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Jun 17, 20232 min read

A possible origin story of OOT-limits - part 2

In the first part, after the introduction we discussed mostly where we should look around searching for OOT-limits. This second part is...

Jun 17, 20232 min read

A possible origin story of OOT-limits - part 1

Disclamer: this and the following posts are only about the release test related OOTs, the stability OOT-limits are not considered. I...

Jun 17, 20231 min read

A small piece of thought about risk assessments

The new version of ICH Q9: Quality Risk Management is going to be implemented in EU in 2023-JUL-23. This version doesn't contain any big...

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...

Jun 17, 20231 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?...

Jun 15, 20231 min read

Be brave! Kill your abandonded records!

Even the best companies might face the situation that an old unclosed event fall out of the closet. It can be a two-year old CAPA, a...

Jun 15, 20231 min read

Empty fields in electronic records

I received the question several times if it is a compliance issue to leave empty fields in electronic record. Let me just copy-paste my...

Jun 14, 20231 min read

Change control vs Control on change part 1: general thoughts

Every pharma company has a well-established Change control system with the related system, SOP etc. But is that the best platform to...

Jun 14, 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...