FDA encourages you to demonstrate that you have effectively remediated your problems by investigating to determine the problem’s scope and root causes, conducting a scientifically sound risk assessment of its potential effects (including impact on data used to support submissions to FDA), and implementing a management strategy, including a global corrective action plan that addresses the root causes. This may include retaining a third-party auditor and removing individuals responsible for data integrity lapses from positions where they can influence CGMP-related or drug application data at your firm. It also may include improvements in quality oversight, enhanced computer systems, and creation of mechanisms to prevent recurrences and address data integrity breaches (e.g., anonymous reporting system, data governance officials and guidelines).

FDA 鼓励公司证明已针对此问题采取行之有效的修复措施：调查确定问题的范围和根本原因，对其可能的影响（包含对已提交给FDA的辅助数据的影响）执行科学全面的风险评估纠正措施计划，实施管理策略：包含解决根本原因的全面的纠正措施计划，这可能包含保留第三方审计人员和开除对数据完整性失效有责任的相关岗位人员（可能影响公司的CGMP相关或药物申请数据的职位）。还可能包括改进质量监督，加强计算机系统，以及建立防止再次发生和解决数据完整性破坏的机制（例如，匿名报告系统，数据管理人员和指南）。


These expectations mirror those developed for the Application Integrity Policy. For more detailed information, see Points To Consider for Internal Reviews and Corrective Action Operating Plans at

这些期望反映出了数据完整性政策的实际应用。更多详细信息见“内审和纠正行动执行计划考虑要点”，在

http://www.fda.gov/ICECI/EnforcementActions/ApplicationIntegrityPolicy/ucm134744.htm.