Organizations in highly regulated industries continue to face pressure to maintain the highest level of quality in every facet of their operations, while at the same time reducing costs and maintaining margins. This presentation from Sparta Systems describes what Enterprise Quality Management Systems (EQMS) can do for these organizations.

1. Creating the Case for Quality

2. Define EQMS In Your Context
Tailor the EQMS Map for Your Organization
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3. Extended, Mobile Quality Enterprise
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Mobile
Employees
Mobile
Devices
Suppliers,
Contractors,
CMOs,
Distributors
Quality
R&D
Commercial
Manufacturing
Regulatory
Affairs
Preclinical/
Clinical
EHS
• Incidents
• Investigations
• Audits
• Commitments
• Product Complaints
• Supplier Defects
• Deviations
• Corrective Actions
• Change Control
• Trends
• Approvals
• Reports
• Status
• Audits
• NCs
• Commitments
• Audit Observations
• Corrective Actions
• Deviations
• Product Complaints
• Certifications
Emerging Requirements
& Capabilities
External Vendor
Quality

4. Post Market
Operating Outside “The Four Walls”
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Supplier Quality Management
Supplier Audit
Supplier
Qualification  EOL
Text Goes Here
Lab Issues &
Nonconformances
Deviations &
Incidents
Audit
Management
Investigations
Risk Evaluation
Root Cause Analysis
Complaint
Handling
CAPA
Change Control
Batch / IT / Process / Document
Material / Equipment
Supplier
Nonconformance
Supplier Corrective Action
Supplier Change Control
Electronic
Reporting
Registration
Tracking
Change
Management
Commitment
Tracking
Recall
Management
Creating the connected quality enterprise!
Effectiveness CheckEffectiveness Check

5.  Poor quality impacts
- Consumers / patients
- Product availability
- Lost revenue
- Brand image / morale
- Stock price / shareholders
 Quality management involves
everyone in the company …
and the extended supply chain
- Top executives are concerned
- But they can’t connect the dots
The Organizational Dynamics of Quality
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Quality
Management
QA
RA
Ops
R&DMfg
EHS
IT
Suppliers
Suppliers
Suppliers

6. A Quality System in Basic Terms
Being able to answer:
 What happened?
 Why did it happen?
 What did we do about it?
 Were we effective?
 Did we follow through on commitments?
 What can we do better?
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If you don’t
document it … it
didn’t happen!
Lack of visibility
means things
won’t get done!
Tracking
Visibility
Enterprise
Control

7. Assess the Current State
Pick your facts wisely
The 80-20 rule applies
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8. What is the Result?
What
happened?
What did we
do?
Were we
effective?
How did we do
as a company?
Why did it
happen?

9. The Future State Transition
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PLM
CRM
LIMS
EQMS
Processes
•Incidents
•CAPA
•Deviations
•Auditing
•Complaints
•Change Control
Functions
•Mfg. - Int.
•Mfg. - Ext.
•R&D
•Clinical
•Suppliers
•Facilities
Locations
•Country
•Region
•Business Unit
•Site
•Department
Other
ERP as the foundation & core of intersystem communications
EQMS is an integral “pillar” system providing seamless interaction of
all quality processes across all locations & functions
Brand protection
Less quality events & recalls
Increase operating margins
Variety of quality “point solutions”
Separate implementations
Manual process integration
Quality information not shared
Global compliance challenges
ERP
ERP PLM CRM LIMS
Q Q Q
Q Q
Fragmented Pillar Systems
Trust.
Safety.
Efficiency.
Current State
“Compliance”
Desire Future Operational State
“Effectiveness”

10.  Local excellence emphasis
 Fragmented quality systems
 Manual corporate reporting
 Limits our assessment of global
process capability
 Global and local blind spots
 Will lead to regulatory findings
 Creates global brand risk
 Lower share price w/  Opx budget
Current State Summary
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Very difficult to clearly understand:
• How are we really doing globally?
• Where are we at risk?
• What can we be doing better?

11. Quantify the Future State Gap
Remember to avoid the curse of knowledge!
Less is more?
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12. The Future State Transition
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Compliance-driven
Project-centric
Approach
Strategic Effectiveness
Platform-centric
Approach
• Global brand risk
• Local process visibility
• Missed opportunities
• Reactive corrections
• Higher operating costs
• Global brand integrity
• Enterprise compliance
• Global transparency
• Proactive change
• Speed to results

13.  Reporting Efficiency & Effectiveness
 Process Efficiency & Effectiveness
 Consolidation Into Platform
 Global Visibility
 Enterprise Transparency
The Future State Impact
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Concrete
Emotional
Tactical
Strategic

14.  Eliminate 90% non-value-
added reporting
- Pulling data out of disparate
systems
- Resolving and aggregating
corporate metrics
- Distributing results for review
and reporting
- Publish results 10-20 days
after end of cycle
Reporting Efficiency & Effectiveness
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Average # of processes: 8
Supplier audit, internal audit, Deviations,
Nonconformance, Complaints, CAPA, RFC/CC,
Effectiveness, Commitment Tracking

