Ennov InSight Administration

Ennov InSight License Modules by Feature

The following tables list Ennov InSight features and the license modules in which they are available.

Product Families, Clinical Trial Shared Data

Subfeature Subfeature Description License Modules
Product family categorization Define parent active substance family.
  • Electronic Lifecycle Publishing
  • Paper Review Publishing
  • Product Detail Management
  • Registered Document Analysis
  • Registration Planning and Tracking
  • Submission Planning and Tracking
Product family extended attributes Full support includes product family attributes.
  • Registration Planning and Tracking
  • Product Detail Management
CT Shared Data Clinical Trial Shared Data for a product family.
  • Registration Planning and Tracking
  • Product Detail Management

Products, Pharmaceutical Products

Subfeature Subfeature Description License Modules
Product detail Define consumable products (Example: dosage forms).
  • Registration Planning and Tracking
  • Product Detail Management
  • Submission Planning & Tracking
  • Electronic Lifecycle Publishing
  • Paper Review Publishing
Pharmaceutical product detail Define a product used to treat disease (Example: medicines or drugs).
  • Registration Planning and Tracking
  • Product Detail Management
  • Submission Planning & Tracking
  • Electronic Lifecycle Publishing
  • Paper Review Publishing

Registrations, Full Product Presentations, Registration FPP Attachments and FPP Previous EV Codes

Subfeature Subfeature Description License Modules
Registration detail Define registration details, including those that vary by country for MRP applications.
  • Registration Planning and Tracking
  • Product Detail Management
Copy Package Set Registration Copy a package set registration.

Requires at least WRITE permissions for the Registrations and Full Product Presentation (FPP) (applicable to the New Package Set specific Registration(s) flow) in the Entity Security section.

  • Registration Planning and Tracking
  • Product Detail Management
Full product presentation detail Define detailed information about the product (Example: Special Measures, Product Strength).
  • Registration Planning and Tracking
  • Product Detail Management
FPP previous EV code detail Define the previous EV code for the full product presentation.
  • Registration Planning and Tracking
  • Product Detail Management
Registration FPP attachment detail Presents an attachment for the detailed product information.
  • Registration Planning and Tracking
  • Product Detail Management
Copy full product presentation Copy a full product presentation under the same registration, or under different registrations.

At least WRITE permissions for the Full Product Presentation (FPP) in Entity Security section.

  • Registration Planning and Tracking
  • Product Detail Management
Medicinal Product detail Medicinal product for registration.

At least WRITE permissions for the Medicinal Product in Entity Security section.

  • Registration Planning and Tracking
  • Product Detail Management
Medicinal Product Action detail Medicinal product action for registration.

At least WRITE permissions for the Medicinal Product Action in Entity Security section.

  • Registration Planning and Tracking
  • Product Detail Management

Registration Attachment

Subfeature Subfeature Description License Modules
Registration Attachment Registration Attachment entity is a Printed Product Information (PPI) attachment type and should be created to later attach it to the Full Product Presentation.
  • Registration Planning and Tracking
  • Product Detail Management
Copy registration attachment Copy a registration attachment.
  • At least WRITE permissions for the Registration Attachment in Entity Security section.
  • At least WRITE permissions for the Full Product Presentation (FPP) in Entity Security section.
  • Registration Planning and Tracking
  • Product Detail Management

Applications

Subfeature Subfeature Description License Modules
Application detail Ability to define overall marketing authorization (Example: NDA).
  • Electronic Lifecycle Publishing
  • Paper Review Publishing
  • Product Detail Management
  • Registered Document Analysis
  • Registration Planning and Tracking
  • Submission Planning and Tracking
Application Countries tab Support for European procedures (MRP and CP) including collection of country-specific data (primarily dates) for the application.
  • Electronic Lifecycle Publishing
  • Paper Review Publishing
  • Product Detail Management
  • Submission Planning and Tracking
  • Registration Planning and Tracking
Copy application Copy an application.
  • Registration Planning and Tracking
  • Product Detail Management
Create Application Wizard Access to the Create Application Wizard from the wizards menu with the WRITE permissions.

Access to Events for the Create Application Wizard from the wizards menu with the WRITE permissions.

