific role and
responsibility structure or
can it vary from organization
and industries
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHO
Page 24Regulatory Change Management
1 Key Roles and Structure
2 Key Functions
3 Key Actions
4 Outcome Results
COMPONENTS OF ROLES AND RESPONSIBILITES
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
Regulatory Change Management
Can Automation and Software
Increase Operational Excellence
and Reduce Risks
Page 26Regulatory Change Management
1 Is Technology perceived
as a catalyst for growth and
performance
2 Are people or technology
barriers to Regulatory
Compliance Automation
Automate Regulatory
Compliance Through Software
Requirements
Regulations
Standards
Business Requirements
Business Process
Risks amp Controls
Organization
Location
Assets
Page 27Regulatory Change Management
Source Global survey by KPMG Inc
BENEFITS OF AN INTEGRATED MANAGEMENT SYSTEM
Automate Regulatory
Compliance Through Software
Regulatory Change Management
Predict360 REGULATORYCOMPLIANCEARCHITECTURE
Page 29Regulatory Change Management
People Planet and Profit
Page 30Regulatory Change Management
Regulatory Change Management
Regulatory amp Operational
Risk Trends
Page 6Regulatory Change Management
Rising Regulations and Cost
Page 7Regulatory Change Management
Source Davis Polk Dodd-Frank Infographics
Regulatory change is significantly impacting
organizations and their policies
Regulatory Change Management
More Complexity More Projects and More
Risks to Manage
Managing Your Operations
Seamlessly While Reducing
Risk
Regulatory Change Management
Why Implement an Enterprise amp
Regulatory Change Management
System
Regulatory Change Management
1 Understanding Regulations- Either Over Complying or Under
Complying-
2 Regulatory Applicability and Managing Regulatory Changes
3 Automating And Streamlining Day To Day Compliance Event And
Incident Management With Respect To Regulatory Change
Management
4 Cost Efficiency By Automating Tracking and Monitoring a Non Compliance
Items Such as Events Incidents Audits amp Investigations
Four Reasons Why Implement Regulatory Change Management
Page 11Regulatory Change Management
Four Reasons Why Implement
Regulatory Change Management
Understanding Regulations
Regulatory Change Management
Regulatory Applicability
Day to Day Compliance Tasking
Event-Driven Compliance Tasking
Incident Management and Root Cause Analysis
Predictive Risk Analysis
Corrective and Preventive Actions
Policy and Procedure
Management
Audit Management
Sustainability
Training Management
Multiple Tools to address Reg
Compliance
Other Industry Pain Points
Regulatory Change Management
Enterprise Risk and Compliance
Management Model
Regulatory Change Management
1 WHY = Regulatory change management
2 WHAT = Risk and internal controls
3 HOW = Operational excellence and workflow
4 WHERE = Location Assets
5 WHO = Defining amp Mapping Roles Key Management Functions
to Metrics amp PampL
Enterprise Risk and Compliance
Management Model ndash Five Steps
Regulatory Change Management
REGULATORYCHANGEMANAGEMENTMODEL
Regulatory Change
Management
Operational Excellence
and Workflow
Risks amp Internal Controls
Organization ndash Roles and
Key Management
Functions
Location
Assets
HOW
WHY
WHAT
WHO
WHERE
Regulatory Change Management
How to Implement an Enterprise
Risk and Compliance
Management System
Page 16Regulatory Change Management
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles and Responsibilities
Locations and Assets
COMPONENTS OF REQUIREMENTS KNOWLEDGE BASE
1 Regulatory Standards Requirements
and Objectives library management
2 Translate regulatory requirements into
action evidence subject frequency
3 Monitor regulatory change
4 Regulations in effect to proposed
5 Mapping- regulatory requirements
mapped to CAPA policy procedures and
evidence
6 Regulation Applicability
Step 1- Requirements Knowledge
Base amp Taxonomy
WHY
Page 17Regulatory Change Management
Step 2- Risk amp Internal Controls1 What is impacted
Environmental Risk
Financial Risk
Legal Risk
Reputational Risk
Operational Risk
2 Define internal controls
Process
Procedures
Risk Assessments
tasks
training
3 Define risk levels
Which details impacting
factors
Is based on a systematic
process allowing the
organization to prioritize more
efficiently
Effectively assesses issues
requiring immediate action
Requirements Knowledge Based amp
Taxonomy
Operational Excellence and
Workflow
Risk and Internal Controls
Reporting ndashRoles and Key management
Functions
Location Assets
WHAT
Page 18Regulatory Change Management
Step 2- Risk amp Internal Controls
Requirements Knowledge Based amp
Taxonomy
Roles and Responsibility
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
Small Workforce Large Workforce
Hig
h R
isk
Lo
w R
isk
Page 19Regulatory Change Management
Weak Technology
bull Documentsamp spreadsheets
bull Email for workflow amp tasks
bull No audit trail or accountability
Moderate Technology
bull Basic workflow amp task management
bull No regulatory content feeds
bull Audit trail for accountability
Strong Technology
bull Enterprise workflow
bull Integrated and actionable regulatory content with policy management
bull Closed loop process ndash everything integrated into one platform
bull Indexing of regulations to other policies
Small Workforce Large Workforce
Hig
h C
om
ple
xity
Low
Co
mp
lexity
Step 2 - Risk amp Internal Controls
Page 20Regulatory Change Management
1 How
2 Compliance process around
sites assets events
3 Process automation and cost
4 Manual VS automation
Step 3- Business Processes
Requirements Knowledge Based amp
Taxonomy
Operational Excellence
and Business Processes
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 21Regulatory Change Management
Automate Corrective Action to Increase Speed Eliminate Waste and Cut Costs
Automate Scheduling Tasking and Tracking
Embed Transparency and Accountability
Automate Management of Change
PROCESSESS THAT CAN BE AUTOMATED
PROCESSESS THAT CANrsquoT BE AUTOMATED
Translation of Requirements
Subject Matter Expertise
Step 3- Business Process
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 22Regulatory Change Management
1 Where is compliance
done
2Compliance done at the
site and asset level
Step 4 Location amp Assets
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHERE
Page 23Regulatory Change Management
1 It is important to define the
roles and responsibilities
before you create an EHS
Regulatory Compliance
Framework
2 So what are the barriers to
creating a Regulatory
Compliance Framework
3 Is there a specific role and
responsibility structure or
can it vary from organization
and industries
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHO
Page 24Regulatory Change Management
1 Key Roles and Structure
2 Key Functions
3 Key Actions
4 Outcome Results
COMPONENTS OF ROLES AND RESPONSIBILITES
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
Regulatory Change Management
Can Automation and Software
Increase Operational Excellence
and Reduce Risks
Page 26Regulatory Change Management
1 Is Technology perceived
as a catalyst for growth and
performance
2 Are people or technology
barriers to Regulatory
Compliance Automation
Automate Regulatory
Compliance Through Software
Requirements
Regulations
Standards
Business Requirements
Business Process
Risks amp Controls
Organization
Location
Assets
Page 27Regulatory Change Management
Source Global survey by KPMG Inc
BENEFITS OF AN INTEGRATED MANAGEMENT SYSTEM
Automate Regulatory
Compliance Through Software
Regulatory Change Management
Predict360 REGULATORYCOMPLIANCEARCHITECTURE
Page 29Regulatory Change Management
People Planet and Profit
Page 30Regulatory Change Management
Page 6Regulatory Change Management
Rising Regulations and Cost
Page 7Regulatory Change Management
Source Davis Polk Dodd-Frank Infographics
Regulatory change is significantly impacting
organizations and their policies
Regulatory Change Management
More Complexity More Projects and More
Risks to Manage
Managing Your Operations
Seamlessly While Reducing
Risk
Regulatory Change Management
Why Implement an Enterprise amp
Regulatory Change Management
System
Regulatory Change Management
1 Understanding Regulations- Either Over Complying or Under
Complying-
2 Regulatory Applicability and Managing Regulatory Changes
3 Automating And Streamlining Day To Day Compliance Event And
Incident Management With Respect To Regulatory Change
Management
4 Cost Efficiency By Automating Tracking and Monitoring a Non Compliance
Items Such as Events Incidents Audits amp Investigations
Four Reasons Why Implement Regulatory Change Management
Page 11Regulatory Change Management
Four Reasons Why Implement
Regulatory Change Management
Understanding Regulations
Regulatory Change Management
Regulatory Applicability
Day to Day Compliance Tasking
Event-Driven Compliance Tasking
Incident Management and Root Cause Analysis
Predictive Risk Analysis
Corrective and Preventive Actions
Policy and Procedure
Management
Audit Management
Sustainability
Training Management
Multiple Tools to address Reg
Compliance
Other Industry Pain Points
Regulatory Change Management
Enterprise Risk and Compliance
Management Model
Regulatory Change Management
1 WHY = Regulatory change management
2 WHAT = Risk and internal controls
3 HOW = Operational excellence and workflow
4 WHERE = Location Assets
5 WHO = Defining amp Mapping Roles Key Management Functions
to Metrics amp PampL
Enterprise Risk and Compliance
Management Model ndash Five Steps
Regulatory Change Management
REGULATORYCHANGEMANAGEMENTMODEL
Regulatory Change
Management
Operational Excellence
and Workflow
Risks amp Internal Controls
Organization ndash Roles and
Key Management
Functions
Location
Assets
HOW
WHY
WHAT
WHO
WHERE
Regulatory Change Management
How to Implement an Enterprise
Risk and Compliance
Management System
Page 16Regulatory Change Management
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles and Responsibilities
Locations and Assets
COMPONENTS OF REQUIREMENTS KNOWLEDGE BASE
1 Regulatory Standards Requirements
and Objectives library management
2 Translate regulatory requirements into
action evidence subject frequency
3 Monitor regulatory change
4 Regulations in effect to proposed
5 Mapping- regulatory requirements
mapped to CAPA policy procedures and
evidence
6 Regulation Applicability
Step 1- Requirements Knowledge
Base amp Taxonomy
WHY
Page 17Regulatory Change Management
Step 2- Risk amp Internal Controls1 What is impacted
Environmental Risk
Financial Risk
Legal Risk
Reputational Risk
Operational Risk
2 Define internal controls
Process
Procedures
Risk Assessments
tasks
training
3 Define risk levels
Which details impacting
factors
Is based on a systematic
process allowing the
organization to prioritize more
efficiently
Effectively assesses issues
requiring immediate action
Requirements Knowledge Based amp
Taxonomy
Operational Excellence and
Workflow
Risk and Internal Controls
Reporting ndashRoles and Key management
Functions
Location Assets
WHAT
Page 18Regulatory Change Management
