#CSA #computersystemvalidation #computersystemassurance
What is CSA? Computer System Assurance
Computer System Assurance (CSA):
Definition:
CSA is a modernized approach that focuses on risk-based and critical thinking to ensure that computer systems meet their intended use and comply with regulatory requirements.
Focus:
CSA emphasizes critical thinking, risk management, and leveraging vendor documentation to ensure system quality and compliance. It aims to streamline processes and reduce unnecessary documentation.
Approach:
CSA adopts an agile, risk-based approach. It prioritizes testing and documentation based on the system's risk and impact on product quality, safety, and data integrity.
Regulatory Guidance:
CSA aligns with the FDA's draft guidance on "Computer Software Assurance for Manufacturing, Operations, and Quality System Software," which encourages a risk-based approach to computer system validation.
Key Activities:
Focus on high-risk areas and critical aspects of the system.
Use of vendor-supplied documentation and testing where appropriate.
Reduction in unnecessary documentation and testing efforts.
Continuous improvement and iterative testing processes.