Labelling Module


About the module

  • Manage the Summary of Product Characteristics (SmPC), store and update the documents and create collections of terms in SmPC

  • Create new CMQs or review SMQs

  • Add lists of terms in collections forsignal detection, aggregate reporting etc. e.g. Keep under review terms

  • For ICSRs, you can use the label collections with an automator to auto-assessment event listedness

  • 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.

Further details

HALOPV Labelling module is a multi-purpose module to keep track of collections for MEDDRA and GMDN e.g. for SmPC management. It is part of the set of Regulatory and Science modules

Want to know more, get a demo or take it for a test drive?

We are ready to provide your with further information, and can setup a demo for you, where we take you through a guided tour of the application. If you would like to take it a step further, we also have test environments for you to explore in detail. 

Write to - we are looking forward to helping your organization!