08.04.26 -- What Is Computer Software Assurance? Plus EO Sterilization Updates

Container Closure Integrity (CCI) is essential to ensure sterile drug products remain safe, effective, and contamination-free throughout their shelf life. USP <1207> recommends evaluating package integrity from development through commercialization by defining the Maximum Allowable Leakage Limit (MALL) and selecting validated, application-specific test methods. The guidance favors quantitative deterministic methods over probabilistic approaches and emphasizes integrating CCI testing, seal quality assessment, stability studies, and lifecycle management to maintain product quality.

Kamila Novak reviews final computer software assurance (CSA) guidance and what it means for those working on medical device clinical trials.