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Nanda, in my revised software validation package, following my risk assessment worksheet, I have added the following table due to the new CSA guidance. I find it really helpful and practical in mapping a risk conclusion to the degree of validation rigor. Framework for Risk-Based Validation Rigor ...

Hi Nanda, I am currently upgrading my software validation processes to reflect impact of the new guidance. I will circle back to you once I have that completed. I have a current client in need of a process assurance/validation that will include software so I will be testing the impact on this project ...