Ennov InSight 7.3.3 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 7.3.3.
The details in these Release Notes supersede all similar details that appear anywhere else in this release of the product or its other documentation.
eCTD 4.0
Ennov InSight 7.3.3 introduces the following enhancements for eCTD 4.0:
— Ability to create an eCTD 4.0 working assembly from the locked eCTD 3.2 assembly submitted view. At this moment, envelope, additional attributes, and SDK creation are not copied over.
— Tracking the long-running process in Job Requests to monitor the creation of large eCTD 4.0 assemblies.
— Ability to map eCTD 4.0 template to Assembly DTD/Schema Types in Data Administration (Assembly > Assembly DTD/Schema Types).
— Recalculate Checksums
— Change Submittal Status wizard
— Create eCTD wizard - Initial assembly creation. For existing assembly, additional attributes are not populated. For more information, see Create an eCTD Submission under Ennov InSight 7.3.3 eCTD 4.0 Publishing help module.
— Please note, when performing incremental publishing, follow existing best practice and generate the XML only when doing the final publishing. This mechanism significantly improves the performance of XML generation.
Regulatory Updates
Ennov InSight 7.3.3 now supports World Health Organization (WHO) v1.0.
For more information about new WHO values, extensions, and rules, see:
— Ennov InSight Data Migration 7.3 > Ennov InSight 7.3.3 Updates
— Ennov InSight Publishing 7.3 > Use eCTD Templates > eCTD Template Files
— Ennov InSight Publishing 7.3 > Submissions > eCTD Attributes World Health Organization
— Ennov InSight Publishing 7.3 > Extension Type and Usage > Extension Type: Regional Folders > WHO
— Ennov InSight Publishing 7.3 > Use eCTD Templates > Mapped eCTD Template Profiles
— Ennov InSight Publishing 7.3 > Extended Attributes Name, Type, and Version
— Ennov InSight Publishing 7.3 > Extension Types and Usage
— Ennov InSight Administration 7.3 > Data Administration > Data Administration Selection Lists: Submission Maintenance
— Ennov InSight Administration 7.3 > eCTD Codes > eCTD Codes for Filing Types > eCTD Filing Types for
WHO
— Ennov InSight Administration 7.3 > eCTD Codes > eCTD Codes for Filing Types > eCTD Filing Types for WHO > eCTD Sub-Filing Types for WHO
— Ennov InSight Administration 7.3 > Assembly XML Specification > Extensions > Groups of Extensions by Version and Country
— Ennov InSight Administration 7.3 > Assembly XML Specification > Extensions > Folder Extensions > m1-who v.
1.0
Ennov InSight 7.3.3 now supports European Union (EU) v3.1 submissions.
For more information about new EU values, extensions, and rules, see:
— Ennov InSight Publishing 7.3 > Use eCTD Templates > eCTD Template Files
— Ennov InSight Publishing 7.3 > Extended Attributes Name, Type, and Version
— Ennov InSight Administration 7.3 > Administrative Activities> Import eCTD Applications > Prepare for Bulk eCTD Import
— Ennov InSight Administration 7.3 > eCTD Codes > eCTD Codes for Country Values
— Ennov InSight Administration 7.3 > eCTD Codes > eCTD Codes for Filing Types > eCTD Filing Types for EU
— Ennov InSight Administration 7.3 > eCTD Codes > eCTD Codes for Filing Types > eCTD Filing Types for EU > eCTD Sub-Filing Types for EU
— Ennov InSight Administration 7.3 > Assembly XML Specification > Groups of Extensions by Version and Country
— Ennov InSight Administration 7.3 > Assembly XML Specification > Folder Extensions > m1-additional > m1additional v. 3.1
— Ennov InSight Administration 7.3 > Assembly XML Specification > Folder Extensions > envelope > envelope v.
3.1
— Ennov InSight Administration 7.3 > eu_module_1_country_specific_information > eu_module_1_country_specific_information v.3.1
— Ennov InSight Administration 7.3 > Folder Extensions > m1-responses > m1-responses v. 3.1
— Ennov InSight Administration 7.3 > Folder Extensions > m1-3-1-spc-label-pl > m1-3-1spc-label-pl v. 3.1
— Ennov InSight Administration 7.3 > Administrative Activities > Manage eCTD and eCTD 4.0 Templates > eCTD Templates
Ennov InSight 7.3.3 now includes assembly templates for China eSubmissions.
IDMP Updates
Note: The IDMP Data Generation, IDMP Data Visualization, IDMP Validation in Job Requests and FHIR message functionalities that were implemented as Proof of Concept (POC) in Ennov InSight 7.3 are updated in Ennov InSight
7.3.3. This release includes enhancements to the Proof of Concept (POC). To see and use the enhancements, rerun the IDMP Data Generation wizard..
To conform to the latest standards set by International Organization for Standardization (ISO) and also improve the user experience, Ennov InSight now includes the following updates:
— New attributes in Data Administration (Other > Data Carrier Identifier Source Values, Registration Maintenance > Data Carrier Type, Product Detail Set Maintenance > Manufacturer Values > Manufacturing Authorization Reference Number).
— Multiple Data Administration tables moved from Registration Maintenance to Application Maintenance.
Ennov InSight RIM 7.3 Release Notes Cumulative
— New Alternate IDMP Reference Active Ingredient attribute on Manufactured Item Reference Active
Ingredient and Pharmaceutical Product Reference Active Ingredient. For both pharmaceutical products and manufactured items, the same substance values can be selected multiple times for the Active Ingredient Name field if the Alternate IDMP Active Ingredient Name field is configured via overrides and contains a unique value.
— New Attached Document Country attribute on the Attached Documents page.
— New Device Quantity Unit of Measurement attribute on the PDS Packaging Detail page.
— The Device Quantity Unit attribute renamed to Device Quantity Unit of Presentation on the PDS Packaging Detail page.
— The length of the Manufactured Item Characteristics/Description value on the Manufactured Item and Manufactured Items tab on the Component is increased.
— Multiple fields renamed for Registrations entity.
IDMP POC Support
— Additional and updated entities and data points with the improved search and filter functionality and the ability to view validation messages from Job Requests on the IDMP Data Visualization page. When data does not meet the validation criteria, entity fields are marked with a symbol denoting errors or warnings.
— Job Requests updates for IDMP Data Generation in Job Requests > Search Results and Excel reports.
Product Search
The improved Product Search selection widget enables to filter products using specific search criteria in the following entities and wizards: — Entities:
- Applications (Create Application > Associated Products, Application Attributes > Associate/ Dissociate Products > Products)
- Events (Create Event > Products, Event Attributes > Associate/Dissociate Products > Associated Products)
- Product Registration (Application Attributes > Create Registration > Products, Registration Attributes > Associate/Dissociate Products > Products)
— Wizards:
- Create Application (Enter values for new application > Associated Products on Create Application and Create Event pages of the wizard)
Support of Special Characters
Ennov InSight 7.3.3 supports the use of more special characters in Documentum and File system. See: Ennov InSight 7.3 > Special Characters
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.