03Session 2 临床试验质量依从性的基础：QAQC要素及质量管理体系 医疗器械临床试验管理与统计分析培训班讲义.pptVIP

The concepts of root cause analysis and corrective and preventive actions are fundamental to quality systems. CAPA is fundamental to continuous improvement, a principle of an effective clinical quality system. CAPA = Corrective and Preventive Actions * 根源分析和纠偏和防偏(CAPA)的概念是质量体系的基础。 CAPA 是持续改善的基础，为有效的临床质量体系的原则。 CAPA = 纠正和预防行动方案（Corrective and Preventive Actions） Corrective actions steps that are taken to remove the root causes of an existing nonconformity or undesirable situation and to identify any affected systems. The corrective action process is designed to prevent the recurrence of nonconformities or undesirable situations ISO 9001:2008. * 纠偏行动方案 针对消除已有不规范根源或不理想情形和鉴别任何受影响的体系所需采取的步骤。 纠偏行动过程是为了防止不规范或不理想情形再次出现 ISO 9001:2008. Preventive actions 防偏行动方案 steps that are taken to remove the causes of potential nonconformities or potential situations that are undesirable. 针对消除可能不规范或潜在不理想情形所采取的步骤 The preventive action process is designed to prevent the occurrence of nonconformities or situations that do not yet exist. 防偏行动过程是为了预防还没有发生的不规范行为或情形出 prevent occurrence by eliminating causes. 通过消除根源来预防发生 The objective of preventive action is to prevent the occurrence of an error in a process or multiple processes 防偏行动的目的是为了防止多个程序中的某一个程序出现错误 ISO 9001:2008. * E6 Section 5.2.1 A sponsor may transfer any or all of the sponsors trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. The CRO should implement quality assurance and quality control. * E6 第5.2.1 部分 申办者可以转移任何或全部申办者的试验相关的职责和职能给一家合同研究组织(CRO), 但是试验数据的质量和完整性的最终责任总是由申办者承担。CRO应当实施质量保障和质量控制。 Data quality can benefit significantly from the use of computerized systems. 数据质量可以主要受益于计算机化系统的使用。 Well-designed and tested computerized systems automate tasks and streamline processes such as the creation, distribution, completion, management, and analysis of data.设计良好和验证的计算化系统使得任务完成自动化成为可能，并且流程化程序，如数据的建立、分发、完成、管理和分析等 S