Clay's Blog

Work orders can be created for a CAPA case from the Evaluation tab of the CAPA form. Permissions to create a WO are granted to users with roles to manage a CAPA including: Principal Investigators (PIs), CAPA Planners, and users assign to action and evaluation roles.The work order creation screen is launched with asset and location of the ...

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...