  • Electronic Lifecycle Publishing
  • Submission Planning and Tracking

Comparators

Subfeature Subfeature Description License Modules
Comparators Comparators are used in clinical trials to compare the success of a medicine under study to another medicine or placebo.
  • Registration Planning and Tracking
  • Product Detail Management

Events

Subfeature Subfeature Description License Modules
Event detail Define initial filing event and other major updates (Example: variations) to an application.
  • Electronic Lifecycle Publishing
  • Paper Review Publishing
  • Product Detail Management
  • Registered Document Analysis
  • Registration Planning and Tracking
  • Submission Planning and Tracking
Copy Event Wizard Copy an event to multiple applications in the product family associated with a source event.
  • Electronic Lifecycle Publishing
  • Product Detail Management
  • Registration Planning and Tracking
  • Submission Planning and Tracking
Create Submission wizard Automates creation of initial applications, major updates and amendments.
  • Electronic Lifecycle Publishing
  • Paper Review Publishing
  • Registered Document Analysis
  • Registration Planning and Tracking
  • Submission Planning and Tracking
Event country status schedule Define projected event status dates, track status history, and compare actual and planned dates for major milestones.
  • Registration Planning and Tracking
  • Submission Planning and Tracking

Sequences

Subfeature Subfeature Description License Modules
Sequence detail Define filings/amendments (regulatory submission correspondence to authorities in support of an application).
  • Electronic Lifecycle Publishing
  • Paper Review Publishing
  • Registered Document Analysis
  • Registration Planning and Tracking
  • Submission Planning and Tracking
Sequence status schedule Define projected sequence status dates, track status history, and compare actual and planned dates for major milestones.
  • Registration Planning and Tracking
  • Submission Planning and Tracking

Product Detail Sets (PDS)

Subfeature Subfeature Description License Modules
Product detail set detail Capture product detail approvals, such as for substance, product, packaging manufacturers, labeling, and product indications.
  • Registration Planning and Tracking
  • Product Detail Management
PDS templates Save PDS information within a product family as a template.
  • Registration Planning and Tracking
  • Product Detail Management

Assembly Types

Subfeature Subfeature Description License Modules
Lifecycle sequence assemblies Build hierarchical collections of source documents associated with specific regulatory activities and sequences, and add to the current view for lifecycle.
  • Electronic Lifecycle Publishing
  • Registered Document Analysis
  • Submission Planning and Tracking
Supporting sequence assemblies Build hierarchical collections of source documents associated with specific regulatory activities and sequences.
  • Electronic Lifecycle Publishing
  • Paper Review Publishing
  • Registered Document Analysis
  • Submission Planning and Tracking
Standalone assemblies Build hierarchical collections of source documents for miscellaneous use.
  • Electronic Lifecycle Publishing
  • Paper Review Publishing
  • Registered Document Analysis
  • Submission Planning and Tracking
Assembly templates Build an assembly template.
  • Electronic Lifecycle Publishing
  • Paper Review Publishing
  • Registered Document Analysis
  • Submission Planning and Tracking

Activity Workflow

Subfeature Subfeature Description License Modules
Activities Activities are steps within the Workflow that are required to complete the assigned Workflow. Workflows can contain multiple Activities, with dependencies and pre-set values. Ennov InSight Workflow Integrations

Projects

Subfeature Subfeature Description License Modules
Global Project Planning (GPP) wizard Facilitates planning and data entry for multiple countries or applications.

At least WRITE privileges for Projects and Events.

Home page access security enabled for GPP wizard.

  • Registration Planning and Tracking
  • Submission Planning and Tracking

Tasks, Notifications, and References

Subfeature Subfeature Description License Modules
Task detail Define hierarchical to-do lists associated with other entities.
  • Registration Planning and Tracking
  • Submission Planning and Tracking
Task status schedule Define the sequence of statuses for a task, and for each status, the projected date when the task first has the status.
  • Registration Planning and Tracking
  • Submission Planning and Tracking
Notification detail Define and automatically send e-mail notifications based on data updates, approvals, and other changes in Ennov InSight .
  • Registration Planning and Tracking
  • Submission Planning and Tracking
Reference detail Associate external documents, URLs, and internal links with entities; supports correspondence and DMS integration.
  • Registration Planning and Tracking
  • Submission Planning and Tracking

Change, Change Details

Subfeature Subfeature Description License Modules
Change Defines the actual regulatory change being planned or requested and have specific metadata associated. Registration Planning and Tracking
Change details Capture details of the Change as a sub-entity to the Change entity. Registration Planning and Tracking

Reports

The reports listed in the table include the reports that you can generate by using Ennov InSight queries.

