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URS in AIQ - how to specify an analytical instrument?

We have covered several parts of the AIQ: a promotion for a couple of fine white papers, DQ, and PQ. Now let's start to think about how...

Deviations during requalification

There was a post earlier about how to manage OOC investigations. But what if your service provider has its own deviation management...

OOC/OOA - how to handle it?

In case of analytical instruments, some companies use the term Out-Of-Calibration, others use Out-Of-Acceptance for failed recalibration...

AIQ - how about the IQ?

In former posts, we discussed the DQ in general, and the analytical instrument PQ. Now let's collect what we need to perform a thourough...

Audit trail review - how to do it properly?

Related to the data integrity fashion-wave, the audit trail review, as a process receives high attention. It's obvious that 'the' audit...

AIQ - what should PQ contain?

Sometimes the question comes up: what should we really test during the PQ on a newly purchased analytical instrument? You did your best...

A couple of great white papers on USP 1058: AIQ

Agilent tries to help the companies understand the essence of the latest (2017) change in USP section <1058>: Analytical Instrument...