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  bullet green arrow 25 Documented process to control and react to changes that impact product realization

bullet green arrow 25Effects of any change, must be addressed, and shall:

astricks-20Define verification and validation activities to ensure compliance with customer requirements;

astricks-20Validate changes before implementation;

astricks-20Document the evidence of related risk analysis; (e.g. FMEA)

astricks-20Retain records of verification and validation.

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