《OQ电子天平Version0.5》.pdfVIP

Table of contents 目录 1 DOCUMENT APPROVAL 方案批准 4 1.1 Meaning of Signatures 签字含义 4 2 DOCUMENT HISTORY文件修订 5 3 SIGNATURE SAMPLES 签名 5 4 PROJECT DESCRIPTION介绍 5 4.1 Objective 目的 5 4.2 SCOPE 范围 6 5 EQUIPMENT DESCRIPTION 设备描述 6 5.1 Major process variables 主要变量 6 6 DATA COLLECTION FOR THE QUALIFICATION 确认数据收集 7 6.1 Qualification Protocol Report 确认方案报告 7 6.2 Corrections 改正 7 6.3 Comments and/or Deviations 备注和/或偏差 7 6.4 Test Failure 测试失败 7 7 OPERATIONAL QUALIFICATION REQUIREMENTS 运行确认要求 8 8 TRAINING OF PERSONNEL ON SOPS对人员SOP的培训 8 8.1 Approach 方法 8 8.2 Training Program 培训程序 9 8.3 Training Records 培训记录 9 9 QUALIFICATION TEST SHEETS确认测试单 9 10 CHANGE CONTROL变更控制 9 11 OPERATIONAL QUALIFICATION TESTS操作确认测试单 10 11.1 标准操作程序确认 10 11.2 开机关机确认 10 11.3 内部校验确认 10 11.4 外部校验确认 10 11.5 称量确认 10 11.6 Operational Qualification Tests Status 操作确认测试状况 11 12 LIST OF ATTACHMENTS 附件清单 13 12.1 OQ report and approval of final package OQ 报告和最终包的批准 14 13 FINAL APPROVAL 完成方案批准 15 14 APPENDIX 附录 15 附录 1：签名 16 附录2 ：标准操作规程确认 17 附录 3：开机/关机操作确认 20 附录4 ：内部校验确认 22 附录 5：外部校验确认 25 附录 6：称量确认 27 附录 7：在操作确认中使用的测量仪器清单 30 附录 8：偏差记录志 31 1 DOCUMENT APPROVAL 方案批准 1.1 MEANING OF SIGNATURES 签字含义 Protocol Reviewers: Protocol reviewers shall have technical expertise to critically assess the content and accuracy of the document. Signing shall signify that the review and acceptance of the plan is complete, technically accurate and meets corporate requirements. 方案审核者：具备专业知识对方案的内容和准确性进行评估。签字表明对计划的 审核是完整、技术方面正确并满足公司要求。 Protocol Approvers: This approval shall signi