Step 2- Risk amp Internal Controls
Requirements Knowledge Based amp
Taxonomy
Roles and Responsibility
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
Small Workforce Large Workforce
Hig
h R
isk
Lo
w R
isk
Page 19Regulatory Change Management
Weak Technology
bull Documentsamp spreadsheets
bull Email for workflow amp tasks
bull No audit trail or accountability
Moderate Technology
bull Basic workflow amp task management
bull No regulatory content feeds
bull Audit trail for accountability
Strong Technology
bull Enterprise workflow
bull Integrated and actionable regulatory content with policy management
bull Closed loop process ndash everything integrated into one platform
bull Indexing of regulations to other policies
Small Workforce Large Workforce
Hig
h C
om
ple
xity
Low
Co
mp
lexity
Step 2 - Risk amp Internal Controls
Page 20Regulatory Change Management
1 How
2 Compliance process around
sites assets events
3 Process automation and cost
4 Manual VS automation
Step 3- Business Processes
Requirements Knowledge Based amp
Taxonomy
Operational Excellence
and Business Processes
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 21Regulatory Change Management
Automate Corrective Action to Increase Speed Eliminate Waste and Cut Costs
Automate Scheduling Tasking and Tracking
Embed Transparency and Accountability
Automate Management of Change
PROCESSESS THAT CAN BE AUTOMATED
PROCESSESS THAT CANrsquoT BE AUTOMATED
Translation of Requirements
Subject Matter Expertise
Step 3- Business Process
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 22Regulatory Change Management
1 Where is compliance
done
2Compliance done at the
site and asset level
Step 4 Location amp Assets
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHERE
Page 23Regulatory Change Management
1 It is important to define the
roles and responsibilities
before you create an EHS
Regulatory Compliance
Framework
2 So what are the barriers to
creating a Regulatory
Compliance Framework
3 Is there a specific role and
responsibility structure or
can it vary from organization
and industries
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHO
Page 24Regulatory Change Management
1 Key Roles and Structure
2 Key Functions
3 Key Actions
4 Outcome Results
COMPONENTS OF ROLES AND RESPONSIBILITES
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
Regulatory Change Management
Can Automation and Software
Increase Operational Excellence
and Reduce Risks
Page 26Regulatory Change Management
1 Is Technology perceived
as a catalyst for growth and
performance
2 Are people or technology
barriers to Regulatory
Compliance Automation
Automate Regulatory
Compliance Through Software
Requirements
Regulations
Standards
Business Requirements
Business Process
Risks amp Controls
Organization
Location
Assets
Page 27Regulatory Change Management
Source Global survey by KPMG Inc
BENEFITS OF AN INTEGRATED MANAGEMENT SYSTEM
Automate Regulatory
Compliance Through Software
Regulatory Change Management
Predict360 REGULATORYCOMPLIANCEARCHITECTURE
Page 29Regulatory Change Management
People Planet and Profit
Page 30Regulatory Change Management
Page 7Regulatory Change Management
Source Davis Polk Dodd-Frank Infographics
Regulatory change is significantly impacting
organizations and their policies
Regulatory Change Management
More Complexity More Projects and More
Risks to Manage
Managing Your Operations
Seamlessly While Reducing
Risk
Regulatory Change Management
Why Implement an Enterprise amp
Regulatory Change Management
System
Regulatory Change Management
1 Understanding Regulations- Either Over Complying or Under
Complying-
2 Regulatory Applicability and Managing Regulatory Changes
3 Automating And Streamlining Day To Day Compliance Event And
Incident Management With Respect To Regulatory Change
Management
4 Cost Efficiency By Automating Tracking and Monitoring a Non Compliance
Items Such as Events Incidents Audits amp Investigations
Four Reasons Why Implement Regulatory Change Management
Page 11Regulatory Change Management
Four Reasons Why Implement
Regulatory Change Management
Understanding Regulations
Regulatory Change Management
Regulatory Applicability
Day to Day Compliance Tasking
Event-Driven Compliance Tasking
Incident Management and Root Cause Analysis
Predictive Risk Analysis
Corrective and Preventive Actions
Policy and Procedure
Management
Audit Management
Sustainability
Training Management
Multiple Tools to address Reg
Compliance
Other Industry Pain Points
Regulatory Change Management
Enterprise Risk and Compliance
Management Model
Regulatory Change Management
1 WHY = Regulatory change management
2 WHAT = Risk and internal controls
3 HOW = Operational excellence and workflow
4 WHERE = Location Assets
5 WHO = Defining amp Mapping Roles Key Management Functions
to Metrics amp PampL
Enterprise Risk and Compliance
Management Model ndash Five Steps
Regulatory Change Management
REGULATORYCHANGEMANAGEMENTMODEL
Regulatory Change
Management
Operational Excellence
and Workflow
Risks amp Internal Controls
Organization ndash Roles and
Key Management
Functions
Location
Assets
HOW
WHY
WHAT
WHO
WHERE
Regulatory Change Management
How to Implement an Enterprise
Risk and Compliance
Management System
Page 16Regulatory Change Management
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles and Responsibilities
Locations and Assets
COMPONENTS OF REQUIREMENTS KNOWLEDGE BASE
1 Regulatory Standards Requirements
and Objectives library management
2 Translate regulatory requirements into
action evidence subject frequency
3 Monitor regulatory change
4 Regulations in effect to proposed
5 Mapping- regulatory requirements
mapped to CAPA policy procedures and
evidence
6 Regulation Applicability
Step 1- Requirements Knowledge
Base amp Taxonomy
WHY
Page 17Regulatory Change Management
Step 2- Risk amp Internal Controls1 What is impacted
Environmental Risk
Financial Risk
Legal Risk
Reputational Risk
Operational Risk
2 Define internal controls
Process
Procedures
Risk Assessments
tasks
training
3 Define risk levels
Which details impacting
factors
Is based on a systematic
process allowing the
organization to prioritize more
efficiently
Effectively assesses issues
requiring immediate action
Requirements Knowledge Based amp
Taxonomy
Operational Excellence and
Workflow
Risk and Internal Controls
Reporting ndashRoles and Key management
Functions
Location Assets
WHAT
Page 18Regulatory Change Management
Step 2- Risk amp Internal Controls
Requirements Knowledge Based amp
Taxonomy
Roles and Responsibility
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
Small Workforce Large Workforce
Hig
h R
isk
Lo
w R
isk
Page 19Regulatory Change Management
Weak Technology
bull Documentsamp spreadsheets
bull Email for workflow amp tasks
bull No audit trail or accountability
Moderate Technology
bull Basic workflow amp task management
bull No regulatory content feeds
bull Audit trail for accountability
Strong Technology
bull Enterprise workflow
bull Integrated and actionable regulatory content with policy management
bull Closed loop process ndash everything integrated into one platform
bull Indexing of regulations to other policies
Small Workforce Large Workforce
Hig
h C
om
ple
xity
Low
Co
mp
lexity
Step 2 - Risk amp Internal Controls
Page 20Regulatory Change Management
1 How
2 Compliance process around
sites assets events
3 Process automation and cost
4 Manual VS automation
Step 3- Business Processes
Requirements Knowledge Based amp
Taxonomy
Operational Excellence
and Business Processes
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 21Regulatory Change Management
Automate Corrective Action to Increase Speed Eliminate Waste and Cut Costs
Automate Scheduling Tasking and Tracking
Embed Transparency and Accountability
Automate Management of Change
PROCESSESS THAT CAN BE AUTOMATED
PROCESSESS THAT CANrsquoT BE AUTOMATED
Translation of Requirements
Subject Matter Expertise
Step 3- Business Process
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 22Regulatory Change Management
1 Where is compliance
done
2Compliance done at the
site and asset level
Step 4 Location amp Assets
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHERE
Page 23Regulatory Change Management
1 It is important to define the
roles and responsibilities
before you create an EHS
Regulatory Compliance
Framework
2 So what are the barriers to
creating a Regulatory
Compliance Framework
3 Is there a specific role and
responsibility structure or
can it vary from organization
and industries
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHO
Page 24Regulatory Change Management
1 Key Roles and Structure
2 Key Functions
3 Key Actions
4 Outcome Results
COMPONENTS OF ROLES AND RESPONSIBILITES
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
Regulatory Change Management
Can Automation and Software
Increase Operational Excellence
and Reduce Risks
Page 26Regulatory Change Management
1 Is Technology perceived
as a catalyst for growth and
performance
2 Are people or technology
barriers to Regulatory
Compliance Automation
Automate Regulatory
Compliance Through Software
Requirements
Regulations
Standards
Business Requirements
Business Process
Risks amp Controls
Organization
Location
Assets
Page 27Regulatory Change Management
Source Global survey by KPMG Inc
BENEFITS OF AN INTEGRATED MANAGEMENT SYSTEM
Automate Regulatory
Compliance Through Software
Regulatory Change Management
Predict360 REGULATORYCOMPLIANCEARCHITECTURE
Page 29Regulatory Change Management
People Planet and Profit
Page 30Regulatory Change Management
Regulatory Change Management
More Complexity More Projects and More
Risks to Manage
Managing Your Operations
Seamlessly While Reducing
Risk
Regulatory Change Management
Why Implement an Enterprise amp
Regulatory Change Management
System
Regulatory Change Management
1 Understanding Regulations- Either Over Complying or Under
Complying-
2 Regulatory Applicability and Managing Regulatory Changes
3 Automating And Streamlining Day To Day Compliance Event And
Incident Management With Respect To Regulatory Change
Management
4 Cost Efficiency By Automating Tracking and Monitoring a Non Compliance
Items Such as Events Incidents Audits amp Investigations
Four Reasons Why Implement Regulatory Change Management
Page 11Regulatory Change Management
Four Reasons Why Implement
Regulatory Change Management
Understanding Regulations
Regulatory Change Management
Regulatory Applicability
Day to Day Compliance Tasking
Event-Driven Compliance Tasking
Incident Management and Root Cause Analysis
Predictive Risk Analysis
Corrective and Preventive Actions
Policy and Procedure
Management
Audit Management
Sustainability
Training Management
Multiple Tools to address Reg
Compliance
Other Industry Pain Points
Regulatory Change Management
Enterprise Risk and Compliance
Management Model
Regulatory Change Management
1 WHY = Regulatory change management
2 WHAT = Risk and internal controls
3 HOW = Operational excellence and workflow
4 WHERE = Location Assets
5 WHO = Defining amp Mapping Roles Key Management Functions
