Original signed IQ/OQ/PQ missing - but have data - Do we do it over?

NikkiQSM

Quite Involved in Discussions
#1
Hi All -

During an audit, I found that our IQ/OQ/PQ report for moving a machine from one side of the facility to the other was missing all the approval signatures.

The IQ/OQ/PQ was done in 2011. I have the template still filled in with all of the data.

But I can not find the originally signed document from 2011.

Does this mean we have to redo the whole IQ/OQ/PQ?

Thanks in advance,
Nikki
 
Elsmar Forum Sponsor
#3
You still have the signed protocol and the data that you got from executing that protocol? Worst-case, rewrite the report and get new signatures today. In the rewrite explain the gap in timing.

If you still have the original report and are just missing signatures from that, I would at least rev up that report to add a section about the gap in timing and get signatures on the revised report.

I'm just answering based on my understanding from your problem description. You really need to evaluate this based on what you still have from 2011.

Follow-up thought: what are your revalidation requirements? At the pharma places I've worked, 7 years was the longest time period for revalidation of any of our processes. I don't know your process or validation requirements, but it seems like you'd be due for revalidation soon (if not past due) anyway.
 
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