Although the responsibility of investigating product complaints generally falls within the Manufacturing or Product Quality business unit, life science companies are required by law to report any product complaints to regulatory authorities if there is an associated adverse event or serious adverse event. The absence of a detailed adverse event evaluation in product complaints often causes serious audit findings, warning letters or even millions of dollars in fines from regulatory agencies. A large part of the problem is that in most pharmaceutical companies, the safety system and the quality management system are not integrated – both the technology and the processes are completely separate. This lack of integration introduces a tremendous amount of regulatory and financial risk to the company. Join our subject matter experts Anjani Jha, Senior Director of November Research Group and Dave Hess, Solutions Consulting at Sparta Systems as they discuss how pharmaceutical companies can leverage and integrate advanced quality management and pharmacovigilance solutions to deliver immediate value into a company’s business process. Topics will include: - Challenges that life science companies face when running separate safety and quality management systems - What an integrated system looks like - Benefits of integration with tangible results

1. November Research Group
Sparta Systems
Why Integration Between Your Quality Management System and
Product Safety System Is Important
June 25, 2015

2. Before We Begin
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3. Presenters
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• 5+ years at Sparta Systems
• Experience in Product Support and Professional Services
• Integration focused with 14 years in programming
- B.S. in Computer Science, Rutgers University
Dave Hess
Solutions Consulting
Anjani Jha
Senior Director
• 4.5 years at November Research Group
• Experience in Process Transformation and Product
Implementations across Product Quality and Product
Safety value chain
• Served Tier-1, 2, 3 Pharmaceutical, Med Devices, CROs and
Bio Tech as Subject Matter Expert (SME), Solution
Architect & Account Manager
- B.Engg. with Honors in Mechanical Engineering

4. A quick Look Into the Presentation
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Need for Integration
Integrated Solution – Use Cases
Data Exchange
Power of Integration
Q&A, Next Steps
About November Research Group, Sparta Systems

5. Need for Integration – Regulation
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21CFR211.198 (a) require Adverse Events associated with the
Product Complaints to be reported to regulatory authorities

6. Need for Integration – Warning Letters - FDA
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• FDA issued warning letters to about 50 firms for lack of compliance
to 21CFR211.198

7. Need for Integration – Recalls - FDA
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• Recent Recalls of Drugs and Medical Devices

8. Need for Integration – Health Canada
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Health Canada slapped penalties and restrictions on drugs linked to
firms and sites with questionable data integrity background

9. Need for Integration - Processes
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• Product Quality evaluation and Drug Safety evaluation

10. Need for Integration - Communication
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• Due to multiple departments processing a single case,
following different processes, there is a need to have in place
an efficient communication path
• Provide the ability to furnish comprehensive details pertaining
to a case to other necessary entities within the organization
(e.g. legal department)

11. Need for Integration – Compliance Risk
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• Lack of Integration causes:
• Late reporting
• Late discovery of serious manufacturing defects
• Compliance risk
• Information reconciliation

12. Need for Integration - Benefits
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• An integrated solution is needed to achieve the stated goals
and eliminate operational inefficiencies
REDUCE RISKS SAVE COSTS
Warning Letters
Compliance
Human Errors
Operational Efficiency
Data Reconciliation
Increase in Productivity

13. Integrated Solution – Use Case # 1
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“A complaint was filed in the complaint system where a
patient reported that the prefilled wonder drug injection
was filled too high with too much medication which led to a
more intense reaction when he injected. Patient said a call
back was fine to discuss this information, but he plans to call
in to talk more about it later”

14. Integrated Solution – Use Case # 1
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15. Integrated Solution – Use Case # 2
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“The drug safety department received a case via an e2b
where the patient reported that she has experienced flu like
symptoms characterized by chills and muscle aches with her
last shipment of prefilled syringes of the wonder drug. When
she received her new shipment she used a dose of that and
experienced no symptoms”

16. Integrated Solution – Use Case # 2
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17. Data Exchange
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Apart from case creation the integrated solution enables efficient
exchange of crucial information between the systems that
facilitates a holistic review of the case
Complaint Process
Sample Results
Patient Correspondence
Investigation Results
Follow-up Information
Batch/Lot Information
Safety Process
Medical Analysis
Patient Correspondence
Case Disposition
Summary
Follow-up Information
Drug/Event Codes

18. The Power of Integration
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Decrease
Effort
Increase
Compliance
Ensure Data
Reconciliation
& Completeness

19. About Us – November Research Group
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Sparta Systems, Inc.
 Founded 1994
 700+ Implementations
 650,000+ Users
 Customers in 30+ Countries
 Industries:
- Pharmaceutical
- Medical Device
- Consumer Products
- Discrete Manufacturing
 98.5% Retention Rate
 ~70% of customers > 5 yrs
Sparta Systems, Inc Headquarters
Hamilton, NJ

21. Questions?
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22. Contact Information
Anjani Kumar Jha– Senior Director, November Research Group
anjani@novemberresearch.com
(347) 551-1700
www.novemberresearch.com
Dave Hess – Solutions Consulting, Sparta Systems
david.hess@spartasystems.com
(609) 807-5261
www.spartasystems.com

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THANK YOU