Verification vs. Validation in Regulated Industries

Overview

The meanings and regulatory requirements of the terms "verification"and "validation"are often confusing to engineers and even some regulatory professionals.

Operations managers are even less well versed. FDA regulations as well as European standards such as ISO 13485:2016 require both verification & validation documentation throughout these regulations and standards.

The terms apply to design control, process control and others. Numerous warning letters on this subject has been issued by FDA to well known manufacturers.

Verification and validation also appear in the "essential requirements"in MDD 93/42/EEC needed for CE marking medical devices in the European Union. Good engineering practices in all industries benefit from well executed verification and validation studies.

This presentation will define and explain the differences (& similarities) in these terms and how they apply to regulated industries as well as the consequences of poor adherence to these principles.