ABSTRACT
This chapter focuses on computerized systems was an attempt to embrace the reality that automation and information management systems were becoming a larger and larger part of the drug development process. In order to achieve this industry had to change the way it developed medical products and established Quality Assurance. In an effort to promote common understanding, the FDA chose to focus on specific areas within the industry through a combination of focused surveillance inspections and presentations at industry professional organizations, such as the Pharmaceutical Manufacturers Association (PMA), the International Society for Pharmaceutical Engineering (ISPE) and the Parenteral Drug Association (PDA). Six Sigma and Lean Kaizen efforts are based upon a structured and measurable approach to process characterization and improvement. Fault Tree Analysis (FTA) is a team-based method used to identify the causal chain that creates a hazard or a failure mode. The Risk Priority Number (RPN) is used to prioritize mitigation actions for each identified risk.
