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cnas软件测试机构数据控制和信息管理程序应包含哪些要素?

检测数据和信息的正确性和完整性直接影响着检测结果的质量,同时检测数据和信息也是实验室保密工作的重要组成部分。cnas软件评测机构需要制定《数据控制和信息管理程序》来确保对数据和信息的有效管理。

 

适用范围

 

适用于软件测试实验室对检测结果有关的数据的采集、处理、记录、报告、存储或检索及其实验室信息管理系统的管理。

 

职责

1、各岗位负责人负责对计算机系统中文件及数据保护、计算机网络及检测专用软件管理。

2、软件测试实验室检测人员负责检测数据的采集、处理、记录、报告和电子方式存储。

3、实验室网络管理员负责数字化实验室管理系统的维护及该系统上的检测资源的管理。

 

工作程序

 

1、实验室信息管理系统要求:

 

1)防止未经授权的访问;

2)安全保护以防止篡改和丢失;

3)在符合系统供应商或实验室规定的环境中运行,或对于非计算机化的系统,提供保护人工记录和转录准确性的条件;

4)以确保数据和信息完整性的方式进行维护;

5)包括记录系统失效和适当的紧急措施及纠正措施。

 

2、数据的采集、记录

 

1)实验室检测人员在检测过程中要同时做原始记录,填写内容要真实、准确。原始记录要依据《记录控制管理程序》、《记录填写规范》和《数值修约规则与极限数值的表示和判定》的要求规范填写。

 

2)计算机和自动设备采集和处理的检测数据要随时打印出来,并标记与检测样品相关联的编号,作为检测原始记录保存。

 

3)计算机和自动设备内的数据要随时备份,以防止数据丢失。

 

 

3、数据的传输

 

1)数据每次转移都必须审核,对原始记录和检测报告须采用“三核一审”方式。检测人员完成检测工作后,对原始数据进行处理、计算所得出检测结果进行自核;同检测岗位的检测人员对原始记录中的原始数据、计算过程、检测结果等进行核对;审核岗位人员要根据原始记录、合同、检测方法对检测人员拟制的实验室检测报告进行复核。样品负责人根据各实验室检测报告拟制检测报告,由同岗位人员进行复核,检测报告签发人员进行最后的全面审核并签发。

 

2)数据的传送过程中要为客户保密,不得向外部人员提供。

 

3)数据在传输过程中要防止被非法修改。

 

 

4、数据的报告

实验室的检测结果以“实验室检测报告”的形式传递到综合业务部门,综合业务部门最后以“检测报告”的形式由授权签字人对外签发。

 

5、数据的保存

 

载有检测数据的原始记录、检测报告副本由资料负责人定期进行整理、装订。

 

6、电子设备的数据控制

 

1)实验室对计算机和自动设备提供保持检测数据完整性所必需的环境和操作条件。

 

2)实验室所使用的自动设备的现行软件,在该设备应用范围内使用,可以认为已经经过了充分的确认。

 

3)实验室使用的经过省级以上技术部门组织鉴定的软件,在该软件应用范围内使用,可以认为已经经过了充分的确认。

 

4)由实验室自行开发的计算机软件应被制定成足够详细的文件,并对其适用性进行适当确认;实验室配置或修改的软件也应进行确认。

 

5)不得私自修改计算机和自动设备内的程序文件和数据,确需修改时需经各实验室主任批准后实施,必要时要经过确认。

 

6)严禁外来存储设备进入实验室内计算机和自动设备,以防带入病毒破坏储存的数据。

 

7、计算机、数字化实验室管理系统的安全管理

 

1)大型精密仪器设备配置的计算机应设置密码,防止非授权人员接触修改计算机软件、数据。

 

2)实验室网络管理员按照实验室的要求,负责本实验室计算机网络安全以及服务器等设备的维护保养。

 

3)实验室网络管理员负责数字化实验室管理系统的维护及该系统上的检测资源的管理。

 

4)本实验室输入、输送检测结果的网络计算机均须安装实验室指定的实时防病毒软件。

 

5)非授权人员不得擅自删除、拷贝、打印数字化实验室管理系统的实验数据。

 

8、计算机软件的控制

 

1)实验室全体工作人员对数字化实验室管理系统的修改建议,应提交实验室综合业务部门,由网络管理员与网络运营商协商实施。

 

2)实验室网络管理员与网络运营商联系,对数字化实验室管理系统修改的可行性进行评审,经实验室技术负责人批准后组织实施。

 

9、计算机采集实验数据的控制

 

1)检验员应通过个人密码登录大型精密仪器设备配置的计算机,进行数据输入、采集、存储(包括本地存储和外部存储)和处理,防止非授权人员接触和修改计算机内的实验数据。

 

2)数据的输入和采集前应对数据进行适当的检查,输入采集后应经过核查无误后由检测人员进行确认。

 

3)数据应根据相关要求由权限所有人依次进行复查和审核并确认。

 

4)所有输出的数据应有检测人员和实验室负责人签名。

 

5)仪器设备自动生成的图谱、标准曲线应打印纸质文件,专门保存或作为检验原始记录的一部分。对有害生物拍摄的图片等必须在硬拷贝上另行保存备份文件。

 

6)计算机和自动化仪器设备应按其使用说明书进行维护,确保其工作环境和条件满足使用要求。