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EXTEDOpulse (20) - eDOCSmanager "Regulatory" Module


Description
This course is part of the EXTEDOpulse eLearning and covers the eDOCSmanager.

EXTEDOpulse is powered by the CARA content management platform. It is fast, highly configurable, and user-friendly. EXTEDOpulse can be used to manage content-less objects as well as documents.
eDOCSmanager is EXTEDOpulse document management solution and relies on the CARA funtionality.

In EXTEDOpulse, the eDOCSmanager workspace is “DMS regulatory” with three views.

The main View is “DMS Regulatory Document”. In this view, the users actively work with documents, for example maintain document versions, renditions, and trigger workflows. With the Drag Out widget a document can easily be dragged to eCTD manager, please see the relevant e-learning course.

The “DMS Regulatory Template” view contains the content templates users can select when creating a new document. In so far it is very similar to the “DMS Regulatory Document” view that deals with the regulatory documents. Some restrictions apply, for example the Drag Out widget is not supported in the “DMS Regulatory Template” view.

"DMS Archived Document" contains archived documents, documents contained in eCTD submissions that have been imported in eCTDmanager, and so-called last-minute-documents. These are documents that have been added to an eCTD submission directly from the file share. To permanently save these last-minute documents, they are also uploaded into eDOCSmanager. The intended use of these documents is different and therefore less information is displayed in the Main View panel’s document list.

(last update Q1, 2023)
Content
  • What's New in eDOCSmanager Release 4.1
  • What's New in eDOCSmanager Regulatory 23.10
  • What's New in eDOCSmanager Release 4.1
  • Introduction
  • Introduction
  • eDOCSmanager - EXTEDO's Document Management Solution for Life Sciences
  • Regulatory Document Management - Introduction
  • Login to eDOCSmanager (2:45)
  • The eDOCSmanager Workspace and its Views (1:30)
  • Viewing Documents
  • Viewing Document Properties (0:55)
  • Viewing the Document Content of a DMS Regulatory Document
  • Viewing Document Content (1:10)
  • Viewing Permissions (0:30)
  • Viewing the Audit Trail of a Document (2:30)
  • Copy ID and Copy URL (1:20)
  • Subscribing and Un-subscribing Documents (1:40)
  • Relationships (2:00)
  • Creating Documents and Folders
  • Creating Documents and Folders
  • Creating New Documents without Content (3:40)
  • Creating New Documents from Templates (1:00)
  • Copying and Duplicating Documents (1:15)
  • Importing Documents (1:20)
  • Importing a File as New DMS Regulatory Document
  • Importing Multiple Files as New DMS Regulatory Documents
  • Importing a New File Into a Draft DMS RegDoc Version And make it Effective
  • Creating Folders (0:15)
  • Annotations
  • DMS Regulatory Document Placeholder
  • Creating a New DMS Regulatory Document Placeholder
  • Adding Document Content to an Empty DMS Regulatory Document Placeholder
  • Working with Documents
  • Editing Documents
  • Editing the Document Content of a DMS Regulatory Document
  • Updating Properties of one/several DMS Regulatory Document(s)
  • Replacing the Document Content of a DMS Regulatory Document
  • Check-Out and Edit Documents (2:30)
  • Quick Check-In (0:20)
  • Cancelling Check-out (0:25)
  • Lifecycles and Status Manager (0:45)
  • Exporting Documents (0:50)
  • Deleting, Trashing and Restoring Documents (1:25)
  • Importing and creating Templates
  • What are Templates?
  • Importing a File as New DMS Regulatory Template
  • Importing Templates (1:30)
  • Creating New Templates (1:30)
  • Creating a New DMS Regulatory Template From a DMS Regulatory Template
  • Creating a New DMS Regulatory Document as a Duplicate From a Template
  • Creating a New DMS Regulatory Document With the 'From Template' Option
  • Regulatory Submission Archive
  • Introduction to Regulatory Submission Archive
  • Relationships Between DMS Regulatory Documents and DMS Archived Documents
  • Manual Import of Submissions Into the Submission Archive
  • Importing a Submission Into the Submission Archive Manually
  • Viewing Relationships Between DMS Regulatory Doc's and DMS Archived Doc's
  • Having a Preview of DMS Archived Document Content
  • Submission Content Plans and Content Plan Items
  • Submission Content Plans and Content Plan Items
  • Life Cycle of SCPs
  • Creating a New Empty Submission Content Plan
  • Creating a New Submission Content Plan From a Template
  • Creating a New Submission Content Plan From an Existing One
  • Creating a New Draft Version From an Approved SCP
  • Creating a New Content Plan Item
  • Editing the Properties of a CPI From the Related Submission Content Plan
  • Editing the Properties of a CPI From the Related Hierarchy Tree
  • Editing the Properties of Multiple CPIs From the Hierarchy Tree at Once
  • Filtering for Content Plan Items That have no DMS Regulatory Document Assigned
  • Submission Content Plan Templates, Life Cycle of SCP Templates
  • Creating a New Submission Content Plan Template
  • Importing a Submission Content Plan Template Structure
  • Building a File with a Submission Content Plan Template Structure Definition
  • Exporting a Submission Content Plan Template Structure
  • Workflows and Tasks
  • Introduction to Workflows and Tasks
  • Workflows and Life Cycle
  • Sending Workflow Tasks (2:05)
  • Task Details (0:15)
  • Receiving and Completing Workflow Tasks (1:40)
  • Color Coding for Completed Workflows
  • Viewing the Details of a Workflow of an Item or Document
  • Related Workflows (0:45)
  • Viewing the Related Workflows of an Item or Document
  • Canceling a Workflow
  • Workflow Reporting (1:45)
  • Using Reporting for Workflows
  • Working with eDOCSmanager's Standard Workflows
  • Standard Workflows in eDOCSmanager
  • Starting a Document Approval Workflow
  • Conducting the Document Review
  • Approving or Rejecting a Document after the Review
  • Confirming the Document Approval or Rejection of the Reviewer
  • Setting a Document to 'Effective'
  • Starting a Document Collaboration Workflow
  • Conducting the Document Collaboration Task
  • Confirming that the Collaboration is Done
  • Starting an Approval Workflow for a SCP or a SCP Template
  • Tasks
  • Tasks - Introduction
  • Tasks Inbox
  • Completed Tasks
  • Opening the Inbox
  • Starting a Task
  • Approving a Task
  • Rejecting a Task
  • Delegating a Task
  • Opening the Task Details
  • Opening the Workflow Details of a Task
  • Workflow Details (0:35)
  • Opening Your Completed Tasks
  • Training Evaluation Form
Completion rules
  • All units must be completed