CFR 21 part 11 compliancy

CFR 21 part 11 compliancy

Are there any plans to make CVF CFR 21 part 11 compliant?
Have you even heard of CFR 21 part 11?

The FDA (and OECD) are requiring that all electronic records comply to regulations CFR 21 part 11. Which means that all software that creates electronic records must comply. And it means that such software must be written using compliers that comply. (I don't know of any compiler vender that is doing this).

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Hadn't heard of this specifically. Help me out - WHERE is it specified what it means for a compiler to comply with this rule? I've read the rule and can't find anything more than this:

11.1(e) Computer systems (including
hardware and software), controls, and
attendant documentation maintained
under this part shall be readily available
for, and subject to, FDA inspection.

All that I can see is that software you write that creates electronic signatures needs to be available for validation - I don't see ANYTHING that relates to tools used to create such software.


Steve - Intel Developer Support

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