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  Documented process to control and react to changes that impact product realization

Effects of any change, must be addressed, and shall:

bullet green arrow 25Define verification and validation activities to ensure compliance with customer requirements;

bullet green arrow 25Validate changes before implementation;

bullet green arrow 25Document the evidence of related risk analysis; (e.g. FMEA)

bullet green arrow 25Retain records of verification and validation.


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