BMS认证文件目录(注射制剂车间)

精选文库文件题目Document Title注射制剂车间控制系统BMS认证文件清单Qualification Documents List for Control System (BMS) for Injection Preparation Plant文件种类Category of DocumentQDL认证文件清单发放部门Department of IssueQA类别 Category人员 Person姓名Name职位Position签名Signature日期Date编写人Compiled by审核人Checked by审核人Checked by审核人Checked by审核人Checked by审核人Checked by批准人Checked by文件分发部门/编号：（ ）Department of document distributed/Code:序号Serial No.部门名称Department Name份数Copies负责人Manager1QA部 QA Dept.2QC部 QC Dept.3验证部 Validation Dept.4工程部 Engineering Dept.5生产部 Production Dept.6注射剂车间（1） Injection Workshop(1)7供应链部 Supply chain Dept.8仓库 Warehouse9技术部 Technical Dept.10M车间 M workshop文件变更历史：History of document changing:版本号Version Code变更日期Changing Date变更内容摘要Abstract of Changing Contents002011-09-05建立文件 File foundation总体General 序号No.文件名称Document Name文件编号Document number 版次Rev日期Date文件归档部门Filing Location备注Remark项目部Project工程部Engineering使用部门User1URS for BMS systems BMS系统用户需求说明书根据会议纪要，在DQ完成后一周内提交，正在修改2GMP and Functional Risk Assessment for BMS system BMS系统GMP和功能性风险评估根据周工要求，在URS提交后2天内提交，已完成，待修改3Qualification Plan for BMS system BMS系统认证方案已提交，在修改. 再递交日期 2011-09-204Verification for Time schedule验证时间计划表已提交。再修改5Qualification Document List for BMS system BMS系统认证文件目录已确认6Qualification Report for BMS system BMS系统认证报告7Final Report after PQ in operation 最终认证报告设计确认Design Qualification （DQ）序号No.文件名称Document Name文件编号Document number版次Rev日期Date文件归档部门Filing Location备注Remark项目部Project工程部Engineering使用部门User1P&ID for BMS system BMS系统P&ID控制流程图XXX-16-08-BMS/1-DQ/01-1.01.0已提交，待审批2Function Specification 功能说明XXX-16-08-BMS/1-DQ/02-1.01.0已完成，提交日期2011-09-213Hardware Design Specification 硬件设计说明XXX-16-08-BMS/1-DQ/03-1.01.0已完成，在修改。提交日期2011-09-204Software Design Specification 软件设计说明XXX-16-08-BMS/1-DQ/04-1.01.0已完成，提交日期2011-09-235Network Design Specification 网络设计说明XXX-16-08-BMS/1-DQ/05-1.01.0在修改，提交日期2011-09-216BMS Equioment ListBMS 设备清单XXX-16-08-BMS/1-DQ/06-1.01.0已完成。提交日期2011-09-207Data Sheets for BMSBMS数据表XXX-16-08-BMS/1-DQ/07-1.01.0已完成。提交日期2011-09-208Calibration List校准清单XXX-16-08-BMS/1-DQ/08-1.01.0已完成。提交日期2011-09-209PLC Wiring DiagramPLC 接线图XXX-16-08-BMS/1-DQ/09-1.01.0已完成。提交日期2011-09-2110Alarm List警报清单XXX-16-08-BMS/1-DQ/10-1.01.0已完成。提交日期2011-09-2011BMS layout for 1st floor1楼布局图XXX-16-08-BMS/1-DQ/11-1.01.0已完成，在审核。提交日期2011-09-2112BMS layout for 2nd floor2楼布局图XXX-16-08-BMS/1-DQ/12-1.01.0已完成，在审核。提交日期2011-09-2113BMS layout for 3nd floor3楼布局图XXX-16-08-BMS/1-DQ/13-1.0已完成，在审核。提交日期2011-09-2114BMS layout for roof floor顶楼布局图XXX-16-08-BMS/1-DQ/14-1.01.0已完成，在审核。提交日期2011-09-2115BMS Network Architecture Diagram BMS网络架构图XXX-16-08-BMS/1-DQ/15-1.01.0已完成，在审核。提交日期2011-09-2116BMS Input/Output List BMS输入输出点位清单XXX-16-08-BMS/1-DQ/16-1.01.0已提交。待审批。