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

就本指南而言，数据完整性是指数据的完全性、一致性和准确性。完全、一致和准确的数据应当具有可归属性（attributable）、清晰可辨性（legible）、即时性（contemporaneously）被记录、原始性（original）或真实有效副本，和准确性（accurate）（ALCOA）。

These characteristics are important to ensuring data integrity and are addressed throughout the CGMP regulations for drugs. For attributable, see §§ 211.101(d), 211.122, 211.186, 211.188(b)(11), and 212.50(c)(10); for legible, see §§ 211.180(e) and 212.110(b); for contemporaneously recorded (at the time of performance), see §§ 211.100(b) and 211.160(a); for original or a true copy, see §§ 211.180 and 211.194(a); and for accurate, see §§ 211.22(a), 211.68, 211.188, and 212.60(g).

这些特性对于可确保数据完整性非常重要，并在药品CGMP法规中得到解决。对于归属性，参见see §§ 211.101(d)、211.122、211.186、211.188(b)(11),和212.50(c)(10)；对于清晰可辨性，参见§§ 211.180(e)和212.110(b)；对于（在操作当场）即时性被记录，参见§§ 211.100(b)和211.160(a)；对于原始或真实有效副本，参见§§ 211.180和211.194(a)；对于准确性，参见§§ 211.22(a)、211.68、211.188和212.60(g)。

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 ends.6 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CGMP 数据生命周期中至关重要, 包括数据的创建、修改、加工、保存、归档、检索、传输和在记录保存期结束后的处置。系统设计和控制应确保数据在整个生命周期内易于检测错误、遗漏和异常结果。