Questions about data manipulation [GxP / QC / QA]

posted by qualityassurance – 2024-04-30 13:38 (20 d 17:12 ago) – Posting: # 23967
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Dear Forum members,

❝ Dr. Anders Fuglsang has developed several software programs to detect such manipulation.


Is it advisable that CRO use this software (after implementing the SOP within the system) and prove that no such manipulation was done during BE study. By this way both sponsors and CROs are relaxed and regulatory authority will also have readily available data from the software.
The idea behind above approach is, there is no other way of finding such manipulation (profile duplication) during routine QA review or monitoring by sponsor.

Regards,
QA

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