The implementation of a QMS in a business requires the establishment of a system of programs, policies, procedures, processes and organizational structure, which assure the quality of the output of the business and the continuous improvement of its business processes.
Key elements of the QMS include (i) the business processes that are used to deliver the outputs of the business to the customer, and (ii) management processes that assure that the business process are operating satisfactorily and are being continuously improved.
These integrated elements include document control, auditing, corrective and preventive actions (CAPA), change control, customer complaints, training etc.. The implementation and effectiveness of the QMS are responsibilities of senior management.
Verta Life Sciences has both the expertise and extensive experience to deliver the effective strategic quality leadership necessary to implement these operational quality management requirements. These include:
- Planning to ensure quality is fully integrated into the client’s strategic and operational planning and business processes.
- Identifying and organizing the required financial, material and personnel resources.
- Establishing effective communications.
- Measuring and reporting quality metrics and trends.
- Reviewing progress and overall effectiveness; and continuous improvement.
- Ensuring compliance with FDA and EU regulations, as well as ICH and ISO requirements.