Yes. All records required under CGMP are subject to FDA inspection. This applies to records generated and maintained on computerized systems, including electronic communications that support CGMP activities. For example, an email to authorize batch release is a CGMP record that FDA may review.

是的。CGMP要求的所有记录都是FDA检查范围。这适用于在计算机化系统上生成和维护的记录，包括支持CGMP活动的电子通信。 例如，授权放行的电子邮件是FDA可能审核的CGMP记录。

You must allow authorized inspection, review, and copying of records, which includes copying of electronic data (§§ 211.180(c) and 212.110(a) and (b)). See also the guidance for industry Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection and section 704 of the FD&C Act. Procedures governing the review of electronic records are described in chapter 5 of the Investigations Operations Manual (IOM) at https://www.fda.gov/iceci/inspections/iom/default.htm.

你必须允许经授权的检查、核实和复制记录，包括电子数据的复制（§§211.180（c），212.110（a）和（b））。另见《构成延迟，拒绝，限制或拒绝药物检查的行业情况》指南和FD＆C法案第704节。 关于电子记录审查的程序见《调查操作手册》（IOM）第5章。