▍来源：Julia翻译
Data Integrity and Compliance With Drug CGMP Questions and Answers
Guidance for Industry1
行业指南：数据完整性与药品CGMP合规问答
2018年12月12日，FDA发布了行业指南《Data Integrity and Compliance With Drug CGMP数据完整性和GMP符合性问答》终稿，期中包括18个问题的解答，如下：
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Please clarify the following terms as they relate to CGMP records: 请澄清以下术语在用于CGMP记录时的含义
a. What is “data integrity”? 什么是“数据完整性”？
For the purposes of this guidance, data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA)5.
本指南中，数据完整性指南数据的完整性、一致性和准确性。完整、一致和准确的数据应可追溯、清晰、同步记录、为原件或真实副本并准确（ALCOA）。
Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archival, retrieval, transmission, and disposition of data after the record’s retention period ends6. System design and controls should enable easy detection of errors, omissions, and aberrant results throughout the data’s life cycle.
数据完整性在整个CGMP数据生命周期中都很关键，包括数据的创建、修改、处理、保存、归档、传输和超保存期后的处置。系统设计和控制应使其在整个数据生命周期中易于发现错误、遗漏和异常结果。b. What is “metadata”? 什么是“元数据”？
Metadata is the contextual information required to understand data. A data value is by itself meaningless without additional information about the data. Metadata is often described as data about data. Metadata is structured information that describes, explains, or otherwise makes it easier to retrieve, use, or manage data. For example, the number “23” is meaningless without metadata, such as an indication of the unit “mg.” Among other things, metadata for a particular piece of data could include a date/time stamp documenting when the data were acquired, a user ID of the person who conducted the test or analysis that generated the data, the instrument ID used to acquire the data, material status data, the material identification number, and audit trails.
元数据是了解数据所需的环境信息。如果没有关于数据的其它信息，一个数据值自身是没有意义的。元数据通常被描述为数据的数据。元数据是结构式的信息，它描述、解释数据或使得数据易于检索、使用或管理。例如，数值“23”如果没有元数据例如显示单位“mg”是没有意义的。此外，元数据是一种特别的数据，可包括日期时间戳以记录数据是何时采集的、用户ID说明是谁执行了检测或分析从而生成该数据、用于采集数据的仪器ID、原料状态数据、原料识别号和审计追踪。
Data should be maintained throughout the record’s retention period with all associated metadata required to reconstruct the CGMP activity (e.g., §§ 211.188 and 211.194). The relationships between data and their metadata should be preserved in a secure and traceable manner.
在记录的整个保存期间，应将重建CGMP活动所需的相关元数据与数据一起保存（例如§§ 211.188 和211.194）。数据与其元数据之间的关系应以安全和可追溯的方式保留。
c. What is an “audit trail”? 什么是“审计追踪”？
For purposes of this guidance, audit trail means a secure, computer-generated, time-stamped electronic record that allows for reconstruction of the course of events relating to the creation, modification, or deletion of an electronic record. For example, the audit trail for a high performance liquidchromatography (HPLC) run should include the user name, date/time of the run, the integration parameters used, and details of a reprocessing, if any. Documentation should include change justification for the reprocessing.
在本指南中，审计追踪意指一种安保用、由计算机生成带有时间戳的电子记录，它使得可以重构与一个电子记录创建、修改或删除有关的事件的过程。例如，HPLC运行的审计追踪应包括有用户名、运行日期时间、所用积分参数以及重新处理的详细信息（如有）。文件记录应包括有重新处理的变更论证。
Audit trails include those that track creation, modification, or deletion of data (such as processing parameters and results) and those that track actions at the record or system level (such as attempts to access the system or rename or delete a file).
审计追踪包括追踪数据创建、修改或删除（如处理参数和结果）的信息，和追踪记录或系统层级动作的信息（如试图访问系统或重命名或删除一份文件）。
CGMP-compliant record-keeping practices prevent data from being lost or obscured and ensure that activities are documented at the time of performance (see §§ 211.68, 211.100, 211.160(a), 211.188, and 211.194). Electronic record-keeping systems, which include audit trails, can support these CGMP requirements.
符合CGMP要求的记录保存规范防止数据丢失或遮盖，确保活动在执行时即被记录（参见§§ 211.68, 211.100, 211.160(a), 211.188和211.194）。含有审计追踪的电子记录保存系统可支持这些CGMP要求。d. How does FDA use the terms “static” and “dynamic” as they relate to record formats? FDA在记录格式方面是如何使用术语“静态”和“动态”的？
For the purposes of this guidance, static is used to indicate a fixed-data record such as a paper record or an electronic image, and dynamic means that the record format allows interaction between the user and the record content. For example, a dynamic chromatographic record may allow the user to change the baseline and reprocess chromatographic data so that the resulting peaks may appear smaller or larger. It also may allow the user to modify formulas or entries in a spreadsheet used to compute test results or other information such as calculated yield.
在本指南中，静态用于表示数据固化的记录，如纸质记录或电子图像，而动态则表示记录格式允许用户与记录内容进行互动，例如，动态色谱记录允许用户改变基线，重新处理色谱数据，这样得到的峰看起来会更小或更大。它亦可允许用户修改用于计算检测结果的数据表中的公式或录入数字，或其它信息如计算结果。e. How does FDA use the term “backup” in § 211.68(b)? FDA是如何使用§ 211.68(b)中的术语“备份”的？
FDA uses the term backup in § 211.68(b) to refer to a true copy of the original record that is maintained securely throughout the record retention period (e.g., § 211.180). Backup data must be exact, complete, and secure from alteration, inadvertent erasures, or loss (§ 211.68(b)). The backup file should contain the data (which includes associated metadata) and should be in the original format or in a format compatible with the original format.
FDA在§ 211.68(b)使用了术语备份用于借指在整个记录保存期内安全保存的原始记录的真实副本（例如§ 211.180）。备份数据必须准确、完整，安全不会被修改、无意擦除或丢失（§ 211.68(b)）。备份文件应含有数据（其中包括相关元数据），并应采用原始格式或与原始格式兼容的格式。
FDA’s use of the term backup is consistent with the term archive as used in guidance for industry and FDA staff General Principles of Software Validation.
FDA对术语备份的使用与行业指南和FDA软件验证员工通则中所用的术语归档具有相同意思。
Temporary backup copies (e.g., in case of a computer crash or other interruption) would not satisfy the requirement in § 211.68(b) to maintain a backup file of data.
临时备份副本（例如，如果计算机死机或其它中断）不能满足§ 211.68(b)的保存数据备份文件要求。
f. What are the “systems” in “computer or related systems” in § 211.68? § 211.68 里面“计算机或相关系统”中的“系统”是什么？
The American National Standards Institute (ANSI) defines systems as people, machines, and methods organized to accomplish a set of specific functions7. Computer or related systems can refer to computer hardware, software, peripheral devices, networks, cloud infrastructure, personnel, and associated documents (e.g., user manuals and standard operating procedures8).
美国国家标准研究所（ANSI）定义系统为组织起来完成一系列指定功能的人员、机器和方法。计算机或相关系统可代指计算机硬件、软件、外围设备、网络、云基础设施、人员和相关文件（例如用户手册和标准操作规程）。
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