A paper printout or static record may satisfy retention requirements if it is the original record or a true copy of the original record (see §§ 211.68(b), 211.188, 211.194, and 212.60). During data acquisition, for example, pH meters and balances may create a paper printout or static record as the original record. In this case, the paper printout or static record, or a true copy, must be retained (§ 211.180).

如果是原始记录或原始记录的真实拷贝，纸质打印记录或静态记录可满足保存要求（见§§211.68(b)，211.188，211.194和212.60）。在数据采集过程中，例如，pH计和天平可能产生纸质打印记录或静态记录作为原始记录。在这种情况下，纸质打印记录或静态记录，或真实有效副本必须被保存（§211.180）。

However, electronic records from certain types of laboratory instruments—whether stand-alone or networked—are dynamic, and a printout or a static record does not preserve the dynamic record format that is part of the complete original record. For example, the spectral file created by FT-IR (Fourier transform infrared spectroscopy) is dynamic and can be reprocessed. However, a static record or printout is fixed and would not satisfy CGMP requirements to retain original records or true copies (§ 211.180(d)). Also, if the full spectrum is not displayed in the printout, contaminants may be excluded.

然而，某些类型的实验室仪器（不论是单机的或联网的）产生的电子记录是动态的，而打印记录或静态记录无法以动态记录格式保存，动态记录格式又是完整原始记录的一部分。例如，FT-IR（傅里叶变换红外光谱法）产生的光谱文件是动态的且可进行后处理。然然而静态记录或打印输出的记录是固定不变的且不能满足CGMP对于保存原始数据或真实副本的要求（(§ 211.180(d))）。另外，如果打印记录没有显示全波段光谱，污染物的光谱可能会被排除在外。

You must ensure that original laboratory records, including paper and electronic records, are subject to second-person review (§ 211.194(a)(8)) to make certain that all test results and associated information are appropriately reported. Similarly, in microbiology, a contemporaneous written record is maintained of the colony counts of a petri dish, and the record is then subject to second-person review.

你必须确保原始实验室记录（包括纸质和电子记录）由他人进行审核，从而确保正确的报告了所有的检测结果和相关的信息。同样的，在微生物检验中，保持培养皿的菌落计数的同时书面记录，然后记录提交给第二个人员审核。

Document control requirements in § 211.180 pertain only to CGMP records.

§211.180中的文件控制要求仅适用于CGMP记录。

For more information on static and dynamic records, see 1.d. in this guidance. For PET drugs, see the guidance for industry PET Drugs—Current Good Manufacturing Practice (CGMP) for discussion of equipment and laboratory controls, including regulatory requirements for records.

更多静态和动态记录相关信息，请参见本指南1.d部分。对于PET药品，请参见PET药品行业指南—cGMP对设备和实验室控制的讨论，包括对记录的监管要求。