to Metrics amp PampL
Enterprise Risk and Compliance
Management Model ndash Five Steps
Regulatory Change Management
REGULATORYCHANGEMANAGEMENTMODEL
Regulatory Change
Management
Operational Excellence
and Workflow
Risks amp Internal Controls
Organization ndash Roles and
Key Management
Functions
Location
Assets
HOW
WHY
WHAT
WHO
WHERE
Regulatory Change Management
How to Implement an Enterprise
Risk and Compliance
Management System
Page 16Regulatory Change Management
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles and Responsibilities
Locations and Assets
COMPONENTS OF REQUIREMENTS KNOWLEDGE BASE
1 Regulatory Standards Requirements
and Objectives library management
2 Translate regulatory requirements into
action evidence subject frequency
3 Monitor regulatory change
4 Regulations in effect to proposed
5 Mapping- regulatory requirements
mapped to CAPA policy procedures and
evidence
6 Regulation Applicability
Step 1- Requirements Knowledge
Base amp Taxonomy
WHY
Page 17Regulatory Change Management
Step 2- Risk amp Internal Controls1 What is impacted
Environmental Risk
Financial Risk
Legal Risk
Reputational Risk
Operational Risk
2 Define internal controls
Process
Procedures
Risk Assessments
tasks
training
3 Define risk levels
Which details impacting
factors
Is based on a systematic
process allowing the
organization to prioritize more
efficiently
Effectively assesses issues
requiring immediate action
Requirements Knowledge Based amp
Taxonomy
Operational Excellence and
Workflow
Risk and Internal Controls
Reporting ndashRoles and Key management
Functions
Location Assets
WHAT
Page 18Regulatory Change Management
Step 2- Risk amp Internal Controls
Requirements Knowledge Based amp
Taxonomy
Roles and Responsibility
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
Small Workforce Large Workforce
Hig
h R
isk
Lo
w R
isk
Page 19Regulatory Change Management
Weak Technology
bull Documentsamp spreadsheets
bull Email for workflow amp tasks
bull No audit trail or accountability
Moderate Technology
bull Basic workflow amp task management
bull No regulatory content feeds
bull Audit trail for accountability
Strong Technology
bull Enterprise workflow
bull Integrated and actionable regulatory content with policy management
bull Closed loop process ndash everything integrated into one platform
bull Indexing of regulations to other policies
Small Workforce Large Workforce
Hig
h C
om
ple
xity
Low
Co
mp
lexity
Step 2 - Risk amp Internal Controls
Page 20Regulatory Change Management
1 How
2 Compliance process around
sites assets events
3 Process automation and cost
4 Manual VS automation
Step 3- Business Processes
Requirements Knowledge Based amp
Taxonomy
Operational Excellence
and Business Processes
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 21Regulatory Change Management
Automate Corrective Action to Increase Speed Eliminate Waste and Cut Costs
Automate Scheduling Tasking and Tracking
Embed Transparency and Accountability
Automate Management of Change
PROCESSESS THAT CAN BE AUTOMATED
PROCESSESS THAT CANrsquoT BE AUTOMATED
Translation of Requirements
Subject Matter Expertise
Step 3- Business Process
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 22Regulatory Change Management
1 Where is compliance
done
2Compliance done at the
site and asset level
Step 4 Location amp Assets
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHERE
Page 23Regulatory Change Management
1 It is important to define the
roles and responsibilities
before you create an EHS
Regulatory Compliance
Framework
2 So what are the barriers to
creating a Regulatory
Compliance Framework
3 Is there a specific role and
responsibility structure or
can it vary from organization
and industries
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHO
Page 24Regulatory Change Management
1 Key Roles and Structure
2 Key Functions
3 Key Actions
4 Outcome Results
COMPONENTS OF ROLES AND RESPONSIBILITES
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
Regulatory Change Management
Can Automation and Software
Increase Operational Excellence
and Reduce Risks
Page 26Regulatory Change Management
1 Is Technology perceived
as a catalyst for growth and
performance
2 Are people or technology
barriers to Regulatory
Compliance Automation
Automate Regulatory
Compliance Through Software
Requirements
Regulations
Standards
Business Requirements
Business Process
Risks amp Controls
Organization
Location
Assets
Page 27Regulatory Change Management
Source Global survey by KPMG Inc
BENEFITS OF AN INTEGRATED MANAGEMENT SYSTEM
Automate Regulatory
Compliance Through Software
Regulatory Change Management
Predict360 REGULATORYCOMPLIANCEARCHITECTURE
Page 29Regulatory Change Management
People Planet and Profit
Page 30Regulatory Change Management
Regulatory Change Management
Why Implement an Enterprise amp
Regulatory Change Management
System
Regulatory Change Management
1 Understanding Regulations- Either Over Complying or Under
Complying-
2 Regulatory Applicability and Managing Regulatory Changes
3 Automating And Streamlining Day To Day Compliance Event And
Incident Management With Respect To Regulatory Change
Management
4 Cost Efficiency By Automating Tracking and Monitoring a Non Compliance
Items Such as Events Incidents Audits amp Investigations
Four Reasons Why Implement Regulatory Change Management
Page 11Regulatory Change Management
Four Reasons Why Implement
Regulatory Change Management
Understanding Regulations
Regulatory Change Management
Regulatory Applicability
Day to Day Compliance Tasking
Event-Driven Compliance Tasking
Incident Management and Root Cause Analysis
Predictive Risk Analysis
Corrective and Preventive Actions
Policy and Procedure
Management
Audit Management
Sustainability
Training Management
Multiple Tools to address Reg
Compliance
Other Industry Pain Points
Regulatory Change Management
Enterprise Risk and Compliance
Management Model
Regulatory Change Management
1 WHY = Regulatory change management
2 WHAT = Risk and internal controls
3 HOW = Operational excellence and workflow
4 WHERE = Location Assets
5 WHO = Defining amp Mapping Roles Key Management Functions
to Metrics amp PampL
Enterprise Risk and Compliance
Management Model ndash Five Steps
Regulatory Change Management
REGULATORYCHANGEMANAGEMENTMODEL
Regulatory Change
Management
Operational Excellence
and Workflow
Risks amp Internal Controls
Organization ndash Roles and
Key Management
Functions
Location
Assets
HOW
WHY
WHAT
WHO
WHERE
Regulatory Change Management
How to Implement an Enterprise
Risk and Compliance
Management System
Page 16Regulatory Change Management
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles and Responsibilities
Locations and Assets
COMPONENTS OF REQUIREMENTS KNOWLEDGE BASE
1 Regulatory Standards Requirements
and Objectives library management
2 Translate regulatory requirements into
action evidence subject frequency
3 Monitor regulatory change
4 Regulations in effect to proposed
5 Mapping- regulatory requirements
mapped to CAPA policy procedures and
evidence
6 Regulation Applicability
Step 1- Requirements Knowledge
Base amp Taxonomy
WHY
Page 17Regulatory Change Management
Step 2- Risk amp Internal Controls1 What is impacted
Environmental Risk
Financial Risk
Legal Risk
Reputational Risk
Operational Risk
2 Define internal controls
Process
Procedures
Risk Assessments
tasks
training
3 Define risk levels
Which details impacting
factors
Is based on a systematic
process allowing the
organization to prioritize more
efficiently
Effectively assesses issues
requiring immediate action
Requirements Knowledge Based amp
Taxonomy
Operational Excellence and
Workflow
Risk and Internal Controls
Reporting ndashRoles and Key management
Functions
Location Assets
WHAT
Page 18Regulatory Change Management
Step 2- Risk amp Internal Controls
Requirements Knowledge Based amp
Taxonomy
Roles and Responsibility
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
Small Workforce Large Workforce
Hig
h R
isk
Lo
w R
isk
Page 19Regulatory Change Management
Weak Technology
bull Documentsamp spreadsheets
bull Email for workflow amp tasks
bull No audit trail or accountability
Moderate Technology
bull Basic workflow amp task management
bull No regulatory content feeds
bull Audit trail for accountability
Strong Technology
bull Enterprise workflow
bull Integrated and actionable regulatory content with policy management
bull Closed loop process ndash everything integrated into one platform
bull Indexing of regulations to other policies
Small Workforce Large Workforce
Hig
h C
om
ple
xity
Low
Co
mp
lexity
Step 2 - Risk amp Internal Controls
Page 20Regulatory Change Management
1 How
2 Compliance process around
sites assets events
3 Process automation and cost
4 Manual VS automation
Step 3- Business Processes
Requirements Knowledge Based amp
Taxonomy
Operational Excellence
and Business Processes
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 21Regulatory Change Management
Automate Corrective Action to Increase Speed Eliminate Waste and Cut Costs
Automate Scheduling Tasking and Tracking
Embed Transparency and Accountability
Automate Management of Change
PROCESSESS THAT CAN BE AUTOMATED
PROCESSESS THAT CANrsquoT BE AUTOMATED
Translation of Requirements
Subject Matter Expertise
Step 3- Business Process
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 22Regulatory Change Management
1 Where is compliance
done
2Compliance done at the
site and asset level
Step 4 Location amp Assets
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHERE
Page 23Regulatory Change Management
1 It is important to define the
roles and responsibilities
before you create an EHS
Regulatory Compliance
Framework
2 So what are the barriers to
creating a Regulatory
Compliance Framework
3 Is there a specific role and
responsibility structure or
can it vary from organization
and industries
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHO
Page 24Regulatory Change Management
1 Key Roles and Structure
2 Key Functions
3 Key Actions
4 Outcome Results
COMPONENTS OF ROLES AND RESPONSIBILITES
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
Regulatory Change Management
Can Automation and Software
Increase Operational Excellence
and Reduce Risks
Page 26Regulatory Change Management
1 Is Technology perceived
as a catalyst for growth and
performance
2 Are people or technology
barriers to Regulatory
Compliance Automation
Automate Regulatory
Compliance Through Software
Requirements
Regulations
Standards
Business Requirements
Business Process
Risks amp Controls
Organization
Location
Assets
Page 27Regulatory Change Management
Source Global survey by KPMG Inc
BENEFITS OF AN INTEGRATED MANAGEMENT SYSTEM
Automate Regulatory
Compliance Through Software
Regulatory Change Management
Predict360 REGULATORYCOMPLIANCEARCHITECTURE
Page 29Regulatory Change Management
People Planet and Profit
Page 30Regulatory Change Management
Regulatory Change Management
1 Understanding Regulations- Either Over Complying or Under
Complying-
2 Regulatory Applicability and Managing Regulatory Changes
