Medical Device Design History File Software (DHF)

Automate the Management of Your Design History Files with MasterControl DHF JumpStart Design History File Management Software

Medical device companies need an out-of-the-box design control tool to help them organize the myriad of drawings, notes, collaborative pieces, reports, and other documents that are created during the design process. They want a tool that bridges the gap between design and manufacturing and provides project management, design control processes, and document control and approval. MasterControl DHF JumpStart is the right design history file management software which meets their desires, point for point.

MasterControl Medical Device (DHF) JumpStart™

Free Resources

Select all the resources you’re interested in downloading

How Can MasterControl DHF JumpStart be Right Design History Files Management Software for You?

MasterControl DHF JumpStart is a tool for medical device developers who work in small- to medium-sized companies. It's a preconfigured document control database that helps development engineers swiftly organize their work so they spend less time with administrative duties and more time in development. The design history file management software provides multiple simple routes for collaboration, approval, and review and is an affordable solution for companies a pre-configured best practices design control process.

MasterControl offers a line of validation products and services addressing different levels of validation needs based on individual risk assessment. They are designed to allow "continuous validation" for FDA-regulated companies by making validation of design history file management software upgrades easier, faster, and more cost effective.

Here's how MasterControl DHF JumpStart addresses some of the major challenges that companies face in meeting FDA design control requirements:

Design History File Management Challenges

MasterControl Design History File Management Solution

Design Review:

All documentation is reviewed at each phase of production. If the Design History File (DHF) is incomplete, resources are wasted while searching for the required documentation.

Electronic DHF JumpStart:

Using MasterControl Explorers, industry best practices, and regulatory guidelines, the design history file management software is configured to swiftly provide documents as needed, whether for a design review or FDA inspection.

Customization Delays:

Smaller companies with tight deadlines rarely have time to work with software requiring full customization as staffing resources are typically not available but MasterControl's DHF JumpStart makes your life easy.

Preconfiguration Speeds Your Work:

MasterControl DHF JumpStart is preconfigured to organize documents in a complete design history file ready for design review or FDA scrutiny.

New Product Delay:

Design control requires that key design documents be reviewed and approved by several individuals. Time spent waiting on this process can impede delivery to market.

Faster Turn Around:

MasterControl design history file management software automates collaboration, routing, follow-up, escalation, and approval of important design control documentation, removing this as an obstacle of product launch. Using electronic signatures further accelerates the approval process and ensures regulatory compliance.

Slow Installation and Training:

Other design history file management software programs can take months to install, weeks for a system administrator to set up and many days for a user to learn.

Quick Start for Staff:

DHF JumpStart is out-of-the-box software requiring minimal system administrator and user training that can be installed in a matter of days. LDAP integration is available, if desired.

Summarized Features of DHF Jumpstart Software

MasterControl DHF JumpStart is an ideal design history file management software solution for growing medical device companies who need an out-of-the-box, pre-configured document control system based on best practices.

Below is a summary of its key features:

  • Analytics and Reporting: MasterControl's DHF JumpStart provides advanced analytics and reporting capability provides standard and customized reports. Design control documents can be summarized in multiple levels such as product, department, and document type. MasterControl includes dashboard and drill-down features.
  • Automated Routing, Escalation, and Approval: Design history file management software automates all design control document tasks, including routing, notification, follow-up, escalation, and approval to improve efficiency and time-to-market.
  • Best Practice Processes: The system is pre-configured based on industry best practices and design control guidelines. Users are able to create, collaborate, and route design documents without having to spend hours configuring the system.
  • Continuous Validation: For FDA-regulated companies, MasterControl offers a "continuous validation" approach that dramatically cuts the time, pain, and cost involved in validation.
  • Electronic Approval Signatures: The system allows documents to display for review, collaboration, and/or electronic approval, accelerating the approval process.
  • Grows with Your Business :Familiarity with the pre-configured design history file management software will allow the customer's sysadmin to make changes to accommodate new processes and procedures. As the company grows, it can move into a full MasterControl system that can include training, CAPA, process automation, etc. without losing the efficiency of the preconfigured system or changes that may have been incorporated along the way.
  • Explorers: MasterControl's Explorer, similar to Windows Explorer, is an easy-to-use tool that helps users find and access documents quickly. DHFs are structured such that design reviews can be conducted entirely from within the DHF Explorer.
  • Part 11-Compliant Features: Design history file management software provides time-stamped audit trail, reporting, and electronic signature capabilities that fully satisfy FDA's 21 CFR Part 11 requirements. Security features include dual passwords for document approval; password expiration, encryption and certification; and account lockout to stop unauthorized users from gaining system access.
  • Publishing: MasterControl DHF JumpStart offers automated conversion/publishing to PDF throughout the document lifecycle. Auto converting of documents to PDF reduces errors commonly associated with manual publishing. PDF conversion from multiple document types into a common, unalterable format helps improve efficiency and reduce costs by eliminating additional desktop software that would be required for users to view documents.
  • Revision Control: Automatic revision control ensures that the history of the design is properly documented. Rights-based access to documents ensures that the most current, approved version of a document is being used.
  • Web-based Platform: MasterControl is Web-based so it can connect all employees involved in the design process from virtually anywhere.
  • Validation: MasterControl DHF JumpStart offers a line of validation products and services addressing different levels of validation needs based on individual risk assessment. They are designed to allow "continuous validation" for FDA-regulated companies by making validation of software upgrades easier, faster, and more cost effective.

To Learn More About MasterControl DHF Jumpstart - Design History File Management Software Systems

To learn more about DHF Jumpstart and how the system from MasterControl can help with your design history file management software needs, please feel free to contact a MasterControl representative.