PROFIT FROM THE Q_METHOD
Doing what is absolutely necessary and omitting what is superfluous. This is where QFINITY∞ ‘s consulting services come in. Our profound knowledge of the regulations coupled with our many years of experience and the dedication of our employees to finding practicable solutions enables QFINITY∞to develop creative solutions where others see only paragraphs and regulations.
QFINITY∞ sees itself as an “enabler”, i.e. our services are designed to pick you up as a customer wherever you are organisationally located. We will work with you to identify risks and develop strategies to minimise them in a resource-efficient manner within the relevant regulatory framework.
Fitness for Intended Use or Purpose
A risk-based approach creates risk transparency, providing valuable tools for management to make the best use of resources along the value chain.
We work according to the motto: Only as much investment as necessary, without losing sight of the regulatory framework. The alignment, breadth and depth of risk reduction measures are geared to the relevant processes in connection with the technologies used and are oriented to the intended purpose. As a result, the solutions can be formally documented as “Fit for Purpose” or “Fit for the intended use”.
The experience from years of practice with a wide range of process support projects gives our experts the opportunity to find the best approach for your company. We will find the right path through the jungle of regulations. After completion of the work together, your company will be in a position to continue along the path you have chosen independently as we step back from the action but remain available to you as consultants.
THE PATIENT IS FRONT AND CENTER
All processes – research and development, manufacture, administration of a drug, application of a medical device – are ultimately directed at the patient’s wellbeing The patient’s safety, the quality and efficacy of the drugs or devices, as well as the quality and integrity of the data must therefore be given top priority.
We achieve a balance between regulatory requirements and processes in practice. The necessary control mechanisms are anchored in the organisational structure based on risk.
We retrace the path back from the patient via the products to the structure of your processes. This ensures that the end product always meets the necessary standard and as well as the regulatory requirements. This includes both the quality and the integrity of the data.
We understand quality management as a living system. It constantly strives for improvement. An existing status quo must be reviewed again and again to be continuously optimized. This is not an end in itself, but gives you the security to avoid stagnation. A dynamic, living system is the best guarantee for the best possible product quality, customer satisfaction and economic success.
Continuous improvement management becomes a natural part of your process planning. Thus, your company is on its way to sustainable strategic planning.