These resources will begin by reviewing validations that have been done over the past three years and identifying gaps, focusing upon, among other things, appropriateness of sample sizes and statistical rationales. After identifying gaps and identifying remediation’s, they will rewrite the protocols, educate those performing executions on some of the problems that may arise and how to address them, then oversee the executions, gather the master data, and write the final reports.
Equipment and Process Validation a MUST
Equipment will include, but not be limited to, CNC mills, mills, asd laser marking equipment. Processes will be customer-specific molding processes, primarily injection molding a MUST.
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