High amounts of quality
are important to achieve Company enterprise objectives. Quality, a way to
obtain competitive advantage, should remain a hallmark of Company products and
services. 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 carry
out their job and also the work processes these people 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
every organizational unit is in charge of ensuring that their particular work
processes are 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 organization quality policy as well as quality objectives. Both
quality control and quality assurance are areas 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 how the requirements
for quality from 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 performed and the information are generated, noted (recorded), and
reported within compliance with GCP and the applicable regulatory requirements.
They serve as a passport
to success by assisting the organization to achieve high-quality techniques,
procedures, systems, the ones, with eventual high-quality products and services
and enhancement of 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 such
as revenue, profitability, and industry share and exporting opportunities;
Alignment regarding
processes with good results of better final 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
from the financial and interpersonal gains from Organization performance and
status.
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