3 Automating And Streamlining Day To Day Compliance Event And
Incident Management With Respect To Regulatory Change
Management
4 Cost Efficiency By Automating Tracking and Monitoring a Non Compliance
Items Such as Events Incidents Audits amp Investigations
Four Reasons Why Implement Regulatory Change Management
Page 11Regulatory Change Management
Four Reasons Why Implement
Regulatory Change Management
Understanding Regulations
Regulatory Change Management
Regulatory Applicability
Day to Day Compliance Tasking
Event-Driven Compliance Tasking
Incident Management and Root Cause Analysis
Predictive Risk Analysis
Corrective and Preventive Actions
Policy and Procedure
Management
Audit Management
Sustainability
Training Management
Multiple Tools to address Reg
Compliance
Other Industry Pain Points
Regulatory Change Management
Enterprise Risk and Compliance
Management Model
Regulatory Change Management
1 WHY = Regulatory change management
2 WHAT = Risk and internal controls
3 HOW = Operational excellence and workflow
4 WHERE = Location Assets
5 WHO = Defining amp Mapping Roles Key Management Functions
to Metrics amp PampL
Enterprise Risk and Compliance
Management Model ndash Five Steps
Regulatory Change Management
REGULATORYCHANGEMANAGEMENTMODEL
Regulatory Change
Management
Operational Excellence
and Workflow
Risks amp Internal Controls
Organization ndash Roles and
Key Management
Functions
Location
Assets
HOW
WHY
WHAT
WHO
WHERE
Regulatory Change Management
How to Implement an Enterprise
Risk and Compliance
Management System
Page 16Regulatory Change Management
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles and Responsibilities
Locations and Assets
COMPONENTS OF REQUIREMENTS KNOWLEDGE BASE
1 Regulatory Standards Requirements
and Objectives library management
2 Translate regulatory requirements into
action evidence subject frequency
3 Monitor regulatory change
4 Regulations in effect to proposed
5 Mapping- regulatory requirements
mapped to CAPA policy procedures and
evidence
6 Regulation Applicability
Step 1- Requirements Knowledge
Base amp Taxonomy
WHY
Page 17Regulatory Change Management
Step 2- Risk amp Internal Controls1 What is impacted
Environmental Risk
Financial Risk
Legal Risk
Reputational Risk
Operational Risk
2 Define internal controls
Process
Procedures
Risk Assessments
tasks
training
3 Define risk levels
Which details impacting
factors
Is based on a systematic
process allowing the
organization to prioritize more
efficiently
Effectively assesses issues
requiring immediate action
Requirements Knowledge Based amp
Taxonomy
Operational Excellence and
Workflow
Risk and Internal Controls
Reporting ndashRoles and Key management
Functions
Location Assets
WHAT
Page 18Regulatory Change Management
Step 2- Risk amp Internal Controls
Requirements Knowledge Based amp
Taxonomy
Roles and Responsibility
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
Small Workforce Large Workforce
Hig
h R
isk
Lo
w R
isk
Page 19Regulatory Change Management
Weak Technology
bull Documentsamp spreadsheets
bull Email for workflow amp tasks
bull No audit trail or accountability
Moderate Technology
bull Basic workflow amp task management
bull No regulatory content feeds
bull Audit trail for accountability
Strong Technology
bull Enterprise workflow
bull Integrated and actionable regulatory content with policy management
bull Closed loop process ndash everything integrated into one platform
bull Indexing of regulations to other policies
Small Workforce Large Workforce
Hig
h C
om
ple
xity
Low
Co
mp
lexity
Step 2 - Risk amp Internal Controls
Page 20Regulatory Change Management
1 How
2 Compliance process around
sites assets events
3 Process automation and cost
4 Manual VS automation
Step 3- Business Processes
Requirements Knowledge Based amp
Taxonomy
Operational Excellence
and Business Processes
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 21Regulatory Change Management
Automate Corrective Action to Increase Speed Eliminate Waste and Cut Costs
Automate Scheduling Tasking and Tracking
Embed Transparency and Accountability
Automate Management of Change
PROCESSESS THAT CAN BE AUTOMATED
PROCESSESS THAT CANrsquoT BE AUTOMATED
Translation of Requirements
Subject Matter Expertise
Step 3- Business Process
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 22Regulatory Change Management
1 Where is compliance
done
2Compliance done at the
site and asset level
Step 4 Location amp Assets
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHERE
Page 23Regulatory Change Management
1 It is important to define the
roles and responsibilities
before you create an EHS
Regulatory Compliance
Framework
2 So what are the barriers to
creating a Regulatory
Compliance Framework
3 Is there a specific role and
responsibility structure or
can it vary from organization
and industries
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHO
Page 24Regulatory Change Management
1 Key Roles and Structure
2 Key Functions
3 Key Actions
4 Outcome Results
COMPONENTS OF ROLES AND RESPONSIBILITES
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
Regulatory Change Management
Can Automation and Software
Increase Operational Excellence
and Reduce Risks
Page 26Regulatory Change Management
1 Is Technology perceived
as a catalyst for growth and
performance
2 Are people or technology
barriers to Regulatory
Compliance Automation
Automate Regulatory
Compliance Through Software
Requirements
Regulations
Standards
Business Requirements
Business Process
Risks amp Controls
Organization
Location
Assets
Page 27Regulatory Change Management
Source Global survey by KPMG Inc
BENEFITS OF AN INTEGRATED MANAGEMENT SYSTEM
Automate Regulatory
Compliance Through Software
Regulatory Change Management
Predict360 REGULATORYCOMPLIANCEARCHITECTURE
Page 29Regulatory Change Management
People Planet and Profit
Page 30Regulatory Change Management
Page 11Regulatory Change Management
Four Reasons Why Implement
Regulatory Change Management
Understanding Regulations
Regulatory Change Management
Regulatory Applicability
Day to Day Compliance Tasking
Event-Driven Compliance Tasking
Incident Management and Root Cause Analysis
Predictive Risk Analysis
Corrective and Preventive Actions
Policy and Procedure
Management
Audit Management
Sustainability
Training Management
Multiple Tools to address Reg
Compliance
Other Industry Pain Points
Regulatory Change Management
Enterprise Risk and Compliance
Management Model
Regulatory Change Management
1 WHY = Regulatory change management
2 WHAT = Risk and internal controls
3 HOW = Operational excellence and workflow
4 WHERE = Location Assets
5 WHO = Defining amp Mapping Roles Key Management Functions
to Metrics amp PampL
Enterprise Risk and Compliance
Management Model ndash Five Steps
Regulatory Change Management
REGULATORYCHANGEMANAGEMENTMODEL
Regulatory Change
Management
Operational Excellence
and Workflow
Risks amp Internal Controls
Organization ndash Roles and
Key Management
Functions
Location
Assets
HOW
WHY
WHAT
WHO
WHERE
Regulatory Change Management
How to Implement an Enterprise
Risk and Compliance
Management System
Page 16Regulatory Change Management
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles and Responsibilities
Locations and Assets
COMPONENTS OF REQUIREMENTS KNOWLEDGE BASE
1 Regulatory Standards Requirements
and Objectives library management
2 Translate regulatory requirements into
action evidence subject frequency
3 Monitor regulatory change
4 Regulations in effect to proposed
5 Mapping- regulatory requirements
mapped to CAPA policy procedures and
evidence
6 Regulation Applicability
Step 1- Requirements Knowledge
Base amp Taxonomy
WHY
Page 17Regulatory Change Management
Step 2- Risk amp Internal Controls1 What is impacted
Environmental Risk
Financial Risk
Legal Risk
Reputational Risk
Operational Risk
2 Define internal controls
Process
Procedures
Risk Assessments
tasks
training
3 Define risk levels
Which details impacting
factors
Is based on a systematic
process allowing the
organization to prioritize more
efficiently
Effectively assesses issues
requiring immediate action
Requirements Knowledge Based amp
Taxonomy
Operational Excellence and
Workflow
Risk and Internal Controls
Reporting ndashRoles and Key management
Functions
Location Assets
WHAT
Page 18Regulatory Change Management
Step 2- Risk amp Internal Controls
Requirements Knowledge Based amp
Taxonomy
Roles and Responsibility
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
Small Workforce Large Workforce
Hig
h R
isk
Lo
w R
isk
Page 19Regulatory Change Management
Weak Technology
bull Documentsamp spreadsheets
bull Email for workflow amp tasks
bull No audit trail or accountability
Moderate Technology
bull Basic workflow amp task management
bull No regulatory content feeds
bull Audit trail for accountability
Strong Technology
bull Enterprise workflow
bull Integrated and actionable regulatory content with policy management
bull Closed loop process ndash everything integrated into one platform
bull Indexing of regulations to other policies
Small Workforce Large Workforce
Hig
h C
om
ple
xity
Low
Co
mp
lexity
Step 2 - Risk amp Internal Controls
Page 20Regulatory Change Management
1 How
2 Compliance process around
sites assets events
3 Process automation and cost
4 Manual VS automation
Step 3- Business Processes
Requirements Knowledge Based amp
Taxonomy
Operational Excellence
and Business Processes
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 21Regulatory Change Management
Automate Corrective Action to Increase Speed Eliminate Waste and Cut Costs
Automate Scheduling Tasking and Tracking
Embed Transparency and Accountability
Automate Management of Change
PROCESSESS THAT CAN BE AUTOMATED
PROCESSESS THAT CANrsquoT BE AUTOMATED
Translation of Requirements
Subject Matter Expertise
Step 3- Business Process
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 22Regulatory Change Management
1 Where is compliance
done
2Compliance done at the
site and asset level
Step 4 Location amp Assets
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHERE
Page 23Regulatory Change Management
1 It is important to define the
roles and responsibilities
before you create an EHS
Regulatory Compliance
Framework
2 So what are the barriers to
creating a Regulatory
Compliance Framework
3 Is there a specific role and
responsibility structure or
can it vary from organization
and industries
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHO
Page 24Regulatory Change Management
1 Key Roles and Structure
2 Key Functions
3 Key Actions
4 Outcome Results
COMPONENTS OF ROLES AND RESPONSIBILITES
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
Regulatory Change Management
Can Automation and Software
Increase Operational Excellence
and Reduce Risks
Page 26Regulatory Change Management
1 Is Technology perceived
as a catalyst for growth and
performance
2 Are people or technology
barriers to Regulatory
Compliance Automation
Automate Regulatory
Compliance Through Software
Requirements
Regulations
Standards
Business Requirements
