Since its foundation, the Scientific Research Center Eco-safety has implemented its own quality management system, which is constantly being developed and improved. The processes the company lives by have a clear algorithm and sequence of actions.
Taking into account the specifics of the work, namely real medical practice when conducting clinical trials, the organization of processes and procedures should be built in accordance with regulatory and normative acts – namely, in accordance with the federal legislation of the Russian Federation and international standards of the GCP system.
In order to optimize the work of the research team in conducting bioequivalence studies and to meet the needs of the customer, the company has implemented a system of orders, regulations, instructions and standard operating procedures. These documents allow to realize the classical approach of “PDCA” (Deming Cycle – “Plan-Do-Check- Act” or “Plan-Do-Check-Act”), regulated by ISO9001 2015 standards.
Such a concept allows to structure each of the processes (from the moment of signing the informed consent form with a healthy volunteer to writing the final report on the clinical trial), to identify the responsible executors, and to establish the process holder. Routine quality control, carried out by competent employees of the quality control and quality assurance department, allows timely and preventive identification of non-conformity with the processes, corrective and preventive measures, as well as, if necessary, revision and modernization of the procedure as a whole.
