High levels of quality are essential to achieve Company objectives. Quality, a source of competitive advantage, should remain any hallmark of Company services and products. High quality is not an added value; it is an essential basic requirement. Quality does not only relate solely to the end products and services a Company provides but in addition relates to what sort of Company employees carry out their job as well as the work processes they will follow to produce products.
The work processes should be as efficient as possible and continually improving. Company employees constitute the most important resource for improving quality. Each employee in all organizational unit accounts for ensuring that their own work processes tend to be efficient and continually improving. A quality system is defined as the organizational structure, responsibilities, processes, procedures and resources for implementing quality management.
Quality management includes those aspects of the overall management function that decide and implement the company quality policy and also quality objectives. Both quality handle and quality assurance are elements of quality management. Quality control is focused on fulfilling quality requirements, and as related to clinical trials, it encompasses the operational techniques and also activities undertaken within the quality assurance method to verify that the requirements for quality from the trial-related activities happen to be fulfilled.
Quality Assurance, on the other hand, is focused on providing confidence that quality requirements are fulfilled. As related to clinical trials, it includes all those planned and systemic actions that are established to ensure that the trial is completed and the data are generated, documented (recorded), and reported in compliance with GCP and the applicable regulatory requirements.
They serve as a passport to achievement by assisting the company to achieve high-quality techniques, procedures, systems, the ones, with eventual high-quality products and enhancement with the following:
Customer satisfaction, and therefore, customer loyalty and repeat business and referral;
Timely registration of drugs by eliminating waste and the need for rework;
Operational results for instance revenue, profitability, market share and foreign trade opportunities;
Alignment of processes with achievement of better results;
Understand and motivation of employees toward the company quality policy and business objectives, as well as participation in continual quality improvement initiatives.
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