Work Processes – Quality Assurance

High amounts of quality are essential to achieve Company enterprise objectives. Quality, a way to obtain competitive advantage, should remain the 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 also relates to the way the Company employees perform their job as well as the work processes they follow to produce services or 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 units is responsible for ensuring that their 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 determine and implement the business quality policy as well as quality objectives. Both qualities manage and quality assurance is areas of quality management. Quality control is focused on fulfilling quality requirements, and as related to clinical trials, it encompasses the operational techniques as well as activities undertaken within the quality assurance program to verify that the requirements for quality with the trial-related activities have been 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 info are generated, noted (recorded), and reported within compliance with GCP and the applicable regulatory needs.

They serve as a passport to accomplishment by assisting the business to achieve high-quality processes, procedures, systems, and the ones, with eventual high-quality products and enhancement with the following:

1) Customer satisfaction, and therefore, customer loyalty and repeat business and referral;

2) Timely registrations of drugs by eliminating waste and the need for rework;

3) Operational results for example revenue, profitability, marketplace share and exporting opportunities;

4) Alignment regarding processes with good results of better final results;

5) Understanding and motivation of employees toward the company quality policy and business objectives, as well as participation in continual quality improvement initiatives; and

6) Confidence of interested parties inside the effectiveness and efficiency of the Company as demonstrated from the financial and interpersonal gains from Organization performance and status.

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