Subfeature Subfeature Description License Modules
Querying menu Run queries and quick search; not all quick search entities may apply to the module; available queries vary by module. The modules related to the kind of query that you run
Public/private customized queries Create both private and public custom queries.
  • Electronic Lifecycle Publishing
  • Paper Review Publishing
  • Product Detail Management
  • Registered Document Analysis
  • Registration Planning and Tracking
  • Submission Planning and Tracking
Ad hoc Reporting Create and execute ad hoc reports against the Ennov InSight reporting schema.
  • Product Detail Management
  • Registered Document Analysis
  • Registration Planning and Tracking
  • Submission Planning and Tracking
Specialized assembly queries Execute specialized queries directly from the assembly tree.
  • Electronic Lifecycle Publishing
  • Paper Review Publishing
  • Registered Document Analysis
  • Submission Planning and Tracking
Application, Event, Sequence report Provides information that you select about product families, applications, events, and sequences.
  • Registration Planning and Tracking
  • Submission Planning and Tracking

Approval Management

Subfeature Subfeature Description License Modules
Approved views Create and view document collections consisting of currently approved versions for a particular country. Full support includes the ability to create new assemblies from these views. Registered Document Analysis
Update Status wizard Automate approval of an application or major update.
  • Registered Document Analysis
  • Registration Planning and Tracking
  • Submission Planning and Tracking

Submittal Management and Lifecycle

Subfeature Subfeature Description License Modules
Submitted view Create and view document collections consisting of currently submitted versions for a particular country. Create and manage eCTD lifecycles. Full support includes ability to create new assemblies from these views.
  • Electronic Lifecycle Publishing
  • Registered Document Analysis
  • Submission Planning and Tracking (does not enable you to create new assemblies)
Change Submittal Status wizard Automate submittal of an application or major update and creation of lifecycle.
  • Electronic Lifecycle Publishing
  • Paper Review Publishing
  • Registered Document Analysis
  • Submission Planning and Tracking
Add to/remove from lifecycle Manually create and manage lifecycle
  • Electronic Lifecycle Publishing
  • Registered Document Analysis
Working view Assign changes and leaf operations from a cumulative view of eCTD submission sequences.
  • Electronic Lifecycle Publishing
  • Registered Document Analysis
  • Submission Planning and Tracking
Sequence view View the current cumulative sequence.
  • Electronic Lifecycle Publishing
  • Paper Review Publishing
  • Registered Document Analysis
  • Submission Planning and Tracking
Publishing view Publish the current cumulative sequence and add publishing effects.
  • Electronic Lifecycle Publishing
  • Paper Review Publishing
  • Registered Document Analysis
  • Submission Planning and Tracking

General Assembly

Subfeature Subfeature Description License Modules
General assembly features and functions Expand/collapse all, edit hierarchical assembly structure (including lifecycle actions, if applicable), browse or search document repositories and assign documents, retrieve document properties from DMS, view DMS documents, modify assembly attributes, delete assemblies.
  • Electronic Lifecycle Publishing
  • Paper Review Publishing
  • Registered Document Analysis
  • Submission Planning and Tracking
Import/export Create an assembly from a template, XML assembly file, or VDM. Export assemblies to XML assembly files and VDMs.
  • Electronic Lifecycle Publishing
  • Paper Review Publishing
  • Registered Document Analysis
  • Submission Planning and Tracking
Document placeholders Create a planned document in the assembly.
  • Electronic Lifecycle Publishing
  • Paper Review Publishing
  • Registered Document Analysis
  • Submission Planning and Tracking
Mass-apply version bindings Incrementally set bindings across the assembly, including locking the binding to the current version.
  • Electronic Lifecycle Publishing
  • Paper Review Publishing
  • Registered Document Analysis
  • Submission Planning and Tracking
View file from document and leaf Viewing in-place repository, submission, and published content.
  • Electronic Lifecycle Publishing
  • Paper Review Publishing
  • Registered Document Analysis
  • Submission Planning and Tracking
Document status awareness Binding icons and View Document List query.
  • Electronic Lifecycle Publishing
  • Paper Review Publishing
  • Registered Document Analysis
  • Submission Planning and Tracking
Support and assignment of unfinalized documents View status of unfinished documents for assembly. Submission Planning and Tracking

Planning and Tracking

Subfeature Subfeature Description License Modules
Planning and tracking assembly features and functions Edit document path and binding information, view/assign related documents, export assembly to Microsoft Excel. Submission Planning and Tracking
Assembly search and replace Search and replace text in assembly element attributes for planning and creating templates of document locations and assignments. Submission Planning and Tracking
Assembly Status query Provides the current assembly status including performance metrics. Submission Planning and Tracking

Review and Approval

Subfeature Subfeature Description License Modules
Review and approval assembly features and functions Version assemblies with assembly currency. Submission Planning and Tracking
Incremental locking Incrementally lock assembly by module and by section or folder hierarchy. Submission Planning and Tracking
Assembly baselines and baseline querying Create baselines for assembly comparison querying. Submission Planning and Tracking
Assembly reference location Create and set reference locations and synchronize with DMS. Submission Planning and Tracking
Assembly status change Change status of assembly including automatic lock down if assembly is finalized. Submission Planning and Tracking
Unlock the folder Unlock the locked assembly folder. Submission Planning and Tracking

Document Analysis

Subfeature Subfeature Description License Modules
Document analysis features and functions Create approved views, query and view registered documents, query and view lifecycle history. Registered Document Analysis
Where Used query Determine where a document is used across applications, countries, products, versions, and assemblies.

