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Proposed Quality Improvement - Thoughts?

#1
I am looking for other points of view regarding this Quality Incident process approval presented to my Quality team. I am open to being robust but I am not in agreement with not having to initiate a deviation from an established process or tracking a deviation in a memo. We are a company that performs packaging and labeling of clinical trial materials which are distributed throughout the world to patients in clinical trial studies.

I appreciate your feedback.
 

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#3
We do not follow any ISO standards as we follow 21 CFR Parts 11, 210, 211, 820 and 1270. We package and label our client's investigational drug for clinical trials.
 
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