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
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