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...
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brunnerbalazs
- Aug 9, 2023
- 2 min
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...
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brunnerbalazs
- Jul 29, 2023
- 1 min
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...
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brunnerbalazs
- Jul 28, 2023
- 2 min
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...
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brunnerbalazs
- Jul 25, 2023
- 2 min
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...
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brunnerbalazs
- Jul 20, 2023
- 3 min
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...
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brunnerbalazs
- Jul 13, 2023
- 2 min
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...
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brunnerbalazs
- Jun 26, 2023
- 1 min
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:...
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brunnerbalazs
- Jun 18, 2023
- 2 min
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...
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brunnerbalazs
- Jun 17, 2023
- 1 min
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?...
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brunnerbalazs
- Jun 14, 2023
- 1 min
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...
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