CHN_cubeLMS_FDA 21 CFR Part 11 Self Check List

Regulation

Compliance

Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine. Such procedures and controls shall include the following:

[11.10a] Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.

CRScube 系统是 Closed system，一次生成的数据文件无法更改。Audit Trail 功能包含 data logger，会捕获系统的所有交互并生成修改记录。

系统Validation(验证)可确保准确性、可靠性、一致的预期性能，并具备识别无效或已更改记录的能力，同时提供两种形式的系统验证和电子记录验证功能。

1. 系统验证程序按照 SOP 151 Software Development 开发系统，并将需求、设计以及基于设计执行的测试文档等重要活动文档化。

2. 执行电子记录验证。

   1. 提供输入数据验证程序执行功能

      • 字符、数字、日期 Type 输入数据检查

      • Field Check: 必填数据输入检查

      • Edit Check: 当超出正常范围值时，执行 Warning Message 或确认操作

[11.10b] The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency. Persons should contact the agency if there are any questions regarding the ability of the agency to perform such review and copying of the electronic records.

可由按照 Role & Privilege 设置的用户进行电子记录查看和副本生成。下载的文件可读、完整且准确。 必要时，可在便携介质 (例如 : CD-ROM) 上打印或复制，并可保存以供日后审计/检查。

[11.10c] Protection of records to enable their accurate and ready retrieval throughout the records retention period.

提供数据保护程序。

• 数据变更时显示确认及警告消息

• 提供输入数据修改原因(Editing Reason)的输入功能

[11.10d] Limiting system access to authorized individuals.

仅允许认证个人访问系统，并使用 ID/PW。

• 通过输入 ID/PW 访问系统

• 5次 Login 失败后用户锁定 (Lock) → 可通过重置密码访问

• 根据设定的 Role & Privilege 限制用户访问系统

[11.10e] Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying.

cubeLMS 运行中发生的变更，可通过审计追踪(Audit Trail)以及系统自动生成的时间戳、用户 ID、输入值和变更原因信息进行追踪。

Data Audit Trail 项目如下所示。

• No. : Audit Trail 的 Row Number

• Date/Time : Data 输入 & 修改的 Date & Time

• User : 输入 & 修改 Data 的 User

• Value : 输入 & 修改的 Value 值

• Reason : Data 修改时 User 输入的原因

1. Data 的删除不会显示在 List 中，但实际上 Data 并不会被删除。

2. Audit Trail 以 read-only 形式显示，且无法修改或删除。

3. Audit Trail 会在 Data 保存期限内保留，因此可在系统内随时访问。

[11.10f] Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate.

cubeLMS 是管理每个人的 Training Record 的系统。

用户 Flow 按管理员和普通用户区分，管理员按 Lecture 创建 → 修改 → 学习内容管理 的流程进行。

普通用户按已注册 Lecture 确认 → 学习 → 学习内容管理 的流程进行。

[11.10g] Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand.

cubeLMS 仅允许获授权人员创建 ID，并可识别用户。已注册用户的系统使用会根据 Role & Privilege 受到限制。

• 仅限被授予访问权限的 Company 才能查询、修改。

• 仅具有查询权限时，修改、输入功能受限。

• Lecture 创建及修改权限受控。

• 管理性活动(用户管理、系统设置等)的执行权限受控。

[11.10h] Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction.

cubeLMS 不使用单独的 device，因此不适用。

[11.10i] Determination that persons who develop, maintain, or use electronic record / electronic signature systems have the education, training, and experience to perform their assigned tasks.

按照 SOP 102 Personal Training 进行与工作相关的培训，并将其执行记录文档化为各自的培训记录。

为 End User 提供 Training，并在系统中提供 User Manual。

[11.10j] The establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions initiated under their electronic signatures, in order to deter record and signature falsification.

这是适用于 Sponsor 和 CRO 组织的流程。

[11.10k] Use of appropriate controls over systems documentation including:

(1) Adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance.

