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Validating pharmaceutical systems: good computer practice in life science manufacturing, edited by John Andrews, CRC Press/Sue Horwood Publishing Ltd., West Sussex, England, UK, 3 August 2005, 576 p., USD 249.95, ISBN 0‐8493‐2324‐X 验证制药系统:生命科学制造中的良好计算机实践，John Andrews编辑，CRC出版社/Sue Horwood出版有限公司，西苏塞克斯，英格兰，英国，2005年8月3日，576页，249.95美元，ISBN 0‐8493‐2324‐X
Quality Assurance Journal Pub Date : 2006-12-01 DOI: 10.1002/qaj.393
R. Mcdowall
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引用次数: 0
Does Quality Assurance need Quality Assurance 质量保证需要质量保证吗
Quality Assurance Journal Pub Date : 2006-12-01 DOI: 10.1002/QAJ.395
R. Hattemer‐Apostel
{"title":"Does Quality Assurance need Quality Assurance","authors":"R. Hattemer‐Apostel","doi":"10.1002/QAJ.395","DOIUrl":"https://doi.org/10.1002/QAJ.395","url":null,"abstract":"","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"28 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2006-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133299545","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
The Role of the Study Director in GLP 研究主任在GLP中的作用
Quality Assurance Journal Pub Date : 2006-09-01 DOI: 10.1002/qaj.383
Deborah Garvin
{"title":"The Role of the Study Director in GLP","authors":"Deborah Garvin","doi":"10.1002/qaj.383","DOIUrl":"https://doi.org/10.1002/qaj.383","url":null,"abstract":"With the complexity of today's studies, it has become increasingly critical that Study Directors understand all disciplines involved in studies under their responsibility. Every phase of a study directly impacts the outcome. If the Study Director does not have sufficient expertise to evaluate problems and issues in all areas as they occur, then study integrity is compromised. The physical location of the Study Director in a multi-site study is of less importance than the education, experience and expertise of that individual. The Study Director must be the single point of control and truly qualified to evaluate all the phases of the study, troubleshoot problems, draw appropriate conclusions, tie all aspects together and write the final report. Copyright © 2006 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"34 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2006-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133663902","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A practical guide to quality management in clinical trial research. G.D. Ogg, CRC Taylor & Francis, Boca Raton, FL, USA, 2006, 214 p., USD 169.96, ISBN 0‐8493‐9722‐7 临床试验研究质量管理实用指南。G.D. Ogg, CRC Taylor & Francis，美国佛罗里达州博卡拉顿，2006年，214页，169.96美元，ISBN 0‐8493‐9722‐7
Quality Assurance Journal Pub Date : 2006-09-01 DOI: 10.1002/QAJ.379
N. Dent
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引用次数: 0
GLP SOPs for equipment calibration and maintenance. Part 2: an organized approach to streamlining procedural documentation 设备校准和维护的GLP标准操作规程。第2部分:流程化过程文档的有组织方法
Quality Assurance Journal Pub Date : 2006-09-01 DOI: 10.1002/QAJ.378
M. Rosa, I. Colligon
{"title":"GLP SOPs for equipment calibration and maintenance. Part 2: an organized approach to streamlining procedural documentation","authors":"M. Rosa, I. Colligon","doi":"10.1002/QAJ.378","DOIUrl":"https://doi.org/10.1002/QAJ.378","url":null,"abstract":"As anyone who has had to deal with a Standard Operating Procedure (SOP) system can testify, managing these documents is a Herculean task, requiring full–time commitment. This article proposes an alternative and more efficient approach to building a manageable set of procedural/instructional documents that will help an organization meet its scientific and regulatory needs while alleviating the strain that a gargantuan SOP system can put on its personnel. \u0000 \u0000Among the benefits of this approach are: (1) Documents are organized to follow the logical and chronological flow of the activities they describe. (2) Documents can be located quickly. (3) Users will find what they need to know, presented in a concise manner, without superfluous information. (4) Increased usability of the documents since there is a logical structure to delivered information; thus, users can control the level of detail based on their need. (5) Reduced effort for upkeep of individual documents. Copyright © 2006 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"12 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2006-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115160719","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 5
The role of the monitor in veterinary clinical studies 兽医临床研究中监护仪的作用
Quality Assurance Journal Pub Date : 2006-09-01 DOI: 10.1002/QAJ.376
Iain McPhee, Monte Reimers
{"title":"The role of the monitor in veterinary clinical studies","authors":"Iain McPhee, Monte Reimers","doi":"10.1002/QAJ.376","DOIUrl":"https://doi.org/10.1002/QAJ.376","url":null,"abstract":"Regulatory requirements for veterinary clinical studies have developed over the last 24 years. This paper covers the current best practice for the clinical study monitor. It describes and qualifies these activities as outlined in the International Conference on Harmonization of Technical Requirements for Registration of Veterinary Products (VICH) Good Clinical Practice (GCP) guidelines (GL9). Copyright © 2006 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"432 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2006-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124239821","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Process improvement evaluation approach using flow diagrams 使用流程图的过程改进评估方法
