Serial Coding Requires Software Validation


Dear Editor:

I found the May 2002 feature, "Marking Medical Packages with Serial Codes," very interesting, and I agree that serial coding can be a major advantage for medical device manufacturing companies. The aspect of potentially reducing product and package liability when manufacturing problems occur has always been a significant goal.

However, I am concerned about the use of computer-controlled printing processes. It is important to reinforce that it is necessary to ensure that the software has been properly validated, as stated in "General Principles of Software Validation; Final Guidance for Industry and FDA Staff," issued by FDA's Center for Devices and Radiological Health on January 11, 2002. As you have stated in numerous previous articles, the number one cause of product package adulteration is labeling. Computer-controlled printing adds a new dimension to this issue, so to employ such printing successfully, manufacturers must do their homework.

Donald S. Barcan
President & CEO
Donbar Industries Inc.
Long Valley, NJ


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