Creating Standardization Using CAPA Model for Global Operations

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 
  1. 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 
  1. Achieved Results

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


Track Wise web

 

 

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