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15th Apr 2016, 09:13 AM
#6
Moderator
Commercial off-the-shelf packages would not require revalidation, but it may be appropriate to undertake installation, operational and performance qualifications. The key requirement is that any trial specific configuration/build/programming etc within the system is evaluated as fit-for-purpose (validated) and that this assessment is appropriately documented. For further information see the MHRA GCP Guide 14.5.
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