Hi,

does anyone have a Part 11 checklist they are willing to share, will save me starting from scratch

many thx Nigel

Hi,

does anyone have a Part 11 checklist they are willing to share, will save me starting from scratch

many thx Nigel

Nigel,

I am not an expert at CFR's, but have you looked here (http://www.google.com/search?hl=en&q=21+CFR+Part+11+checklist+&btnG=Google+Search&aq=f&oq=)?

There seem to be some sites including checklists available for download...

Stijloor.

Anyone have one they can share here to help us build upon our local collection?

Have created one, and have attached for anyone else to use, feedback would be good if anyone has oppinion on improving.


cheers Nigel

Here is one I got a few years back. NOTE: I am not sure of where it came from. I believe I recall that it came from a group that had compiled it as a response of sorts to the compliance. It looks pretty decent.

:magic:1st post

Try this one, produced by a company that consults/specializes in Part 11, software validation and other FDA compliance issues (I have no connection to the company).

can't post links yet, but try the standard dubya dubya dubya stuff, then http://www.certifiedcompliance.com/documents/Electronic_Checklist.doc

Medmfgguy

Thank you all,it is very usefull

Here are some 21 CFR Part 11 references I ran across the other day. Not sure where I got them from, and they appear to be around 2001. But I believe they would provide a fairly good starting point for those having to tackle that requirement.