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RE: OneWorld Auditing

MKlehm

Member
RE: OneWorld Auditing

Hi Sean,

2 things:

1) Ask your JDE Engagement Manager for the whitepaper on JDE's =
compliance with FDA 21CFR, part 11. Depending upon your interpretation, =
JDE might be compliant.=20

2) If you determine JDE is non-compliant w/ part 11, check out a =
product called DetectIT (http://www.detect-it.com).

-Mike Klehm
 
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