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Based on the risk, any deviation can be classified into three categories:
Critical Deviation
Deviation from Company Standards and/or current regulatory expectations that provide immediate and significant risk to product uality, patient safety or data integrity or a combination/repetition of major deficiencies that indicate a critical failure of ystems.
Major Deviation
Deviation from Company Standards and/or current regulatory expectations that provide a potentially significant risk to product quality, patient safety or data integrity or could potentially result in significant bservations from a regulatory agency or a combination/repetition of “other” deficiencies that indicate a failure of system(s).
Minor Deviation
Observations of a less serious or isolated nature that are not deemed Critical or Major, but require correction or suggestions given on how to improve systems or procedures that may be compliant but would benefit from improvement (e.g. incorrect data entry).
