Ennov InSight 7.3 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.
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 release provides the same functionality and regulatory updates as Ennov InSight 7.2.7.
eCTD 4.0
Ennov InSight introduces a new functionality to maintain a new eCTD 4.0 standard that contains a new harmonized submission unit, updated document reuse capability, and context of use life cycle. For full details, see Ennov InSight 7.3 Publishing: eCTD 4.0. The high level list of updates is below:
— The creation and maintenance of eCTD 4.0 submissions structure across the life cycle of the application. — The Create, Read, Update and Delete (CRUD) operation on eCTD 4.0 assembly as well as its nodes. — Electronic publishing related functionality updated.
— Changes to the following:
- assembly, folders, leaf attributes
- publishing settings library
- prepare to publish
- publish request
— Priority number management — New Modified Leaf field view
— Ability to quickly and easily incorporate regulatory agencies provided controlled vocabularies for future eCTD 4.0 specification updates.
— The XML import and export of eCTD 4.0 assemblies.
— Setting and reflecting priority for siblings under one parent.
— Context of Use definition for specified elements: Group titles, study group orders supported according to Health Authority specifications.
— New Regional Information page for eCTD 4.0 assembly root and Additional Information page for eCTD
4.0 assembly folder to set up Context of Use attributes and assembly regional attributes.
— The applicant contact type has been updated in Data Administration for eCTD 4.0.
— Applicant contact maintenance for eCTD 4.0.
— Same document reuse in several places.
— Sender-defined keywords maintenance to get better quality of the data entered.
— Tracking the long-running processes in Job Requests:
- Add Assembly to Lifecycle
- Remove Assembly from Lifecycle
- Duplicate (of large folder)
- Creating assembly
— Process of duplicating a folder. If the number of folder and child nodes exceeds the allowed limit, using the Duplicate option displays a message to see Job Requests for the status.
— Process of creating an assembly from another assembly. If the number of folder and child nodes exceeds the allowed limit, a message to see Job Requests for the status is displayed.
— Performance improvement. Duplicating folder with documents takes less time now.
Entity and Tabs Changes
To conform to the eCTD 4.0 requirements, changes have been made to the following entities: See: Entity Fields and Columns Added: Ennov InSight 7.3, Entity Fields and Columns Updated: Ennov InSight 7.3
— Entities:
- Application updates (Application Attributes, Sender-defined Keywords).
- Sequence updates (Sequence Attributes).
- Wizards updates.
- Product Family updates (Product Family Attributes, Application tab).
- Data Administration updates.
IDMP Updates
For full details, see Ennov InSight 7.3 IDMP. The high level list of updates is below:
Note:
— IDMP Data Generation, IDMP Data Visualization, IDMP Validation in Job Requests and FHIR message are implemented as Proof of Concept (POC). They will be expanded with additional functionality and features in the next releases of Ennov InSight .
— Current IDMP Data Generation, IDMP Data Visualization, IDMP Validation in Job Request and FHIR message are for EMA authority only. This IDMP functionality will be expanded for other authorities in the next releases.
— The final implementation of IDMP Data Generation and Data Visualization will be available in future Ennov InSight releases.
When available, remember to restart the IDMP Data Generation wizard for each medicinal product action entity to get the results for the IDMP Data Visualization page and validation messages in Job Requests.
To maintain a standardized and structured method of collecting, reporting, coding, and evaluating authorized medicinal product data, Ennov InSight 7.3 includes updates to the following:
— Entities:
- Medicinal Product Action (Attached Documents) updates.
- Manufactured Item (under Components) updates.
- PDS (Medical Devices, Package Set, Intended Effect/Comorbidity) updates.
- Data Administration updates.
- Security Administration updates. — IDMP Data Visualization:
- The DV (Data Visualization) icon is now available on the Medicinal Product Actions Attributes page.
