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...
A Device Master Record (DMR) is a collection of all the records that must be used to produce a medical device product. Let’s imagine that your medical devices company is planning on manufacturing a new and improved coronary stent, which is a Class III medical device....
Design Controls indicate that the medical devices your company makes are both safe and efficacious for the end-users. Let us say that your R&D department has come with a brilliant idea for a knee implant that will eliminate the disadvantages of currently available...
The Design History File (DHF) is a collection of documents that outlines the design history of a medical device. A DHF is one of the first documents that a regulatory body such as the FDA inspects for accrediting purposes. The primary function of the DHF is to provide...
