New in Ennov InSight 7.3.3: Registrations

The new features and enhancements for Registration functionality are as follows.

Affected Area Update Benefit
Applications These entities are updated to include the The widget enables effective
Events improved Product Search selection widget. and faster product search in these entities.

Product

Registration

See: Entity Fields, Columns and Options Updated: Ennov InSight 7.3.3
Create Application wizard
Affected Area Update Benefit

Medicinal

Product Actions

Changes to IDMP include updates for the following:

— New and updated nodes on the IDMP Data Visualization page. See Ennov InSight IDMP> IDMP Data Visualization Attributes.

— New field on the Attached Documents page.

See:

Entity Fields and Columns Added: Ennov

InSight 7.3.3

Entity Fields and Columns Updated: Ennov InSight 7.3.3

— Job Requests updates.

See: Job Requests Updated: Ennov InSight 7.3.3

To conform to the latest standards set by International

Organization for

Standardization (ISO) and also improve the user experience to capture IDMP data in Ennov InSight in preparation for submitting IDMP data to EMA.

Registrations

To support the latest IDMP requirements, changes are made to the following Registrations tabs:

— Package Sets

— Package Descriptions

— PDS-Manufacturer Details

— Alternate IDMP Reference Active Ingredient field added

See: Entity Fields, Columns and Options Updated:

Ennov InSight 7.3.3

To conform to the latest standards set by International

Organization for

Standardization (ISO) and also improve the user experience to capture IDMP data in Ennov InSight in preparation for submitting IDMP data to EMA.

Ennov InSight RIM 7.3 Release Notes Cumulative

Affected Area Update Benefit
Manufactured Items

To support the latest IDMP requirements, the Manufactured Items page now includes the following updates:

— Manufactured Item Characteristics/

Description field length increased

— If Alternate IDMP Reference Active Ingredient is configured via overrides and populated with a unique value, the Active Ingredient field on the Create Active Ingredient page allows users to select same substance values multiple times.

See: Entity Fields, Columns and Options Added: Ennov InSight 7.3.3

Entity Fields, Columns and Options Updated: Ennov InSight 7.3.3

To conform to the latest standards set by International

Organization for

Standardization (ISO). The update also improves user experience of capturing IDMP data in Ennov InSight in preparation for submitting IDMP data to EMA.

Pharmaceutical Products

To support the latest IDMP requirements, changes are made to the following:

— New Alternate IDMP Reference Active

Ingredient field added on the Reference Active Ingredient page

— If Alternate IDMP Reference Active Ingredient is configured via overrides and populated with a unique value, the Active Ingredient field on the Create Active Ingredient page allows users to select same substance values multiple times.

See: Entity Fields, Columns and Options Added:

Ennov InSight 7.3.3

To conform to the latest standards set by International

Organization for

Standardization (ISO). The update also improves user experience of capturing IDMP data in Ennov InSight in preparation for submitting IDMP data to EMA.

Affected Area Update Benefit
PDS Details

To support the latest IDMP requirements, the PDS Packaging Detail page now includes the following updates:

— New field added Device Quantity Unit of

Measurement

— The Device Quantity Unit field is renamed to Device Quantity Unit of Presentation

See: Entity Fields, Columns and Options Added: Ennov InSight 7.3.3 and Entity Fields, Columns and Options Updated: Ennov InSight 7.3.3

To conform to the latest standards set by International

Organization for

Standardization (ISO). The update also improves user experience of capturing IDMP data in Ennov InSight in preparation for submitting IDMP data to EMA.