Ennov InSight RIM 7.1 RNs Cumulative

New in Ennov InSight 7.1: Registrations

New features and enhancements for Registration functionality is listed below.
Affected Area Update Benefit
Registration-Package Sets To include the changes for IDMP, you can now:
  • define Package Descriptions entity attributes.
  • select PDS Package Sets with a status of Pending Add.
  • add new attributes for Registration Package Sets. See: Entity Fields and Columns Added.

The following new tabs are also included in Ennov InSight.

  • The Medicinal Product and Medicinal Product Actions tabs are added to the Registrations Attributes page.
  • The Medicinal Product Names tab is added to the Medicinal Product Attributes page.
  • The Attached Documents tab is added to the Medicinal Product Actions Attributes page.
The ability to capture IDMP Iteration 1 data in Ennov InSight in preparation for submitting IDMP data to EMA.
Product Detail Sets (PDS) To include the changes for IDMP, additional attributes and updates are made for the following:
  • PDS Medical Device
  • PDS Active Ingredients
  • PDS Indications/Intended Use
  • PDS Manufacturer Detail
  • PDS Flu Strain
  • PDS Shelf Life
  • PDS Package Set
  • PDS Substance Detail
  • Global Project Plan

To support the changes for the IDMP, a new Pack Size node is introduced in the PDS tree. You can associate the Pack Size Detail for product packaging with a PDS package set. See: Associate Pack Size with a PDS

The Active Ingredients on the PDS are now autopopulated with the Active Ingredient details captured on the Component. See: Associate an Active Ingredient with a PDS.

The ability to capture IDMP Iteration 1 data in Ennov InSight in preparation for submitting IDMP data to EMA.