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How do I get and set digital signatures with the 21 CFR part 11 standards as defined by the Food&Drug Administration of the USA?

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1 Answer 1

Reading the regulations themselves is a big start there. I'd also look at the most recent guidance that I've found. As I quickly interpret it, these aren't digital signatures in the way that most of us are familiar with. Rather, they are fields on data set by a controlled process which requires authentication, creates audit logs, and is under appropriate controls.

I'd implement something like that with a table that links signatures to document ids and records all entries with sequential numbering.

Beyond that, you're probably into needing to pay for consulting work.

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Thats what i get after reading the rules, im so lost... is there a free signature service? all that i found are so expensive. thanks – –  razstec Sep 27 '11 at 14:08
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You're seeking guidance on something that is a very broad concept and dependent upon a lot of details about your needs. If you're completely lost, you need to have somebody else more seasoned in this are to look at this for you. This is a systems design and internal controls problem. –  Jeff Ferland Sep 27 '11 at 14:28
    
ok, thanks for all –  razstec Sep 27 '11 at 14:43

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