November Research GroupSparta Systems

Why Integration Between Your Quality Management System and Product Safety System Is Important

June 25, 2015

Before We Begin

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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 HessSolutions Consulting

Anjani JhaSenior 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

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

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

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

Need for Integration – Recalls - FDA

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• Recent Recalls of Drugs and Medical Devices

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

Need for Integration - Processes

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• Product Quality evaluation and Drug Safety evaluation

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)

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

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

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”

Integrated Solution – Use Case # 1

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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”

Integrated Solution – Use Case # 2

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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

The Power of Integration

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Decrease Effort

Increase Compliance

Ensure Data Reconciliation

& Completeness

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 HeadquartersHamilton, NJ

Questions?

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Contact Information

Anjani Kumar Jha– Senior Director, November Research Groupanjani@novemberresearch.com(347) 551-1700www.novemberresearch.com

Dave Hess – Solutions Consulting, Sparta Systemsdavid.hess@spartasystems.com(609) 807-5261www.spartasystems.com

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THANK YOU