Result Audit Viewer in Empower 3 FR2
Answers
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Additional information would be helpful.
1. In particular, it would be useful to know the version that was in use prior to the E3FR2 upgrade.
2. Does the error occur with data acquired in newly created projects since the upgrade?
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Hi, thanks for the reply.
The "Error - unable to load Method Set 0!!" message center entry appears to be caused by processing a sample set using a processing method which is not in the method set and instead manually selected. The Method Set tab in RAV is blank if this is the case and spawns the error. This makes sense. Processing a sample set using the default 'use method set PM' option gets rid of the error message and the versions of the method set are listed on the Method Set tab.
The second and more important issue is that when I load a result set or individual results into review and then run the RAV tool, I do not get any info on the 'result differences tab'. I would expect this tab to show me additional versions of the selected result and the differences between them. This is the case even if I send all versions of the result into review. I get the list of results at the top, the list of peaks at the bottom and all other tabs in the middle section are populated other than the Result Differences tab.
I have performed the work in a brand new project created under FR2, SR2 with all current hotfixes, with brand new methods created under the same. I should add that the AQT does not indicate any issues with the IQ or OQ, and prior to the upgrade we were running Empower 3, SR1.
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Hi Jason,
The Result Differences tab in the Result Audit Viewer shows differences between the current result and anything that it has superseded. This happens only when a manual change is made to a result in the Review window and then saved.
The RAV tool was developed primarily to aid in the reviewing of Audit Trails, and it was thought that it might be too confusing to be presented with every result associated with that channel/injection, especially if results were processed several times with different processing methods.
We have had requests for the functionality you were looking for, and we are currently trying to find an appropriate solution for that type of information/comparison in Empower.
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Thank you Christopher, this was very helpful. I would look forward to any developments in this area as it comes under intense scrutiny these days from all our regulators (pharmaceutical).
cheers
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Hi Jason,
A few of the clients that I work for have recently undergone what I would consider to be an electronic records compliance audit. I believe these audits were conducted in light of the new FDA and somewhat older MHRA guidances that were issued for electronic records.
Though these companies did well in these audits overall, I did notice one common thread between all companies that were audited: there is no documentation that these audit trails were being reviewed. I should also note that this comment extended beyond the Empower CDS to just about every digital 21 CFR 11 compliant software in use.
At the end of the day, the question is this: how are you documenting your review of the RAV in Empower? My initial reaction to bring this into compliance would be a logbook or an item on work lists that specifically state: has audit trail been fully reviewed?
Just curious to hear your opinion/thoughts.
Thanks,
Shaun
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Hi Shaun,
For sure an FDA auditor will challenge a sites ability to find data integrity non-compliances. Like all regulators they want to know that you have identified the areas of concern through risk assessment, implemented and validated a range of control measures to limit the risk, and collect and periodically review the finding after the system has gone live and adjust accordingly.
I have gone through FDA/MHRA audits and I agree with your assertion that audit trail review is a key point.
I have found that this can be captured adequately by having an SOP that guides through the review process (audit trails, result versions etc.) and specifically states that the e-signature and/or analyst check signature in the worksheet/ELN etc. confirms that all required raw and meta data as defined by the SOP have been checked for consistency and completeness. The analyst, check analyst and authorising body (lab manager/QA whatever) have to do these checks.
We design test scenarios into the analyst training with a range of non compliances to challenge the process and demonstrate peoples competence to find issues if they exist, e.g. multiple result versions for an injection, with only 1 being reported in the final lab worksheet, or insufficient justification for multiple versions etc..
Often a place misses out this small detail of defining exactly what a signature is saying and yet they do all the checks but as it isn't explicitly stated and controlled by a QA controlled document they get an observation.
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Hi Jason,
I appreciate your detailed response and your insight into the issue is much appreciated!
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