Ennov InSight 7.2 Release Notes (Cumulative)

Ennov InSight 7.2 Release Notes

The Release Notes contain information about updated files, new functionality, resolved issues, and any open issues or workarounds in this release of Ennov InSight 7.2.

The details in these Release Notes supersede all similar details that appear anywhere else in this release of the product or its other documentation.

IDMP Entity and Tabs Changes

Changes have been made to the following entities and tabs for enhanced tracking of the medicinal product data. See: Entity Fields and Columns Added: Ennov InSight 7.2, Entity Fields and Columns Updated: Ennov InSight 7.2.
  • Entities:
    • Product Family (Product Family Attributes, CT Shared Data)
    • Application (Application Attributes)
    • PDS (Active Ingredient, Substance, Flu Strain, Shelf Life/Storage Condition(s), Package)
    • Manufactured Item (Manufactured Item Attributes)
    • Registrations (Package Set Registration, Registration Package Set, Registration Package Set Country)
    • Registration Package Set Attributes (PCIDs, Package Descriptions,Data Carrier Identifiers)
    • Medicinal Product (MPID, Medicinal Product Name, PMSIDs)
    • IDMP
    • PhPID
    • Medicinal Product Action
    • Active Ingredients and Reference Active Ingredients for Component, Pharmaceutical Product, Manufactured Item, PDS Details (Active Ingredients, Substance​​​​, Flu Strain)
    • Substances and Reference Substances (Pharmaceutical Product, Manufactured Item)
    • Queries, Wizards, Data Administration updates
  • Pending Changes for Application, Registration (Registration Package Set, Registration Package Set Country) and Medicinal Product at the Event level. Pending Changes allows you to track pending IDMP changes that are specific to Registration attributes. Pending Changes are used for related IDMP data generation and defined in the scope of Event approval. See Registrations>Events> Data Carrier Identifiers Attributes.
  • Tabs:
    • My Home

Other Entity Updates

Changes have been made to the CT Shared Data to enhance the EU CTR application functionality.

Functionality and Technology Not Supported

Starting with Ennov InSight 7.2, the following functionality will not be supported:
  • D2/LSRD
  • Data Exchange

In preparation to capture Substance Management Services (SMS) data for IDMP, the framework is implemented.The SPOR Master List for Substance is empty as EMA has not released the Substances (SMS) controlled vocabulary. You cannot map RIM substance values on the tab of Substance Values.

API Updates

Ennov InSight 7.2 includes multiple API updates including the update for IDMP.

Changes between Ennov InSight 7.2 and Ennov InSight 7.1 API are documented in the Ennov InSight Administration guide. See: Ennov InSight Administration > Technical Administration > Ennov InSight API Documentation.

Data Administration Lists - APIs CRUD Operations

Ennov InSight now includes the API Create, Read, Update, Deactivate (CRUD) operations for Data Administration and new end points. See: Ennov InSight Administration > Technical Administration > Ennov InSight API Documentation.

Additional API Data Administration Updates

The framework for implementing Data Administration lists that are associated with RMS is completed in Ennov InSight 7.2​.

The RMS Associated Data Administration Lists will be fully implemented in Ennov InSight 7.3 now that the framework is in place.

Power BI

The SQL Direct Access model now includes support for Publishing and Audit data.