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...

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

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

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...

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

In some ways, almost everybody met the term 'master data' (only for my Hungarian fellows: törzsadat :) ). It's used not exclusively in...

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...