Projects

Projects

Regulatory Document authoring on Essenvia is made specifically to streamline and comply with requirements for regulatory authorities. Document authoring on Essenvia is designed at three levels:

1. Projects
2. Sections and Sub-Sections
3. Text area with heading, open text editor, files, tables, etc. 

Understanding Projects

Each Project is a submission to a regulatory authority for pre-market clearance/approval or for post-market clinical reports. Projects usually represent multiple sections, documents, and files from several cross-functional areas. Here are a few examples of Projects: 510(k) Traditional, Technical Documentation for CE Mark, Post-market Surveillance and Clinical Evaluation Reports, etc

Ways to Create a Project

Users with permission to create projects can do so in two ways:

  1. Select a template from the templates screen
  2. From Projects screen within a Space

Project Dashboard

Projects dashboard is broken up into five sections:
  1. Overview
  2. Sections
  3. Files
  4. Version
  5. Team
Each section has its own tab, which can be found at the top of the dashboard. Below, is a description of what each sections entails.

Overview

The overview tab in your Project Manager dashboard is broken into three sections: Project Status, Section Status, and Activity.


Project Status

The Project Status section can be found in the top of half of your screen. Here is where you will find three key project statuses:
  1. Number of days until your project is due
  2. How much of your project has been completed
  3. The overall status of your project

Section Status

The Section Status section can be found in the bottom half of your screen. Here is where you will find three key section statuses:
  1. Number of overall drafts
  2. Number of sections in review
  3. A chart showing what percentage of your sections are "In Progress", "Not Started", and "Completed".

Activity

Here is where all activity conducted by anyone who has access to your project. 

Sections

The "Sections" tab in your dashboard allows you to see a list of each section in your project. Each section has its own line and includes key overview information such as the title of the section, who on your team has access to it, percentage completed, and its status.



To access the authoring environment, all you need to do is click on the name of the section you wish to work on. 

How to add, edit and archive a section?

A new section can be added from the Sections page within a project. Sections take the highest level numbering scheme 1.0, 2.0, 3.0, etc. in the published version fo the document. A new section can be created in two ways:
Creating a new section from blank: 
  1. Click on the "+ New Section" icon on the top right-hand side of the Sections page in the Project


  2. Choose "Blank Section" and enter the name of the Section


  3. Click "Continue" to insert the section. 
  4. The new section will be added to the bottom of the Sections - you can drag and drop the section on the "Sections" page to move the section to a different location
Create a section from a template: 
  1. Create a section from blank: Click on the "+ New Section" icon on the top right-hand side of the Sections page in the Project
  2. Choose "A pre built template on Essenvia" 

  3. Choose the template you would like to use from the "Section Template" dropdown

  4. Add the desired name of the section (this can be updated later) 
  5. Click "Continue" to insert the section. 
  6. The new section will be added to the bottom of the Sections - you can drag and drop the section on the "Sections" page to move the section to a different location

Files

The Files tab is where you can filter through all files uploaded over the course of your project. You can search through all of your files by using the search function at the top of the screen.

Underneath the search function, you will find three tabs that break your files into three categories:
  1. All files within your project
  2. All files that you added
  3. Files that you have requested from other team members
After you select one of the three tabs listed above, you can use one or all of the three filter functions listed below:
  1. Added By
  2. Format
  3. Tags
Lastly, you can upload or request a new file by using the buttons on the topright-hand side of your screen.



You can now also select the Document Type for each type of file that you upload to the project so that you can sort and filter them easily. 

Uploading a File to the Project

  1. Log in to your account and navigate to the project where you want to upload files
  2. Click on "Files" at the top of the screen
  3. Click "Upload File" on the top-right of the screen

  4. Choose the source of the file - if you have file(s) in Box, Dropbox or SharePoint, you can choose that to import the files. If you are uploading the file from your computer, click "My Device" and then click "Select from your device"



Version

This section shows each version of your project, the date it was created, the number of version it was, and who it was last updated by. You also have the option of duplicating a version. If you have multiple versions, you are also able to restore a prior version. 



Team

The last tab in your project manager dashboard shows each project collaborator. This section has a full list of every single person working on your project including their name, company they work for, e-mail, and role.

Here is where you have the option to add a new team member, remove a current member, or change their role.


Click here to see details about adding a team member to a project. 

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