ISPE GAMP指南：记录和数据可靠性-翻译（2)

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ISPE GAMP® Records and Data Integrity Guide


[翻译交流] ISPE GAMP指南：记录和数据可靠性-翻译（1）

1 Introduction介绍

1.1 Background背景

Theimpact of record and data integrity issues can be significant on a regulated company. It canresult inrecalls of products,warning or untitled letters,import alerts, injunctions, seizures,Application Integrity Policy Invocations/legal action, and ultimately thepotential for patient harm. These regulatory actions can also have asignificant financial impact.

记录和数据完整性问题的影响对于一个受监管的公司来说是很重要的。它可以导致产品召回、警告或未命名的信件、进口警告、禁令、没收、应用完整性政策调用/法律行动，以及最终潜在的对病人的伤害。这些监管行动也可能产生重大的财务影响。

Therehas been increased regulatory focus on all aspectsof data integrity, including publication of specific regulatoryguidance on the topic, and increased number of citations in the area.

监管部门已经加强了对数据完整性的所有方面的关注，包括发布关于该主题的具体监管指南，以及增加该领域的引用数量。

Forthe purposes of this Guide:

以下本指南的目的:

•Regulated data is information used for a regulated purpose or to support aregulated process.

•受监管的数据是用于监管目的的信息，或支持受监管的工艺。

•“Metadata is data that describes the attributes of other data, and providecontext and meaning. Typically, these are data that describe the structure,data elements, inter-relationships, and other characteristics of data.”

•“元数据是描述其他数据属性的数据，并提供上下文和含义。通常，这些数据描述了数据的结构、数据元素、内部关系和其他特征”

•A regulated record is a collection of regulated data (and any metadatanecessary to provide meaning and context) with a specific GxP purpose, content,and meaning, and required by GxP regulations. Records include instructions as well as data and reports.

•受监管的记录是受监管的数据(以及提供意义和上下文所需的任何元数据)与特定的GxP目的、内容和意义，以及GxP规则所要求的集合。记录包括指令以及数据和报告。

•“Data Integrity is defined as the extentto which all data are complete, consistent and accurate throughoutthe data life cycle.”

•“数据完整性被定义为所有数据在整个数据生命周期中完整性、一致性和准确性的程度。”

•The integrity of records depends on the integrity of underlying data, and signatures executed to electronic recordsshould be trustworthy and reliable. See Appendix D3.

•记录的完整性依赖于底层数据的完整性，而执行电子记录的签名应该是值得信赖和可靠的。参见附录D3.

ThisGuide addresses paper records, electronic records,and hybrid situations, while encouraging a move away from hybridsituations, wherever practical.

本指南介绍了纸质记录、电子记录和混合情况，同时鼓励人们远离混合环境，无论实际情况如何。

1.2 Purpose目的

ThisISPE GAMP® Guide: Records and DataIntegrity provides principles and practical guidance on meeting currentexpectations for the management of GxP regulated records and data, ensuringthat they are complete, consistent, secure, accurate, and available throughouttheir life cycle. This approach is intended to encourage innovation andtechnological advance while avoiding unacceptable risk to product quality,patient safety, and public health.

这个ISPE指南:记录和数据完整性提供了原则和实用性指导以满足当前GxP规范预期的记录和数据的管理,确保它们是完整的、一致的、安全、准确和可用的在整个生命周期里。这种方法旨在鼓励创新和技术进步，同时避免产品质量、病人安全和公共卫生的不可接受的风险。

ThisGuide is intended as a stand-alone Guide. It isaligned with ISPE GAMP® 5: A Risk-Based Approach to Compliant GxPComputerized Systems. This Guide has been designed so that it can be used inparallel with guidance provided both in ISPE GAMP® 5 and other ISPE GAMP® GoodPractice Guides.

本指南旨在作为一个独立的指南。它是与ISPEGAMP5:遵从GxP计算机化系统监管的风险管理方法。本指南的设计使它可以与ISPEGAMP5和其他ISPEGAMP良好的实践指南并行使用。

Althoughthe scope of this document is wider, it replaces theISPE GAMP® Good PracticeGuide: A Risk-Based Approach to Compliant Electronic Records and Signatures.

虽然本文档的范围是广泛的,它取代了ISPEGAMP 良好的实践指南:基于风险的电子记录和签名方法。

本文转自微信公众号：分析实验室 AnalyticalLab，陆续更新中......

ISPE GAMP® 记录和数据完整性-翻译（4）1.1 背景

ISPE GAMP® 记录和数据完整性-翻译（5）1.2 目的

syhorchid

了解一下

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