15.  Reduce process cycle time
- # days from OPEN to CLOSE
 Improve right first-time
- Eliminate rework / cycling
 Improve on-time completion
- Due date extensions and
overdue record management
Process Efficiency & Effectiveness
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Category Change
%
Change
#
Records
+25,000  60%
Average
Cycle
Time
-90 days  65%
Right
First
Time
N/A  9%
Open
Record
Inventory
-5,000  50%
On-time N/A TBD
Note: A recent TrackWise example (3 year change)

16.  Processing time reductions
- Amount of “touch time” per
record to move from OPEN to
CLOSED
- Elimination of non-value-
added “data assembly” from
multiple systems
 Largest efficiencies include
- Initiation, initial review, and
assignment
- Investigations and analysis
- CAPA and effectiveness
planning
Process Efficiency & Effectiveness
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Process
Processing Time
Reduction
Deviations  55%
Complaints  65%
Internal Audits  20%
Investigations  50%
CAPA  50%
Change Control  35%
Tracking, Visibility & Control
Streamline Processes

17.  Reduces infrastructure
complexity
 Reduces integration
complexity
 Reduces development and
support costs
 Enables process and
reporting effectiveness
System Consolidation
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Average # of processes: 8
Supplier audit, internal audit, Deviations,
Nonconformance, Complaints, CAPA, RFC/CC,
Effectiveness, Commitment Tracking

18.  Best-in-class enterprise
quality management
- People & process changes
institutionalized with a
TrackWise platform
 Accelerating knowledge
transfer & results
- Share local results globally
- Share global results locally
Global Visibility
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Category Benefit Summary
# Quality Events  70%
Gross Margins  2-3%
# Recall Events  >60%
Serious Injury
Rate
 >30%
Quality Event
Backlog
 >90%
Results attained in 3+ years

19.  Streamlined communications
inside & outside the company
 Efficient operations
 Effective oversight
 Systematic follow through
 Efficiencies gained in dealing
with quality “outside your 4
walls”
Enterprise Transparency
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Average # of processes: 4
Annual update/audit, supplier nonconformance,
supplier corrective action, supplier change control
Assumes 150 events per supplier per year

20. Create a Compelling Story
The science of making your case stick
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21. Making It Stick
 Simple
- Avoid the “Curse of Knowledge”
 Unexpected
- Surprise draws attention, focus and retention
 Concrete
- Examples and analogies are memorable
 Concise
- Avoid providing too much information (TMI)!
 Emotional
- This is core to “stickiness”
 Story
- People remember a good story!
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22. The Opportunity
 Our brand image is dictated by
supplier performance
 Over 60% of our recalls and
withdrawals are supplier-related
 Our supplier interactions are slow,
cumbersome and ineffective
Future State / Benefits
 A centralized management tool with
supplier access eliminates all paper
 Duplicate efforts, data copying, and
costly delays will be eliminated
 Resolutions will occur 40% faster.
 Recalls will be reduced by at least 50%
Example 1 – Supplier Quality Management
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Current State
 All supplier interactions are paper,
email, phone call and FAX based
 Last year there were an estimated
20,000 supplier interactions
 The # of suppliers & interactions is
growing at least 10% each year
Requested Action
 One less recall is a $10M savings
 A supplier quality management
solution is a small fraction of 1 recall
 This approach enables key suppliers
to become part of our R&D and
quality teams

23. Example 2 – EQMS Consolidation
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The Opportunity
 Our quality tools resemble 1990s MRP
 A recent IT audit revealed 43 critical
Excel, Access and SQL tools to release
product beyond 2 that IT knew about
 We have successfully grown through
acquisition to 25 sites
Future State / Benefits
 A more centralized approach will save
at least $10M per year
 More importantly, benchmarks show
that we can reduce quality events by
70% and improve gross margins 2-3%
 This can be done in 3 years
Current State
 We have duplicate audit, deviation,
complaint, NC, CAPA and change tools
 We estimate a redundant spend in
excess of $10M annually across sites
 A recent audit uncovered consistent
compliance gaps despite redundancy
Requested Action
 Our brands & stock price are at risk
 Quality needs an enterprise platform
 Each quarter, Excel is used for event
cycle counting & reconciliation
 An enterprise solution costs <$5M
 Rolled out globally <24 months

24. Category Example 1 – Supplier Quality Mgmt Example 2 – EQMS Consolidation
Simple
Our brand image is dictated by supplier
performance
Quality needs an enterprise platform
Unexpected
Over 60% of our recalls and withdrawals
are supplier-related
We estimate a redundant spend in
excess of $10M annually across sites
Concrete
Last year there were an estimated
20,000 supplier interactions
Each quarter, Excel is used for quality
event cycle counting & reconciliation
Concise
All supplier interactions are paper, email,
phone call and FAX based
A recent IT audit revealed 43 critical
Excel, Access and SQL tools to release
product beyond the 2 that IT knew
about
Emotional
A supplier quality management solution
is a small fraction of the cost of 1 recall
Our quality tools resemble 1990s MRP
Story
Supplier resolutions will occur 40% faster
Recalls will be cut in half.
Suppliers become quality team members
An EQMS platform will allow us to:
•Reduce # quality events by 70%
•Increase gross margins by 2-3%
•Cut $10M in redundant costs
In Review
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Sparta Systems
We Help Protect Millions of Lives Everyday
www.spartasystems.com
609-807-5100