基于FMECA的LIMS风险评估在药物安全性评价流程中的应用研究

Application of FMECA Based on LIMS Risk Assessment in Drug Safety Evaluation Process

目的:探讨药物安全评价研究机构对实验室信息管理系统(LIMS)实施风险评估的方法,并基于评估结果制定措施降低风险,确保研究质量。方法:采用“故障模式、影响和危害性分析”(FMECA)方法,对LIMS实施整体的风险评估。首先确定风险评估的目的、范围、依据和评估工具,并建立风险评估组织,根据风险评估流程对LIMS实施的整体合规性风险评估过程进行梳理。结果与结论:通过对系统实施的整体合规性评估明确了风险来源,发现了会影响研究质量的风险,并制定了降低风险措施以保证系统的整体合规要求,进一步提升了药物安全评价研究的数据质量。FMECA方法可应用在用于药物安全性评价研究流程中的LIMS,对提升数据质量有很好的帮助。

Objective:To explore the risk assessment methods for laboratory information management systems(LIMS) implemented by drug safety evaluation research institutions,and develop measures based on the assessment results to reduce risks in the process and ensure research quality.Methods:Using the "Failure Mode,Effects,and Criticality Analysis"(FMECA) method,conduct an overall risk assessment of the LIMS.Firstly,determine the purpose,scope,basis,and evaluation tools of risk assessment,and establish a risk assessment organization to sort out the overall compliance risk assessment process of LIMS implementation based on the risk assessment process.Results and Conclusion:Through the overall compliance assessment of the system implementation,the sources of risks were identified,risks that could af fect the quality of research were identified,and risk reduction measures were developed to ensure the overall compliance requirements of the system,further improving the data quality of drug safety evaluation research.The FMECA method can be applied to LIMS used in drug safety evaluation research processes,which is very helpful in improving data quality.