Let’s take a quick look at what the regulations require.

Documented Procudures

First, a documented procedure is required. This is a good idea, especially with CAPA, to ensure that the process covers all the aspects of CAPA and that everyone has the opportunity to follow the process. It also ensures that there’s a common language for the process – you may recall previously that there’s no common definition for some of the concepts so establishing a company-wide definition is key.

FDA and CAPA

The FDA defines a prescriptive set of activities for CAPA. The FDA in a way merges CAPA into a single process. ISO 13485, though, has a prescriptive set of procedures defined for CA and another set for PA. Fortunately, there’s overlap between 21 CFR 820 and ISO 13485.