Requirements Intelligence Module
About the module
Maintain overview of global requirements (“obligations”) towards partners and authorities. Following requirement types are supported: Regulations / guidance, ICSR reporting, PV system and system master file, Periodic SUSAR reporting, Data Monitoring Committee, Medical Device reporting, Local QPPV / Safety Responsible, Risk Management Plan / Documents, Renewal Documents, Periodic Safety Update Report, Developments Safety Update Report, Signal Detection / Management
Allow for workflow-based management e.g. have local personnel to do the updates of a country’s rules. Setup approvals in the workflow e.g. from HQ
Requirements configured can auto-schedule to other modules of HALOPV e.g. Aggregate reporting or Submissions for generation and tracking of activities - or auto-generate reporting rules in Argus Safety via integration
Maintains an audit trail for all changes and updates
Is GxP validated* and ready to use in the cloud
*Validation package provided with documented proof of execution of test cases according to Insife’s standard process configuration. Additional validation activities may be needed to satisfy needs for your organization.
GRIP - Global Regulatory Intelligence Club for Pharmacovigilance
Combine our Requirements Intelligence module with the unique GRIP that provides coverage of global regulations and actionable rules. Read more about GRIP
Want to know more, get a demo or take it for a test drive?
We would love to tell you more and answer any questions you have, take you through a demo or let you test the system so you can explore yourself. Just email email@example.com.
We look forward to working with you.