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Validity : 21st Apr'24 to 01st May'24
If you have reoccurring problems showing up in your quality systems, your Quality system is not effective and you have not performed an in-depth root cause analysis to be able to detect through proper problem solving tools and quality data sources, the true root cause of your problem. Unless you can get to the true root cause of a failure, nonconformity, defect or other undesirable situation, your Quality System will not be successful. Historically, 483s in the pharmaceutical industry related to CAPAs, are due to lack of inadequate root cause investigations, among other factors.