GxP Versus Non-GxP


While every project is either GxP or it’s not GxP, this year I seem to have gotten into the middle of quite a few projects where there’s some question about whether or how this comes into play in the project.

First of all, something is GxP or it’s not. It’s not “kind of” GxP or “GxP-like.”

Second of all, just because a project isn’t for GxP data doesn’t mean it doesn’t have structure. As we should all know by now, project structure isn’t based on whether something is GxP as much as it’s based on how large and complicated the project is. Thus, the question of GxP or not doesn’t affect whether you need a project manager, installation documents, or any other particular bits of documentation. A large project needs a lot of structure, a small one doesn’t. If it’s GxP, it has unique names for some of these things, but they still exist.

While I’m on that subject, let’s all try to use the right terminology. If a project is for GxP data, use the GxP terms. If it isn’t, don’t try to use the GxP terms. Either way, by not using the right terminology it alarms people who hear you use the wrong terminology and it doesn’t convince them you understand their unique needs. Non-GxP people appear to live in fear that some amount of GxP features will be foist upon them. Their fear is so common because this does actually sometimes happen to them.

And then, there’s the classic discussion regarding whether to combine a non-GxP lab and a GxP lab into the same system. Some do this, others don’t. Regardless, they don’t quite have the same workflows. They can share some amount of programs and configuration but there will be quite a few differences, regardless. Additionally, the non-GxP people don’t want to have to do all those e-signatures required by the GxP folks for 21 CFR Part 11, so that’s yet another item to plan will be different. On top of this, there’s the question whether to put the non-GxP in an ELN and the GxP in a LIMS. First of all, many labs of both types are going for both an ELN AND a LIMS. On top of that, with the way the terminology and features are changing in our industry’s products, we should start thinking about this, differently.

Gloria Metrick
GeoMetrick Enterprises
http://www.GeoMetrick.com/


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