- Data Visualization includes the color coding. — Wizards:
- IDMP Data Generation wizard
- Ennov InSight now generates data in FHIR (Fast Healthcare Interoperability Resources) standard. Ennov InSight supports FHIR version 5.0.
— Versioning:
- Updates to IDMP entities are now tracked in versions.
— Job Requests updates for IDMP Data Generation in Job Requests > Search Results.
Referentials Management Services (RMS) for IDMP
The Referentials Management Services (RMS) updates for entities and Data Administration are introduced to capture additional RMS data for IDMP. The RMS for IDMP includes description for attributes of medicinal products, such as lists of dosage forms, units of measurement and routes of administration.
XEVMPD Submission Wizard
In Ennov InSight 7.3, some XEVMPD Submission wizard sections were removed to conform to the EMA specification for XEVMPD. Regulatory Updates
To support the Structured Product Labeling (SPL) for Risk Evaluation and Mitigation Strategies (REMS) in the US for eCTD 3.3, the US 3.3 assembly template is updated to include additional folders and leafs.
Assembly Updates
Ennov InSight introduces the ability to track the download process of big files in Job Requests. When clicking View File and the file size exceeds the limit, the message is displayed asking to check the Job Requests for a download status.
Ennov InSight now displays the job progress in Job Requests for the following:
— Downloading of large files. If the file size exceeds the allowed limit, using the View File option displays a message to see Job Requests for download status.
Performance Improvements
The performance related to application and products query reports is improved.
Substance Search
The improved Substance Search selection widget included for the following entities allows you to search for a substance to associate it with an entity. You can search by EV Code and Substance name. — Product Family
— Product (Component > Reference Active Ingredient)
— Manufactured Item (Component> Manufactured Item> Substance and Reference Substance)
— Comparator
— Pharmaceutical Product (Substance and Reference Substance)
— Product Detail Set and Product Detail Set Template (Substance and Reference Strain)
— Data Administration (Manufacturer Values > Global Product Details, Other > Certificate Master File Values) — Wizards (GPP > Update Product Detail Sets)
See: Get Started with Ennov InSight 7.3 > Substance Search. Functionality and Technology Not Supported
In preparation to capture Substance Management Services (SMS) data for IDMP, the framework was implemented in earlier Ennov InSight releases. The SPOR Master List for Substance is empty as EMA has not released the Substances
(SMS) controlled vocabulary. The Term ID value for the new Substance Search selection widget will not be available in this release.
The following functionality is not available for eCTD 4.0 but will be included in future releases:
— Create eCTD 4.0 Assembly from: Submitted view, virtual document.
— Export to Microsoft Excel spreadsheet and Documentum virtual document (sometimes known as a compound document, depending on the repository type).
— Create eCTD wizard
— Recalculate Checksums
— Change Submittal Status wizard
— Create Study Reports wizard
— Linking activities
— Forward compatibility
— Grouped submissions
— Parallel submissions
— Applicant Contact lifecycle
— PDF Properties management
— Publishing variables defined in leafs or folders.
— Virtual Document and Veeva Binder assignment
— eCTD Import
— Submission Validation
— eCTD 4.0 Viewing — Workflows
The following functionality is deprecated in eCTD 4.0 and will not be included in future releases:
— View Baseline Differences report
— Related Documents
— Create Version
— Publishing Summary Query
— Export Published Output
— Append lifecycle operation
— Paper Publishing
— Publishing assembly view
— Standalone assemblies
— Assembly versions
— Publishing elements
— The Change Type option for folder elements
— The eCTD Lock option
Data Administration Lists - APIs CUD Operations
Ennov InSight 7.3 now includes the API Create, Update, Deactivate (CUD) operations for all Data Administration entities. See: Ennov InSight Administration > Technical Administration and Ennov InSight API Documentation.
DaaS Updates
Ennov InSight 7.3 includes updated DaaS database schema. See: Ennov InSight 7.3 DaaS DatabaseTables Changed.