Presentation to ABC Company

1
Managing Complex Compliance Needs Across the
Enterprise September 2006
Raana Abbasey - Grieder Vertical Marketing Life
Sciences Joel Reed VP Marketing Business
Development
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Intro slides us

• Raana Abbasey - Grieder Vertical Marketing Life
  Sciences
• Raana is the Vertical Marketing Manager
  responsible for the overall strategy for the Life
  Sciences Industry. Ensuring that QADs solutions
  remain current to assist medical manufacturers to
  manage compliance with complex regulatory
  requirements is her top priority. Prior to QAD,
  she was the Industry Manager for Life Sciences at
  JD Edwards. She has over 10 years of experience
  in ERP and CRM software. Raana is a Certified
  Public Accountant and holds a BS in
  Accounting/French from Nazareth College of
  Rochester, NY. She lives outside of Philadelphia
  with her husband and two children.
• Joel Reed - Vice President of Business
  Development and Marketing for NetRegulus
• Responsible for marketing, customer service
  and support and business partner alliances
  worldwide. Prior to joining NetRegulus, Joel was
  Vice President of Marketing and Business
  Development with JCIT International a global
  business consulting organization. Before that,
  Joel spent 7 years with J D Edwards/PeopleSoft as
  Vice President of Product Marketing. In this
  role, Joel was responsible for both industry and
  product marketing. Prior to his tenure with J D
  Edwards, Joel was with Nortel in Raleigh, NC for
  12 years where he held various roles with a focus
  on global process and system development. Joel
  has a Master of Business Administration from the
  University of North Carolina at Chapel Hill and a
  BS in Ceramic Engineering from the Pennsylvania
  State University.

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Agenda

• Introductions
• Todays Regulatory Environment
• Compliance Complexity
• Solution Targets and Opportunities
• Q A

4
FDA Audits in the United States
Increased 99 over 5 years
13 result in Official Action Indicated (OAI)
5
Top 4 Subsystems Identified in 483s
Add 483 definition

1. CAPA
2. Production and Process Control
3. Document Control
4. Management Responsibilities

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Top 4 Warning Letters in 2005

• CAPA
• Complaints
• Management Responsibility
• Acceptance Activities
• These account for over 55 of the total letters
  issued or these four reasons account for
  216 warning letters in the U.S.
  in 2005

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Why is CAPA Number 1 ?
Quality
System
Inspection
Technique
QSIT - Defines process for FDA inspections and
defines the concept of CAPA plus 1
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System Interactions
9
Costs of not being in control

• Time/labor of researching and responding to a 483
  or warning
• Stop shipment
• Recalls
• Fines
• Market valuation

2.5 billion in fines levied since 2000
10
Case Study
Bausch Lomb Solution RecallExposes Risks for
Eye Infections Studies Pointed to Problems As
Long as Nine Years Ago Wall Street Journal July
26, 2006
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Case Study
Boston Scientific gets FDA warning Potentially
defective devices were sent out By Stephen
Heuser, Globe Staff    August 24, 2005 Boston
Globe
The FDA described mistakes that allowed the
Natick medical device maker to ship eight Taxus
coronary stents, five Vaxcel ports, which are
used to administer drugs to cancer patients, and
an unspecified number of Symmetry balloon
catheters, even though the products were
quarantined for failing tests or because of
potential safety problems. ''These events
indicate a complete failure of your quality
system, and are significant and serious," the FDA
said in the letter, posted yesterday on its
website, and signed by the agency's acting
director for New England.
You should know that these serious violations of
the law may result in FDA taking regulatory
action without further notice to you," the agency
added. "These actions include, but are not
limited to, seizing your product inventory,
obtaining a court injunction against further
marketing of the product or assessing civil money
penalties."
Boston Scientific stock dropped 1.23 to close at
25.92 yesterday, down 4.5 percent.
The letter follows a recall of the Vaxcel port
this year after the FDA found problems with its
manufacturing, and a recall last year of about
100,000 Boston Scientific stents because their
balloon catheter delivery systems could fail to
deflate, creating potentially fatal blockages
inside of arteries
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The Problem

