When generated to satisfy a CGMP requirement, all data become a CGMP record.14 You must document, or save, the data at the time of performance to create a record in compliance with CGMP requirements, including, but not limited to, §§ 211.100(b) and 211.160(a).

所有为满足CGMP要求而生成的数据均为CGMP记录。在执行创建符合GCMP要求（包括但不限于§§ 211.100(b)和211.160(a)）的记录时，你必须记录或保存这些数据。

FDA expects processes to be designed so that data required to be created and maintained cannot be modified without a record of the modification. For example, chromatographic data should be saved to durable media upon completion of each step or injection (e.g., peak integration or processing steps; finished, incomplete, or aborted injections) instead of at the end of an injection set, and changes to the chromatographic data or injection sequence should be documented in an audit trail. Aborted or incomplete injections should be captured in audit trails and should be investigated and justified.

FDA期望企业能够设计出一套能防止要求创建和维护的质量数据在没有修改记录的情况下被修改的程序。例如，色谱图应在每一步骤或每一次进样（例如峰值积分或处理步骤；完成，未完成，或终止进样）完成后，而不是在一个进样组运行结束后，即被保存至耐用的媒介。色谱数据或进样顺序的变化应在审计追踪中被记录。终止或未完成的进样针应该在审计追踪时被识别并进行调查和论证。

It is not acceptable to record data on pieces of paper that will be discarded after the data are transcribed to a permanent laboratory notebook (see §§ 211.100(b), 211.160(a), and 211.180(d)). Similarly, it is not acceptable to store electronic records in a manner that allows for manipulation without creating a permanent record.

将数据记录在纸片上，随后誊抄到永久实验记录本上并将纸片丢弃的行为是不允许的（参考§§ 211.100(b)， 211.160(a)，和315 211.180(d)）。同样地，在创建永久记录前，以允许操作而不创建永久记录的方式存储电子记录是不允许的。

You may employ a combination of technical and procedural controls to meet CGMP documentation practices for electronic systems. For example, a computer system, such as a Laboratory Information Management System (LIMS) or an Electronic Batch Record (EBR) system, can be designed to automatically save after each entry. This would be similar to indelibly recording each entry contemporaneously on a paper batch record to satisfy CGMP requirements. The computer system described above could be combined with a procedure requiring data be keyed in or otherwise entered immediately when generated.

可以综合使用技术手段和程序控制来满足CGMP对电子系统的文档规范。例如，计算机系统，如电子信息管理系统（LIMS）或电子批记录（EBR）系统，可以被设计为每次录入后自动保存。这与同时在纸质批记录上不可去除的记录每个条目以满足CGMP的要求是类似的。上述计算机系统可以与一个要求数据产生后立即键入或以其他方式录入的程序相结合。

For PET drugs, see the “Laboratory Controls” section of the guidance for industry PET Drugs—Current Good Manufacturing Practice (CGMP).

对于PET药品，见PET药品—现行CGMP行业指南的“实验室控制”部分。

14 Under section 704(a) of the FD&C Act, FDA inspections of manufacturing facilities “shall extend to all things therein (including records, files, papers, processes, controls, and facilities) bearing on whether prescription drugs [and] nonprescription drugs intended for human use ... are adulterated or misbranded ... or otherwise bearing on violation of this chapter.” Accordingly, FDA routinely requests and reviews records not intended to satisfy a CGMP requirement but which nonetheless contain CGMP information (e.g., shipping or other records that may be used to reconstruct an activity).

根据FD＆C法案第704（a）节，FDA对生产设施的检查“应扩展到其中的所有内容（包括记录，文件，文件，工艺，控制和设施），与处方药[和]非处方药是否用于 人类使用......掺假或贴错标签......或以其他方式违反本章。“因此，FDA定期要求和审核不是为了满足CGMP要求但仍包含CGMP信息（例如，运输或其他记录）的记录 可用于重建活动）。