top of page

Dictionaries & Terms​ 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.

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


We look forward to working with you.

bottom of page