November 22, 2021: Virtual Assistant for Master Information, embed a project as a section and more.
Virtual Assistant for Master Information
We have added a virtual assistant to Master Information similar to the authoring environment. The virtual assistant provides contextual tips and best practices to populate the section you are working on. To view the Virtual Assistant, click on the Help icon on the right-hand side of the screen.
The Virtual Assistant will show tips based on the section that is being worked on.
Embed a project as a section
Now you can embed a project as a section - this means that you can have an entire submission attached to a different submission (project). Once you embed a project as a section, Essenvia will attach a PDF of the linked project to the submission. To embed a project as a section, navigate to the project where you want to embed another project and click "New Section" on the top right.
Choose "Embed a project as a section", then select the project you would like to embed, enter the name of the section and hit "Continue".
- Request Files: We have made improvements to the request files feature within a project to make it easier for you to get the files you need including requesting changes to files that were uploaded by the team member.
- Applicable Standards in Regulatory Strategy in Master Information: we made under the hood improvements to Applicable Standards so that you can now search faster for standards using either Designation Number, FDA Recognition Number or Title of the Standard.
- Bug fixes: We fixed a few minor bugs in this release.
Understanding Master Information
What is Master Information (MSI)? Master information (MSI) is a collection of the most common "mandatory attributes" used in regulatory documentation across the medical device lifecycle. MSI was carefully designed to combine fields across three ...
October 6, 2021: Duplicate Projects, Master Information Completion Percentage and bug fixes.
Duplicating Projects: We are adding new functionality to duplicate projects. Duplicating projects are useful in multiple scenarios including when you get an Additional Information (AI) request for which you only need to make changes to specific ...
October 12, 2021: Changes to file upload process, visual changes to Items linked to Master Information and more.
Changes to File Upload Process We have revamped the file upload process to include a visual update as well as the ability to tag files based on document type. The changes have been made to the file upload process within a section as well as on the ...
Regulatory Information category in Master Information (MSI) is used to create and manage regulatory strategy for various marketing geographies. It has a generic section for Indications of Use and then geography-specific sections: Regulatory Strategy ...
The General Information category in Master Information contains the following attributes to be completed by the user. Geographic Location Company Information Contact information