Supplier and Internal Auditing

Supplier and Internal Auditing. The criticality of auditing to the field of medical devices can never be understated, because medical devices play a direct role in human safety. Supplier and internal auditing are separate, but related aspects of the supply chain and quality aspects of medical devices. It is a common practice in the industry […]

Verification and Validation of HACCP

Verification and Validation of HACCP. Hazard Analysis Critical Control Point (HACCP) is a mechanism meant for ensuring food safety. It is a comprehensive set of guidelines that straddles across the food supply chain, right from harvest till the time it is consumed.Being such a systematic and total approach; HACCP attaches utmost importance to prevention of […]

Why is Computer System Validation Important in FDA Regulated Industries?

Asking why Computer System Validation (CSV) is important in FDA-regulated industries is like asking why an engine is important to a vehicle. Before going on to get an understanding of this issue, let us understand that there is a difference between the ways in which the term “validation” is used in the general area of […]