FDA Guidelines

[Tony]

Hello,

Is there a document outlining how developers can produce
access databases according to TGA (Theraputics and Good
Administration) Australia - FDA (food and Drug
Administration)USA - or EMEA (European version) guidelines?


Regards,

Tony.

 

[Larry Linson]

I'm not aware that the Food and Drug Administration regulates databases in
the US. What are you talking about?

Do you mean the agency that regulates safety in the workplace? In the US,
that'd be OSHA, and I don't know where you'd find their guidelines -- but
you could start looking at their website, http://www.osha.gov/.

 

[sue]

If you are talking about part 11 compliance of FDA
regulations, here's an interesting article with a link to
a vendor with an Accesss solution.

The Part 11 Toolkit for MS Access can make any Access
database compliant with Part 11, including audit trails,
electronic signatures and user/password controls. See how
fast and easy it can be to build a secure Access database
that's ready for validation.
How can I get a free trial copy? To celebrate the release
of Version 2.0, we are offering free installation and a
free trial copy of The Part 11 Toolkit. To see how easy
compliance can be, visit www.OfniSystems.com.