Design Control

Create an Electronic Design History File (DHF)

Grand Avenue’s Design Control module tracks and manages product development actions and tasks while maintaining an electronic Design History File (DHF).

MANAGE DESIGN PROJECTS ACROSS THE DEVELOPMENT LIFECYCLE

Design Control manages the product development tasks and activities by deliverable, by phase. 

The Design Control checklist provides visibility to what needs to be done, what is being worked on now, and what still needs attention.

DHF – MAINTAINED ELECTRONICALLY

Product development information (files and documents) is stored for each deliverable for each phase of the development project.

Dynamic links to Document Control documents automatically keep the Design History File up-to-date.

Design Control from Grand Avenue

Out-of-the-box Functionality

  • Define and manage the product development process (PDP) for your company.
  • Use the available sample 5-phase PDP for medical devices to get started if applicable.
  • Assign a Project Manager and Project Viewers for each project.
  • Initiate deliverable work assignments to team members.
  • Send tasks and emails to individuals informing them of work to do.
  • Append files, documents, information, and evidence to the deliverables within each phase.
  • Capture reviews within each phase as needed: technical reviews, deliverable reviews, status reviews.
  • Conduct electronic phase review and approval when deliverables are completed in a phase.
  • Define and maintain the electronic Design History File (DHF) online in real time.
  • Maintain all information along with the associated reviews and approvals online by project.
  • Measure and track project and phase status.