PDATR31计算机实验室数据验证(中英文对照)1999年VIP专享VIP免费

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 Va...