Information Security Stack Exchange is a question and answer site for information security professionals. Join them; it only takes a minute:

Sign up
Here's how it works:
  1. Anybody can ask a question
  2. Anybody can answer
  3. The best answers are voted up and rise to the top

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?

share|improve this question

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.

share|improve this answer
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
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

Your Answer


By posting your answer, you agree to the privacy policy and terms of service.

Not the answer you're looking for? Browse other questions tagged or ask your own question.