Clinical Trials Resource Center

验证和遵守21CFR11- Page 2

What software features must be included?
Page II of III

What software features are necessary to be 21 CFR Part 11 compliant?

Security

• 定义哪个个人可以访问该软件 - 当前列表应始终可用
• Define what the user roles are for the software (i.e. administrator, data entry, approver, etc.) and what each role can do
• 访问软件应要求每个用户具有唯一的用户名和密码
• 定义数量的错误登录尝试应将用户锁定在软件中
• A defined time of inactivity shall lock the software for a given user

Audit Trails
An audit trail shall be implemented that allows a means to reconstruct data modification.

审计记录应包括:使用的名称r that made the entry, what was changed (not obscuring the original value), the date and time of change and the reason for change.

Electronic Signatures/Digital Signatures
If electronic signatures will be used, they must include the following:

1. 签名者的名称
2. 签名时间和日期
3. Meaning of signature

Note: An electronic signature consists of two components: id code (username) and password. This is different than the initial login to the software.

Reporting
Users must have the ability to obtain meaningful data from the software.

软件工作流程
The software shall be designed in such a way that a logical process workflow is incorporated (i.e. you are unable to approve until all required pieces are completed).

Record Protection
Data must be backed up on a regular basis

标准作业程序

1. 标准操作程序确保软件的持续使用
2. Procedures should be developed on how the software will be used for a specific task
3. Procedures shall also be developed for administrative functions of the software: how to add users, etc.
4. 还应为在软件之外进行的活动制定程序，以确保最准确的数据

Training
Training should be documented to verify that only trained individuals are using the software.

Validation
A quality validation methodology shall be used to ensure the system (software, people, etc) is performing as intended. It is important to understand that you are validating a SYSTEM and not just the software.

Page III: Click这里for the Validation Process

ADDITIONAL RESOURCES

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OFFICE OF RESEARCH

Clinical Trials Resource Center (CTRC)
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phone 713-500-3622
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clinicaltrials@uth.tmc.edu