Risk Management Methodology of Data Integrity Implementation in Drug Quality Control Laboratories
OBJECTIVE To discuss the risk management methodology of data integrity implementation in drug quality control la-boratories.METHODS The regulations and guidelines for data integrity were interpreted.How to apply quality risk management in data management was discussed,and combining the practical experience of laboratory,how to implement data integrity work in drug quality control laboratories through risk management was proposed.The focus was to systematically identify and map the processes,data flows,and systems of the laboratory based on the data life cycle,and analyze the gap between the current data management status and the regulation requirements.Then,using the risk management tools of ICH Q9,risk evaluation,control,and review need to be con-ducted to form a closed-loop risk management to control the data integrity risk within an acceptable range.RESULTS AND CON-CLUSION Drug quality control laboratories should implement data management based on quality risk management principles.The implementation method proposed in this article can comprehensively evaluate and control the data integrity risks of the laboratory,which has strong practicality and can be used as a reference for other drug quality control laboratories.
data integrityrisk managementgap analysisfailure mode effect analysis(FMEA)drug quality control laboratory
万方数据
维普
