Ennov InSight RIM 7.1 RNs Cumulative

Ennov InSight 7.1 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 7.1.

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

Note: Unless stated otherwise, this platform release provides the same functionality and regulatory updates as Ennov InSight 6.2 CHF 7.

IDMP

To maintain a standardized and structured method of collecting, reporting, coding, and evaluating authorized medicinal product data, Ennov InSight now includes:
  • New Entities/Entity tabs:
    • Manufactured Items (under Components)
    • Active Ingredients/Reference Active Ingredients (under Manufactured Items and Pharmaceutical Products)
    • Substances/Reference Substances (under Manufactured Items and Pharmaceutical Products)
    • Package Descriptions (under Registration-Package Sets)
    • Orphan Designations (under Application)
    • Medicinal Products, Medicinal Product Actions, and IDMP (for Package Set type Registration)
    • Medicinal Product Names, Product Cross-Reference, and MPIDs (for Medicinal Products)
    • Attached Document (for Medicinal Product Actions)
    • PDS Pack Size node
    • Tasks, References, Activities, Workflows, Notifications (under Manufactured Items, Pharmaceutical Products, and Medicinal Products)
    • PhPIDs (for Pharmaceutical Products)
  • 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

EU Clinical Trial Regulation Application Type

To capture EU Clinical Trial data as required by EU 536/2014 regulation, the new EU Clinical Trial Regulation type of Application is introduced and 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.
Note: The API functionality for EU CTR Applications has not been fully tested but you can enter the data manually. The API functionality will be available in a future release.

Term Search for Organization

The Term Search included for these Data Administration entities allows you to search for the Organization to associate it with the entity. You can search for the SPOR OMS Organization to associate the location id with the entity.
  • MAH/Development Sponsor/Organization Values
  • Manufacturer
  • Health Authority

Term Search for Referentials Management Services (RMS)

The Referentials Management Services (RMS) terms includes referential master data for attributes of medicinal products. RMS allows you to map a SPOR Term with the Data Administration values.
  • Lists of Dosage Forms
  • Units of Measurement
  • Routes of Administration

Dose Form Search

The Dose Form Search included for the following entities allows you to search for a dose form to associate it with the entity. You can search for a dose form by EV Code, Term ID, Type Term, and Dose Form name.
  • Product
  • Component
  • Pharmaceutical Product
  • Manufactured Item
  • Full Product Presentation
  • Medicinal Product

See: Get Started with Ennov InSight 7.1 > Dose Form Search.

API Updates

Ennov InSight 7.1 includes multiple API updates including the update for IDMP.

Changes between Ennov InSight 7.0 API and Ennov InSight 7.1 API are documented in the Ennov InSight Administration and Ennov InSight Data Exchange guide. See: Ennov InSight Administration > Technical Administration > Ennov InSight API Documentation and Ennov InSight 7.1 Data Exchange > Data Exchange API > Data Exchange API Document > Ennov InSight 7.1 Data Exchange Change .

The following Data Administration entities now support API:
  • ATC
  • Country
    • Region
    • Procedure Type Details
  • Dosage-Pharmaceutical Form
    • Dosage/Pharmaceutical Form XEVMPD Information
  • Indications/Intended Use
  • Product Family
  • Route of Administration
    • Route of Administration XEVMPD Information
  • Substance
These components are available via the Ennov InSight 7.1 on Azure  or as on-premises installations:
  • Rendering 5.0.1.1
  • Viewing 5.5 CHF 7 (5.5.0.6.0015)
  • Validator 5.1 CHF 10 (5.1.0.124)
  • Linking plug-in (PDF) 1.8 CHF 1 + (hotfix 1.8.1.4)
  • Linking add-in (Word) 1.8 CHF 1 + (hotfix 1.8.1.4)
  • Cumulative View Builder 2.3 (2.3.0.2)
  • Authoring and QC plug-in (PDF) 4.2 CHF 1 (4.2.0.42)
  • Authoring add-in (Word) 3.2 CHF 2 (3.2.022)

Functionality and Technology Not Supported

The support of D2/LSRD functionality ends with Ennov InSight 7.2 version. The ability to synchronize registration data between Ennov InSight and OpenText Documentum D2 and D2 Data Dictionaries will no longer be available.

Internet Explorer 11 Not Supported

Ennov InSight 7.1 no longer supports Internet Explorer 11 browser.