cancel
Showing results for 
Search instead for 
Did you mean: 
cancel
Showing results for 
Search instead for 
Did you mean: 

Community Tip - Visit the PTCooler (the community lounge) to get to know your fellow community members and check out some of Dale's Friday Humor posts! X

Companies that deal with the FDA....

WayneBeck
1-Newbie

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.


This thread is inactive and closed by the PTC Community Management Team. If you would like to provide a reply and re-open this thread, please notify the moderator and reference the thread. You may also use "Start a topic" button to ask a new question. Please be sure to include what version of the PTC product you are using so another community member knowledgeable about your version may be able to assist.
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.

Top Tags