Hi, can anyone provide me an audit checklist for 21 CFR Part 820 ?

Thanks in advance,
Ajit:thanx:

You can find one in the thread Seeking: 21 CFR 820 Audit Checklist. (http://elsmar.com/Forums/showthread.php?t=6603)

You should also look at the flow charts in the FDA Guide to Quality Systems Inspections. (http://elsmar.com/Forums/attachment.php?attachmentid=2418&d=1090851152) You can develop a checklist from them.

Thanks a lot, Al:)

Does anyone has a Checklist for doing QuickStarts based on the 21CFR Part 820 for:
NCMR
DCR
ICAR
Route Sheets

thanks

Does anyone has a Checklist for doing QuickStarts based on the 21CFR Part 820 for:
NCMR
DCR
ICAR
Route Sheets

thanksWhat is QuickStarts?

I moved the thread to this section as it relates to FDA.

What is QuickStarts?
QuickStarts are "Check Lists" for the above documents. This check list should incorporate the FDA Regulations 21 CFR 820 . This should be a 1 pager and can be used as a measurement system, that is measuring a signed of document to this check list. So for the NCMR you will get a Check List that will indicate FDA Requirements and show you steps in the process so you won't forget anything. This is something that I want to setup for my FDA Preparedness Project. Maybe other people have experience with these Check Lists.

Let me know.

Thanks,

Patrick