Business Process
Risks amp Controls
Organization
Location
Assets
Page 27Regulatory Change Management
Source Global survey by KPMG Inc
BENEFITS OF AN INTEGRATED MANAGEMENT SYSTEM
Automate Regulatory
Compliance Through Software
Regulatory Change Management
Predict360 REGULATORYCOMPLIANCEARCHITECTURE
Page 29Regulatory Change Management
People Planet and Profit
Page 30Regulatory Change Management
Regulatory Change Management
Enterprise Risk and Compliance
Management Model
Regulatory Change Management
1 WHY = Regulatory change management
2 WHAT = Risk and internal controls
3 HOW = Operational excellence and workflow
4 WHERE = Location Assets
5 WHO = Defining amp Mapping Roles Key Management Functions
to Metrics amp PampL
Enterprise Risk and Compliance
Management Model ndash Five Steps
Regulatory Change Management
REGULATORYCHANGEMANAGEMENTMODEL
Regulatory Change
Management
Operational Excellence
and Workflow
Risks amp Internal Controls
Organization ndash Roles and
Key Management
Functions
Location
Assets
HOW
WHY
WHAT
WHO
WHERE
Regulatory Change Management
How to Implement an Enterprise
Risk and Compliance
Management System
Page 16Regulatory Change Management
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles and Responsibilities
Locations and Assets
COMPONENTS OF REQUIREMENTS KNOWLEDGE BASE
1 Regulatory Standards Requirements
and Objectives library management
2 Translate regulatory requirements into
action evidence subject frequency
3 Monitor regulatory change
4 Regulations in effect to proposed
5 Mapping- regulatory requirements
mapped to CAPA policy procedures and
evidence
6 Regulation Applicability
Step 1- Requirements Knowledge
Base amp Taxonomy
WHY
Page 17Regulatory Change Management
Step 2- Risk amp Internal Controls1 What is impacted
Environmental Risk
Financial Risk
Legal Risk
Reputational Risk
Operational Risk
2 Define internal controls
Process
Procedures
Risk Assessments
tasks
training
3 Define risk levels
Which details impacting
factors
Is based on a systematic
process allowing the
organization to prioritize more
efficiently
Effectively assesses issues
requiring immediate action
Requirements Knowledge Based amp
Taxonomy
Operational Excellence and
Workflow
Risk and Internal Controls
Reporting ndashRoles and Key management
Functions
Location Assets
WHAT
Page 18Regulatory Change Management
Step 2- Risk amp Internal Controls
Requirements Knowledge Based amp
Taxonomy
Roles and Responsibility
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
Small Workforce Large Workforce
Hig
h R
isk
Lo
w R
isk
Page 19Regulatory Change Management
Weak Technology
bull Documentsamp spreadsheets
bull Email for workflow amp tasks
bull No audit trail or accountability
Moderate Technology
bull Basic workflow amp task management
bull No regulatory content feeds
bull Audit trail for accountability
Strong Technology
bull Enterprise workflow
bull Integrated and actionable regulatory content with policy management
bull Closed loop process ndash everything integrated into one platform
bull Indexing of regulations to other policies
Small Workforce Large Workforce
Hig
h C
om
ple
xity
Low
Co
mp
lexity
Step 2 - Risk amp Internal Controls
Page 20Regulatory Change Management
1 How
2 Compliance process around
sites assets events
3 Process automation and cost
4 Manual VS automation
Step 3- Business Processes
Requirements Knowledge Based amp
Taxonomy
Operational Excellence
and Business Processes
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 21Regulatory Change Management
Automate Corrective Action to Increase Speed Eliminate Waste and Cut Costs
Automate Scheduling Tasking and Tracking
Embed Transparency and Accountability
Automate Management of Change
PROCESSESS THAT CAN BE AUTOMATED
PROCESSESS THAT CANrsquoT BE AUTOMATED
Translation of Requirements
Subject Matter Expertise
Step 3- Business Process
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 22Regulatory Change Management
1 Where is compliance
done
2Compliance done at the
site and asset level
Step 4 Location amp Assets
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHERE
Page 23Regulatory Change Management
1 It is important to define the
roles and responsibilities
before you create an EHS
Regulatory Compliance
Framework
2 So what are the barriers to
creating a Regulatory
Compliance Framework
3 Is there a specific role and
responsibility structure or
can it vary from organization
and industries
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHO
Page 24Regulatory Change Management
1 Key Roles and Structure
2 Key Functions
3 Key Actions
4 Outcome Results
COMPONENTS OF ROLES AND RESPONSIBILITES
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
Regulatory Change Management
Can Automation and Software
Increase Operational Excellence
and Reduce Risks
Page 26Regulatory Change Management
1 Is Technology perceived
as a catalyst for growth and
performance
2 Are people or technology
barriers to Regulatory
Compliance Automation
Automate Regulatory
Compliance Through Software
Requirements
Regulations
Standards
Business Requirements
Business Process
Risks amp Controls
Organization
Location
Assets
Page 27Regulatory Change Management
Source Global survey by KPMG Inc
BENEFITS OF AN INTEGRATED MANAGEMENT SYSTEM
Automate Regulatory
Compliance Through Software
Regulatory Change Management
Predict360 REGULATORYCOMPLIANCEARCHITECTURE
Page 29Regulatory Change Management
People Planet and Profit
Page 30Regulatory Change Management
Regulatory Change Management
1 WHY = Regulatory change management
2 WHAT = Risk and internal controls
3 HOW = Operational excellence and workflow
4 WHERE = Location Assets
5 WHO = Defining amp Mapping Roles Key Management Functions
to Metrics amp PampL
Enterprise Risk and Compliance
Management Model ndash Five Steps
Regulatory Change Management
REGULATORYCHANGEMANAGEMENTMODEL
Regulatory Change
Management
Operational Excellence
and Workflow
Risks amp Internal Controls
Organization ndash Roles and
Key Management
Functions
Location
Assets
HOW
WHY
WHAT
WHO
WHERE
Regulatory Change Management
How to Implement an Enterprise
Risk and Compliance
Management System
Page 16Regulatory Change Management
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles and Responsibilities
Locations and Assets
COMPONENTS OF REQUIREMENTS KNOWLEDGE BASE
1 Regulatory Standards Requirements
and Objectives library management
2 Translate regulatory requirements into
action evidence subject frequency
3 Monitor regulatory change
4 Regulations in effect to proposed
5 Mapping- regulatory requirements
mapped to CAPA policy procedures and
evidence
6 Regulation Applicability
Step 1- Requirements Knowledge
Base amp Taxonomy
WHY
Page 17Regulatory Change Management
Step 2- Risk amp Internal Controls1 What is impacted
Environmental Risk
Financial Risk
Legal Risk
Reputational Risk
Operational Risk
2 Define internal controls
Process
Procedures
Risk Assessments
tasks
training
3 Define risk levels
Which details impacting
factors
Is based on a systematic
process allowing the
organization to prioritize more
efficiently
Effectively assesses issues
requiring immediate action
Requirements Knowledge Based amp
Taxonomy
Operational Excellence and
Workflow
Risk and Internal Controls
Reporting ndashRoles and Key management
Functions
Location Assets
WHAT
Page 18Regulatory Change Management
Step 2- Risk amp Internal Controls
Requirements Knowledge Based amp
Taxonomy
Roles and Responsibility
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
Small Workforce Large Workforce
Hig
h R
isk
Lo
w R
isk
Page 19Regulatory Change Management
Weak Technology
bull Documentsamp spreadsheets
bull Email for workflow amp tasks
bull No audit trail or accountability
Moderate Technology
bull Basic workflow amp task management
bull No regulatory content feeds
bull Audit trail for accountability
Strong Technology
bull Enterprise workflow
bull Integrated and actionable regulatory content with policy management
bull Closed loop process ndash everything integrated into one platform
bull Indexing of regulations to other policies
Small Workforce Large Workforce
Hig
h C
om
ple
xity
Low
Co
mp
lexity
Step 2 - Risk amp Internal Controls
Page 20Regulatory Change Management
1 How
2 Compliance process around
sites assets events
3 Process automation and cost
4 Manual VS automation
Step 3- Business Processes
Requirements Knowledge Based amp
Taxonomy
Operational Excellence
and Business Processes
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 21Regulatory Change Management
Automate Corrective Action to Increase Speed Eliminate Waste and Cut Costs
Automate Scheduling Tasking and Tracking
Embed Transparency and Accountability
Automate Management of Change
PROCESSESS THAT CAN BE AUTOMATED
PROCESSESS THAT CANrsquoT BE AUTOMATED
Translation of Requirements
Subject Matter Expertise
Step 3- Business Process
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 22Regulatory Change Management
1 Where is compliance
done
2Compliance done at the
site and asset level
Step 4 Location amp Assets
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHERE
Page 23Regulatory Change Management
1 It is important to define the
roles and responsibilities
before you create an EHS
Regulatory Compliance
Framework
2 So what are the barriers to
creating a Regulatory
Compliance Framework
3 Is there a specific role and
responsibility structure or
can it vary from organization
and industries
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHO
Page 24Regulatory Change Management
1 Key Roles and Structure
2 Key Functions
3 Key Actions
4 Outcome Results
COMPONENTS OF ROLES AND RESPONSIBILITES
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
Regulatory Change Management
Can Automation and Software
Increase Operational Excellence
and Reduce Risks
Page 26Regulatory Change Management
1 Is Technology perceived
as a catalyst for growth and
performance
2 Are people or technology
barriers to Regulatory
Compliance Automation
Automate Regulatory
Compliance Through Software
Requirements
Regulations
Standards
Business Requirements
Business Process
Risks amp Controls
Organization
Location
Assets
Page 27Regulatory Change Management
Source Global survey by KPMG Inc
BENEFITS OF AN INTEGRATED MANAGEMENT SYSTEM
Automate Regulatory
Compliance Through Software
Regulatory Change Management
Predict360 REGULATORYCOMPLIANCEARCHITECTURE
Page 29Regulatory Change Management
People Planet and Profit
Page 30Regulatory Change Management
Regulatory Change Management
REGULATORYCHANGEMANAGEMENTMODEL
Regulatory Change
Management
Operational Excellence
and Workflow
Risks amp Internal Controls
Organization ndash Roles and
Key Management
Functions
Location
Assets
HOW
WHY
WHAT
WHO
WHERE
Regulatory Change Management
How to Implement an Enterprise
Risk and Compliance
Management System
Page 16Regulatory Change Management
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles and Responsibilities
Locations and Assets
COMPONENTS OF REQUIREMENTS KNOWLEDGE BASE
1 Regulatory Standards Requirements
and Objectives library management
