Changes

# Verify the Bill of Materials corresponds to raw materials and manufacturing procedures

# Correlate incoming and in-process inspection procedures with the process specifications

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| Linkage between component and raw material specifications and appropriate incoming inspection procedures

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# Review supplier audit reports for compliance

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| Calibration records and preventive maintenance records; in-process / incoming inspection test methods and related test method validations

# Was machine operational qualification performed?

# Was the measurement equipment validated?

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!rowspan="2"|Validation Report