Configuration Management and Document Control is our business
CMDC systems inc. is a consulting and systems development company that recognized the need for expertise and experience in product documentation, especially in medical device manufacturing. Documentation is all we do at CMDC. While we have over thirty years of experience in class 2 and class 3 medical device manufacturing, engineering, product development and document control, we have taken the time to study what works and what does not. To that end we have developed a new paradigm for configuration management and document control that is low cost, efficient, and effective.
We are not a compliance company per se. It is our belief that a business must have a configuration management and document control system that meets the needs of the business first, not the perceived needs of regulators. If one is truly meeting the needs of the business, the regulatory issues take care of themselves.
We began by recognizing that the change process is one of the most complex processes routinely undertaken by any company. The key to efficiency and effectiveness in product design, development, and manufacturing is being able to make changes quickly and correctly. It takes a well designed and managed configuration management and document control system to manage change effectively.
CMDC has developed a comprehensive configuration management and documentation program designed for the small to medium sized medical device manufacturer. The system requires a miminum of one desk-top computer to operate, and it can be made available to all users through a network.
Our goals:
Provide a uniform methodology for handling all product documentation as a set of interrelated documents
Present a detailed framework establishing relationships between documents
Provide guidance on the content of documents
Outline the mechanics of managing the creation, change, distribution, storage, and destruction of documents
Outline those policies and management practices necessary to insure system success
We have written a 300 page book detailing what it takes to have an effective configuration management and documentation system. The book describes a new paradigm for configuration management and document control, and points out common practices that are a source of inefficiency.
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