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Companies that deal with the FDA....

WayneBeck
1-Visitor

Companies that deal with the FDA....

Our qualtiy department is telling us that we need to have signatures on all of our prints to prove they have been checked. We currently do not have workflows with CFR-11 turned on. We currently state that the ECN that is signed is our proof that the drawings and BOM have been reviewed. I would like some input on how other companies deal with signoffs.


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1 REPLY 1

We also use the MC or DCO as the sign-off mechanism.


Are your models/assemblies under control as well? If so, how would you sign-off on them?


Regards,
Michael Braaten
Senior PLM/CAX Systems Analyst - Synthes, Inc.

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