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A review of the FDA draft guidance document for software validation: guidance for industry. 对FDA软件验证指南文件草案的审查:行业指南。
Quality assurance (San Diego, Calif.) Pub Date : 1999-01-01 DOI: 10.1080/105294100277723
K L Keatley
{"title":"A review of the FDA draft guidance document for software validation: guidance for industry.","authors":"K L Keatley","doi":"10.1080/105294100277723","DOIUrl":"https://doi.org/10.1080/105294100277723","url":null,"abstract":"<p><p>A Draft Guidance Document (Version 1.1) was issued by the United States Food and Drug Administration (FDA) to address the software validation requirement of the Quality System Regulation, 21 CFR Part 820, effective June 1, 1997. The guidance document outlines validation considerations that the FDA regards as applicable to both medical device software and software used to \"design, develop or manufacture\" medical devices. The Draft Guidance is available at the FDA web site http:@www.fda.gov/cdrh/comps/swareval++ +.html. Presented here is a review of the main features of the FDA document for Quality System Regulation (QSR), and some guidance for its implementation in industry.</p>","PeriodicalId":77339,"journal":{"name":"Quality assurance (San Diego, Calif.)","volume":"7 1","pages":"49-55"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/105294100277723","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21560510","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: 19
Teaching fractional factorial experiments via course delegate designed experiments. 通过课程委托设计实验进行分数阶乘实验教学。
Quality assurance (San Diego, Calif.) Pub Date : 1999-01-01 DOI: 10.1080/105294100277714
S Coleman, J Antony
{"title":"Teaching fractional factorial experiments via course delegate designed experiments.","authors":"S Coleman,&nbsp;J Antony","doi":"10.1080/105294100277714","DOIUrl":"https://doi.org/10.1080/105294100277714","url":null,"abstract":"<p><p>Industrial experiments are fundamental in enhancing the understanding and knowledge of a process and product behavior. Designed industrial experiments assist people in understanding, investigating, and improving their processes. The purpose of a designed experiment is to understand which factors might influence the process output and then to determine those factor settings that optimize the process output. Teaching \"design of experiments\" using textbook examples does not fully shed light on how to identify and formulate the problem, identify factors, and determine the performance of the physical experiment. Presented here is an example of how to teach fractional factorial experiments in a course on designed experiments. Also presented is a practical, hands-on experiment that has been found to be extremely successful in instilling confidence and motivation in course delegates. The experiment provides a great stimulus to the delegates for the application of experimental design in their own work environment.</p>","PeriodicalId":77339,"journal":{"name":"Quality assurance (San Diego, Calif.)","volume":"7 1","pages":"37-48"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/105294100277714","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21560509","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: 4
Auditing of chromatographic data. 审核色谱数据。
Quality assurance (San Diego, Calif.) Pub Date : 1998-10-01 DOI: 10.1080/105294199277789
J T Mabie
{"title":"Auditing of chromatographic data.","authors":"J T Mabie","doi":"10.1080/105294199277789","DOIUrl":"https://doi.org/10.1080/105294199277789","url":null,"abstract":"<p><p>During a data audit, it is important to ensure that there is clear documentation and an audit trail. The Quality Assurance Unit should review all areas, including the laboratory, during the conduct of the sample analyses. The analytical methodology that is developed should be documented prior to sample analyses. This is an important document for the auditor, as it is the instrumental piece used by the laboratory personnel to maintain integrity throughout the process. It is expected that this document will give insight into the sample analysis, run controls, run sequencing, instrument parameters, and acceptance criteria for the samples. The sample analysis and all supporting documentation should be audited in conjunction with this written analytical method and any supporting Standard Operating Procedures to ensure the quality and integrity of the data.</p>","PeriodicalId":77339,"journal":{"name":"Quality assurance (San Diego, Calif.)","volume":"6 4","pages":"229-33"},"PeriodicalIF":0.0,"publicationDate":"1998-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/105294199277789","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21503108","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
Using benchmarking to improve organizational communication. 运用标杆管理改善组织沟通。
Quality assurance (San Diego, Calif.) Pub Date : 1998-10-01 DOI: 10.1080/105294199277761
D Gardner, C Winder