2 Translate regulatory requirements into
action evidence subject frequency
3 Monitor regulatory change
4 Regulations in effect to proposed
5 Mapping- regulatory requirements
mapped to CAPA policy procedures and
evidence
6 Regulation Applicability
Step 1- Requirements Knowledge
Base amp Taxonomy
WHY
Page 17Regulatory Change Management
Step 2- Risk amp Internal Controls1 What is impacted
Environmental Risk
Financial Risk
Legal Risk
Reputational Risk
Operational Risk
2 Define internal controls
Process
Procedures
Risk Assessments
tasks
training
3 Define risk levels
Which details impacting
factors
Is based on a systematic
process allowing the
organization to prioritize more
efficiently
Effectively assesses issues
requiring immediate action
Requirements Knowledge Based amp
Taxonomy
Operational Excellence and
Workflow
Risk and Internal Controls
Reporting ndashRoles and Key management
Functions
Location Assets
WHAT
Page 18Regulatory Change Management
Step 2- Risk amp Internal Controls
Requirements Knowledge Based amp
Taxonomy
Roles and Responsibility
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
Small Workforce Large Workforce
Hig
h R
isk
Lo
w R
isk
Page 19Regulatory Change Management
Weak Technology
bull Documentsamp spreadsheets
bull Email for workflow amp tasks
bull No audit trail or accountability
Moderate Technology
bull Basic workflow amp task management
bull No regulatory content feeds
bull Audit trail for accountability
Strong Technology
bull Enterprise workflow
bull Integrated and actionable regulatory content with policy management
bull Closed loop process ndash everything integrated into one platform
bull Indexing of regulations to other policies
Small Workforce Large Workforce
Hig
h C
om
ple
xity
Low
Co
mp
lexity
Step 2 - Risk amp Internal Controls
Page 20Regulatory Change Management
1 How
2 Compliance process around
sites assets events
3 Process automation and cost
4 Manual VS automation
Step 3- Business Processes
Requirements Knowledge Based amp
Taxonomy
Operational Excellence
and Business Processes
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 21Regulatory Change Management
Automate Corrective Action to Increase Speed Eliminate Waste and Cut Costs
Automate Scheduling Tasking and Tracking
Embed Transparency and Accountability
Automate Management of Change
PROCESSESS THAT CAN BE AUTOMATED
PROCESSESS THAT CANrsquoT BE AUTOMATED
Translation of Requirements
Subject Matter Expertise
Step 3- Business Process
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 22Regulatory Change Management
1 Where is compliance
done
2Compliance done at the
site and asset level
Step 4 Location amp Assets
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHERE
Page 23Regulatory Change Management
1 It is important to define the
roles and responsibilities
before you create an EHS
Regulatory Compliance
Framework
2 So what are the barriers to
creating a Regulatory
Compliance Framework
3 Is there a specific role and
responsibility structure or
can it vary from organization
and industries
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHO
Page 24Regulatory Change Management
1 Key Roles and Structure
2 Key Functions
3 Key Actions
4 Outcome Results
COMPONENTS OF ROLES AND RESPONSIBILITES
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
Regulatory Change Management
Can Automation and Software
Increase Operational Excellence
and Reduce Risks
Page 26Regulatory Change Management
1 Is Technology perceived
as a catalyst for growth and
performance
2 Are people or technology
barriers to Regulatory
Compliance Automation
Automate Regulatory
Compliance Through Software
Requirements
Regulations
Standards
Business Requirements
Business Process
Risks amp Controls
Organization
Location
Assets
Page 27Regulatory Change Management
Source Global survey by KPMG Inc
BENEFITS OF AN INTEGRATED MANAGEMENT SYSTEM
Automate Regulatory
Compliance Through Software
Regulatory Change Management
Predict360 REGULATORYCOMPLIANCEARCHITECTURE
Page 29Regulatory Change Management
People Planet and Profit
Page 30Regulatory Change Management
Regulatory Change Management
How to Implement an Enterprise
Risk and Compliance
Management System
Page 16Regulatory Change Management
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles and Responsibilities
Locations and Assets
COMPONENTS OF REQUIREMENTS KNOWLEDGE BASE
1 Regulatory Standards Requirements
and Objectives library management
2 Translate regulatory requirements into
action evidence subject frequency
3 Monitor regulatory change
4 Regulations in effect to proposed
5 Mapping- regulatory requirements
mapped to CAPA policy procedures and
evidence
6 Regulation Applicability
Step 1- Requirements Knowledge
Base amp Taxonomy
WHY
Page 17Regulatory Change Management
Step 2- Risk amp Internal Controls1 What is impacted
Environmental Risk
Financial Risk
Legal Risk
Reputational Risk
Operational Risk
2 Define internal controls
Process
Procedures
Risk Assessments
tasks
training
3 Define risk levels
Which details impacting
factors
Is based on a systematic
process allowing the
organization to prioritize more
efficiently
Effectively assesses issues
requiring immediate action
Requirements Knowledge Based amp
Taxonomy
Operational Excellence and
Workflow
Risk and Internal Controls
Reporting ndashRoles and Key management
Functions
Location Assets
WHAT
Page 18Regulatory Change Management
Step 2- Risk amp Internal Controls
Requirements Knowledge Based amp
Taxonomy
Roles and Responsibility
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
Small Workforce Large Workforce
Hig
h R
isk
Lo
w R
isk
Page 19Regulatory Change Management
Weak Technology
bull Documentsamp spreadsheets
bull Email for workflow amp tasks
bull No audit trail or accountability
Moderate Technology
bull Basic workflow amp task management
bull No regulatory content feeds
bull Audit trail for accountability
Strong Technology
bull Enterprise workflow
bull Integrated and actionable regulatory content with policy management
bull Closed loop process ndash everything integrated into one platform
bull Indexing of regulations to other policies
Small Workforce Large Workforce
Hig
h C
om
ple
xity
Low
Co
mp
lexity
Step 2 - Risk amp Internal Controls
Page 20Regulatory Change Management
1 How
2 Compliance process around
sites assets events
3 Process automation and cost
4 Manual VS automation
Step 3- Business Processes
Requirements Knowledge Based amp
Taxonomy
Operational Excellence
and Business Processes
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 21Regulatory Change Management
Automate Corrective Action to Increase Speed Eliminate Waste and Cut Costs
Automate Scheduling Tasking and Tracking
Embed Transparency and Accountability
Automate Management of Change
PROCESSESS THAT CAN BE AUTOMATED
PROCESSESS THAT CANrsquoT BE AUTOMATED
Translation of Requirements
Subject Matter Expertise
Step 3- Business Process
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 22Regulatory Change Management
1 Where is compliance
done
2Compliance done at the
site and asset level
Step 4 Location amp Assets
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHERE
Page 23Regulatory Change Management
1 It is important to define the
roles and responsibilities
before you create an EHS
Regulatory Compliance
Framework
2 So what are the barriers to
creating a Regulatory
Compliance Framework
3 Is there a specific role and
responsibility structure or
can it vary from organization
and industries
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHO
Page 24Regulatory Change Management
1 Key Roles and Structure
2 Key Functions
3 Key Actions
4 Outcome Results
COMPONENTS OF ROLES AND RESPONSIBILITES
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
Regulatory Change Management
Can Automation and Software
Increase Operational Excellence
and Reduce Risks
Page 26Regulatory Change Management
1 Is Technology perceived
as a catalyst for growth and
performance
2 Are people or technology
barriers to Regulatory
Compliance Automation
Automate Regulatory
Compliance Through Software
Requirements
Regulations
Standards
Business Requirements
Business Process
Risks amp Controls
Organization
Location
Assets
Page 27Regulatory Change Management
Source Global survey by KPMG Inc
BENEFITS OF AN INTEGRATED MANAGEMENT SYSTEM
Automate Regulatory
Compliance Through Software
Regulatory Change Management
Predict360 REGULATORYCOMPLIANCEARCHITECTURE
Page 29Regulatory Change Management
People Planet and Profit
Page 30Regulatory Change Management
Page 16Regulatory Change Management
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles and Responsibilities
Locations and Assets
COMPONENTS OF REQUIREMENTS KNOWLEDGE BASE
1 Regulatory Standards Requirements
and Objectives library management
2 Translate regulatory requirements into
action evidence subject frequency
3 Monitor regulatory change
4 Regulations in effect to proposed
5 Mapping- regulatory requirements
mapped to CAPA policy procedures and
evidence
6 Regulation Applicability
Step 1- Requirements Knowledge
Base amp Taxonomy
WHY
Page 17Regulatory Change Management
Step 2- Risk amp Internal Controls1 What is impacted
Environmental Risk
Financial Risk
Legal Risk
Reputational Risk
Operational Risk
2 Define internal controls
Process
Procedures
Risk Assessments
tasks
training
3 Define risk levels
Which details impacting
factors
Is based on a systematic
process allowing the
organization to prioritize more
efficiently
Effectively assesses issues
requiring immediate action
Requirements Knowledge Based amp
Taxonomy
Operational Excellence and
Workflow
Risk and Internal Controls
Reporting ndashRoles and Key management
Functions
Location Assets
WHAT
Page 18Regulatory Change Management
Step 2- Risk amp Internal Controls
Requirements Knowledge Based amp
Taxonomy
Roles and Responsibility
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
Small Workforce Large Workforce
Hig
h R
isk
Lo
w R
isk
Page 19Regulatory Change Management
Weak Technology
bull Documentsamp spreadsheets
bull Email for workflow amp tasks
bull No audit trail or accountability
Moderate Technology
bull Basic workflow amp task management
bull No regulatory content feeds
bull Audit trail for accountability
Strong Technology
bull Enterprise workflow
bull Integrated and actionable regulatory content with policy management
bull Closed loop process ndash everything integrated into one platform
bull Indexing of regulations to other policies
Small Workforce Large Workforce
Hig
h C
om
ple
xity
Low
Co
mp
lexity
Step 2 - Risk amp Internal Controls
Page 20Regulatory Change Management
1 How
2 Compliance process around
sites assets events
3 Process automation and cost
4 Manual VS automation
Step 3- Business Processes
Requirements Knowledge Based amp
Taxonomy
Operational Excellence
and Business Processes
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 21Regulatory Change Management
Automate Corrective Action to Increase Speed Eliminate Waste and Cut Costs
Automate Scheduling Tasking and Tracking
Embed Transparency and Accountability
