Quality audits are a fundamental component of compliance and operational excellence within highly regulated industries, including pharmaceuticals, medical devices, and food manufacturing. They provide a structured mechanism for evaluating whether organisational processes align with regulatory requirements and internal quality standards.

Process validation is a critical component in the manufacturing of regulated products, ensuring that processes consistently produce results meeting predetermined quality criteria. In the pharmaceutical, biotechnology, and medical device sectors, regulatory agencies such as the United States Food and Drug Administration (FDA) enforce stringent requirements for process validation. Despite clear regulatory expectations, many companies receive FDA 483 observations highlighting deficiencies in process validation. This review explores the prevalence and root causes of inadequate process validation, offering insights into why regulated companies continue to struggle with compliance.