Global CAPA Implementation
I. Objectives
• Implementation was triggered by MD’s 483 procedures.
• Implement a robust, standardized process across all functional units in all four divisions
II. 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
III. Achieved Results
• Standardization, implementation and global roll-out across 40 sites of a single instance, web-based CAPA system
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