Annotation tool usage - compliance concerns?

Hi everyone,
There is a system policy setting "Disallow Use  of Annotation Tool" that controls a users ability to annotate reports and on the review screen.  In the past I seem to recall concern over the use of this tool and possible compliance impacts.  Are these annotation comments audit trailed?  Can they be seen after saving the report?  And on the review screens?

If you can share your opinion on the compliance impact for using this tool, it would be appreciated!  Thanks, Ralph

Best Answer

  • Accepted Answer
    This topic has been discussed A LOT!  Annotations are just that, annotations on either a printed or saved to pdf document report. If your company is leveraging printing or saving to pdf records ( i.e static and incomplete copies of the electronic records) to make scientific or business decisions, then you should consider if you wish to allow users to 'manipulate' the report before creation. While genuine comments and observations or clarifications might be considered excellent practice, concerns I have heard include such things and putting white boxes over impurity peaks and joining up the chromatography with a straight line!!!!  If you have people in your lab that might consider that acceptable practice, then remove that system policy,

    Just to be clear, annotations do not affect the stored electronic dynamic original Empower result. And, if you use electronic sign off, all annotations are REMOVED before the recording your view of the data at signature is saved in either Empower or NuGenesis LMS. But they will persist in printed or pdf records created from Report Publisher/Preview only.

    The reason this is so widely discussed is that we believe in other (likely non CDS) applications, annotations could obscure information in actual electronic records and a term "electronic whiteout" has been doing the rounds. But at Waters we believe that the use of annotations to manipulate or add to, or obscure data in reports is not a GxP concern as it does not change in any way the electronic record. 

    At the end of the day, the System Polices are there in case you wish to disallow any actions in Empower, so the administrators can consider the risk of obscuring data in  printouts or saved pdfs via the reporting tool, and choose how much control is needed.

Answers

  • If I recall correctly, the annotation is not audit-trailed and is not saved within the pdf report which makes the tool useless anyway.  I've been fully paperless in Empower for years now so if we were to use it, then we'd have to print, hand-sign, and then deal with having a paper record that potentially contradicts the electronic record in some fashion.
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