Chromatography Forum

Hi,
Lately, in the company where I work, we started think about data integrity (CFR 21 part 11), as I know that in other countries, this is already common, I would like to know how you do to explain some things like:

- Invalid injections within the project;
-Result ID repeated;
-Manual integrations;

If you remember more things that were pertinent in the course of adapting the culture of integrity, please share so that you can adapt the system more and more. I currently use Empower and Openlab, last week I received a auditor and they asked to me about review of Audit trail, is it normal to you?

Thank you.

If you have Full Audit Trail (FAT) configured as default in the Empower System Policies, then audit trails are connected to practically everything you do in Empower from log on to logout. The tab "Audit Trail" in your project gives a chronological view of every single activity you perform.

Invalid injections? You mean test or trial injections? Not great to do this at all but if SOPs allow it, you should stick to a standard injection (never a sample) and provide a full comment and only do it to test the signal of an idle system or after an intense washdown of a detector etc.

Result IDs repeating are due to processing your sample data more than once or possibly quantifying samples using the same standard labels. Processing codes or features like "Manual" "Integration Type" and Processing Locked can be thrown into a report method to flag any unusual results.