电子记录管理SOP

文件 题 快递公司问题件快递公司问题件货款处理关于圆的周长面积重点题型关于解方程组的题及答案关于南海问题 目 Document Title 电子记录管理SOP SOP - Management of electric records 文件编号 Document Code 文件版本号 Version Code 00 (2011) 文件种类 Category of Document 管理类 Management 发放部门 Department of Issue QA 人员 Person 类别 Category 姓名/职位 Name /Position 签名 Signature 日期 Date 编写人 Compiled by 审核人 Check by 批准人 Approved by 生效日期 Valid from 文件分发部门：（ ） Department of document distributed: 序号 Serial No. 部门名称 Department Name 房间号 Room No. 负责人 Manager 1 2 3 4 5 6 7 8 9 10 11 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 Contents 00 (2011) 2011.05.16 建立文件 File foundation 1. 目的 Aim 规范 编程规范下载gsp规范下载钢格栅规范下载警徽规范下载建设厅规范下载 电子记录的管理和保存程序。 This SOP Standardizes electronic records management and preservation program. 2. 范围 Scope 本SOP适用于本公司所有的电子记录，包括由所使用的设备在使用过程中形成的检验的原始图谱、温湿度的监测自动记录数据、环境持续监测记录、设备的灭菌过程监测曲线、压差监测记录（隔离器）、灌装机及冻干机记录等。 This SOP applies to all electronic records of the Company, including the original test map generated in the using of the equipment, sustainability environmental monitoring records, automatically temperature and humidity monitoring data, sterilization process monitoring curve of equipment, pressure difference monitoring records(isolator), records in filling machine and lyophilize machine. 3. 职责 Responsibilities 3.1 QA部负责建立和更新本SOP QA Department is responsible for establishing and updating of the SOP 3.2 各车间和部门负责本部门设备、仪器产生的电子数据的管理。 The workshops and departments are in charge of management of electronic data generating from their department equipment and apparatus. 3.3 QA负责监督全公司电子记录的管理。 QA is responsible for supervising company-wide electronic records management. 3.4 QA负责人负责对经生产总监确认后的批生产记录进行审核，作为产品放行的参考依据。 Head of QA is responsible for reviewing the batch production records qualified by the production director, this is taken as a reference for product release. 4. 内容 Content 4.1 QC部门在检验过程中产生的原始图谱数据，包括高效液相图谱、紫外吸收图谱、红外图谱、稳定性实验箱的温湿度曲线等，应及时打印出来，作为相关检验记录的一部分。检验操作人应在打印的图谱上原件上签上操作人的姓名和日期。 The original test atlas and data generated in the process of testing in QC department, including HPLC atlas, UV absorption spectra atlas, IR spectra atlas, temperature and humidity curve of stability test box, should be printed out in time as a part of related test record. Test operator should sign the name and date on the printed original atlas. 4.2 仓库的温湿度监测数据，应由仓库按月打印成坐标图，作为手工记录的附件和手工记录一起保存。仓库贮存条件监控负责人应在打印的图表上签上姓名和日期。 Temperature and humidity monitoring data of warehouse should be printed to monthly coordinate graphs, and saved as accessories of the manual records. Person in charge of the warehouse storage condition monitoring should sign the name and date on the printed chart. 朗读 显示对应的拉丁字符的拼音   字典 1. 名词 1. content 2. contents 3. substance 4. detail 4.3 生产车间的设备灭菌曲线，在设备进行灭菌时自动记录和打印。隔离器、灌装机、冻干机的生产过程记录，在生产过程中应进行自动记录和打印。以上记录应附在批生产记录中，相关操作人员应在此记录上签上姓名和日期。 Workshop equipment sterilization curve is automatically recorded and printed when sterilization equipment is working. Production process record of Isolator, filling machine and lyophilizer should be automatically recorded and printed in production process. These records should be attached to the batch records, the relevant operators should sign on this record the name and date. 4.4 环境监测打印数据，应作为原始记录的一部分，粘贴在相应的监测记录上。相关监测人应在记录上签上姓名和日期，以及其它必要的标注。 Environmental monitoring print data should be used as part of the original record, paste in the relevant monitoring records. Relevant monitoring person should sign on the record the names and dates, and other necessary annotations. 朗读 显示对应的拉丁字符的拼音   字典 1. 名词 1. content 2. contents 3. substance 4. detail 4.5 其它电子记录也采取同上原则，由记录部门及时打印，并由操作人在打印记录上签名后，作为手工记录的附件，和相应的手工记录一起保存。 Take the same principle, other electronic records should be printed in time by the record department. They should be saved as attachments with the manual records after signed by the operators. 朗读 显示对应的拉丁字符的拼音   字典 1. 名词 1. content 2. contents 3. substance 4. detail 4.6 所有的电子记录都在记录过程中打印出来，作为手工记录的附件，和相应的手工记录同时保存，并按相应的手工记录的要求进行管理。 All electronic records should be printed out when recording, saved as attachments with the related manual records and managed according to the requirement of manual records management. 4.7 电子记录除打印纸质版本归档外，每半年应在QA的监督下进行一次存盘，刻录成光碟，交付QA文件 资料 新概念英语资料下载李居明饿命改运学pdf成本会计期末资料社会工作导论资料工程结算所需资料清单 室进行备份。 Except for the paper record, the electronic records of company must be save in CD and deliver to QA document room for back-up semiannually. 生效日期： Valid from: 版本号： 00 Version code: 页码： 4/4 Page No.: