We are trying to get our act together in relation to computers/software and FDA 21 CFR part 11 at our Cellular Therapy Product lab. Does anybody have any pointers or validation plan that may help us to start planing ours?

Most sites use a third party to validate their computer systems. In the long run it saves time, money, and a lot of aggravation.

Let me know if you're interested in a 3rd party validation provider. I can help.

We validate in house and with one exception always have. There are some nice software packages that will do it for you, but most vendors supply a script that you can use at your discretion to stress test the system.

However, 21 CFR 11 deals with electronic signatures and not, necessarily, computer system validation. So my question, to answer your question, is are you validating a home-rolled system that uses electronic signatures or trying to make certain your LIS has the ability to properly document electronic signatures?

We do not use an LIS per se, and also we do not use electronic signatures (yet). We do save patient documentation from loggers and controlled rate freezers in our computers and also have electronic documents (SOP's and other forms) that we use.

I think that more than anything we want to know especifically what would " trigger" part 11 on the way we use computers and what we should be doing to validate, or, if there is an alternative to stop " triggering" part 11 (if that makes any sense).

There is a draft guidance from the FDA (from 2007). It's just a draft, so it's not "official", but it is very thorough.

FDA guidance for computer validation 2007.pdf