One More GxP Compliance Issue


Just this week, I noticed the post GxP Versus Non-GxP had an unusually high number of readers. With Autumn quickly approaching, I will guess that people are starting to think about new projects and, with that, compliance issues.

Most of what I have to say about GxP situations versus those which are not GxP can be found in the GxP Versus Non-GxP post. However, I do mention in that post that we do sometimes want to combine GxP labs with non-GxP labs in the same LIMS instance.

That is a topic that comes up rather frequently – the question of whether to combine non-GxP and GxP labs into one system. The answer to that is that it depends on the system you purchase. If you think you might want to combine everyone into one system, you need to ask whether the audit and the electronic signature features can be configured (or programmed) so that they can be used differently by different groups of users in the same instance.

This is just a feature like any other feature – if you need details, ask for them before you buy the system. Getting a demo on what you need to do to split this up isn’t a bad idea, either.

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


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