The Drug Information Association (DIA) will be publishing a textbook this fall, 2009 regarding this very topic..Computerized Systems in Clinical Research. This textbook will the be 'the reference' for 21 CFR Part 11 that the entire team can utilize and learn the requirements for your computerized systems to be compliant with this regulatory requirement. I know about this personally, as I am one (1) of 80 contributing authors to the textbook.
Once it is released, I will let the forums know.
Also, check the Society of Quality Assurance website www.sqa.org.
With best Regards,
Liz Wool,
ACRP Northern California Chapter President