Deviation

Anything that varies from the accepted norm or standard is called a deviation. It is common in math and science, but it can refer to anything that differs from the expected.

Critical Deviation
Deviation from Company Standards and/or current regulatory expectations that provide immediate and significant risk to product quality, patient safety or data integrity or a combination/repetition of major deficiencies that indicate a critical failure of systems.

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 observations 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).

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