Paresh Mistry
Accutest Research India Pvt. Ltd., India
Title: Reason for failure of quality system in clinical research
Biography
Biography: Paresh Mistry
Abstract
It has been observed many times despite of quality system, clinical research division and organization suffering with major non compliance and critical observation from regulatory agency/Vendor. Management supposes to add more quality persons as a investment towards improvement of quality. More often there are several reason for failure to build up quality system like people selection, audit style, chronicle negligence, qualification of auditors, personal behavior, more adage procedures etc. However there are remedies to improve the discussed reason. People selection play major role as the selected auditor will be part of organization. Audit style can be evaluated and make changes to improve and audit as per requirement. Positive team building can add value but be conscious about right role assignment for QA towards the user department. Some of chronic negligence affects the quality with unattended area. Improve the same periodic review of process add advantage as a self inspection. Qualification is must required as per the requirement of role which will be assigning to the auditor, experience can be superseded qualification but minimum qualification should be as rule. Behavioral issues can lead the bad or good culture vice versa with different auditor and user department and add or reduce value in team building. So it can be conclude that there are reasons for failure of quality system but with proper evaluation and handling it can be converting in good quality system.