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Process Improvements

Process Validation

Master Validation Plan development

Installation Qualification (IQ) / Operational Qualification (OQ) / Performance Qualification (PQ)

Process Failure Modes and Effects Analysis

Statistical Process Controls


Collection and interpretation of metrics to guide future improvements


Creation of templates for all Design Controls deliverables

Define / Measure / Analyze / Improve / Control (DMAIC)

Tool Validation

Change Control / Management

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