电子文件管理作业指导

文件分发部门：（）

文件变更历史：

1. 目的Aim

规范电子文件的管理程序。

To standardizes the procedure of electronic document management.

2. 范围Scope

本SOP适用于本公司所有的电子版本的GMP文件。

This SOP applies to all our company’s electronic GMP documents.

3. 职责Duty

3.1 QA部负责建立和更新本SOP

QA department is responsible to establish and update this SOP.

3.2 各部门和车间负责本部门电子文件的管理。

The departments and workshops are responsible to manage their electronic documents.

3.3 QA负责监督全公司电子文件的管理。

QA department is responsible to supervise the electronic document management of entire company.

4. 内容Content

4.1.制定原则Principle

4.1.1.所有文件必须同时具有电子版本，电子版本文件的内容和格式必须同纸质版本一致；附属的记录，与源文件放置在同一个文件夹里。

Electronic version of each document should be available and consistent with the paper version; subsidiary records should be placed in the same folder together with source document.

4.1.2.电子版本文件的名称须与文件名称一致，由文件名称和文件编号组成，比如：“文件的分类与编码SOP”。

The name of electronic version must be consistent with the paper version, including title and code, for example: “ SOP - Taxonomy and code of GMP documents”.

4.1.3.电子版本由文件起草人负责，在文件批准后，将最终版本递交给文件管理QA。

After a document approved, the document drafter submits the final electronic version to document administrative QA.

4.1.4.未递交电子版本的文件，QA部不予发放文件。

QA department shall not dispense a document until the electronic version has been received by QA department.

4.1.

5.每个子文件夹中设置一个“旧版文件”文件夹，每次文件升级后，将相应的旧版电子文件移至“旧版文件”文件夹中。

Set up an folder named "superseded documents" in each subfolder, the superseded electronic version of specific document should be moved to "superseded documents" after upgraded.

4.2.电子文件的归档Archiving of Electronic Documents

4.2.1.公司电子文件的归档管理由QA部文件管理QA负责，各部门、车间电子文件由各部门、车间指定人员负责。The document administrative QA is responsible for filing of electronic documents, the designated personnel of each department and workshop is responsible for electronic documents

4.2.2.电子文件归档Filing of electronic documents

文件起草人将批准后的文件送至文件管理QA处，同时将最终电子版本交至文件管理QA处。

Drafter of document must send the electronic version document to document administrative QA as well as delivering the approved original document to him/her.

文件管理QA在电脑中建立文件夹，对文件进行分类保存。

Document administrative QA creates folders in computer and saves documents according to categories.

4.2.4.产品年度质量回顾文件Annual Product Quality Review Document

产品年度质量回顾的所有原始记录和年度回顾报告的电子版文件在每年产品年度质量回顾完成后，由

文件管理QA保存。

Electronic versions of all raw records and annual review reports should be saved by the document administrative QA of QA department.

QA部文件管理员在电脑中建立文件夹，并将电子版产品年度质量回顾文件存放在相应的文件夹中。

Document administrative QA creates folders in computer and saves the electronic version of annual quality review document in corresponding folders.

4.3.电子文件的查看权限Access to Electronic Document

部门递交电子文件时，由QA部文件管理员设置电子文件的修改密码，电子版文件不得随意复制、删除和修改，如

需复制、删除和修改必须经QA经理签字批准。

Document administrative QA should set password for electronic documents. Electronic versions of documents should not be copied, deleted and revised. Unless approved by QA manager.

5.注意事项Precautions

文件管理QA每年12月25日到12月30日，将电脑中的电子文件刻录在光碟上，保存在档案室，保存期限为10年。

Document administrator of quality department should file electronic documents in the manner of CD-ROM from Dec 25th to Dec 30th annually, save them for 10 years in archiving room.

电子文件仅用于存档，而不作为执行依据，各车间、部门需按照QA部盖章发放的书面文件为准。

Electronic versions of documents are used only for archiving, rather than as basis for implementation, the written document which has been sealed is authoritative.