| 张曦,刘晓萌,赵曼曼,于连东,耿兴超,谢寅.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[J].中国药事,2023,(12):1421-1430 |
| 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 SafetyEvaluation Process |
| 投稿时间：2023-02-16 |
| DOI：doi:10.16153/j.1002-7777.2023.12.012 |
| 中文关键词: 数据质量 计算机化系统 风险评估 实验室信息管理系统 |
| 英文关键词: data quality computerized systems risk assessment LIMS |
| 基金项目: |
|
| 摘要点击次数: 542 |
| 全文下载次数: 257 |
| 中文摘要: |
| 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。 |
| 英文摘要: |
| 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 theassessment 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 assessmentorganization to sort out the overall compliance risk assessment process of LIMS implementation based on therisk assessment process. Results and Conclusion: Through the overall compliance assessment of the systemimplementation, the sources of risks were identifi ed, risks that could aff ect the quality of research were identifi ed,and risk reduction measures were developed to ensure the overall compliance requirements of the system, furtherimproving the data quality of drug safety evaluation research. The FMECA method can be applied to LIMS usedin drug safety evaluation research processes, which is very helpful in improving data quality. |
|
查看全文
查看/发表评论 下载PDF阅读器 |
| 关闭 |
|
|
|