• Complexity
• Of the Processes
• Of the Regulatory Environment
• Of the tools and systems employed
• Paper
• Point solutions
• Multiple solutions across facilities

13
Do survey

• Paper based processes
• Multiple solutions
• Compliance as a top 3 strategy

14
What is the most influential decision driving
technology investments to address compliance in
your company?
15
Data-Information-Application Silos
Data - Information Application Silos
Extended Supply Chain
Customer Facing
Supply Chain
CRM
ERP
PLM
EDMS
Supply Chain Applications and APS
Financials
Enterprise
Product Specs
Plant Centric ERP
Procurement
MES
Specialty Quality
Administration
Plant
Formula Management
Materials management
Organization
Batch Management
LIMS
Production Unit
Process Optimization
KPIs
EBR
Data Historian
FCS/Factory Scheduling
In Process Testing
SCADA
Production Process t
LIMS
MES
SPC/ Trending
MMI
Process Control
Machine
Control logic
Data Capture
Automation
Recipe/ Work Order Execution
Plant Operational Analysis
Machine logic
Process Management
Process Control/SPC
Supply Chain Manager
Business Processes
Production Scheduling and business processes
Customer
Production and Business Process Management
16
Impact Areas of this Environment

• Visibility
• Within and across processes, facilities and
  products
• Latency
• Real time access
• Cost and Complexity
• Condition of Approval Studies

17
The Problem

• So is the complexity driven by the processes or
  by the tools employed?

18
Default Complaints Workflow
Intake
Evaluation
Review Close
Investigation?
RegulatoryDecision(s)?
No
No
Yes
Complaints Originator
ComplaintsCoordinator
Yes
ComplaintsCoordinator
Investigation
Vigilance
Canada
MedWatch
Investigator
Vigilance Reviewer
Canada Reviewer
MedWatch Reviewer
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Default CAPA Workflow
Closure
Request
Review
Meet CAPA Criteria?
No
CAPA Coordinator
CAPA Coordinator
Originator
Yes
Investigation
No
Action Tasks
Action(s) Required?
CAPA Owner
Task Owner(s)
Yes
No
Actions
Approval(s) Required?
Yes
Approvers
Action Owner
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Where to Focus

• Complexity
• Of the Processes
• Of the Regulatory Environment
• Of the tools and systems employed
• Paper
• Point solutions
• Multiple solutions across facilities

21
System perspective of a Complaint flow
Call/contact center
Complaint
Investigation
CAPA Required
CAPA
Warehousing Incoming
ERP Device history
Field service
Supply/ incoming
Management oversight/dashboard
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System perspective of a Complaint flow
Call/contact center
Complaint
Investigation
CAPA Required
CAPA
Warehousing Incoming
ERP Device history
Field service
Supply/ incoming
Management oversight/dashboard
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Solution Needs

• Business Need
• Reduced complexity
• Increased visibility
• To critical and relevant information
• To the people that need it when they need it
• Automate unique business

• Solution Design
• Broad enterprise-wide solutions
• Integrated capabilities
• Real-time data
• Robust ad hoc and standard reporting
• Process and threshold based alerts
• Configurable solutions
• Integrated workflow

