Understanding Sections

All Projects in Essenvia are a collection of sections (documents) created from templates. A template used for a Project becomes a section and can then be updated as per the specific regulatory requirements based on the type of device and project.

Building blocks of a Section

A template is a collection of various building blocks required to meet the regulatory requirements relevant to that section. The building blocks in a section are organized to meet the technical requirements of the final published regulatory document to be submitted to the regulatory authority. A section has the following blocks in order of hierarchy of information contained:

1. Section Number and Name
2. Sub-section Name
3. Text or Text with heading
4. Tables
5. Files and figures

Let's go through the different items related to Sections:

1. Ways to build sections
2. Authoring a section
3. Building blocks in a section

Ways to build Sections in Essenvia

Understanding how to build sections in Essenvia towards completing a Project is an important step to make the most of your time creating and managing regulatory requirements and documents. Sections in a project can be of the following three types in Essenvia:

1. Templated forms prescribed by Regulatory authorities
2. Essenvia templates
3. Sections built from scratch

Below we will see how to build and complete different types of sections:

1. Templated forms: Essenvia has pre-built forms for standard templates already prescribed by regulatory authorities. They are either already included in the appropriate regulatory submission project types or also available on a standalone basis to be inserted into a project. Since these are standardized, these sections are mostly completed by auto-populating data from Master Information. Examples of forms in 510(k)'s: CDRH coversheet, Indications for Use Statement, etc. Examples of forms in Technical Documentation: the Declaration of conformity, GSPR, etc.
2. Essenvia templates: Essenvia's template library contains some of the most widely used pre-built smart templates based on guidance from regulatory authorities. Most of these templates have help text associated with them that users can use to understand specific content requirements for the section.
3. Sections built from scratch: We understand that you may already have created templates that are specific to the needs of your device and organization and therefore Essenvia provides users the ability to build their templates from a blank document as well as add the building blocks in order to complete the section easily.

Authoring a Section

Authoring might vary based on the type of sections you are working on. Here is how you can complete various types of sections:

How to author a templated regulatory form?

The best way to get started on a templated section is to complete Master Information. There might be remaining mandatory fields and signatures but these are only a very small part of templated forms that are already available on Essenvia. For example, on completing the fields in company information, device information, and regulatory information within Master Information, CDRH Coversheet is at least 70% completed.

How to author an Essenvia-templated Section?

Essenvia provides two types of templates for use in projects. The first kind of templates just need to be updated with content with no changes to the structure or the need to add or modify the base templates with new building blocks - examples of these templates include 510(k) Cover letters, 510(k) Summary, etc. The content in these forms is already populated by Master Information and usually require just a little bit more information to complete such as a signature or logo, etc.

The second type of templates have the basic structure and properties required by the regulatory authorities but they usually need slight modifications when it comes to the specific details of the device in scope. These sections are best done by first completing the Master Information, then completing specific unfilled parts of the pre-built templates, and lastly adding additional building blocks required for completion.

How to author a section built from blank?

While working on Essenvia you will also encounter scenarios where section templates don't exist. In these cases new sections can be created from blank forms and users can add building blocks to create the structure of the template that best suits the needs of the regulatory requirement. The next section in the article covers the steps to build a section.

How to add, edit and delete a new section?

A new section can be added only inside a project. Sections take the highest level numbering scheme 1.0, 2.0, 3.0, etc. in the published version of the document. A new section can be created in two ways:

1. Create a section from blank: Click on the "+" icon above the section names on the top left-hand side of the project page
   
   
2. Add the desired name of the section (this can be updated later) and then select the position (before or after) where the section needs to be inserted and then choose the section name.
   
   
3. Click "Add" to insert the section. 

Create a section from a template: 

1. Create a section from blank: Click on the "+" icon above the section names on the top left-hand side of the project page
   
   
2. Add the desired name of the section (this can be updated later) and then select the position (before or after) where the section needs to be inserted and then choose section name
   
   
3. If you have previously saved a section as a template, select the template name from the drop-down to insert in the desired position in the project
   
4. Click "Add" to insert the section. 

To edit or update a section name simply click on the section name inside the authoring environment and retype the section name as shown below:

To delete a section click on the menu next to the section name on the left-hand side navigation menu to see the option to delete the section. Click and confirm to delete the section. Note: A version history is created of the previously deleted section and can be retrieved from the version history panel.

How to add, update and delete a Sub-section?

A new sub-section can be added only inside a project. Sub-sections are automatically prefixed by 1.1, 2.1, 2.2, 3.1, etc. in the final published PDF. A new sub-section can be created in two ways:

1. Click on the menu next to the section name on the left-hand side navigation menu to see the option to "Add subsection"
   
   
2. Add the desired name of the section (this can be updated later) and choose "Default Template" for the template
   
   
3. Click "Add" to add the sub-section. The sub-section will be added in the section chosen.

Create a sub-section from a template: 

1. Click on the menu next to the section name on the left-hand side navigation menu to see the option to "Add subsection"
   
   
2. Add the desired name of the section (this can be updated later)
   
   
3. If you have previously saved a section as a template, select the template name from the drop-down
   
4. Click "Add" to add the sub-section. The sub-section will be added in the section chosen. 

To edit the name of the sub-section, click on the sub-section name inside the section and retype the section name as shown below:

To delete a sub-section:

1. Hover the mouse on the left margin beside the sub-section name to see the drag icon
   
   
2. Click to see the delete option
   
   
3. Click delete and then click "Yes" on the prompt to confirm the deletion of the sub-section. Note: A version history is created of the previously deleted sub-sections and can be retrieved from the version history panel.
   
   

How to add, update and delete a text block with or without heading?

To add a new text block:

1. Hover your mouse on the left margin of the section title and click the '+' icon.
   
   
2. Click on "Text with Heading" or "Text" option
   
   
3. If you chose "Text with Heading", click on the heading name to update the name. Text headings are third in the hierarchy and follow the numbering scheme 2.1.1, 2.1.2, etc. in the published documents.
   

Text blocks can be updated in three ways:

1. Inherited content automatically cascaded from Master Information
   
2. Content that can be populated by typing '#' inside a text area to see the option to cross-reference data from master information, table names, section name, etc.
   
   
3. Directly typing into the text area