Validation of Computerized Systems - Robert Tollefsen
Validation of a new computerized system for recording and analyzing druginduced tremor in rats. J Pharmacol Toxicol Methods. 2001;46:137–43.A.Fonsecaa, F.Reiszel Pereirab, R.Santos, Validation of a new computerized system for recording and analysing drug-induced tremor in rats, Journal of ...
内容提示: GAMP Good Practice Guide for Validation of Laboratory Computerized Systems, Part 1 Guidance to help validation of computerized systems used within regulated laboratories is always welcome but is it always helpful? In the first part, I present an overview of the Guide, different approach ...
Validation of computerized analytical systems 来自 Springer 喜欢 0 阅读量: 25 作者: L Huber 摘要: Validation of analytical equipment can be a relatively complex and expensive process, especially when computer systems are involved. This article is the first in a series of seven that will recommend...
The best parts of the GAMP laboratory system GPG are the life cycle models for both development and implementation of computerized laboratory systems.1 The writers of the guide are to be congratulated for producing life cycle models for development and implementation that reflect computerized systems ...
Guidance to help validation of computerized systems used within regulated laboratories is always welcome but is it always helpful In the first part, I present an overview of the Guide, different approach to life cycle validation and system classification. Over the past years I have not spoken in...
Computerized optimization of the high-performance liquid chromatographic enantioseparation of a mixture of 4-dinitrophenyl amino acids on a quinine carbama... It has been assumed that systematic information on the behavior of a series of analytes in a number of chromatographic systems can be exploited...
范围 3Glossary 术语 4Relationship between validation and qualification 验证和确认之间的联系 5.Validation 5.1.Approaches to validation 验证方法 5.2.Scope of validation 验证范围 5Qualification 确认 6Calibration and verification 校准和核实 7Validation master plan 验证主计划 8Qualification and ...
Article 7 An up to date listing of all relevant systems and their GMP functionality (inventory) should be available. 11 中国GMP附录计算机化系统 New China GMP annex- Computerized system (2015) 基于风险评估 Risk based 第十二条软件是计算机化系统的重要组成部分。企业应当根据风险评估的结 果,对所采用...
Trust your computerized system validation to the company that designs and supports your system.Storing electronic records? Does your laboratory operate to GxP, CLIA, ISO, or other global regulations? If so, you may need to validate your computer systems. ...