e-DHF

Design History File Management System

overview

e-DHF is an advanced Design History File (DHF) management system tailored for organizations involved in product development and manufacturing, particularly in regulated industries such as medical devices. The system leverages AI technology to automate, streamline, and ensure compliance throughout the design and development lifecycle, making it easier to manage complex regulatory requirements and maintain thorough documentation.

e-DHF is the ultimate solution for organizations looking to manage their Design History Files efficiently, ensuring compliance, enhancing productivity, and improving control over the product design and development lifecycle.

Key Features:

Regulatory Forms Supported: e-DHF supports industry-specific regulatory forms such as FDA and ISO-compliant documentation, ensuring adherence to international design control standards. The system allows for easy customization to meet company-specific design history requirements.
Automated Workflow and Approvals: Simplify the review and approval process with automated workflows. Design documents are automatically routed to the relevant personnel for review, ensuring timely approvals. Notifications and reminders help maintain momentum and avoid bottlenecks.
Automated Form Filling and Submission: The system uses AI to pull data from design systems and populate forms accurately, reducing human error and speeding up the documentation process. e-DHF ensures that all critical information is captured and submitted according to regulatory requirements.
Centralized Document Management: e-DHF serves as a centralized hub for all design-related files and documentation. Version control, secure storage, and quick retrieval make managing complex design history files efficient and easy. Users can access all documents in one place, ensuring accuracy and compliance.
Scalability and Flexibility: Whether managing a single project or handling multiple design histories across different products, e-DHF is designed to scale. The flexible system allows you to add new functionalities or expand usage as your product design operations grow.
Secure Data Management: Protect sensitive design and intellectual property data with advanced security features such as encryption and access controls. e-DHF complies with stringent industry standards, ensuring that all design files are secure and protected against unauthorized access.
Reporting and Analytics: AI-powered analytics provide deep insights into the design process, helping organizations understand project progress, identify risks, and ensure compliance. Custom reports offer an overview of design history file statuses, submission timelines, and review cycles.
Integrations with Enterprise Systems: e-DHF easily integrates with existing Product Lifecycle Management (PLM) systems, ERP systems, and other enterprise tools. This ensures smooth data flow between departments and systems, minimizing manual data entry and improving efficiency.
Integrated Compliance Tracking: e-DHF ensures real-time compliance tracking throughout the design process. The system provides an audit trail of all design decisions, reviews, and approvals, giving full transparency and helping organizations stay compliant with evolving regulations.

Benefits of e-DHF:

Ensures compliance with design control regulations.
Streamlines the documentation and approval process.
Centralizes all design history files for easy management.
Provides real-time insights into design progress and compliance.
Scales according to project and organizational needs.
Enhances data security and regulatory audit readiness.

e-DHF

overview

Key Features:

Benefits of e-DHF:

site map

Information

contact us

Made by Nicky's