Most Frequently Question & Answer CSA.
Data Integrity App Most Frequently Question & Answer CSA. Question 01: What is the difference between computer system validation (CSV) and computer software assurance (CSA)? Best Answer: If you think of the 80/20 rule, the current CSV methodology has manufacturers spending 80% of their time documenting and only 20% of their time testing. The FDA wants to flip this so that 80% of a manufacturer’s time is spent on critical thinking and applying the right level of testing to higher-risk activities, while only 20% of their time is spent documenting (CSA methodology). This critical thinking should be focused on three questions: Does this software impact patient safety? Does this software impact product quality? Does this software impact system integrity? Using a risk-based approach is nothing new, and regulatory agencies such as the International Society for Pharmaceutical Engineering (ISPE) who author Good Automated Manufactu...