Ennov InSight RIM 7.1 RNs Cumulative

New in Ennov InSight 7.1 : Common Functionality

This table shows new features and enhancements of Ennov InSight 7.1 functionality.

Identification of Medicinal Products (IDMP)

To support capturing data elements for European Medicine Agency (EMA) Iteration 1 implementation of IDMP.

Affected Area Update Benefit
Entities/Entity tabs Сhanges for IDMP now include:
  • New Entities/Entity tabs:
    • Components are updated to include Manufactured Items
    • Manufactured Items and Pharmaceutical Products are updated to include Active Ingredients/Reference Active Ingredients
    • Manufactured Items and Pharmaceutical Products)Substances/Reference Substances
    • Package Descriptions are updated to include Registration-Package Sets
    • Application is updated to include Orphan Designations
    • Package Set type Registration updated to include Medicinal Products, Medicinal Product Actions, and IDMP
    • Medicinal Products updated to include Medicinal Product Names, Product Cross-Reference, and MPIDs
    • Medicinal Product Actions updated to include Attached Document
    • PDS Pack Size node
    • Manufactured Items, Pharmaceutical Products, and Medicinal Products updated to include Tasks, References, Activities, Workflows, Notifications
    • Pharmaceutical Products updated to include PhPIDs
  • Entity updates:
    • Product Family
    • Products
    • Component Active Ingredients/Reference Active Ingredients
    • Pharmaceutical Products
    • Application
    • PDS
      • Active Ingredient
      • Substance
      • Flu Strain
      • Medical Device
      • Indications/Intended Use
      • Shelf Life
      • Packaging
      • Manufacturing
    • Registrations (Package Set type)
    • Registration-Package Set and Package Set Country
    • Queries, Wizards, Data Administration updates
  • New Dose Form Search selection widget

Changes for Comments include the new fields to record comments for create/modify actions on Event - Country Status, Sequence Status Date, and Task Status Dates.

To support EU Clinical Trial data in Ennov InSight as required by EU 536/2014 regulation, the new EU Clinical Trial Regulation type of Application includes:
  • New fields for Application Country Notifications.
  • The ability to associate Member States Concerned to sequence.
  • The ability to associate/disassociate multiple CT shared data to event.
  • The ability to withdraw a country from application.
The ability to capture IDMP Iteration 1 data in Ennov InSight in preparation for submitting IDMP data to EMA.

The ability to capture and provide visibility of EU CTR data for EU CTR applications in Ennov InSight.

Querying To conform to IDMP standards, Queries now include:
  • Updated list of fields for Product Family
  • Updated list of fields for Application
  • Updated list of fields for Product and Component, and Component Active Ingredients
  • Updated list of fields for Manufactured Item
IDMP data elements are reflected in out-of-the-box queries.
Data Administration Updates to Data Administration have been made to conform with IDMP standards.

A new SPOR Master List has been included to support OMS/ RMS.

With Ennov InSight 7.1, Data Administration now includes:
  • new RMS tabs
  • new OMS tabs
  • new Term Search widget

The Manufacturer page under the Product Detail Set Maintenance > Manufacturer Values now includes a new Manufacturing Authorisation Reference Number tab.

For details, see Data Administration Tables Added, Data Administration Tables Updated.

Ability to capture and map SPOR ids to IDMP data elements within RIM.
Application To include the changes for IDMP:
  • The Application Attributes page now includes the new Orphan Designation entity tab.

To support EU Clinical Trial data in Ennov InSight based on the EU 536/2014 regulation, the new EU Clinical Trial Regulation type of Application affects PDS, Sequences, Events and Registrations where the withdrawn countries are not available for selection.

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

The ability to capture and provide visibility of EU CTR data for EU CTR applications in Ennov InSight.

Component To include the changes for IDMP:
  • The Component Attributes page now includes the new Manufactured Item entity tab.
  • The Manufactured Item Attributes page now includes the new Active Ingredients tab.
  • The Reference Active Ingredients entity tab is added under Manufactured Item > Active Ingredients and includes all the respective fields.
  • The Manufactured Item Attributes now includes the new Substances tab.
  • The Reference Substances entity tab is added under Manufactured Item > Substances and includes all the respective fields.
The ability to capture IDMP Iteration 1 data in Ennov InSight in preparation for submitting IDMP data to EMA .
Pharmaceutical Product To include the changes for IDMP:
  • The Pharmaceutical Product Attributes page now includes the new Active Ingredients tab.
  • The Reference Active Ingredients entity tab is added under Pharmaceutical Product > Active Ingredients and includes all the respective fields.
  • The Pharmaceutical Product Attributes now includes the new Substances tab.
  • The Reference Substances entity tab is added under Pharmaceutical Product > Substances and includes all the respective fields.
  • The Pharmaceutical Product Attributes page now includes the new PhPIDs tab.
The ability to capture IDMP Iteration 1 data in Ennov InSight in preparation for submitting IDMP data to EMA .
Full Product Presentation The Full Product Presentation Attributes page now includes Pharmaceutical Products tab. Ability to capture pharmaceutical products.