Which kind of media (CD Roms, WORMs, etc.) can be considered “21CFRPart11 compliant” from point of view of good retention period?
In an effort to remain technologically neutral, the FDA does not specify the kind of media that one must use for archiving. There are studies currently underway from independent sources that are trying to test the ‘lifetime’ of such media as CD ROM, although there is no set standard lifetime for such media. Some companies are doing their own tests on media lifetime.