{"title":"Using benchmarking to improve organizational communication.","authors":"D Gardner,&nbsp;C Winder","doi":"10.1080/105294199277761","DOIUrl":"https://doi.org/10.1080/105294199277761","url":null,"abstract":"<p><p>Best practice refers to those practices that lead to superior performance in a company or enterprise relative to industry or international leaders. Benchmarking of those activities that are critical to organizational performance is an important part of the identification and implementation of best-practice approaches. This article looks at communication as one aspect in the development of best practice in the management of safety, environment, and quality. A number of barriers to effective communication are identified, and benchmarks for the evaluation of organizational communication are suggested.</p>","PeriodicalId":77339,"journal":{"name":"Quality assurance (San Diego, Calif.)","volume":"6 4","pages":"201-11"},"PeriodicalIF":0.0,"publicationDate":"1998-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/105294199277761","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21502438","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: 9
Assessment of uncertainty in mechanical testing of dental materials. 牙科材料力学试验不确定度评定。
Quality assurance (San Diego, Calif.) Pub Date : 1998-10-01 DOI: 10.1080/105294199277770
M R Cimpan, N R Gjerdet, E Cimpan
{"title":"Assessment of uncertainty in mechanical testing of dental materials.","authors":"M R Cimpan,&nbsp;N R Gjerdet,&nbsp;E Cimpan","doi":"10.1080/105294199277770","DOIUrl":"https://doi.org/10.1080/105294199277770","url":null,"abstract":"<p><p>A generally valid and commonly accepted model for assessing the reliability of measurements in the field of medical and dental materials is hard to establish. The results obtained in different laboratories sometimes are difficult to compare. We therefore discuss different assessors of the quality of measurements from both conceptual and operational perspectives. Especially addressed are the customary terms accuracy, error and uncertainty, these terms that often are mixed rather confusingly in expressing the quality of experiments. The aim of this work is to present the advantages of choosing uncertainty rather than error as the appropriate assessor of the reliability of measurements. The transverse deflection testing of four denture-base acrylic resins served as an experimental basis for the analysis.</p>","PeriodicalId":77339,"journal":{"name":"Quality assurance (San Diego, Calif.)","volume":"6 4","pages":"213-28"},"PeriodicalIF":0.0,"publicationDate":"1998-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/105294199277770","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21503104","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
Computer validation in toxicology: historical review for FDA and EPA good laboratory practice. 毒理学中的计算机验证:FDA和EPA良好实验室规范的历史回顾。
Quality assurance (San Diego, Calif.) Pub Date : 1998-10-01 DOI: 10.1080/105294199277752
D L Brodish
{"title":"Computer validation in toxicology: historical review for FDA and EPA good laboratory practice.","authors":"D L Brodish","doi":"10.1080/105294199277752","DOIUrl":"https://doi.org/10.1080/105294199277752","url":null,"abstract":"<p><p>The application of computer validation principles to Good Laboratory Practice is a fairly recent phenomenon. As automated data collection systems have become more common in toxicology facilities, the U.S. Food and Drug Administration and the U.S. Environmental Protection Agency have begun to focus inspections in this area. This historical review documents the development of regulatory guidance on computer validation in toxicology over the past several decades. An overview of the components of a computer life cycle is presented, including the development of systems descriptions, validation plans, validation testing, system maintenance, SOPs, change control, security considerations, and system retirement. Examples are provided for implementation of computer validation principles on laboratory computer systems in a toxicology facility.</p>","PeriodicalId":77339,"journal":{"name":"Quality assurance (San Diego, Calif.)","volume":"6 4","pages":"185-99"},"PeriodicalIF":0.0,"publicationDate":"1998-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/105294199277752","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21502437","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: 2
Applying total quality management techniques to improve software development. 应用全面质量管理技术来改进软件开发。
Quality assurance (San Diego, Calif.) Pub Date : 1998-07-01 DOI: 10.1080/105294199277824
T Mezher, M Assem Abdul Malak, H el-Medawar
{"title":"Applying total quality management techniques to improve software development.","authors":"T Mezher,&nbsp;M Assem Abdul Malak,&nbsp;H el-Medawar","doi":"10.1080/105294199277824","DOIUrl":"https://doi.org/10.1080/105294199277824","url":null,"abstract":"<p><p>Total Quality Management (TQM) is a new management philosophy and a set of guiding principles that represent the basis of a continuously improving organization. This paper sheds light on the application of TQM concepts for software development. A fieldwork study was conducted on a Lebanese software development firm and its customers to determine the major problems affecting the organization's operation and to assess the level of adoption of TQM concepts. Detailed questionnaires were prepared and handed out to the firm's managers, programmers, and customers. The results of the study indicate many deficiencies in applying TQM concepts, especially in the areas of planning, defining customer requirements, teamwork, relationship with suppliers, and adopting standards and performance measures. One of the major consequences of these deficiencies is considerably increased programming errors and delays in delivery. Recommendations on achieving quality are discussed.</p>","PeriodicalId":77339,"journal":{"name":"Quality assurance (San Diego, Calif.)","volume":"6 3","pages":"149-64"},"PeriodicalIF":0.0,"publicationDate":"1998-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/105294199277824","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21446750","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: 2
