why should you integrate your product quality and product safety systems?

1
Years Of Experience NRG EQMS PV DECREASE EFFORT By enabling companies to meet aggressive me frames for regulatory reporng and contribung to a more comprehensive safety profile INCREASE COMPLIANCE ENSURE DATA RECONCILIATION & COMPLETENESS BENEFITS SAVE COSTS REDUCE RISKS NOVEMBER RESEARCH GROUP EXPERIENCE Sparta TrackWise cerficaon Data migraon kits Custom APIs for system integraon Representave project me frame: 2-3 months PEOPLE TOOLKITS PROJECTS PEOPLE Proven methodology for integraon and migraon 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 EVENTS ADVERSE 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 automang the mely exchange of crical safety and complaint data By reducing the operaonal 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.com Email: [email protected]

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Why should you integrate your product quality and product safety systems? November Research Group announced that the company’s Enterprise Quality Management Software (EQMS) experts are now TrackWise Core Accreditation Certified. The Sparta Systems Accreditation Exams are built to challenge partners’ key TrackWise resources in both their core knowledge as well as their ability to apply that knowledge in a consistent and standardized process. This allows our clients to be confident that our TrackWise experts have met the same high standards as Sparta Systems’ internal resources.

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Page 1: Why Should You Integrate Your Product Quality and Product Safety Systems?

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]