Objective:Discuss the application of audit trail and the effect to the management of electronic records.Method:Audit-trail the whole life circle of electronic records to inspect the operation of electronic records.Conclusion:Pharmaceutical industries should gradually improve the computer system;and introduce audit trail to ensure the authenticity,integrity and effectiveness of electronic records.%目的:讨论审计追踪的应用及其对电子记录管理的作用。方法:对电子记录整个生命周期进行监控,以检查操作人员对电子记录的操作。结论:制药企业应逐步完善计算机系统,引入审计追踪来保障电子记录的真实性、完整性及有效性。
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