Design Control Module

The Design Control Module from Grand Avenue Software is built for MedTech teams managing product development from concept through commercialization. It provides a connected platform for maintaining a real-time Design History File (DHF), aligning work with a Product Development Plan (PDP), and ensuring full traceability and regulatory compliance across all development phases.

The module is intended for medical device companies that need structured, audit-ready documentation without relying on manual processes. It integrates task tracking, phase-gate controls, and document management into a single system to keep teams coordinated and projects on schedule.

Core Capabilities

• Define and manage the Product Development Plan (PDP) using built-in templates
• Assign roles, deliverables, and responsibilities by team, project, and phase
• Capture design phase reviews and approvals directly within the platform
• Maintain a real-time Design History File (DHF) with linked documentation
• Monitor project and phase status to track progress against milestones
• Support phase-based tracking of tasks and deliverables for full lifecycle visibility

Design History File (DHF) Management

• Stores all product development documentation, including design inputs, testing records, and validation data
• Uses automated version control to track all changes throughout the development lifecycle
• Customizable phases and deliverables to match each product's specific development structure
• After a phase review is completed, the screen is frozen at the reviewed revisions, creating a clear and auditable electronic DHF (eDHF)
• Built-in integration with Document Control ensures the DHF reflects the latest project documents automatically

Task Tracking and Workflow Automation

• Tracks product development tasks through automated workflows tied to project phases such as design, testing, and validation
• Sends notifications and reminders to help teams complete tasks on time
• Supports phase-gate controls to ensure documentation and compliance requirements are met before progressing
• Includes a sample 5-phase PDP for medical device companies covering concept, design, development, validation, and production, each with built-in documentation and compliance requirements

Collaboration and Review Tracking

• Supports real-time review tracking across team members
• Provides automated approval workflows for design documents
• Includes commenting features so all inputs are documented and traceable
• Enables collaborative review and approval of design documentation to support compliance and traceability requirements

The Design Control Module integrates with Grand Avenue's Document Control system, keeping the DHF current without manual updates. This connection improves audit readiness, reduces delays from outdated documentation, and supports regulatory compliance throughout the product development lifecycle.