Implementation

Oracle Argus Safety Implementation

 

HighPoint’s Pharmacovigilance Practice as an Oracle Argus Specialized Implementation Partner offers comprehensive Argus implementation solutions. With deep levels of Argus expertise, the solutions include Argus version upgrades, implementation and consulting services. Our approach for Argus projects is a combination of expert resources capable of exemplary project delivery, structured methodology for best practice based repeatable project execution, and the leverage of highly developed automated tools to increase project efficiencies.

The Pharmacovigilance team brings this three pronged approach for full lifecycle execution that includes business process re-design, configuration, data migration, validation, integration, report development, training, go-live and post implementation support. A phased approach is adopted based on industry best practices and lessons learned from having delivered over 40 Argus projects. In addition, our team can also assist companies in understanding the deployment options (standard software purchase, outside hosting, CRO services, etc.) for their software applications.

 

Oracle AERS Implementation

 

HighPoint’s Pharmacovigilance Practice offers extensive experience in helping companies maximize the value of their investments in Oracle AERS from upgrade projects to retirement.  We will work with you to:

  • Monitor changing global Pharmacovigilance regulations to ensure you remain in compliance
  • Perform periodic reviews of your Oracle AERS technology stack and configuration, to confirm it supports your current business processes
  • Carry out regular maintenance and system monitoring, perform solid technical support and develop a testable disaster recovery plan

 

 

Enterprise Quality Management Systems (EQMS) / Trackwise Services

 

Pharmacovigilance Practice’s Enterprise Quality Management Systems (EQMS) services offers several years of Industry experience which includes successful implementations and validation of a leading quality management software solution TrackWise.

EQMS services include:

  • Implementation & upgrade of TrackWise System
  • Business Process Transformation around product complaint handling
  • Configuration of various Quality Processes within TrackWise
  • Computer system validation
  • Data Migration Services
  • Integrations
  • Support Services

 

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