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Sunrise Pharmaceutical, 01/10
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Date Published:
Thu, 01/14/2010
Warning Letter citation concerning lack of lab system security and failure to review audit trails.
Poll
When performing a quality risk assessment for a software application, which of these hazards would be rated the most critical?:
A calculation error that could result in an overcharge to the manufacturing organization
A data integrity error that results in a record that a lab analyst had been trained when he/she had not
A faulty lab instrument interface that oculd give a wrong potency level reading for the drug being tested
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