Changes
/* Review components */
| Calibration records and preventive maintenance records; in-process / incoming inspection test methods and related test method validations
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# Check the entire equipment-related lifecycle
# Was machine operational qualification performed?
# Was the measurement equipment validated?
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| DV&V reports, Shelf-life reports, Biocompatibility test reports, Sterilization reports, Packaging Validation reports, Process Validation Reports
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#
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