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    188宝金博页面版: PDA TR31计算机化的实验室数据收集系统的验证和确认-中英文版

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    内容提示： PDA TR31 (Chn-Eng) 1 / 30 计算机化的实验室数据收集系统的验证和确认 Validation and Qualification of Computerized Laboratory Data Acquisition Systems PDA 技术报告 No. 31 Technical Report No. 31 PDA 1. Objective 目的 The purpose of this article is to provide guidance to laboratory scientists, technicians and managers responsible for the implementation, testing, control and usage of Laboratory Data Acquisition Systems (LDAS) used within a GMP, GLP, and GCP regulated environment. 本文为实验室科学家、技术员...

    文档格式：PDF | 页数：30 | 浏览次数：223 | 上传日期：2015-12-10 13:11:19 | 文档星级：
    PDA TR31 (Chn-Eng) 1 / 30 计算机化的实验室数据收集系统的验证和确认 Validation and Qualification of Computerized Laboratory Data Acquisition Systems PDA 技术报告 No. 31 Technical Report No. 31 PDA 1. Objective 目的 The purpose of this article is to provide guidance to laboratory scientists, technicians and managers responsible for the implementation, testing, control and usage of Laboratory Data Acquisition Systems (LDAS) used within a GMP, GLP, and GCP regulated environment. 本文为实验室科学家、技术员以及管理者提供了在 GMP, GLP 和 GCP 规范化环境下使用的 LDAS 的执行、测试、控制和用途方面的指南。 2. Scope 范围 This article specifically addresses computerized LDAS within a regulated environment. This guidance is also applicable to systems considered critical to the operations of a company, department or function regardless of the system’s regulatory impact. The scope of this article excludes the typical Laboratory Information Management System (LIMS). The fundamental difference between a LIMS and an LDAS system is that the LDAS has a laboratory instrument as its primary focus, such as a computerized HPLC, whereas a LIMS, though instruments may be attached, has the management of data as its primary focus. The guiding key practices for testing and controlling an LDAS are similar to those for testing and controlling a LIMS; 1 the fundamental differences lie in the application of these key practices. 本文仅涉及在规范化环境下的计算机化的 LDAS。本指南同样适用于那些被视为对公司、部门或团体的运作起关键作用的系统，无论这些系统是否在规范化的体系内。本文的范围不包括典型的 LIMS（实验室信息管理系统）。LIMS 和 LDAS 最基本的区别在于 LDAS 优先考虑实验室仪器，比如计算机化的 HPLC；而 LIMS 虽然也和仪器有关联，但它主要考虑的是数据的管理。LDAS 测试和控制的关键实践指南和 LIMS 类似，基本区别在于其应用。 3. Overview of Validation Concepts 一些验证概念的综述 The testing, calibration and control of laboratory systems are not new concepts. Instruments are usually calibrated (i.e. tested) prior to their use in an experiment. Likewise, controls are typically utilized to ensure that the instrument remains in calibration thus assuring the on-going quality of the data. It is the extent of testing and control and the amount of subsequent documentation required, especially within the regulated environment, which has changed dramatically over the past years. 实验室系统的测试、校准和控制并不是什么新鲜的概念。仪器一般在实验使用前进行校准（比如检测）。同样，控制一般用于确保仪器始终处于校准状态以保证数据的持续性质量。这是测试和控制的范围以及后续文档的数量所需要的，特别是在规范化的环境中，在过去几年里已经发生了巨大的变化。 Several years ago, validation was a term inappropriately applied only to the documented testing of a system. This testing verified the proper functioning of the system. Procedures for maintaining the system in this ‘‘validated’’ state assured the scientist that the system was under control and produced consistent and reliable results. 几年前，验证只是不恰当地应用于系统的文件化测试的一个术语。这种测试确认了系统可以正常运转。用于维持系统在已验证状态的规程使科学家确信系统在控制中并可以产生稳定的和可靠的结果。 As a result of regulatory concerns, the testing and control of a system is now a larger process. Validation involves the documented assurance that a system has been defined, designed, developed and delivered in a manner consistent with its intended purpose. It should include processes that address on-going support, control, and the retirement of the system. 由于涉及到法规问题，系统的测试和控制现在是一个更大的过程。验证为系统符合其预期用途的定

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