Can anyone provide me an audit checklist for 21 CFR Part 820?

[Ajit Basrur]

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

Thanks in advance,
Ajit

[Al Rosen]

You can find one in the thread Seeking: 21 CFR 820 Audit Checklist.

You should also look at the flow charts in the FDA Guide to Quality Systems Inspections. You can develop a checklist from them.

[Ajit Basrur]

Thanks a lot, Al

[patrickmeussen]

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

thanks

[Al Rosen]

In Reply to Parent Post by patrickmeussen

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

thanks

What is QuickStarts?

[Ajit Basrur]

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

[patrickmeussen]

In Reply to Parent Post by Al Rosen

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