Automate Management of Change
PROCESSESS THAT CAN BE AUTOMATED
PROCESSESS THAT CANrsquoT BE AUTOMATED
Translation of Requirements
Subject Matter Expertise
Step 3- Business Process
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 22Regulatory Change Management
1 Where is compliance
done
2Compliance done at the
site and asset level
Step 4 Location amp Assets
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHERE
Page 23Regulatory Change Management
1 It is important to define the
roles and responsibilities
before you create an EHS
Regulatory Compliance
Framework
2 So what are the barriers to
creating a Regulatory
Compliance Framework
3 Is there a specific role and
responsibility structure or
can it vary from organization
and industries
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHO
Page 24Regulatory Change Management
1 Key Roles and Structure
2 Key Functions
3 Key Actions
4 Outcome Results
COMPONENTS OF ROLES AND RESPONSIBILITES
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
Regulatory Change Management
Can Automation and Software
Increase Operational Excellence
and Reduce Risks
Page 26Regulatory Change Management
1 Is Technology perceived
as a catalyst for growth and
performance
2 Are people or technology
barriers to Regulatory
Compliance Automation
Automate Regulatory
Compliance Through Software
Requirements
Regulations
Standards
Business Requirements
Business Process
Risks amp Controls
Organization
Location
Assets
Page 27Regulatory Change Management
Source Global survey by KPMG Inc
BENEFITS OF AN INTEGRATED MANAGEMENT SYSTEM
Automate Regulatory
Compliance Through Software
Regulatory Change Management
Predict360 REGULATORYCOMPLIANCEARCHITECTURE
Page 29Regulatory Change Management
People Planet and Profit
Page 30Regulatory Change Management
Page 17Regulatory Change Management
Step 2- Risk amp Internal Controls1 What is impacted
Environmental Risk
Financial Risk
Legal Risk
Reputational Risk
Operational Risk
2 Define internal controls
Process
Procedures
Risk Assessments
tasks
training
3 Define risk levels
Which details impacting
factors
Is based on a systematic
process allowing the
organization to prioritize more
efficiently
Effectively assesses issues
requiring immediate action
Requirements Knowledge Based amp
Taxonomy
Operational Excellence and
Workflow
Risk and Internal Controls
Reporting ndashRoles and Key management
Functions
Location Assets
WHAT
Page 18Regulatory Change Management
Step 2- Risk amp Internal Controls
Requirements Knowledge Based amp
Taxonomy
Roles and Responsibility
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
Small Workforce Large Workforce
Hig
h R
isk
Lo
w R
isk
Page 19Regulatory Change Management
Weak Technology
bull Documentsamp spreadsheets
bull Email for workflow amp tasks
bull No audit trail or accountability
Moderate Technology
bull Basic workflow amp task management
bull No regulatory content feeds
bull Audit trail for accountability
Strong Technology
bull Enterprise workflow
bull Integrated and actionable regulatory content with policy management
bull Closed loop process ndash everything integrated into one platform
bull Indexing of regulations to other policies
Small Workforce Large Workforce
Hig
h C
om
ple
xity
Low
Co
mp
lexity
Step 2 - Risk amp Internal Controls
Page 20Regulatory Change Management
1 How
2 Compliance process around
sites assets events
3 Process automation and cost
4 Manual VS automation
Step 3- Business Processes
Requirements Knowledge Based amp
Taxonomy
Operational Excellence
and Business Processes
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 21Regulatory Change Management
Automate Corrective Action to Increase Speed Eliminate Waste and Cut Costs
Automate Scheduling Tasking and Tracking
Embed Transparency and Accountability
Automate Management of Change
PROCESSESS THAT CAN BE AUTOMATED
PROCESSESS THAT CANrsquoT BE AUTOMATED
Translation of Requirements
Subject Matter Expertise
Step 3- Business Process
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 22Regulatory Change Management
1 Where is compliance
done
2Compliance done at the
site and asset level
Step 4 Location amp Assets
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHERE
Page 23Regulatory Change Management
1 It is important to define the
roles and responsibilities
before you create an EHS
Regulatory Compliance
Framework
2 So what are the barriers to
creating a Regulatory
Compliance Framework
3 Is there a specific role and
responsibility structure or
can it vary from organization
and industries
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHO
Page 24Regulatory Change Management
1 Key Roles and Structure
2 Key Functions
3 Key Actions
4 Outcome Results
COMPONENTS OF ROLES AND RESPONSIBILITES
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
Regulatory Change Management
Can Automation and Software
Increase Operational Excellence
and Reduce Risks
Page 26Regulatory Change Management
1 Is Technology perceived
as a catalyst for growth and
performance
2 Are people or technology
barriers to Regulatory
Compliance Automation
Automate Regulatory
Compliance Through Software
Requirements
Regulations
Standards
Business Requirements
Business Process
Risks amp Controls
Organization
Location
Assets
Page 27Regulatory Change Management
Source Global survey by KPMG Inc
BENEFITS OF AN INTEGRATED MANAGEMENT SYSTEM
Automate Regulatory
Compliance Through Software
Regulatory Change Management
Predict360 REGULATORYCOMPLIANCEARCHITECTURE
Page 29Regulatory Change Management
People Planet and Profit
Page 30Regulatory Change Management
Page 18Regulatory Change Management
Step 2- Risk amp Internal Controls
Requirements Knowledge Based amp
Taxonomy
Roles and Responsibility
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
Small Workforce Large Workforce
Hig
h R
isk
Lo
w R
isk
Page 19Regulatory Change Management
Weak Technology
bull Documentsamp spreadsheets
bull Email for workflow amp tasks
bull No audit trail or accountability
Moderate Technology
bull Basic workflow amp task management
bull No regulatory content feeds
bull Audit trail for accountability
Strong Technology
bull Enterprise workflow
bull Integrated and actionable regulatory content with policy management
bull Closed loop process ndash everything integrated into one platform
bull Indexing of regulations to other policies
Small Workforce Large Workforce
Hig
h C
om
ple
xity
Low
Co
mp
lexity
Step 2 - Risk amp Internal Controls
Page 20Regulatory Change Management
1 How
2 Compliance process around
sites assets events
3 Process automation and cost
4 Manual VS automation
Step 3- Business Processes
Requirements Knowledge Based amp
Taxonomy
Operational Excellence
and Business Processes
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 21Regulatory Change Management
Automate Corrective Action to Increase Speed Eliminate Waste and Cut Costs
Automate Scheduling Tasking and Tracking
Embed Transparency and Accountability
Automate Management of Change
PROCESSESS THAT CAN BE AUTOMATED
PROCESSESS THAT CANrsquoT BE AUTOMATED
Translation of Requirements
Subject Matter Expertise
Step 3- Business Process
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 22Regulatory Change Management
1 Where is compliance
done
2Compliance done at the
site and asset level
Step 4 Location amp Assets
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHERE
Page 23Regulatory Change Management
1 It is important to define the
roles and responsibilities
before you create an EHS
Regulatory Compliance
Framework
2 So what are the barriers to
creating a Regulatory
Compliance Framework
3 Is there a specific role and
responsibility structure or
can it vary from organization
and industries
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHO
Page 24Regulatory Change Management
1 Key Roles and Structure
2 Key Functions
3 Key Actions
4 Outcome Results
COMPONENTS OF ROLES AND RESPONSIBILITES
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
Regulatory Change Management
Can Automation and Software
Increase Operational Excellence
and Reduce Risks
Page 26Regulatory Change Management
1 Is Technology perceived
as a catalyst for growth and
performance
2 Are people or technology
barriers to Regulatory
Compliance Automation
Automate Regulatory
Compliance Through Software
Requirements
Regulations
Standards
Business Requirements
Business Process
Risks amp Controls
Organization
Location
Assets
Page 27Regulatory Change Management
Source Global survey by KPMG Inc
BENEFITS OF AN INTEGRATED MANAGEMENT SYSTEM
Automate Regulatory
Compliance Through Software
Regulatory Change Management
Predict360 REGULATORYCOMPLIANCEARCHITECTURE
Page 29Regulatory Change Management
People Planet and Profit
Page 30Regulatory Change Management
Page 19Regulatory Change Management
Weak Technology
bull Documentsamp spreadsheets
bull Email for workflow amp tasks
bull No audit trail or accountability
Moderate Technology
bull Basic workflow amp task management
bull No regulatory content feeds
bull Audit trail for accountability
Strong Technology
bull Enterprise workflow
bull Integrated and actionable regulatory content with policy management
bull Closed loop process ndash everything integrated into one platform
bull Indexing of regulations to other policies
Small Workforce Large Workforce
Hig
h C
om
ple
xity
Low
Co
mp
lexity
Step 2 - Risk amp Internal Controls
Page 20Regulatory Change Management
1 How
2 Compliance process around
sites assets events
3 Process automation and cost
4 Manual VS automation
Step 3- Business Processes
Requirements Knowledge Based amp
Taxonomy
Operational Excellence
and Business Processes
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 21Regulatory Change Management
Automate Corrective Action to Increase Speed Eliminate Waste and Cut Costs
Automate Scheduling Tasking and Tracking
Embed Transparency and Accountability
Automate Management of Change
PROCESSESS THAT CAN BE AUTOMATED
PROCESSESS THAT CANrsquoT BE AUTOMATED
Translation of Requirements
Subject Matter Expertise
Step 3- Business Process
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 22Regulatory Change Management
1 Where is compliance
done
2Compliance done at the
site and asset level
Step 4 Location amp Assets
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHERE
Page 23Regulatory Change Management
1 It is important to define the
roles and responsibilities
before you create an EHS
Regulatory Compliance
Framework
2 So what are the barriers to
creating a Regulatory
Compliance Framework
3 Is there a specific role and
responsibility structure or
can it vary from organization
and industries
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHO
Page 24Regulatory Change Management
1 Key Roles and Structure
2 Key Functions
3 Key Actions
4 Outcome Results
COMPONENTS OF ROLES AND RESPONSIBILITES
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
Regulatory Change Management
Can Automation and Software
Increase Operational Excellence
and Reduce Risks
Page 26Regulatory Change Management
1 Is Technology perceived
