What is Business Continuity Plan? Before starting to think about Business Continuity Plan for computerized systems, let's clarify the...

There was a post earlier about how to manage OOC investigations. But what if your service provider has its own deviation management...

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...

Introduction Okay. So this is going to be interesting. A really fashionable and fascinating topic, but also kind of sensitive. For this...

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...

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?...

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...