Basic Concepts

A DHF element is a user-defined classification for a Design History File. You configure DHF classifications on controlled bookmarks and tasks.

To configure a DHF element on the bookmark level, see Bookmarks Page; to configure it on the task level, see Working the Structured View.When configured on bookmarks and tasks in a project template, the DHF classifications will be copied over when creating a project from the project template.

On the task schedule, an icon shows for a DHF bookmark that is out of sync with any task deliverables. You can click the icon to sync task deliverables to respective bookmarks. Upon task completion, the sync operation is performed on DHF content automatically.

You can view the content of a Design History File, which typically contains the controlled bookmarks and documents that comprise Design Input, Design Output, Design Review, Design Changes, Design Transfer, and the like. For details, see DHF View.

You can work with design projects, which are sub types of a project space.

For details, see Design Projects.

Features and functions supported by design project options include:

• Creating and exporting design projects
• Creating design project templates
• Putting a design project on hold or resuming its activity

You can create snapshots of a product's DHF, projects, or hazards. Snapshots show the structure and status of objects at a moment in time.

For details, see Design Project Snapshots, DHF Snapshots, and Hazard Snapshots.

Features and functions supported by snapshots include:

• Creating snapshots
• Comparing snapshots in a split view

Hazards define risks for patients which can occur because of the failure/fault in the design of the product.

For details, see Working With Hazards and Working With Hazard Templates.

Features and functions supported by hazards include:

• Creating hazards
• Creating hazard templates
• Processing hazards through their phases
• Performing hazard control for products
• Create hazard snapshots and comparisons

If the Traceable Requirements Management app is installed, you can work with a matrix that shows traceability of design elements to child requirements in a design project.

For details, see Working With Traceability.

Features and functions supported by traceability include:

• View requirement traceability
• Select design output, design verification, and hazard elements and relate them to child requirements in the traceability matrix.

You can also work with objects that support projects and products.

Additional features and functions include:

• Project management
• Working with business goals
• Scheduling tasks in a project
• Working with project members
• Working with project assessments
• Maintaining bookmarks and content