Configuration Management and Document Control
Fundamentals for Medical Device and Quality Certified Manufacturing
by Daniel P. Brennand & David P. Tondreau

This book is about effectively managing what the FDA calls the Device Master Record (DMR). The DMR is basically just all of the documentation that defines a product. While all manufacturers have a DMR in some form, many have not formally defined all of these aspects:

• Content of the DMR

• Organization and structural relationships between documents

• Conditions under which the DMR may or may not be changed

• Relationship with the Device History Record (the DHR: mainly production records)

• Use of the DMR in the organization as a valuable business tool

Effectively managing the DMR is the key to effective configuration management and document control. Defining the content, organization, and structural relationships at the beginning creates a very powerful planning and control tool for product development. Properly structuring the DMR reduces the number of changes required to maintain the DMR, and keeps configuration consistent across product lines.

Content and structure are discussed in great detail in the book. The book shows you exactly how to establish and control relationships between documents. In addition the book discusses how to:

• Determine what data is necessary to effectively control the DMR

• Implement a fully structured DMR

• Implement an effective Design History File (DHF)

• Define the roles of change originators and reviewers

• Recognize the fundamental differences between managing documents in the DMR and physical parts in MRP

• Establish an effective relationship between MRP and document control

• Effectively control temporary changes

• Effectively control document distribution

• Increase efficiency of document and change processing

• Measure the performance of the documentation and change control system

• Develop an effective numbering system

• Become aware the of pitfalls of automating document systems

The Authors:
Daniel Brennand and David Tondreau have over 30 years of experience in the medical device industry. Dan is an electrical engineer with over 20 years in manufacturing of class 2 medical devices. Dave has over12 years of experience in document control of class 2and class 3 medical devices. Both have developed manual and automated document control systems.

Dan holds a B.S. degree in Electrical Engineering from the University of New Mexico and Dave holds a B.S. in Library Science from Bowling Green State University,  Ohio, and an M.S. in Systems Management from the University of SouthernCalifornia.

Price: $110.00 USD plus $7.00 Shipping and Handling ($20.00 S/H for international orders)

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