Ennov InSight 7.2 Release Notes (Cumulative)

New in Ennov InSight 7.2: Registrations

New features and enhancements for Registration functionality is listed below.
Affected Area Update Benefit
Registrations (Package Set type) The Registration Package Set fields are updated for IDMP. See Entity Fields and Columns Updated. To be updated.
Registration-Package Sets The Registration-Package Sets Attributes page is updated for IDMP. See Entity Fields and Columns Added, Entity Fields and Columns Removed. To be updated.
Registrations (Package Set Country) The Registration Package Set Country fields are updated for IDMP. See Entity Fields and Columns Updated.

The Registrations Package Set-Country Attributes page now includes a new Data Carrier Identifiers tab.

To be updated.
Product Detail Sets (PDS) The following attributes and updates are included to conform to the IDMP standards:
  • PDS (Active Ingredient Detail Attributes)
  • PDS (Substance Detail Attributes)
  • PDS (Flu Strain Detail Attributes)
  • PDS (Shelf Life/Storage Condition(s) Attributes)
  • PDS (Package Detail Attributes)
To be updated.
Events The Event Attributes page now includes a new Pending Changes tab. In the Pending Changes tab you can enter values for pending changes for Application, Registration, Registration Package Set, Registration Package Set Country and Medicinal Product.
Medicinal Product
  • The Medicinal Product Attributes page is updated for IDMP . See: Entity Fields and Columns Added and Entity Fields and Columns Removed.
  • The Medicinal Product entity and all the associated child entities are moved from the Registration to the Application level:
    • Medicinal Product Names
    • Pharmaceutical Products
    • Product Cross-References
    • MPIDs
    • Tasks
    • References
    • Notifications
To be updated.
Medicinal Product Action
  • The Medicinal Product Action and Attached Document entities are removed from the Registration and added at the Application level.
  • The Medicinal Product Action Attributes page is updated for IDMP . See Entity Fields and Columns Updated.
To be updated.
IDMP The IDMP tab is removed from Registration and added at the Application level with the updated fields. To be updated.
Active Ingredients and Reference Active Ingredients The following updates are included to conform to the IDMP standards:
  • Component Active Ingredients and Reference Active Ingredients
  • Pharmaceutical Product Active Ingredients and Reference Active Ingredients
  • Manufactured Item Active Ingredients and Reference Active Ingredients
  • PDS:
    • PDS (Active Ingredient Detail Attributes)
    • PDS (Substance Detail Attributes)
    • PDS (Substance Detail Attributes)
    • PDS (Package Detail Attributes)
  • You can now add multiple Reference Active Ingredients to Manufactured Item Active Ingredients and Pharmaceutical Product.
  • You can now associate or disassociate the Active Ingredients on the Product Family Attributes page if a Product Family has associated Products with no Components, PDSs, or PDS Templates related to these Products.
To be updated.
Substances and Reference Substances The following updates are included to conform to the IDMP standards:
  • Pharmaceutical Product Substances and Reference Substances
  • Manufactured Item Substances and Reference Substances
To be updated.
Create Application Wizard When creating an Event from the Create Application Wizard for the Application with the CP Procedure Types, the Countries field displays the European Union value only in the Selected box. Other countries are displayed in the Available box. To be updated.
Query The Registration Planning and Tracking query list now includes two new query:
  • List of RMS Fields
  • List of OMS Fields
To be updated.