This whitepaper provides guidance on how to overcome the challenges associated with software validation and its compliance for the healthcare and pharmaceutical Industries, who are looking to take up Computer System Validation (CSV) for the first time.
It also elaborates on how the risk-based approach is important in developing systems by Quality by Design and thus, helps the system to be robust throughout the Software Development Life Cycle (SDLC).
It also throws light on the risk management practices to be followed and the documentation required for the entire lifecycle of the system.
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