Effective DHR and Web Document Management: Becoming 100% Compliant With the FDA's QSR

In highly regulated medical device environments, regulatory requirements no longer revolve solely around the manufacturing process. Per the FDA's QSR design elements, a salient FDA focus (if not the most essential focus) is the medical device design process.

Design in the Medical Device Industry
When it comes to accurate design, easier cycle management between design inputs/outputs and 100 percent compliance with the FDA, it is essential to maintain an accurate DHF (Design History File). The DHF file allows designers (and auditors) to demonstrate (or easily recognize) that a particular device was developed as planned and that if design changes occurred they were properly documented via established change management procedures.

DHF Advantages
When assembled properly a DHF provides the following benefits:

• Provides a design document repository that can easily be referenced by designers and manufacturers;
• Allows auditors to easily access documentation related to the various elements of design required by the QSR;
• Saves medical device professionals hundreds and thousands of administrative hours that can be more effectively utilized during development;
• Allows design steps to be more readily understood via DHF documentation. These steps include design planning, design input, output, review, verification, validation, transfer and changes.

DHF Management Challenges
Like anything that requires significant management energies, DHFs present some unique challenges. One challenge is the simple fact that a DHF will inevitably require the conglomeration of hundreds of design related documents. Many these documents will reference other documents. Managing a large amount of inter-reliant documentations often results in extreme frustration and excessive man hours.

DHR and Web Document Management: A Search for Solutions
Medical device designers may choose to avoid this DHR administrative nightmare by investing in DHR and web document management software solutions. These solutions should allow medical device designers to effectively track design documentation from start to finish, to integrate DHR with quality system processes such as customer complaint management or CAPAs, and to effectively integrate DHR management with an existing ERP system. In regard to the latter, combined DHR and web document management solutions that interface with an ERP system allow for a smoother transfer from design to manufacture and eradicates the necessity of duplicating information from one system to another.

Additional Benefits of Combined DHR and Web Document Management Solutions
When searching for combined DHR and web document management solutions, medical device professionals should also search for DHR and web based management solutions that provide the following benefits:

• Collaborative, Virtual Workspace
• Advanced Search
• Electronic Sign-Off Capabilities
• Robust Workflows
• Simplistic File Structures
• Powerful Tracing Features
• Audit Trail Capabilities
• Automation of Task Assignments
• Document Templates

Medical Device Expertise in the Web Document Management Market
There are hundreds of web document management vendors. These vendors, when effective, are constantly planning and preparing newer software versions that will more effectively meet the needs of their customers. When searching for combined DHR and web document management solutions, medical device professionals should search for those vendors with particular interest in the medical device industry. These vendors will provide off-the-shelf web document management solutions that can be implemented in a timely fashion, and further configured to meet the unique needs of highly regulated device companies.

Conclusion
In an industry where med device designers and manufacturers need to speed effective compliance to effectively compete with their respective proprietary products, combined DHR and web document management solutions may be a valuable option for faster advancement.

Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. To learn more about DHF and web document management, please feel free to contact a MasterControl representative.