维护实验室电子记录的特点和优点

高实验室吞吐量与高效和安全的数据交换相结合，确保了领先实验室的竞争优势。

什么是电子记录？

US FDA defines electronic records as any combination of text, graphics, data, audio, pictorial or any other information in digital form that is created, modified, maintained, archived, retrieved or distributed by a computer system

Benefits of maintaining e-records

电子记录提供了不同的好处和数据存储和传输节省时间，同时克服了每个阶段的人类错误，并在所需的安全性下克服。可以概述优势：

• 提高运营效率和易于获取信息
• Paperless workplace environment
• 额外保护表单软拷贝中的数据
• 保存文档的存储空间要求
• 更快的数据分析有助于及时纠正和预防措施
• Multi-user access of data and multitasking benefits

电子签名

电子签名是计算机编译的任何符号或一系列符号的数据，该符号由个人采用或授权被个人采用或授权与个人的手写签名相当于具有法律约束力。它包括用户ID，密码或基于加密的数字签名。

• 签名的电子记录验证了签字人的印刷名称
• Safeguards ensure freedom from tampering
• 用于确保密码的完整性和安全性的识别码和密码
• Audit trails lead to the signing person’s identification

封闭系统

Access is controlled by persons who were responsible for the content of the electronic record,i.e, authenticity, integrity, confidentiality and non-repudiation. Such access is contained within an organization’s local area network. A person whose electronic signature appears cannot absolve himself of responsibility of the record

开放系统

Access is universal as in case of Internet. Such documents should ensure authenticity, integrity, confidentiality and non-repudiation from point of creation to point of access. Additional measures should be taken such as encryption and digital signatures.

数据备份的好处

总有一个潜藏的恐惧dat数据丢失a backup gives secure access to large volumes of data at the click of a mouse. It is a good practice to create backups daily

• All data should be backed up daily and transferred to a secure distant location to prevent accidental loss
• Irretrievable loss due to system failure can be prevented by a backup procedure
• 可以保存工作表，以便为指定的时间保存，以启用存储数据的构建
• Backups can be conveniently made on CDs

软件升级指南

Advances in technology necessitate upgradation of softwares from time to time

Upgradation on computers which are integral part of instruments

• Software changes and upgrading must be recorded and validated before putting to routine use
• Software upgrades if installed by supplier should be entered in instrument maintenance record
• At time of repair service engineers should not be allowed to load any software modifications which are not authorized by laboratory management

Upgradation on computer systems managed by external agencies

• Software changes should be upgraded only against request made by authorized laboratory personnel
• Software updates under direct control of outside agency servers should be brought to the knowledge of laboratory management
• Laboratory management should authenticate such changes before these are implemented
• 外部机构应提供对先前版本的访问，以便在需要时验证早期数据

Electronic data security

Authentication, access control and auditing constitute the three supporting pillars for data security.

Authentication

• Authentication verifies the identity of users before they can gain access to data and perform transactions on electronic records through user id’s or biometric records
• 在实验室使用之前，应该在实验室之前进行身份验证任何新软件
• Laboratory analysts should get their spreadsheets for calculation and data processing authorized by laboratory management before use.
• 通过使用密码，应通过授权的更改来保护涂抹纸张
• 所有更改都应追溯到制作此类更改和原始值的人员

Access control

• 用户可以使用多级访问权限
• URL级别的访问权限限制，以保护基于Web的资源，例如域，目录，部门，服务器等
• Medium grained access to values associated with fields, application records, specific files, objects on we pages, etc
• 细粒度授权可访问组织政策和决策的变化
• Auditing traceability to user and not just the device
• 在告警消息的情况下要采用的程序
• Alerts on failed login attempts while in progress
• Security on preservation of user locks to prevent fraudulent misuse
• 结束所有用户活动的结束审计跟踪

Introduction of advanced automated analysis techniques and e-maintenance of e-records can improve efficiency of laboratory operations and pave the way to your laboratory’s unstoppable growth.