Changes to software are not magic. They should not be a surprise. Changes that are made to your validated software should not surprise you. You should be able to trace them and decline unnecessary updates.
So you are plugging along using your validated 21CFR11 software and you notice something is a little weird…Was that field here before? Didn’t there use to be a shortcut for this? Did something change on this report? Something did change. Now you have to change your procedure of how you use your software. Maybe you have to retest some things.
Hopefully the changes are infrequent, announced in advance, you have the option to decline them, and they are well documented. This way, you don’t find out in the middle of some inspection that all of the sudden, your software isn’t as validated as you thought it was.
Some software marketed for GMP compliance don’t give you the option to accept or decline changes, and maybe they don’t document the testing or traceability of the changes in a way that is accessible to you. So you end up being a reactive mode if you find a change, and hopefully that doesn’t happen during an audit.
GxPReady! prioritizes change control to make software reliable so that changes infrequent, pre-announced, provided with the appropriate change control documentation, and you almost always can decline to implement changes for your deployment. You have a package you can show an inspector documenting that YOU have control over your deployment and it is traceable to your requirements at all times.
Surprises on a stage are great fun! Surprises in your software can lead to non-compliance. Keep control. Try GxPReady Suite for your validated CMMS system. Contact us here.