(2) Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation.

cubeLMS 根据以下 SOP 编写、管理并分发系统相关文档。

• 与系统开发相关的产出物生成管理

  • SOP 151 Software Development

• 提供关于文档分发、管理和访问的管理程序

  • SOP 112 Document Control

  • SOP 121 System Manual

  • SOP 155 Change and Configuration Management

Regulation

Compliance

[11.30] Persons who use open systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, as appropriate, the confidentiality of electronic records from the point of their creation to the point of their receipt. Such procedures and controls shall include those identified in 11.10, as appropriate and additional measures such as document encryption and use of appropriate digital signature standards to ensure, as necessary under the circumstances, record authenticity, integrity, and confidentiality.

cubeLMS 不是 Closed System 的适用对象。

Regulation

Compliance

[11.50a] Signed electronic records shall contain information associated with the signing that clearly indicates all of the following:

(1) The printed name of the signer;

(2) The date and time when the signature was executed; and

(3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature.

cubeLMS不执行电子签名，因此不适用。

[11.50b] The items identified in paragraphs (a)(1), (a)(2), and (a)(3) of this section shall be subject to the same controls as for electronic records and shall be included as part of any human readable form of the electronic record (such as electronic display or printout).

cubeLMS不执行电子签名，因此不适用。

Regulation

Compliance

[11.70] Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means.

cubeLMS不进行电子签名，因此不适用。

Regulation

Compliance

[11.100a] Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else.

cubeLMS 不进行电子签名，因此不适用。

[11.100b] Before an organization establishes, assigns, certifies, or otherwise sanctions an individual's electronic signature, or any element of such electronic signature, the organization shall verify the identity of the individual.

这是适用于 Sponsor 和 CRO 组织的流程。

[11.100c] Persons using electronic signatures shall, prior to or at the time of such use, certify to the agency that the electronic signatures in their system, used on or after August 20, 1997, are intended to be the legally binding equivalent of traditional handwritten signatures.

(1) The certification shall be submitted in paper form and signed with a traditional handwritten signature, to the Office of Regional Operations (HFC-100), 5600 Fishers Lane, Rockville, MD 20857.

(2) Persons using electronic signatures shall, upon agency request, provide additional certification or testimony that a specific electronic signature is the legally binding equivalent of the signer's handwritten signature.

这是适用于 Sponsor 和 CRO 组织的流程。

Regulation

Compliance

[11.200a] Electronic signatures that are not based upon biometrics shall:

(1) Employ at least two distinct identification components such as an identification code and password.

(i) When an individual executes a series of signings during a single, continuous period of controlled system access, the first signing shall be executed using all electronic signature components; subsequent signings shall be executed using at least one electronic signature component that is only executable by, and designed to be used only by, the individual.

(ii) When an individual executes one or more signings not performed during a single, continuous period of controlled system access, each signing shall be executed using all of the electronic signature components.

(2) Be used only by their genuine owners;

(3) Be administered and executed to ensure that attempted use of an individual's electronic signature by anyone other than its genuine owner requires collaboration of two or more individuals.

cubeLMS不进行电子签名，因此不适用。

[11.200b] Electronic signatures based upon biometrics shall be designed to ensure that they cannot be used by anyone other than their genuine owners.

cubeLMS不支持生物识别。

Regulation

Compliance

Persons who use electronic signatures based upon use of identification codes in combination with passwords shall employ controls to ensure their security and integrity. Such controls shall include:

[11.300a] Maintaining the uniqueness of each combined identification code and password, such that no two individuals have the same combination of identification code and password.

cubeLMS确保用户 ID / Password 组合始终唯一。用户 ID 不可更改。

[11.300b] Ensuring that identification code and password issuances are periodically checked, recalled, or revised (e.g., to cover such events as password aging).

cubeLMS会控制登录 Password 每90天更改一次。

[11.300c] Following loss management procedures to electronically deauthorize lost, stolen, missing, or otherwise potentially compromised tokens, cards, and other devices that bear or generate identification code or password information, and to issue temporary or permanent replacements using suitable, rigorous controls.

cubeLMS不提供用于生成 ID 或 Password 的设备。如果忘记 ID 或 Password，可通过 Find your ID, Reset Password 找回 ID 或重置密码后访问系统。

[11.300d] Use of transaction safeguards to prevent unauthorized use of passwords and / or identification codes, and to detect and report in an immediate and urgent manner any attempts at their unauthorized use to the system security unit, and, as appropriate, to organizational management.

系统会在登录失败时显示剩余尝试次数，并在登录失败5次时将用户账户 Lock 并限制访问。

[11.300e] Initial and periodic testing of devices, such as tokens or cards, that bear or generate identification code or password information to ensure that they function properly and have not been altered in an unauthorized manner.

cubeLMS不使用令牌或卡等设备。