Abstract

A REVIEW ON QUALITY ASSURANCE –IMPORTANCE OF SYSTEMS AND STANDARD OPERATING PROCEDURES

Tanya Kunwar*, Ishika Jain and Ravinder Kaur

ABSTRACT

To deliver high-quality goods and services that fully satisfy the needs and expectations of their clients, clinical trial sponsors and contract research organization must establish, maintain, and closely monitor their QC and QA systems, as well as their integral standard operating procedures and other quality documents. The primary quality systems incorporate both quality assurance and control systems. Control and quality assurance are essential parts of quality management. Quality assurance ensures that the standards are met, whereas quality control ensures that they are met. The organization's business goals and model need to be in line with the quality systems. To ensure that quality systems are accessible, suitable, and maintained, senior management dedication and active engagement are essential. The ideal outcome of a standardization process is a set of standards, which in the context of quality systems are comprised of papers that are either connected to or of high quality. Excellent quality is a crucial essential requirement, not an extra benefit. Ensuring the effectiveness and continuous
improvement of work processes is the responsibility of every employee across all organizational units.

Keywords: QA, QC, quality management, quality standards, quality systems.