What is your root cause? [Study As­sess­ment]

posted by ElMaestro  – Belgium?, 2019-04-19 13:14 (554 d 01:30 ago) – Posting: # 20194
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Hi Libaiyi,

may I ask if you did a root cause analysis and if you did, were you able to assign a root cause to this case?

The RC determines the CAPA. In the absence of a really good RC here, the CAPA could be quite impossible. If nothing is done, it could happen again, so obviously something's gotta be changed here.

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

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