Gauge Capability Analysis: classical versus ANOVA. 测量能力分析:经典与方差分析。
Quality assurance (San Diego, Calif.) Pub Date : 1998-07-01 DOI: 10.1080/105294199277842
J Antony, G Knowles, P Roberts
{"title":"Gauge Capability Analysis: classical versus ANOVA.","authors":"J Antony,&nbsp;G Knowles,&nbsp;P Roberts","doi":"10.1080/105294199277842","DOIUrl":"https://doi.org/10.1080/105294199277842","url":null,"abstract":"<p><p>In order to use Statistical Process Control (SPC) efficiently and effectively in today's modern industrial environment, it is essential to analyze and determine the extent of gauge variability. The variation that occurs on a control chart is essentially a combination of product and gauge variation. Studies of measurement or gauge variation are absolutely a waste of resources unless they can lead to a substantial reduction in process variability or to an improvement in process and product quality. The goal of gauge capability analysis is an understanding and quantification of the various sources of variability present in the measurement process. The purpose of this paper is to illustrate the fundamental difference between Classical Gauge Capability Analysis (CGCA) and the use of a more powerful approach based on the Analysis of Variance (ANOVA). The author recommends that the latter approach is more useful and powerful in the presence of an interaction between the parts and the operators involved in the measurement process. An example is illustrated in the paper to demonstrate the two approaches.</p>","PeriodicalId":77339,"journal":{"name":"Quality assurance (San Diego, Calif.)","volume":"6 3","pages":"173-81"},"PeriodicalIF":0.0,"publicationDate":"1998-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/105294199277842","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21446753","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: 19
The facility between certification and accreditation. 认证和认可之间的便利。
Quality assurance (San Diego, Calif.) Pub Date : 1998-07-01 DOI: 10.1080/105294199277815
R Lasala, R Rizzello
{"title":"The facility between certification and accreditation.","authors":"R Lasala,&nbsp;R Rizzello","doi":"10.1080/105294199277815","DOIUrl":"https://doi.org/10.1080/105294199277815","url":null,"abstract":"<p><p>The market, and therefore the inevitable need to produce and sell products and services, encourages companies to try to ensure that they themselves and their products can be recognized and characterized. It thus follows that the producer's activities must be qualified with special certificates. Over the last few years the number of companies wishing to qualify their organization and their products has increased considerably. This phenomenon also affects organizations that conduct research, i.e., those defined as contract research organizations, which provide a research service to a limited, demanding clientele, and that have long seen in these certifications not only simple compliance with their legal obligations, but also a tool for persuading the market of the validity of their \"products.\" For management it may, at times, be difficult to find the way through the jungle of certifications because the purpose, aims and actions related to the different types of attestation (accreditation, certification, registration, etc.) are often little known or misunderstood. An investigation has been carried out to clarify the whole scenario of necessary, possible, and useful certificates and qualifications for research organizations today, as well as the terminology used. In addition, an attempt was made to find possible similarities between the various recognitions analyzed.</p>","PeriodicalId":77339,"journal":{"name":"Quality assurance (San Diego, Calif.)","volume":"6 3","pages":"137-48"},"PeriodicalIF":0.0,"publicationDate":"1998-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/105294199277815","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21446839","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
Essentials of quality in "the gold standard veterinary clinical trial". 《兽医临床试验金标准》的质量要点。
Quality assurance (San Diego, Calif.) Pub Date : 1998-07-01 DOI: 10.1080/105294199277833
N J Dent
{"title":"Essentials of quality in \"the gold standard veterinary clinical trial\".","authors":"N J Dent","doi":"10.1080/105294199277833","DOIUrl":"https://doi.org/10.1080/105294199277833","url":null,"abstract":"<p><p>Quality Assurance (QA) has played a pivotal role within Good Laboratory Practice (GLP) since its inception in 1976. GLP is now recognized as a quality standard, as can be seen from the introductory statement of the recently issued OECD Principles of GLP (revised in 1997) that clearly state \"GLP is a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported\". We can, therefore, see a close comparison between GLP compliance and the ISO/EN accreditation systems that have been adopted by other institutes on a worldwide basis.</p>","PeriodicalId":77339,"journal":{"name":"Quality assurance (San Diego, Calif.)","volume":"6 3","pages":"165-72"},"PeriodicalIF":0.0,"publicationDate":"1998-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/105294199277833","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21446747","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: 2
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