Clay's Blog

CAPA is added in Calem in the coming release of R2024b (June 2024). This blog present the steps to implement CAPA in Calem. 1. What is CAPA The FDA (U.S. Food and Drug Administration) mandates CAPA processes for medical device manufacturers under 21 CFR 820. Here is the CAPA FDA web site. CAPA has a general appeal for an organization to g...