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1.6.1
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...
brunnerbalazs
Sep 11, 20232 min read
What is master data? - part 2: a simple example
-------------- In a previous post, we tried to define master data, and collect the requirements to it. Now let's try to go through some...
brunnerbalazs
Aug 9, 20232 min read
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...
brunnerbalazs
Jul 29, 20231 min read
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...
brunnerbalazs
Jul 28, 20232 min read
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...
brunnerbalazs
Jul 25, 20232 min read
Any clue on validation of a glassware washing machine?
Every company comes up with an approach how to handle glassware washing machine qualification. If it's a new company, somebody definitely...
brunnerbalazs
Jul 20, 20233 min read
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...
brunnerbalazs
Jul 13, 20232 min read
Change control vs Control on change - part 2: QC laboratories
In part 1, I cautiously questioned that the big-guy change control system should be used for every change. Let me give an example area:...
brunnerbalazs
Jun 26, 20231 min read
What is master data? - part 1
In some ways, almost everybody met the term 'master data' (only for my Hungarian fellows: törzsadat :) ). It's used not exclusively in...
brunnerbalazs
Jun 18, 20232 min read
How can a computerized system differentiated from an instrument?
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?...
brunnerbalazs
Jun 17, 20231 min read
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...
brunnerbalazs
Jun 14, 20231 min read
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