提交日期2011-09-1517PLC Cabinet Layout Design PLC控制柜布局设计XXX-16-08-BMS/1-DQ/17-1.01.0已完成，在审核。提交日期2011-09-2118Equipment Wiring Diagram现场设备接线图XXX-16-08-BMS/1-DQ/18-1.01.0已完成，在审核。提交日期2011-09-2119Custom graphics Verification(PC)自定义图形确认XXX-16-08-BMS/1-DQ/19-1.01.0已完成模板，在审核。提交日期2011-09-2520Custom graphics Verification(HMI)自定义图形确认XXX-16-08-BMS/1-DQ/20-1.01.0已完成模板，在审核。提交日期2011-09-25安装确认Installations Qualification （IQ）序号No.文件名称Document Name文件编号Document number版次Rev日期Date文件归档部门Filing Location备注Remark项目部Project工程部Engineering使用部门User1IQ Test Specification for BMS system BMS系统IQ测试说明XXX-16-08-BMS/1-IQ/01-1.01.02Attachment 1: Measurement Instrument List附件1:测量仪器列表XXX-16-08-BMS/1-IQ/02-1.01.03Calibration List 校准清单XXX-16-08-BMS/1-IQ/03-1.01.04Windows ConfigurationWindows配置XXX-16-08-BMS/1-IQ/04-1.01.05WinCC ConfigurationWincc 配置XXX-16-08-BMS/1-IQ/05-1.01.06PLC Hardware configurationPLC硬件配置XXX-16-08-BMS/1-IQ/06-1.01.07Function Verification of AI(Analogue Input)AI功能确认XXX-16-08-BMS/1-IQ/07-1.01.08Function Verification of AO(Analogue Output)A0功能确认XXX-16-08-BMS/1-IQ/08-1.01.09Function Verification of DI(Digital Input)DI功能确认XXX-16-08-BMS/1-IQ/09-1.01.010Function Verification of DO(Digital Output)DO功能确认XXX-16-08-BMS/1-IQ/10-1.01.011IQ deviation formIQ偏差方式XXX-16-08-BMS/1-IQ/11-1.01.012IQ Deficiency/ Deviation ListIQ偏差列表XXX-16-08-BMS/1-IQ/12-1.01.0运行确认Operation Qualification （OQ）序号No.文件名称Document Name文件编号Document number版次Rev日期Date文件归档部门Filing Location备注Remark项目部Project工程部Engineering使用部门User1OQ Test Specification for BMS system BMS系统OQ测试说明XXX-16-08-BMS/1-OQ/01-1.01.02 pages2BMS Computer VerificationBMS系统计算机验证XXX-16-08-BMS/1-OQ/02-1.01.03Access & Security Function Test访问和安全功能测试XXX-16-08-BMS/1-OQ/03-1.01.04UPS TestUPS不间断电源测试XXX-16-08-BMS/1-OQ/04-1.01.05PLC Program Backup and Recovery TestPLC程序备份和恢复测试XXX-16-08-BMS/1-OQ/05-1.01.06WinCC Backup and Recovery TestWINCC 程序备份和恢复测试XXX-16-08-BMS/1-OQ/06-1.01.07Recovery from Power loss失电恢复测试XXX-16-08-BMS/1-OQ/07-1.01.08Parameters checking after power failure检查电源故障后的参数XXX-16-08-BMS/1-OQ/08-1.01.09Security for Set parameter changing verification安全设置参数变化的验证XXX-16-08-BMS/1-OQ/09-1.01.010Verification for Setting parameter MIN/MAX验证参数设置最小/最大值XXX-16-08-BMS/1-OQ/10-1.01.011Alarm Verification报警验证XXX-16-08-BMS/1-OQ/11-1.01.012History and Trend Verification历史和趋势验证XXX-16-08-BMS/1-OQ/12-1.01.013Custom graphics Verification(PC)自定义图形验证XXX-16-08-BMS/1-OQ/13-1.01.014Custom graphics Verification(HMI)自定义图形验证XXX-16-08-BMS/1-OQ/14-1.01.015Sequence of Operation Verification顺序操作的验证XXX-16-08-BMS/1-OQ/15-1.01.016Testing of Data/Alarm/Audit trail Logging and Report测试的数据/警报/审计日志记录和报告XXX-16-08-BMS/1-OQ/16-1.01.017SOP Verification标准操作步骤验证XXX-16-08-BMS/1-OQ/17-1.01.018Verification of BMS behaviour as per FDA 21CFR Part11验证BMS行为符合FDA