Ennov InSight 7.3.1 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 7.3.1.

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

To support in-process linking for Linking plug-in (PDF) without accessing the Document Management System (DMS) of users, the following sections are updated:

— Publishing Settings Library

— Document Attributes

See: Entity Fields, Columns and Options Removed: Ennov InSight 7.3.1. Linking plug-in (PDF)/Linking add-in (Word) Issue Resolved

In Ennov InSight 7.3.1, the authoring links created using Linking plug-in (PDF)/ Linking add-in (Word) with target documents in all supported file shares work correctly. See: Defect DE30391 in Ennov InSight 7.3.1, Resolved Issues

XEVMPD Updates

To support the latest European Medicine Agency (EMA) XEVMPD requirements, the following entities and wizards have been updated. See: Entity Fields and Columns Added: Ennov InSight 7.3.1, Database Columns Changed Ennov InSight 7.3.1 — Entities:

  • Registration Attachment

— Wizards:

  • XEVMPD Submission wizard

XEVMPD Submission Updates

In Ennov InSight 7.3.1, access rules for the XEVMPD Submission wizard are changed. Now, users with Data Administration rights set to NO can also create the XEVPRM .zip file for submission to the EMA.

Entity and Tab Changes

To improve application usability, changes have been made to the following entities and tabs. See: Entity Fields and Columns Added: Ennov InSight 7.3.1.

— Entities:

  • Create Pending Changes

— Tabs:

  • Pending Changes

Privacy Policy

To ensure compliance with data protection requirements, a link to the Privacy Policy is added to the Ennov InSight application, available from the Username menu on the top-right corner.

Regulatory Updates

Support for South Africa (ZA) eCTD Module 1 version 3.0.

For more information about new ZA values, extensions and rules, see:

— Ennov InSight 7.3 Publisher > Submissions > Create eCTD Wizard > eCTD Attributes South Africa

— Ennov InSight 7.3 Publisher > Extension Type and Usage > Extension Type: Regional Folders > South Africa

Affected Area Update Benefit
Pending Changes The Pending Changes tab is updated with new option. See Entity Fields, Columns and Options Added: Ennov InSight 7.3.1 and Registrations > Apply Pending Changes. The ability to apply all/selected pending changes without closing an event.
Pending Changes The Pending Changes tab is updated with new column. See Entity Fields, Columns and Options Added: Ennov InSight 7.3.1 and Registrations > Pending Changes and Entity Attributes. The ability to view countries associated with Change Scope > Registration on the Pending Changes tab.

— Ennov InSight 7.3 Publisher > Administrative Activity > Import eCTD Applications > Prepare for Bulk eCTD Import > ZA 3.0 Applications

— Ennov InSight 7.3 Administration > eCTD Codes > eCTD Filing Types for ZA

— Ennov InSight 7.3 Administration > eCTD Filing Types for ZA > eCTD Sub-Filing Types for ZA

— Ennov InSight 7.3 Administration > Assembly XML Specification > m1-za v. 3.0

TOC Templates Updates

The following TOC templates have been added for Chinese and Japanese languages: — CNSampleTOCTemplate.docx

— JPSampleTOCTemplate.docx

Oracle Updates

To reduce the risk of the cursor leaks issue that was found to be an Oracle issue, Oracle jdbc driver is updated.