You need an effective documentation system. Can the CMDC system be used for a non-medical device manufacturer?
Yes, the CMDC system can be used by any manufacturer. From a documentation standpoint there is no fundamental difference between a medical device and non-medical device manufacturer. In the book, terms such as Device Master Record or DMR are used, and FDA regulations cited, but the fundamentals are the same. The medical device manufacturer generally maintains more documentation simply because its products must be approved by the FDA. Submission documents, clinical trials, and investigational device studies are not part of a typical non-medical device manufacturer's product documentation. The system also controls design documentation and reviews, qualifications and validations, and equipment documentation. Most other systems are not designed to accommodate such product related information. The CMDC system allows for such specialized needs without creating unnecessary work or complexity. The CMDC system is basically a general-purpose documentation system which will accommodate all requirements of the FDA and ISO regulations for product
documentation.
The CMDC system is not a compliance solution. The system was conceived to meet the business needs of any manufacturer who understands the necessity of maintaining good information systems. The CMDC system is designed to organize all product related information. Effective control and efficiency are results of good document organization. It's no secret that compliance is a big issue in the medical device industry. The usual approach is a system specifically designed to meet compliance issues. While this approach can satisfy compliance documentation needs and improve system performance, it does not address many compliance issues involved. For example, this system will provide a place to put the report from a design review, but it does not tell you how to do a design review.
There is nothing in government regulations for documentation that requires a manufacturer to go beyond what makes good business practice. What the FDA requires is just documented evidence that the manufacturer has done everything necessary to ensure that the product shipped is safe and does what it is supposed to do. Your customers may not care about the documentation, but they want safe and functional products. The CMDC system will help you efficiently organize whatever level of detail is appropriate for your business.
We encourage you to purchase our book which explains the CMDC approach to configuration management and document control. It will help make your documentation system into a powerful business asset. The system may be the solution for you.
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