Transcription of Managing corrective and preventive action (CAPA) …
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Managing corrective and preventive action (CAPA) …
IBM asset management solutions White paperManaging corrective and preventive action (CAPA) in a life sciences environment. March 2007 Contents 2 Executive summary 4 Setting the stage 5 When is CAPA relevant? 6 How to manage CAPA 7 Incident management 8 CAPA process 9 Background 10 Benefits 12 IBM Maximo Asset Management as a framework to support CAPA processes 17 Conclusion 19 For more information 19 About Tivoli software from IBMM anaging corrective and preventive action (CAPA) in a life sciences 2 Executive summaryIn the life sciences industry, the process of Managing non-conformities or defects from manufacturing, engineering, quality or other quality data sources, such as product complaints leading to corrective or preventive actions, is a formal and controlled one used to identify, correct and prevent problems that occur. Today, the industry is facing strong pressure from regulatory bodies government as well as from the industry itself to focus on quality and, at the same time, the need to increase asset utilization and efficiencies, and lower cost as much as possible.
In parsing any CAPA definition, there are subtle but key differences between . corrective action and preventive action. Corrective action is defined as an action
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