Years Of Experience
NRG
EQMS PV
DECREASE EFFORT
By enabling companies to meet aggressive time frames for regulatory reporting and contributing to a more comprehensive
safety profile
INCREASE COMPLIANCE ENSURE DATA RECONCILIATION & COMPLETENESS
BENEFITS
SAVE COSTSREDUCE RISKS
NOVEMBER RESEARCH GROUP EXPERIENCE
Sparta TrackWise certification
Data migration kits
Custom APIs for system integration
Representative project time frame: 2-3 months
PEOPLE
TOOLKITS
PROJECTSPEOPLE
Proven methodology for integration and migration projects
Knowledge of product safety and product quality convergence
Average of 12 years of experience in the regulatory industry
Global presence with offices in U.S., India, and Japan
Oracle Gold Partner, Sparta TrackWise Partner
10%10%ADVERSE EVENTSADVERSE EVENTS
10-40% of cases that life science companies receive in their product safety system are quality complaints
10% of cases that life science companies receive in their product quality system are adverse events
QUALITY COMPLAINTS
THE POWER OF INTEGRATION
By automating the timely exchange of critical safety and
complaint data
By reducing the operational inefficiencies associated with a
manual process
FDA Warning Letters Compliance Human Errors
Operational Efficiency
Data Reconciliation
Increase in Productivity
+35%
+20%
WHY SHOULD YOU INTEGRATE YOUR PRODUCT QUALITY AND PRODUCT SAFETY SYSTEMS?
WHY SHOULD YOU INTEGRATE YOUR PRODUCT QUALITY AND PRODUCT SAFETY SYSTEMS?
10-40%
Website: www.NovemberResearch.comEmail: [email protected]
