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.
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