| 陈爽,阮昊,梁晶晶,陈龙珠,项新华.医药行业实验室数据的审计追踪及其审核[J].中国药事,2022,36(2):146-149 |
| 医药行业实验室数据的审计追踪及其审核 |
| Pharmaceutical Industry Laboratory Data Audit Trail and Audit Trail Review |
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| DOI：10.16153/j.1002-7777.2022.02.005 |
| 中文关键词: 实验室 数据完整性 审计追踪 审核 管理 |
| 英文关键词: laboratory data integrity audit trail review management |
| 基金项目: |
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| 中文摘要: |
| 目的：加强对实验室数据的审计追踪审核，完善医药行业实验室数据完整性的管理。方法：从国内国际的法规和指南出发，结合工作实际，阐述审计追踪对于数据完整性管理的重要性，并进一步探讨审计追踪的评估、审计追踪审核的方法以及审计追踪审核的实施，从而完善数据完整性管理。结果与结论：医药行业实验室在数据完整性管理中应重视审计追踪及其审核，通过对审计追踪的审核，审核者可以识别出是否存在影响数据真实准确的违规事件，降低质量风险，从而完善数据完整性的管理。 |
| 英文摘要: |
| Objective: To strengthen the audit trail review of laboratory data and improve the management of pharmaceutical industry laboratory data integrity. Methods: From the domestic and international regulations and guidelines, combined with practical work experience, the importance of audit trail for data integrity management was expounded, and the evaluation of audit trail, the methods of audit trail review and the implementation of audit trail review were further discussed, so as to improve data integrity management. Results and Conclusion: Pharmaceutical industry laboratories should attach importance to audit trail and audit trail review in data integrity management. By auditing trail review, auditors could identify whether there are violations that affect the authenticity and accuracy of data, so as to reduce quality risk and improve the management of data integrity. |
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