Software versions

[CLIMBER514]

Would it be a big deal if you were a FDA inspector and noticed that a site was running two different versions of software in a live environment?

Say, for instance the server software was on 2.1.5, and the client software was on 2.1.3.

Would it be the responsiblity of the hospital/donor center to make sure the correct versions were synched?

OR

Would it be the responsiblity of the software company to make sure there functionality built into the software that ONLY allowed server version 2.1.5 to talk/communicate with client version 2.1.5.

Curious what your opinions are... what you would do if you discovered such a problem in the midst of implementation?

[Bill]

What does the Test Validation document state? Also, if all validation procedures were properly completed and documented, then you have documentation that the system is working properly--IF these same versions were tested the same as what is in live.

It is the computer system's responsibility only if that is what is stated in the contract.

It's the same idea--do all your PC's run the exact same version of operating system with all exactly same updates on ALL PC's?

[rnozick]

The FDA usually expects the vendor to tell their clients any restrictions on software version and/or Equipment needed to make the system work according to specs. If there are no restrictions, then it is up to the client to validate their entire system works according to their requirements. I might call my vendor and make sure Vx of something works with Vy of something else as far as they know. It IS, after all, up to you as the user to make sure of this, but most of the vendors will help you with this verification if you ask.

The FDA knows that not all parts of a system will be the same version, however the Vendor has to prove to the FDA that these versions work together as a system or that's when there might be restrictions placed on versions. Hope this helps. Robin