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4th Aug 2015, 04:31 PM
#1
Can the temperature logs be reviewed during on-site monitoring instead? Then you can check they exist and confirm no deviations noted.
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10th Aug 2015, 01:35 PM
#2
We can do that but we will not be given any evidence from site that this is the case during or after the study
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22nd Jan 2016, 06:39 PM
#3
What sort of SOP are they quoting that prohibits them from providing documented evidence that they have taken appropriate care of somebody else's property?
What happens when the trial master file is audited several years down the track, when their temperature monitoring system has been superseded and they can no longer retrieve historical data?
Speaking from the QP/GMP auditor perspective that sort of response aks me wonder what else they might make difficult to prove?
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