Product DHF Tab

The Product DHF tab lists the product design history files (DHFs) for the submission project. The DHF typically consists of the controlled folders and documents that comprise Design Plan, Design Input, Design Output, Design Verification, Design Validation, Design Review, Design Changes, Design Transfer, and any other type of DHF classified controlled folder for the submission project.

Note: This page is only available if you have Project and DHF Management installed.

Required access role: Regulatory User that has read access to the design project to view the Product DHF tab. If the design project was not created with access for all members of the company, individual users must be a member of the design project to view the information in this tab.

Important: This app stores personal data in some settings. To follow good personal data management practices, Business Administrators might need to edit these settings to remove personal data, such as names, email addresses, and phone numbers.

To access the list of product DHFs for a submission project:

  1. Open a submission project. See Opening a Submission.
  2. In the navigation pane, select Folders.
  3. Select the Project DHF tab.

To access the list of product DHFs for a submission project task deliverable:

  1. Open a submission project. See Opening a Submission.
  2. In the navigation pane, select Schedule.
  3. Select a submission project task.
  4. In the navigation pane, select Deliverables.
  5. Select the Project DHF tab.

This topic describes:

This page discusses:

Columns

Column Name Description
Name The automatically-generated name of the product, project, folder, or document.
(Higher Revision Exists) indicates that a higher revision of the object exists.
(Locked For Use) Number of files locked/number of files checked into the document. For example, 2/4 indicates 2 files of the 4 files checked into this document are locked.
Drag Drag the icon to the Drop column of the folder where you want to move the document. Press the Ctrl key while dragging to copy the document in the new location instead of moving it.

This action is only available to users with add and remove access to the document.

Projects A comma-separated list of design projects to which the document is connected via a controlled folder.
Action

The actions displayed are based on the user's access permissions to the document.

Icon Name Action


Subscribe

View and select subscriptions for a document.



Download

Download the files in the Document to your local machine. Browse to the directory or folder you want to contain the file.

When the document contains multiple files they are downloaded in a single zip file.



Check Out and Lock

Check out the files in the Document to your local machine and lock the files from other users who cannot unlock it. Navigate to the folder or directory you want to contain the file.

When the document contains multiple files they are downloaded in a single zip file.



Update Files

Update a checked-out file to its next version.



Check In

Check in a new file.



Lock

Lock the file without checking it out.



Unlock

Unlock the file without checking in a new version.

Type The type of product associated with the submission project.
Title A descriptive name for the object.
File Size The file size of the document.
Rev The revision level of the object.
Ver The version number of the document or an icon indicating that there are multiple files associated with the document.
Approvers A comma-separated list of the approvers for the change object or approval route associated with the object.
Related Items A comma-separated list of the items associated with the object.
State Last Modified The most recent date that changes were made to the object.
State The current lifecycle state of the object.
Owner The person responsible for the object.
Description A detailed description of the object.

Actions/Toolbar Commands

Action Name Description For More Information
Add to Selected

This action is not available when the Product DHF tab is accessed from the Deliverables category of a submission project.

Adds the selected documents in the Product DHF tab to the selected folder in the Local Folder tab.

Required access role: Regulatory Lead or submission project owner can perform this action when the page is accessed from the Folders category of a submission.

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Add to Deliverables

This action is only available when the Product DHF tab is accessed from the Deliverables category of a submission project and when the deliverable task is not in the In Review state or higher.

Adds the selected documents in the Product DHF tab to the selected folder in the Deliverables tab.

Required access roles:

  • Submission template owners with the Regulatory User role can perform this action when the page is accessed from the Deliverables category of a submission project task.
  • Regulatory Lead or submission project owner can perform this action when the page is accessed from the Deliverables category of a submission project task.

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