Design History Files (DHF)

Automate Design History Files (DHF) Management Processes to Improve Efficiency and Ensure Compliance with FDA 21 CFR Part 820 / FDA's QSR

The advantages of continuously documenting and compiling an up-to-date DHF (Design History File) include the following:

• Serves as a repository for essential DHF, reference and compliance information;
• Provides an easy-to-follow road map of design controls required by the FDA's QSR;
• Well-organized documentation organized by design element (e.g., design planning, input, output, review, verification, validation, transfer and changes)

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Converting a paper-based design history files management process to an electronic process may be challenging, but it ultimately helps eliminate common errors that could lead to serious regulatory problems.

How can MasterControl Design History Files (DHF) Software Benefit You?

MasterControl DHF and MasterControl Documents are an integrated part of the MasterControl's software suite that automates electronic document management and design control processes in an efficient and cost-effective manner. Here are some of the features and benefits of implementing an electronic document management software solution:

• Revision Control: MasterControl provides automatic document revision control to ensure that only the current version of DHF and a standard operating procedure SOP is available. When a user makes a change in the InfoCard (the MasterControl tool that provides basic information for every electronic document), the user must enter a reason for the change. The software tracks all changes made to the InfoCard.
• Solid Audit Trail: Provides a secure, time-stamped audit trail exceeding 21 CFR part 11 requirements. MasterControl documents the identity of anyone who creates or modifies an electronic record, when the action occurred, and the changes made.
• Security: 21 CFR Part 11 emphasizes security practices that limit access to authorized users and holding them accountable for written policies. With MasterControl, an electronic document for design history files is stored in virtual vaults located in a central database for access by authorized users only. The software automatically locks both login and approval anytime either one is compromised.
• Advanced Tracking: MasterControl's electronic document management system tracks DHF and documents by status or history. A document will show as either in process or complete if tracked by status. The revision or approval history of electronic documents can also be reviewed using the history feature.
• Analytics and Reporting: MasterControl's electronic document management system uses advanced analytics and reporting capabilities in the form of standard and customized reports to help increase management oversight by viewing design history files.
• Electronic Sign-offs: With MasterControl, electronic DHF can be signed and approved in an automated fashion. Electronic signature manifestation name, date, time, and meaning of electronic signature can be appended automatically to each document.
• Manage Different Document Types: MasterControl's electronic document management system is uniquely qualified to be the focal point of any compliance initiative because it can manage different documents-based processes and handle all types of design history files and electronic documents regardless of the software used to create them.
• Easy Access: MasterControl's DHF is web-based so it can connect all employees involved in document and quality control from virtually anywhere. Provides a centralized repository for easy access, search, and retrieval of electronic documents by all authorized users.
• Automates Routing, Escalation, Approval: Reduces document cycle time by automating routing and approval and incorporating escalation for overdue tasks.
• Dependent Routing: Completion of a task can be made dependent on another task to give managers more control and reduce cycle time by prompting users immediately to their next task.
• Streamlines Collaboration: Creating and revising design history files as a team is easier because MasterControl provides a collaboration workspace that allows a user to see other people's input, avoiding duplication. A rejected document is automatically returned to the originator for a new task, so rejected packets don't languish in the system.
• Integrates with Other Applications: MasterControl's electronic document management system can integrate DHF with other applications like ERP, LIMS, accounting, and human resources applications to accommodate departmental needs.
• Pre-Defined Workflow: Company-wide policies, SOPs, and other electronic documents that require inter-departmental collaboration move along a pre-defined workflow, from one department to the next. Overdue tasks automatically escalate to a manager to view them from the design history files.
• Automation of Forms-Based Processes: Design history files and form processes unique to a department (i.e., application forms for HR, customer satisfaction survey forms for Customer Service Department) can be integrated with document-based processes under one secure repository. A department can keep the look and function of existing forms or create entirely new ones.
• Easy to Search: A standardized, Google-like, search window is available throughout the application, which means all authorized users throughout the organization can search for design history files, tasks, training records, policies, and other documents using a familiar search interface.
• Easy to Find: MasterControl's Organizer, similar to Windows Explorer, is an easy-to-use tool that helps users find and access DHF quickly. Every department can maintain its own Organizers and documents can be stored in multiple Organizers. System administrators can control and automatically update the documents through a dynamic link in the InfoCard.

The Consequences of Faulty Design History Files (DHF) Management

The consequences of faulty DHF management can be severe. For medical device companies that do not have a properly assembled DHF, forced product recalls for failure to establish probable cause for questionable product issues can result in serious revenue, profit, and reputation losses.

"Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part 1."

For More Information on Design History Files

To learn more about electronic DHF management, document control and change management technical products, please contact a MasterControl representative.