`Til Death Do Us Part, But First, the Pre-Nup: Why CAPA Needs to Evolve
A guest editorial from Emil Ciurczak, Contributing Editor, PharmaManufacturing.com While reading a trade magazine recently, I was struck with the detailed information on how to design and implement a Corrective and Preventive Action (CAPA) system. ISO 9001:200, Clause 8.5.2 states, “…the organization shall take action to eliminate the cause of nonconformities encountered…” For medical devices, […]