In a scenario that I am involved with, a DME (
data medium exchange) file is used in conjunction with another software to allow customers to design a regulated class II part. We treat the DME file as a controlled document. It is stored in a document and change control software system.
The DME gets revised from time to time and it needs to get pushed (uploaded) into customer systems so they have the most current version. To do this upload, the DME needs to be exported from the document control system as a zipfile onto desktop of tech support employees; the zipflle is then uploaded through "ftp" into customer systems.
If number of customers is large, it would mean doing the update of the DME may take several days. During these several days, the DME which is a controlled document will reside in more than 1 place; the document control system and desk tops of tech support employees.
Will this be acceptable to FDA and other regulatory entities? What would be the best way to do this?
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Robert Nami
Carlsbad CA
United States
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