FDA Global UDI Database: Record Submission Retention

Pmarszal

Involved In Discussions
#1
As many of you may know, the Class III and Class II deadlines are past and have some post-submission question.

How does your company handle records of the submission to GUDID database? Is there any requirements for us to meet?

Our current process is to save a copy of the submitted GUDID record to our database and keep a running locked UDI spreadsheet as we move forward.

Is there anything I am missing?

I appreciate your response in advance.
 
Elsmar Forum Sponsor

QA-Man

Involved In Discussions
#2
First we made a quality plan on what to do and updated when appropriate. We kept track of the information entered using SharePoint but we didn't keep records of actual submissions.

Then we put the DI and the PI's to be used on the artwork (labeling spec - implied by 21CFR820.120(b)). That went into the DMR.

UDI's (with actual PI's when applicable) are documented in the DHR (21CFR820.184)
 
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