Computer System Validation: Typical Approach for Category Wise Software validation | GAMP5 | CSV

Computer System Validation: Typical Approach for Category Wise Software validation | GAMP5 | CSV

The FDA defines software validation as: “Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled”
In this I have discussed, the typical Approach for category-wise software validation as per GAMP 5 guidelines.
Software Classification as per GAMP 5 Guideline:    • Computer System Validation | GAMP 5 |...  

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