Electronic Records and Signatures - 21 CFR Part 11

[Marc]

The pharmaceutical industry is moving towards the electronic records/electronic signatures and the FDA has issued regulations regarding electronic records/signatures (21 CFR Part 11). You may review the regulation by visiting the FDA web site, www.fda.gov/ora/compliance_ref/part11/

[This message has been edited by Marc Smith (edited 05 April 2001).]

Anybody knows if Adobe Acrobat suffices using it's electronic signature option, to comply with this.

Our corporate headquarters want us to use Lotus Notes, but cost wise I am more interested in transferring my MS Office documents into PDF files.

S.

[Marc]

I can't say for sure on this. I do get the 21cfrpart11 posts from the 21cfrpart11 folks at www.yahoogroups.com responses e-mailed to me but there are so many I really don't read them very often any more. The 21cfrpart11 folks do have a web site but I can't remember the url off hand.

QualPro - can you help here?

[QualPro]

Off hand I do not know of a website for 21 CFR Part 11, other than the FDA main website (in the CFR section), which puts you directly into the CFR text.

Also, the FDA does have "guidance documents" on 21 CFR Part 11 that you can link to from the main FDA website at www.fda.org.

In short, the FDA website is the best place to start.

Regarding Adobe Acrobat, I doubt if it is an appropriate tool, since it "probably" does not provide the audit trail and security required.

This is an area of great interest to me. I will be doing some research on this subject since I plan on developing a tool for small companies to achieve electronic signature. I am willing to share notes if you are interested.



QualPro