2014上半年 FDA EMA 检查缺陷项汇总.pdfVIP

2014上半年 FDA/EMA 现场检查缺陷项汇总 - 如何透过信息化建设提升GMP质量管理合规性与效率 Oct 01, 2014 洛施德企业管理咨询 (上海) 有限公司 Michael Hsu / 许哲毓 Executive Director 执行总监 michael.hsu@ +86 1 of 39 “your preferred Partner to Compliance” 介绍大纲 √  2014上半年FDA/EMA 现场检查缺陷项汇总  Data Integrity and Computer System Validation  Laboratory – Testing and OOS  Quality System  Falsify  洛施德咨询公司介绍  洛施德咨询自主研发的 《SISQP GMP全面质量管理系统》 2 of 39 “your preferred Partner to Compliance” Year 2014 FDA 483 Report and EMA Non-Compliance Report Data Integrity and Computer System Validation 1. data recording and integrity in the QC laboratory not in compliance 实验室的数据存在记录和完整性的不合规操作 2. All laboratory employees were granted full privileges to the computer systems. 所有实验室人员都享有有关计算机系统的各方面权限。 3. Current computer users in der laboratory were able to delete data from analyses. 实验室中的现有计算机用户可以删除分析数据。 4. Numerous deleted raw data files on computers used for the GC instruments in the QC lab. The software on the computers used to control the GC instruments allowed the analysts to delete files from the hard drive with no audit trail or adequate form of traceability in the operating system to document deletion activity. QC实验室GC仪器中的系统上有大量已删除的原始数据文件。分析人员可以从控制GC仪器的计算机软件的硬盘驱动 器上删除文件，且对此删除活动没有审计追踪或在操作系统中没有足够的追踪表记录删除活动。 5. HPLC and GC computer software lacked active audit trail functions to record changes to data, including information on original results, the identity of the person making the change, and the date of the change.