Product Development
Strategy and Planning
Supplier Selection and Oversight
Intended Use and User Needs
Design Input Requirements
Risk Management
Test Method Validation
Design Verification and Validation
Root Cause Analysis
Product Commercialization
Strategy and Planning
CMO Selection and Oversight
Risk Management
Test Method Validation
Equipment Qualification
Process Validation
Design Transfer
Process Monitoring
Documentation
Design History File
Risk Management File
Technical File
Specifications and Drawings (GD&T)
Policies and Procedures
Work Instructions and Templates
Quality System Development
Strategy and Planning
Quality Policy and Manual
Design Control
Risk Management
Statistical Techniques
Purchasing Control
Change Control
Deviation and CAPA Management