The Output File hyperlink in the Where Used query is supported only for sequence assemblies, not standalone and template assemblies.

  • Registered Document Analysis
  • Submission Planning and Tracking

General Publishing

Subfeature Subfeature Description License Modules
Publishing job queue and audit trail View the status of all publishing jobs; sort, export, and cancel jobs.
  • Electronic Lifecycle Publishing
  • Paper Review Publishing
Publishing Readiness query, Summary query, Link Inspector, and publishing log View eCTD conformity and status before and after the publishing job is executed.
  • Electronic Lifecycle Publishing
  • Paper Review Publishing
Repository export utility Transfer published output from any repository source to any repository destination (DMS or File/Folder).
  • Electronic Lifecycle Publishing
  • Paper Review Publishing
Automatic extractions Create document extractions for use in bookmarks, TOCs, and links automatically upon assignment.
  • Electronic Lifecycle Publishing
  • Paper Review Publishing (with only)
Automatic renditions Create PDF renditions automatically and by request upon publishing or Prepare to Publish when existing renditions are missing or outdated. Requires an additional license for .
  • Electronic Lifecycle Publishing
  • Paper Review Publishing (with  only)

eCTD Publishing

Subfeature Subfeature Description License Modules
eCTD publishing assembly features and functions Create eCTD and electronic output, specify assembly-level publishing options for eCTD, links, and variables, change element types to specify leaf-specific publishing properties, request generated published output (eCTD and electronic). Electronic Lifecycle Publishing
Electronic hyperlinks Create, retarget, and set channel and settings on hyperlinks.
  • Electronic Lifecycle Publishing
  • Paper Review Publishing
Reference leaf elements Create leaf elements to reference other leaf elements with querying on referenced leaf elements for a specific submission.
  • Electronic Lifecycle Publishing
  • Registered Document Analysis (query only)
eCTD import and merge Import one or multiple eCTD sequences; merge eCTD sequences. Electronic Lifecycle Publishing
Create eCTD wizard Create or update an eCTD sequence. Electronic Lifecycle Publishing
Bulk eCTD Wizard Migrate multiple eCTD submissions to Ennov InSight from another system in a supported document management system (DMS). Electronic Lifecycle Publishing
Create Study Reports wizard Add study reports to an eCTD sequence. Electronic Lifecycle Publishing
Create Submission Plan Wizard Create a submission plan and associate entities such as applications, events, and sequences to the submission plan.
  • Electronic Lifecycle Publishing
  • Submission Planning and Tracking

Paper Publishing

Subfeature Subfeature Description License Modules
Paper publishing assembly features and functions Create paper and electronic output, specify assembly-level publishing options for publishing effects, change folder and document attributes for publishing effects, request published output (paper and electronic).
  • Electronic Lifecycle Publishing
  • Paper Review Publishing
Table of contents Create, edit, generate, and modify TOCs. Access the TOC editor.
  • Electronic Lifecycle Publishing
  • Paper Review Publishing
Special sheets Create, edit, generate, and modify special sheets including slip sheets, tabs, and cover pages. Paper Review Publishing
Volumes Create and modify volumes, bulk volumize, move, lock, and manipulate volumes. Paper Review Publishing
Overlays Define and use overlays. Define page size, shape, scaling, and format for output. Paper Review Publishing
Paper cross-references Create, retarget, and set channel, stamp, and settings on paper cross-references. Paper Review Publishing

Administration

Subfeature Subfeature Description License Modules
Administration menus (Data, Security and Technical) Modify data picklists, connect to and define DMS and file system repositories, administer security.

Not all options displayed to an administrator are available in all modules. Example: picklist options for data admin may not be displayed in an application.

Notification administration does not apply to all modules. Includes all audit trail querying.

  • Electronic Lifecycle Publishing
  • Paper Review Publishing
  • Registered Document Analysis
  • Registration Planning and Tracking
  • Product Detail Management
  • Submission Planning and Tracking