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How can a computerized system differentiated from an instrument?

Updated: Jun 18

It's easy to decide if something is to be handled as a computerized system, or 'only' an instrument - most times.

What is at stake here? to apply GAMP 5 rules or not. Naturally, all data integrity requirements are still to be kept.

So if I hesitate, what is in my hand, how can I think about this?

First question: is the equipment connected to a higher level system?

If yes (like a probe connected to a SCADA), we can stop right now: all rules apply for the higher-level system, we only need to take care about the periodic maintenance and calibration/qualification of the instrument. But if the answer is 'No', let's see the next question.

Second question: how the GxP-data are collected?

If the answer is 'on paper' (either by printing, or by manual observation and paper-based registration), we have an instrument in our hands that is not needed to be considered as a computerized system. However, let's not forget about managing all GxP-data that are not collected, but configured (maybe we will have a post about master data later). But back to the question: if the answer is 'electronic', we have a computerized system, with all the beautiful requirements coming from GAMP 5.

But since we started this evaluation, let's have a bonus question on our computerized system:

Third question: How is GxP-data reported (and signed-off)?

If the answer is 'electronically', then we have an 'old-fashioned', fully electronic computerized system. If the answer is 'on paper', then it is a hybrid computerized system.

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