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Compliance Solution Coverage - QAD
Data - Information Application Silos
Extended Supply Chain
Customer Facing
Supply Chain
CRM
ERP
Financials
Enterprise
Product Specs
Plant Centric ERP
Procurement
MES
Specialty Quality
Administration
Plant
Formula Management
Materials management
Organization
Batch Management
Production Unit
Process Optimization
KPIs
FCS/Factory Scheduling
In Process Testing
Production Process t
Machine
Recipe/ Work Order Execution
Plant Operational Analysis
Machine logic
Process Management
Process Control/SPC
Supply Chain Manager
Business Processes
Production Scheduling and business processes
Customer
Production and Business Process Management
25
Data and Integration Silos
Compliance Solution Coverage QAD and NetRegulus
Data - Information Application Silos
Extended Supply Chain
Customer Facing
Supply Chain
CRM
ERP
Financials
Enterprise
Product Specs
Plant Centric ERP
Procurement
MES
Specialty Quality
Administration
Plant
Formula Management
Materials management
Organization
Batch Management
LIMS
Production Unit
Process Optimization
KPIs
Data Historian
FCS/Factory Scheduling
Production Process t
LIMS
SPC/ Trending
Process Control
Machine
Data Capture
Recipe/ Work Order Execution
Plant Operational Analysis
Machine logic
Process Management
Process Control/SPC
Supply Chain Manager
Business Processes
Production Scheduling and business processes
Customer
Production and Business Process Management
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Compliance Solution Coverage
Extended Supply Chain
Customer Facing
Supply Chain
CRM
ERP
PLM
Doc Management
Supply Chain Applications and APS
Financials
Enterprise
Product Specs
Plant Centric ERP
Procurement
MES
MES
Specialty Quality
Administration
Plant
Formula Management
Materials management
Organization
Batch Management
LIMS
Production Unit
Process Optimization
Process Optimization
KPIs
EBR
KPIs
Data Historian
FCS/Factory Scheduling
In Process Testing
SCADA
Production Process t
LIMS
SPC/ Trending
SPC/ Trending
MMI
Process Control
Machine
Control logic
Data Capture
Automation
Recipe/ Work Order Execution
Plant Operational Analysis
Machine logic
Process Management
Process Control/SPC
Supply Chain Manager
Business Processes
Production Scheduling and business processes
Customer
Production and Business Process Management
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Compliance Solution Coverage
Extended Supply Chain
Customer Facing
Supply Chain
CRM
ERP
PLM
Doc Management
Supply Chain Applications and APS
Financials
Enterprise
Product Specs
Plant Centric ERP
Procurement
MES
MES
Specialty Quality
Administration
Plant
Formula Management
Materials management
Organization
Batch Management
LIMS
Production Unit
Process Optimization
Process Optimization
KPIs
EBR
KPIs
Data Historian
FCS/Factory Scheduling
In Process Testing
SCADA
Production Process t
LIMS
SPC/ Trending
SPC/ Trending
MMI
Process Control
Machine
Control logic
Data Capture
Automation
Recipe/ Work Order Execution
Plant Operational Analysis
Machine logic
Process Management
Process Control/SPC
Supply Chain Manager
Business Processes
Production Scheduling and business processes
Customer
Production and Business Process Management
28
Conceptual Integration QAD with NetRegulus
Service and Support
Quality Management
Study Applications
Quality Applications
Financial Management
Event Driven
Master Data
Master Data
Scheduled
29
Master Data Integration QAD with NetRegulus
Master Data
Master Data
Scheduled

• Scheduled/Batch Data Integration
• Item Master item number, description, site,
  serial or lot number (if exists)
• Supplier Master supplier number, supplier name
• Customer Master customer number, customer name
• Employee Master employee number, employee name
• Site Manufacture Master site number, site name
• Install Base Master will bring serial lot and
  install history

Populate/Update Master Data
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The Result is Improved Control of Key Quality
System Areas

1. CAPA
2. Production and Process Control
3. Document Control
4. Management Responsibilities

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Joint Solution Process Support - Complaints
Call/contact center
Complaint
Investigation
CAPA Required
CAPA
Warehousing Incoming
ERP Device history
Field service
Supply/ incoming
Management oversight/dashboard
32
Management Oversight and Visibility
Complaint Trending by Product Number
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Management Oversight and Visibility
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Management Oversight and Visibility
Trending by Complaint Entry (Owner) Group
Trending by Ownership or Point of Origin
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Trending by Product Number
Management Oversight and Visibility
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Complaints Aging Report
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Management Oversight and Visibility
Nonconformance Trending by Status
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QAD slide
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QAD slide
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QAD slide