Project and DHF Management
offers the following functionality:
- Dashboards for advanced visual project tracking of all product
introduction projects
- Project structure that decomposes complex product development
activities into smaller projects and tasks
- Project content and deliverables which are stored securely within
controlled and uncontrolled bookmarks
- Project templates which allow you to develop and drive project
consistency by standardizing project creation with templated task and bookmark
structures
- Issues which track real incidents, inquiries, or problems that
impact a project negatively
- Risks which capture, track, and close issues for a project
- Business goals for identifying which projects to approve and fund
based on impact strategy
- A financial plan defined for each project
- Support for associating a project member to multiple project roles
- Support for adding and managing related items to tasks and projects
- Support for managing the
Design History File (DHF) for a new
medical device product
- Automatic synchronization of DHF contents under project bookmarks
- A DHF view which shows DHF classification of controlled bookmarks for
a product
- Hazard analysis for a product that
includes a color-coded risk matrix, risk reduction options, hazard
snapshots and their comparisons, and
reports
- If the
Traceable Requirements Management
app is installed, a
traceability matrix shows how available
design input elements are mapped to design output,
design changes, design verification, and
hazards.
Project and DHF Management
provides information for products created in
Product Line Management.