Tuesday 21 January 2014

Posted by Wrightandru
No comments | Tuesday, January 21, 2014


High levels of quality are necessary to achieve Company business objectives. Quality, a way to obtain competitive advantage, should remain any hallmark of Company 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 how a Company employees do 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 most organizational unit is responsible for ensuring that their particular work processes are usually efficient and continuously 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 organization quality policy and quality objectives. Both quality handle and quality assurance are parts of quality management. Quality control is focused on fulfilling quality requirements, and as related to clinical trials, it encompasses the operational techniques and activities undertaken within the quality assurance program to verify the requirements for quality of 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 conducted and the info are generated, documented (recorded), and reported within compliance with GCP as well as the applicable regulatory specifications.

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

  • Customer satisfaction, and therefore, customer loyalty and repeat business and referral; 
  • Timely registrations of drugs by eliminating waste and the need for rework;
  • Operational results such as revenue, profitability, marketplace share and foreign trade opportunities;
  •    Alignment associated with processes with achievement of better results;
  •  Understanding and motivation of employees toward the company quality policy and business     objectives, as well as participation in continual quality improvement initiatives;
  • Confidence of interested parties in the effectiveness and efficiency from the Company as demonstrated by the financial and sociable gains from Company performance and status.


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