CAPA reports are critical in every regulatory inspection for medical devices, pharmaceuticals, and other life science companies worldwide including the EU and the US. They must be accurately written and should provide the auditors the information about the CAPA...
Corrective and preventive action (CAPA) procedures are critical to the success of the quality management system (QMS) and CAPA sub-system in any life science organization. A poorly written or implemented CAPA procedure can lead to failed corrective and preventive...
CAPA consists of a specific set of actions that an organization must complete to resolve and eliminate recurring non-conformance. CAPAs are commonly used when medical devices are non-conforming. Let us say that your medical devices company is manufacturing lifesaving...
Product quality is a key factor for any pharmaceutical organization and the CAPA process helps ensure that the products are of high quality. The CAPA process plays an important role in the quality management system of any pharmaceutical company. It helps to identify,...
A CAPA form is a tool used to initiate the CAPA process from different non-conformance events. Corrective Actions and Preventive Actions (CAPA’s) can also be used to eliminate causes of other events such as complaints, audit findings, and others. Let’s...
Corrective action and preventive action (CAPA) comprises a set of actions aimed to improve an organization’s processes by eliminating the causes of recurring non-conformances and other unwanted situations. CAPA’s are typically used in industries like medical devices,...
