CSV vs. CSA: A Detailed Comparison

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CSV is the traditional approach focused on validating software systems to ensure they meet predefined requirements, primarily through extensive documentation and testing. 

 CSA is a modern, risk-based approach that focuses on critical thinking, patient safety, and product quality, emphasizing targeted assurance activities over exhaustive validation. 

CSV:  Compliance through extensive documentation and predefined testing of all system functionalities.

CSA:  Risk-based assurance, focusing on critical functionalities that impact patient safety, product quality, and data integrity. 

CSV:   Documentation-driven; relies heavily on following predetermined protocols and producing voluminous validation records Evidence-driven; prioritizes testing and activities that directly demonstrate software assurance, with less emphasis on documentation.

CSA:  Risk-based assurance, focusing on critical functionalities that impact patient safety, product quality, and data integrity. 

CSV: “Test everything” approach; often leads to redundant and excessive testing, including low-risk functions.

CSA: Test what matters; focuses on the most critical aspects, minimizing redundant testing of low-risk areas. 

CSV: Heavy documentation requirements, including validation plans, scripts, reports, and traceability matrices.

CSA:  Minimal and targeted documentation that directly supports assurance activities; less paperwork overall, focusing on critical evidence. 

CSV:  Limited integration of risk management; often treats all system components equally, regardless of their impact.

CSA: Core element of CSA; risk management is embedded throughout the assurance process, prioritizing high-risk functions.  

CSV:  Limited integration of risk management; often treats all system components equally, regardless of their impact.

CSA: Core element of CSA; risk management is embedded throughout the assurance process, prioritizing high-risk functions.