Pharmacovigilance is the most important system that controls the entire life span of any medicinal product. Bodies providing a full range of services for pharmacovigilance should be fully staffed with appropriate means and equipment.
As stated in the Rules of Good Pharmacovigilance Practice, achieving the required the level of quality in the implementation of a full range of pharmacovigilance services and the results obtained is also associated with providing the system with the necessary means and equipment used in these processes. Achieving the required quality level in the implementation of pharmacovigilance processes and the results obtained is also associated with the provision of the system with the necessary means and equipment, used in these processes.
To achieve a full range of pharmacovigilance services, means and equipment must be located, designed, adapted and maintained in such a way as to meet the set goal according to the quality objectives pharmacovigilance. Means, equipment and their functional properties important for pharmacovigilance are subject to appropriate verification, qualifications and / or validation to demonstrate fitness for the intended purpose. For determining the scope of testing, qualification or validation should be used a documented risk assessment. This risk management method is necessary apply during the entire service life of tools and equipment, taking into account such factors such as impact on patient safety and data quality, as well as complexity appropriate facilities and equipment.