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

Metrics

Collection and interpretation of metrics to guide future improvements

Templates

Creation of templates for all Design Controls deliverables

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

Tool Validation

Change Control / Management