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By Allan Marinelli and Abhijit Menon | The authors conclude their 4-part article series on computer systems validation (CSV) pitfalls using real case studies to illustrate points related to inattention to details. | |
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By Andy O’Connor, ERA Sciences | Statistical analysis provides a backbone for establishing critical process parameters and offers evidence of process validation for regulatory submissions. | |
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By Mark F. Witcher, Ph.D. | Human errors account for many manufacturing failures, simply due to the roles in our activities and systems. Relational risk analysis (ReRA) fundamentally changes the way risks are analyzed. | |
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