Jump to content

Writing a computer validation plan


Recommended Posts

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. :cries: Does anybody have any pointers or validation plan that may help us to start planing ours?

Link to comment
Share on other sites

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?

Link to comment
Share on other sites

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).

Link to comment
Share on other sites

Create an account or sign in to comment

You need to be a member in order to leave a comment

Create an account

Sign up for a new account in our community. It's easy!

Register a new account

Sign in

Already have an account? Sign in here.

Sign In Now
  • Recently Browsing   0 members

    • No registered users viewing this page.
  • Advertisement

×
×
  • Create New...

Important Information

We have placed cookies on your device to help make this website better. You can adjust your cookie settings, otherwise we'll assume you're okay to continue.