Benefits of a Comprehensive QMS

What is a QMS?

A quality management system (QMS) is defined as a collection of business processes focused on achieving quality policy and quality objectives to fulfil customer requirements. The QMS will also help in the coordination and organization of activities to meet the regulations and requirements of both regulatory agencies and customers. The use of quality management systems is increasing and is successfully used in industries including pharmaceutical, manufacturing and monitoring.

It is often believed that a QMS is an expensive software product, and therefore some companies may be reluctant to adopt it, nevertheless, a QMS can simply be a set of documented procedures and processes that will ensure consistency of any task that is performed in a clinical trial. In addition, it is important to mention that a QMS is not necessarily a large system, indeed an effective QMS should be simple and flexible.

How to develop an effective QMS

Key to the functioning of a clinical site QMS is the development of Standard Operating Procedures (SOP), such as the training SOP, which describes requirements for regulatory training, as well as protocol-specific training before anyone can be assigned to a study. Similarly, a continuity SOP is crucial to ensure the smooth handover of a study from one staff member to another. Other relevant applications of QMS are the development of an informed consent SOP, source documents SOP, internal assessment SOP, and inspection readiness SOP.

In addition, it is necessary to define how the elements and foundational aspects of QMS are going to be evaluated in order to define the effectiveness and efficiency of clinical QMS. Firstly, the current workings must be assessed against a clinical QMS conceptual framework in order to identify gaps or inefficiencies and evaluate their impact, prioritize development and implement identified improvements. Finally recommend actions should be sent to senior leadership. Management review by senior leadership is a valuable step in identifying whether the QMS fulfils the quality objectives, if it is aligned with the strategic direction of the organization, as well as if it is supported by the appropriate resources.

A clinical QMS has many key elements that need to be taken into consideration when implementing it. For example, establishing resources, roles and responsibilities will help to make clear what needs to be done and supervised by the staff members, as well as state collaborations and its potential needs, expectations, limitations and risks. Furthermore, risk and issue management are tools that will allow management to predict situations that may arise, and be able to prioritize resources to solve them.

Why should clinical research sites develop a QMS?

The first and main responsibility of the clinical research site is the conduction of research complying with all the regulations and protocols. Auditors verify compliance, but the site staff are the ones responsible for it.

In addition to regulatory compliance, there are several business benefits of having a comprehensive QMS. For example, if ISO 9001, the gold standard of QMS is adopted, pharmaceutical processes will be more efficient and generate less waste, there will be greater control of major business processes, a better understanding of the customer needs, solidification of successful working practices, better internal communication, differentiation from competitors, a reduction in the cost of errors, and many other improvements in efficiency and productivity ultimately resulting in increased profits.

Beyond the internal impact on an organization, an effective QMS enables processes to be better identified and improved, improving the safety of the patients in the trial. There will also be a consistent framework for regulatory authorities, ensuring data integrity, a reduction in the number of delayed studies, fewer repetitive quality issues, greater consistency in the quality of products and services provided and increased customer satisfaction.

Acceler8 Clinical Research is aware that an effective QMS is integral to the successful development of a clinical trial, hence, we develop them based on the client’s unique needs. Our independent Quality Assurance division, The CQA Company, has vast experience with strategic development, QMS assessment and legacy operations, GAP Analysis, SOP development and preparation, as well as risk management and other aspects of Quality Management.

Leave a Reply

Your email address will not be published. Required fields are marked *