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On Sat, Dec 29, 2007 at 03:14:11PM -0500, Stephen Adler wrote: > So here is the issue which has brought up my interest in digital > signatures. I'm setting up a quality system to develop software which > will pass the rigors of FDA compliance. What the FDA needs is to have > documents which are signed for approval my management types. (i.e. All > the documents which are generated need a signature and typically this > involves some secretary running around cubicles with a pen, getting > signatures on a hard copy document which is then filed away.) So using a > digital signature would be a great move forward, especially if I want to > set up a web based FDA control process. In the end, this all gets very > legal where as someone can sue for big bucks if a product goes wrong in > a hospital, and the quality system under which the device was developed > then comes into play. So this may give you a better idea of how far I > need to go with a digital signature. My preference is to slide the bar > as far to the "this is a properly digitally signed document" which can > hold up in a court of law.
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