Data created as part of a CGMP record must be evaluated by the quality unit as part of release criteria (see §§ 211.22 and 212.70) and maintained for CGMP purposes (e.g., § 211.180).9 Electronic data generated to fulfill CGMP requirements include relevant metadata required to reconstruct the CGMP activity captured in the record. Invalidating test results to exclude them from quality unit decisions about conformance to a specification requires a valid, documented, scientifically sound justification. See, for example, §§ 211.160(b), 211.188, 211.192, and 212.71(b) and the guidance for industry Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production. Even if test results are legitimately invalidated on the basis of a scientifically sound investigation, the full CGMP batch record provided to the quality unit would include the original (invalidated) data, along with the investigation report that justifies invalidating the result. The requirements for record retention and review do not differ depending on the data format; paper-based and electronic data record-keeping systems are subject to the same requirements.

作为CGMP记录的一部分所创建的任何数据必须作为放行标准的一部分由质量部门评估（见§§211.22和212.70），并予以保存以符合CGMP（例如，§ 211.180）。为满足CGMP要求产生的电子数据应包括用以重建所记录CGMP活动的相关元数据。若要判定检测结果无效并不考虑作为批次符合性标准的判定，必须有一个有效的、有据可查的、科学合理上的理由（见参见§§8 211.160(b)、第211 188、211. 192 和 212.71(b)和《FDA行业指南：OOS调查》。即使检验结果在科学合理调查的基础上被判定为无效, 提供给质量部门的完整CGMP批记录仍需要包含初始的 (无效) 数据, 以及证明结果无效的调查报告。记录保留和审查的要求不因数据格式而异；纸质和电子数据记录保存系统具有同样的要求。

9 For purposes of this guidance, the term quality unit is synonymous with the term quality control unit. For the definition of quality control unit, see § 210.3(b)(15).

9 在本指南中, "质量部门" 一词是 "质量控制部门" 一词的同义词。有关质量控制部门的定义, 请参见§ 210.3(b)(15)。

In computer science, validation refers to ensuring that software meets its requirements. However, this may not meet the definition of process validation as found in guidance for industry Process Validation: General Principles and Practices: “The collection and evaluation of data … which establishes scientific evidence that a process is capable of consistently delivering quality products.” See also ICH guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, which defines validation as providing assurance that a specific process, method, or system will consistently produce a result meeting predetermined acceptance criteria. For purposes of this guidance, validation is being used in a manner consistent with the above guidance documents.

在计算机科学中, 验证是指确保软件满足其要求。然而, 这可能FDA行业指南《工艺验证：一般原则和规范》中对工艺验证的定义：数据的收集和评估，建立工艺能够持续生产出符合其质量的产品的科学证据。另请参阅ICH Q7 关于活性药物成分GMP指南, 该指南将验证定义为保证特定的工艺、方法或系统将持续产生预先制定的接受标准的结果。因此，验证的使用方式与上述指导文件一致。