as a catalyst for growth and
performance
2 Are people or technology
barriers to Regulatory
Compliance Automation
Automate Regulatory
Compliance Through Software
Requirements
Regulations
Standards
Business Requirements
Business Process
Risks amp Controls
Organization
Location
Assets
Page 27Regulatory Change Management
Source Global survey by KPMG Inc
BENEFITS OF AN INTEGRATED MANAGEMENT SYSTEM
Automate Regulatory
Compliance Through Software
Regulatory Change Management
Predict360 REGULATORYCOMPLIANCEARCHITECTURE
Page 29Regulatory Change Management
People Planet and Profit
Page 30Regulatory Change Management
Page 20Regulatory Change Management
1 How
2 Compliance process around
sites assets events
3 Process automation and cost
4 Manual VS automation
Step 3- Business Processes
Requirements Knowledge Based amp
Taxonomy
Operational Excellence
and Business Processes
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 21Regulatory Change Management
Automate Corrective Action to Increase Speed Eliminate Waste and Cut Costs
Automate Scheduling Tasking and Tracking
Embed Transparency and Accountability
Automate Management of Change
PROCESSESS THAT CAN BE AUTOMATED
PROCESSESS THAT CANrsquoT BE AUTOMATED
Translation of Requirements
Subject Matter Expertise
Step 3- Business Process
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 22Regulatory Change Management
1 Where is compliance
done
2Compliance done at the
site and asset level
Step 4 Location amp Assets
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHERE
Page 23Regulatory Change Management
1 It is important to define the
roles and responsibilities
before you create an EHS
Regulatory Compliance
Framework
2 So what are the barriers to
creating a Regulatory
Compliance Framework
3 Is there a specific role and
responsibility structure or
can it vary from organization
and industries
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHO
Page 24Regulatory Change Management
1 Key Roles and Structure
2 Key Functions
3 Key Actions
4 Outcome Results
COMPONENTS OF ROLES AND RESPONSIBILITES
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
Regulatory Change Management
Can Automation and Software
Increase Operational Excellence
and Reduce Risks
Page 26Regulatory Change Management
1 Is Technology perceived
as a catalyst for growth and
performance
2 Are people or technology
barriers to Regulatory
Compliance Automation
Automate Regulatory
Compliance Through Software
Requirements
Regulations
Standards
Business Requirements
Business Process
Risks amp Controls
Organization
Location
Assets
Page 27Regulatory Change Management
Source Global survey by KPMG Inc
BENEFITS OF AN INTEGRATED MANAGEMENT SYSTEM
Automate Regulatory
Compliance Through Software
Regulatory Change Management
Predict360 REGULATORYCOMPLIANCEARCHITECTURE
Page 29Regulatory Change Management
People Planet and Profit
Page 30Regulatory Change Management
Page 21Regulatory Change Management
Automate Corrective Action to Increase Speed Eliminate Waste and Cut Costs
Automate Scheduling Tasking and Tracking
Embed Transparency and Accountability
Automate Management of Change
PROCESSESS THAT CAN BE AUTOMATED
PROCESSESS THAT CANrsquoT BE AUTOMATED
Translation of Requirements
Subject Matter Expertise
Step 3- Business Process
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Reporting
Regulatory Compliance
Software
HOW
Page 22Regulatory Change Management
1 Where is compliance
done
2Compliance done at the
site and asset level
Step 4 Location amp Assets
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHERE
Page 23Regulatory Change Management
1 It is important to define the
roles and responsibilities
before you create an EHS
Regulatory Compliance
Framework
2 So what are the barriers to
creating a Regulatory
Compliance Framework
3 Is there a specific role and
responsibility structure or
can it vary from organization
and industries
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHO
Page 24Regulatory Change Management
1 Key Roles and Structure
2 Key Functions
3 Key Actions
4 Outcome Results
COMPONENTS OF ROLES AND RESPONSIBILITES
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
Regulatory Change Management
Can Automation and Software
Increase Operational Excellence
and Reduce Risks
Page 26Regulatory Change Management
1 Is Technology perceived
as a catalyst for growth and
performance
2 Are people or technology
barriers to Regulatory
Compliance Automation
Automate Regulatory
Compliance Through Software
Requirements
Regulations
Standards
Business Requirements
Business Process
Risks amp Controls
Organization
Location
Assets
Page 27Regulatory Change Management
Source Global survey by KPMG Inc
BENEFITS OF AN INTEGRATED MANAGEMENT SYSTEM
Automate Regulatory
Compliance Through Software
Regulatory Change Management
Predict360 REGULATORYCOMPLIANCEARCHITECTURE
Page 29Regulatory Change Management
People Planet and Profit
Page 30Regulatory Change Management
Page 22Regulatory Change Management
1 Where is compliance
done
2Compliance done at the
site and asset level
Step 4 Location amp Assets
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHERE
Page 23Regulatory Change Management
1 It is important to define the
roles and responsibilities
before you create an EHS
Regulatory Compliance
Framework
2 So what are the barriers to
creating a Regulatory
Compliance Framework
3 Is there a specific role and
responsibility structure or
can it vary from organization
and industries
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHO
Page 24Regulatory Change Management
1 Key Roles and Structure
2 Key Functions
3 Key Actions
4 Outcome Results
COMPONENTS OF ROLES AND RESPONSIBILITES
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
Regulatory Change Management
Can Automation and Software
Increase Operational Excellence
and Reduce Risks
Page 26Regulatory Change Management
1 Is Technology perceived
as a catalyst for growth and
performance
2 Are people or technology
barriers to Regulatory
Compliance Automation
Automate Regulatory
Compliance Through Software
Requirements
Regulations
Standards
Business Requirements
Business Process
Risks amp Controls
Organization
Location
Assets
Page 27Regulatory Change Management
Source Global survey by KPMG Inc
BENEFITS OF AN INTEGRATED MANAGEMENT SYSTEM
Automate Regulatory
Compliance Through Software
Regulatory Change Management
Predict360 REGULATORYCOMPLIANCEARCHITECTURE
Page 29Regulatory Change Management
People Planet and Profit
Page 30Regulatory Change Management
Page 23Regulatory Change Management
1 It is important to define the
roles and responsibilities
before you create an EHS
Regulatory Compliance
Framework
2 So what are the barriers to
creating a Regulatory
Compliance Framework
3 Is there a specific role and
responsibility structure or
can it vary from organization
and industries
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
WHO
Page 24Regulatory Change Management
1 Key Roles and Structure
2 Key Functions
3 Key Actions
4 Outcome Results
COMPONENTS OF ROLES AND RESPONSIBILITES
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
Regulatory Change Management
Can Automation and Software
Increase Operational Excellence
and Reduce Risks
Page 26Regulatory Change Management
1 Is Technology perceived
as a catalyst for growth and
performance
2 Are people or technology
barriers to Regulatory
Compliance Automation
Automate Regulatory
Compliance Through Software
Requirements
Regulations
Standards
Business Requirements
Business Process
Risks amp Controls
Organization
Location
Assets
Page 27Regulatory Change Management
Source Global survey by KPMG Inc
BENEFITS OF AN INTEGRATED MANAGEMENT SYSTEM
Automate Regulatory
Compliance Through Software
Regulatory Change Management
Predict360 REGULATORYCOMPLIANCEARCHITECTURE
Page 29Regulatory Change Management
People Planet and Profit
Page 30Regulatory Change Management
Page 24Regulatory Change Management
1 Key Roles and Structure
2 Key Functions
3 Key Actions
4 Outcome Results
COMPONENTS OF ROLES AND RESPONSIBILITES
Step 5 Roles amp Responsibility
Requirements Knowledge Based amp
Taxonomy
Business Process
Risk and Internal Controls
Roles amp Responsibility
Location Assets
Regulatory Change Management
Can Automation and Software
Increase Operational Excellence
and Reduce Risks
Page 26Regulatory Change Management
1 Is Technology perceived
as a catalyst for growth and
performance
2 Are people or technology
barriers to Regulatory
Compliance Automation
Automate Regulatory
Compliance Through Software
Requirements
Regulations
Standards
Business Requirements
Business Process
Risks amp Controls
Organization
Location
Assets
Page 27Regulatory Change Management
Source Global survey by KPMG Inc
BENEFITS OF AN INTEGRATED MANAGEMENT SYSTEM
Automate Regulatory
Compliance Through Software
Regulatory Change Management
Predict360 REGULATORYCOMPLIANCEARCHITECTURE
Page 29Regulatory Change Management
People Planet and Profit
Page 30Regulatory Change Management
Regulatory Change Management
Can Automation and Software
Increase Operational Excellence
and Reduce Risks
Page 26Regulatory Change Management
1 Is Technology perceived
as a catalyst for growth and
performance
2 Are people or technology
barriers to Regulatory
Compliance Automation
Automate Regulatory
Compliance Through Software
Requirements
Regulations
Standards
Business Requirements
Business Process
Risks amp Controls
Organization
Location
Assets
Page 27Regulatory Change Management
Source Global survey by KPMG Inc
BENEFITS OF AN INTEGRATED MANAGEMENT SYSTEM
Automate Regulatory
Compliance Through Software
Regulatory Change Management
Predict360 REGULATORYCOMPLIANCEARCHITECTURE
Page 29Regulatory Change Management
People Planet and Profit
Page 30Regulatory Change Management
Page 26Regulatory Change Management
1 Is Technology perceived
as a catalyst for growth and
performance
2 Are people or technology
barriers to Regulatory
Compliance Automation
Automate Regulatory
Compliance Through Software
Requirements
Regulations
Standards
Business Requirements
Business Process
Risks amp Controls
Organization
Location
Assets
Page 27Regulatory Change Management
Source Global survey by KPMG Inc
BENEFITS OF AN INTEGRATED MANAGEMENT SYSTEM
Automate Regulatory
Compliance Through Software
Regulatory Change Management
Predict360 REGULATORYCOMPLIANCEARCHITECTURE
Page 29Regulatory Change Management
People Planet and Profit
Page 30Regulatory Change Management
Page 27Regulatory Change Management
Source Global survey by KPMG Inc
BENEFITS OF AN INTEGRATED MANAGEMENT SYSTEM
Automate Regulatory
Compliance Through Software
Regulatory Change Management
Predict360 REGULATORYCOMPLIANCEARCHITECTURE
Page 29Regulatory Change Management
People Planet and Profit
Page 30Regulatory Change Management
Regulatory Change Management
Predict360 REGULATORYCOMPLIANCEARCHITECTURE
Page 29Regulatory Change Management
People Planet and Profit
Page 30Regulatory Change Management
Page 29Regulatory Change Management
People Planet and Profit
Page 30Regulatory Change Management
Page 30Regulatory Change Management
