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Proposed Quality Improvement - Thoughts?

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.


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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