Quality Assurance Journal Pub Date : 2006-09-01 DOI: 10.1002/QAJ.377
P. C. Constant
{"title":"Process improvement evaluation approach using flow diagrams","authors":"P. C. Constant","doi":"10.1002/QAJ.377","DOIUrl":"https://doi.org/10.1002/QAJ.377","url":null,"abstract":"Maintaining company processes will afford optimum operation and enhance the company's quality management system. A vital part of maintaining processes is their periodic evaluation. An important part of the monitoring and evaluation process is the flow diagram. A detailed flow diagram is an important tool that affords ease in visualizing the total process and is an aid in locating problem areas. The evaluation of a process is broken down into 15 steps. These steps cover gathering pertinent information, such as problem symptoms from knowledgeable sources and carrying these through their route to potential problem areas to the problems, potential causes, and the root cause of the problem. Knowing the problems brings about the need to assess their impact on the process operation as well as what changes to the process are needed and what impact these changes will have on the product – its improved quality and cost – and other vital information, such as, production rate increase, competition status, and company image. With this information, the appropriate changes are made according to a process change action plan. The plan is executed, and the process is continuously monitored according to a monitoring and evaluation plan. The paper ends with conclusions. Copyright © 2006 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"34 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2006-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129409711","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Improving service quality in the global economy: achieving high performance in public and private sectors, 2nd edition. Michael E. Milakovich, Auerbach Publications, 432 p., GBP 39.99 or USD 69.99, ISBN 0‐8493‐3819‐0 提高全球经济中的服务质量:实现公共和私营部门的高绩效，第2版。Michael E. Milakovich, Auerbach出版社，432页，39.99英镑或69.99美元，ISBN 0‐8493‐3819‐0
Quality Assurance Journal Pub Date : 2006-09-01 DOI: 10.1002/QAJ.380
David Long
{"title":"Improving service quality in the global economy: achieving high performance in public and private sectors, 2nd edition. Michael E. Milakovich, Auerbach Publications, 432 p., GBP 39.99 or USD 69.99, ISBN 0‐8493‐3819‐0","authors":"David Long","doi":"10.1002/QAJ.380","DOIUrl":"https://doi.org/10.1002/QAJ.380","url":null,"abstract":"","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"10 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2006-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129852092","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Writing and reviewing skills. Martin Robinson, 2005 by ICR Publishing, Marlow, Bucks, UK, 46 p., ISBN 1‐905238‐00‐2, GBP 15.00 (UK), EUR 30.00 (Europe), USD 35.00 (Rest of the World) 写作和复习技能。马丁·罗宾逊，2005年由ICR出版，马洛，巴克斯，英国，46页，ISBN 1‐905238‐00‐2,15.00英镑(英国)，30.00欧元(欧洲)，35.00美元(世界其他地区)
Quality Assurance Journal Pub Date : 2006-09-01 DOI: 10.1002/QAJ.385
Bob Mcdowall
{"title":"Writing and reviewing skills. Martin Robinson, 2005 by ICR Publishing, Marlow, Bucks, UK, 46 p., ISBN 1‐905238‐00‐2, GBP 15.00 (UK), EUR 30.00 (Europe), USD 35.00 (Rest of the World)","authors":"Bob Mcdowall","doi":"10.1002/QAJ.385","DOIUrl":"https://doi.org/10.1002/QAJ.385","url":null,"abstract":"","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"32 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2006-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121640575","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
GLP SOPs for Equipment Calibration and Maintenance. Part 1: an overview 设备校准和维护的GLP标准操作规程。第1部分:概述
Quality Assurance Journal Pub Date : 2006-06-01 DOI: 10.1002/QAJ.369
M. Rosa
{"title":"GLP SOPs for Equipment Calibration and Maintenance. Part 1: an overview","authors":"M. Rosa","doi":"10.1002/QAJ.369","DOIUrl":"https://doi.org/10.1002/QAJ.369","url":null,"abstract":"Writing Standard Operating Procedures (SOPs) for laboratory equipment is viewed as a necessary evil. As a result, many of these documents are not practical or useful to a reader. Writing these documents does not have to be so frustrating. With forethought, careful planning and collaboration, laboratory SOPs can be practical and user-friendly documents that support continued compliance and create a platform for future growth. Copyright © 2006 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"53 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2006-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124111888","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 7
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