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Jul 25, 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...

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Jul 14, 20233 min read

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...

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Jul 1, 20232 min read

Electronic archiving - true copy

Even in 2023, the digitization is not fully implemented in every company. What is the result of this? You still need to maintain...

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Jun 22, 20232 min read

Annex 11 quality agreement with IT

There seems to be some work on updating EU GMP Volume 4, Annex 11. I'm looking forward to it! But even in the current version we can read...

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Jun 20, 20232 min read

Orphan data management

Another term that cannot be found in regulations or guidelines: orphan data. How can we define it, and what requirement should be...

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Jun 18, 20232 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...

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Jun 17, 20231 min read

Electronic or digital signature

Sometimes these two terms are mixed up. But is there any real difference? Let me quickly say a big 'Yes' here. What does FDA say (21 CFR...

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