top of page

How to Explain, What We Did and Why We Did

When we use any GMP-compliant device or software in the lab, there is one thing that can get really frustrating: when we make any changes, an input form appears asking why we made it. Try to close it, it will not be closed; if you leave it blank, it will not accept, finally meaningless texts such as "ok", "1" or "." are entered and it is forcibly shut. The audit trail repository is already an audit trail dump, when an auditor arrives and examines it. How seriously can an inspector take the work carried out in this laboratory after seeing - to say the least - meaningless audit trail texts?

So why do these softwares want us to make such an entry? Or how should we fill this field most accurately? What actually requested here is, to explain why the action was taken or to enter a valid justification. For this reason, the explanation written here should be the reason for doing the action rather than what is done. Most applications already record the type of action or what has been done automatically.

A statement such as "Mispelling" may be applicable to correct an actual misspelled text, however if all amendments are done because of misspelling, that statement loses its meaning. The most accurate explanation here is to enter why the action was actually taken, for example "Annotation due to SOP revision" or "Standard weighing repeated due to analysis repetition".

Entering the audit reason records correctly can only be achieved by training the users and keeping an eye on those audit trail records. Recently, audit trail review records have also been requested by auditors. For this reason, this process is now tried to be carried out by periodically reviewing the lists of audit trail records and archiving them with the approval signature.

In laboratories where the Manage laboratory management system is used, this process can be carried out much more easily by approving the audit trail records attached to the relevant item, and these records can also be readily accessed and examined by the auditors. Presenting such an audit trail archive, which is properly kept, checked and approved to the auditor, will not only increase your prestige and have a very positive effect on the auditor's perspective, and will also enable you to pass the audit much easier.

5 views0 comments

Recent Posts

See All


bottom of page