Creating Standardization Using CAPA Model for Global Operations

1. Objectives

• Implementation was triggered by MD’s 483 procedures.
• Implement a robust, standardized process across all functional units in all four divisions 

2. Methodology

• Gap analysis & process re-engineering
• Consolidation of general office & manufacturing facility practices
• Developed & trained out an interim Access based, web CAPA system
• TrackWise implementation Project Management
• Quality sub-systems non-conformity processes evaluation
• Development of escalation processes to management review
• Overall project management for FDA commitment tracking 

3. Achieved Results

• Standardization, implementation and global roll-out across 40 sites of a single instance, web-based CAPA system