A medical device manufacturer in Research Triangle Park, North Carolina needed a complete solution for the management of their growing Document Control Center (DCC) records. The goal of the organization was to develop a comprehensive system for managing the complete life cycle of DCC records, which were not subject to revision control.

As the organization was quickly growing so was the DCC. The DCC catalogued and controlled all the documents and information related to FDA applications and approval processes involving surgical devices. The DCC houses records associated with, but not limited to, the development, application, design, approval and implementation and quality assurance of surgical medical devices. The increased volume was placing pressure on the Document Control Center to provide correct and timely delivery of information to the organization's information consumers.

A solution was required to accommodate multiple information indexes regarding complex document and file management procedures. Standard database practices needed to be incorporated into the system. These standards were required to allow for joint cross-referencing, unique and complex indexing, and relational, complex data models. The software needed to be secure, but user friendly. The "open room" DCC required strict user compliance and competency, in a demanding fast past environment. The solution needed to comply with FDA guidelines including adherence to "Good Document Practices" and "Current Good Manufacturing Practice for Medical Devices". These compliance issues could not jeopardize the organizational requirement for the software solution to be powerful, flexible, and customizable.

The DCC is adding to its total volume of 15,000 records by 5 to 10% each month. These documents are valuable assets to the company, therefore the system had to be scalable. Initially the system would be rolled out to six users. (This number later rose to over 50, and is projected to be corporate wide soon) It was the challenge of the DCC department staff to manage substantial growth while continuing to maintain internal information retrieval requirements. At the same time, the department was challenged with completely redesigning its document control procedures. It required the DCC find dedicated a partner\vendor that could not only offer a product, but also, professional services, consulting and complete satisfaction.

Objectives were set for the system to:

• Use proven bar code technology to facilitate tracking of items - from the time they are data created, physically created, requested, delivered, returned and\or destroyed,
• Provide easy user access to information about the locations of items - in a form that would allow users to quickly locate needed information,
• Provide audit trails and reports - sufficient to support the reasonable probability that the documents, file folders, binders, and any other media under the DCC control are accounted for at all times regardless of location; previous, present, and future.
• Provide information and reports regarding the length of time items have been in storage - to insure information media are retained as long as necessary but no longer,
• Provide a high level of system security - to insure the integrity of the database,
• Provide reports and tools to facilitate tracking information media dispersed across an unlimited number of different containers and different locations
• Minimize Costs - by minimizing the manual labor of record keeping through automation

In its search for vendors, the medical device manufacturer discovered FileOnQ through a local certified filing and storage products reseller. FileOnQ worked with the local reseller to offer professional services to manage the project, design the solution, create the application using FileOnQ's powerful Profiler module, implement the solution, train the users, and support the use of the solution over time. FileOnQ proved to be an effective solution to manage their current and future document and regulatory management challenge.

Why FileOnQ?

Simply put, FileOnQ's basic bar code tracking software and optional modules meet all of the objectives established for the content collection tracking system. Equally important, FileOnQ offers modular growth and optional modules to meet new challenges that may arise. And, FileOnQ integrates with host systems to manage the content collection process and assign retention classification to ensure complete accessibility to documents and timely review or destruction.

How Has It Worked?

The project has provided significant benefits:

• Complete Records - Completion of the bar-coding of items and entry of those items to the FileOnQ database has provided a complete record of information under the control of the DCC. Lost folders costing thousands of dollars is no longer a threat.
• Improved Service - Internal and external "customers" of the DCC no longer search by going to the DCC location. The users can request a file be delivered, on line. The FileOnQ request monitor provides on demand or batch printing of requests with current location data eliminating 75% of the typical work time spent requesting corporate files.
• Improved Control over Destruction of Items - Retention guidelines are enforced with routine audit reports. Records review or destruction is recorded with barcode scans for easy data updates.
• Certification of Operations - FileOnQ was validated as an application by a third party consultant for its high quality in use as a content collection management system. This level of approval meets FDA certification guidelines.
• Reduced Operating Costs - The FileOnQ ease of use has increased productivity allowing DCC staff to handle the growing volume of work without increases in personnel.

Future Plans

Expansion of this application will also include web access to document processing data via FileOnQ's WebView. Through the corporate web site clients will be able to search, view and request content. The application will also be expanded to include storage and tracking of electronic objects like digital photographs, document images, notification letters, and other relevant items that can be stored as an electronic file and linked to evidence and property records.