Why Integration Between Your Quality Management System and Product Safety System Is Important
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Transcript of Why Integration Between Your Quality Management System and Product Safety System Is Important
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?
Please submit your questions using the Questions feature in the GoToWebinar panel
Contact Information
Anjani Kumar Jha– Senior Director, November Research [email protected](347) 551-1700www.novemberresearch.com
Dave Hess – Solutions Consulting, Sparta [email protected](609) 807-5261www.spartasystems.com
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THANK YOU