As I occasionally like to do, I’m writing today’s post as a response to a search phrase that brought someone to this blog. The phrase was “how to identify if something is gxp.”
I you have a laboratory informatics system where some information will be GxP and other information will not, you can add a flag, somewhere, and I have done this for some customers.
For example, you might add it as a field to a Project, where all samples logged for certain projects are GxP, and others aren’t, as identified by a True/False flag on the project. The same could be done for anything else. Possibly, you could have the flag on the samples and have a special sample login template that sets this flag to GxP?=True and all other sample login templates would set it to GxP?=False.
That identifies it. Then, for labeling, handling or reporting purposes, you could easily tell what samples are GxP and which aren’t, by the fact that the screen, label or report will show that.
However, if you need to change the workflow based on this, you will have to build it in. If your system requires a lot of programming to add in a workflow, you could merely add more screens and tell the people working with the process to use the GxP-based screens and reports, instead of trying to program it.
These are some ideas to get you started.