A framework for assessing the use of third-party software qualityassurance standards to meet FDA medical device software process controlguideline's

The proliferation of medical device software (MDS) potentially increases the risks of patient injury from software defects. The US Food and Drug Administration (FDA) in 1998 updated its MDS regulations, moving away from a product-based regulatory approach toward one more focused on quality assurance processes. However, what constituted acceptable software quality assurance (SQA) processes and whether regulations could be met by the use of third-party standards was not specified. The FDA has implicitly sanctioned using third-party SQA audits in submissions for accelerated review of modifications of existing MDS, but it has neither approved nor rejected their use in submissions for new MDS approval. Suppliers must assess whether adopting a third-party SQA standard assures full or only partial conformance with FDA requirements because they remain potentially liable for damages resulting from software defects. However, substantial differences in the philosophy and organization of FDA requirements and third-party standards make this assessment difficult. This research develops a framework to assess whether third-party SQA standards can meet FDA requirements and then employs the framework to determine if ISO 9000-3 or the Software Engineering Institute's Capability Maturity Model is sufficient to meet such requirements. The authors' research analyzes four SQA categories specified by the FDA guidelines: process management, requirements specification, design control, and change control. Analysis indicates that while neither third-party SQA standard by itself fully meets FDA requirements, either standard is worth adopting and is approximately equivalent in its usefulness     

Toward Developing Data Warehousing Process Standards: An Ontology-Based Review of Existing Methodologies

A data warehouse is developed using a data warehousing process (DWP) methodology. Currently, there are a large number of methodologies available in the data warehousing market. The reason for this is the lack of any centralized attempts at creating platform-independent DWP standards. For the development of such standards, it is very important that we first examine the current practices being followed by the data warehousing industry. In this study, we review 30 commercial data warehousing methodologies and analyze the standard practices they have adopted with respect to DWP. To perform the analysis, we first develop an ontological model of DWP based on a thorough review of the literature and inputs from experts in the data warehousing field. The ontological model consists of two hierarchies: a composition hierarchy which shows the decomposition of DWP tasks such as system development, extract, transform, and load (ETL), and end-user application design; and a classification hierarchy which specifies the alternative methods or techniques available for performing the tasks. We next apply hierarchical cluster analysis to group the methodologies that share a common set of standards. Our study provides valuable insights into the prevailing standard practices for different DWP tasks-system development, requirements analysis, architecture design, data modeling, ETL, data extraction, and end-user application design-and identifies important directions for future research on DWP standardization     

IETM的采办与标准符合性验证的研究

标准是产品采办的依据内容之一,在制定采办要求时要对适用的标准进行充分分析,同样在制定标准时也要考虑在采办时可能出现的问题,二者是互为基础的。符合标准性验证是标准实施的一种有效手段,是军方在订购IETM时为保证IETM满足其需求和质量的重要内容之一。从美军《交互式电子技术手册采办指南》可以看出IETM采办的最后一个阶段为"接受和测试IETM交付物",主要通过技术手册合同要求(TMCR)对IETM的验证提出要求,结合我军IETM开发和订购的实际情况,考虑在交付IETM前应对IETM进行验证,可采取自验证或第三方形式。该论文结合GJB 6600规范提出IETM在采办与符合性验证过程中的有关问题及解决方案,可以为我军有关IETM采办及验收要求提供借鉴。     

Virtual Standards Development Environments for Concurrent Standardization Process

Recently, the increased handling of online standards information has emerged as an important feature of information and communications technology (ICT) standardization. In order to meet market needs for on-time standards deployment, most standards organizations are actively seeking more efficient ways of standardization using electronic means in order to accelerate the standards making process. This paper suggests a virtual standard development environment designed for standards developers to carry out their standards-related activities online. In this paper, we outline a conceptual model of a concurrent standardization process and describe the design and implementation of an Extranet-based network system called standards information cooperative network (SICN). The system was created with a view to fostering faster standards development with functionalities such as a virtual management of networked standards developers, collaboration support tools, a workflow-based electronic signature system, and dynamic links for ready retrieval of standards information stored in a database. We conclude this paper with an introduction to the concept of a virtual standards development organization (VSDO) that supports all the features needed by the relevant standards making bodies to carry out their activities in a dynamic on-line environment.     

软件资产管理标准体系研究

研究了国际软件资产管理标准体系的发展现状,分析了在我国建立相应标准体系的要求,提出符合国情的软件资产管理标准体系框架,重点介绍了实施指南和成熟度评估基准两项标准的内容.     

仪器仪表产品功能安全评估测试技术研究与分析

文中分析工业控制领域中仪器仪表特点和功能安全标准,并横向比较研究安全相关领域,包括核电、铁路、汽车等对于功能安全评估的要求。研究进行评估过程中采用的测试技术,包括EMC试验方法和软件验证和确认方法。功能安全产品的试验不同于普通产品型式试验要求,因此部分EMC试验指标与基础试验标准的试验指标相比,主要在试验时间、范围以及次数上针对功能安全提出要求。同时,在软件验证和确认过程,针对功能安全产品进行软件验证和确认过程,包括文档评审、编码规则检查、单元测试和集成测试。最后就已完成项目,对功能安全评估测试技术进行小结,提出今后研究主要内容。     

Standards and their influence on MAC bridges

The influence that consensus standards have had on the development of media access control (MAC) bridges is examined. The intent is to give an intuitive feel for the standards process and its effect on bridges without detailing the specific groups and processes associated with the standards organizations. It is shown that standards developed under the consensus procedure must follow a certain pattern     

民机无线电导航设备安全性相关需求分析

安全性相关需求作为民机需求的重要组成,与安全性评估过程紧密关联。本文介绍了民机的安全性评估过程,针对某型构架下的民机无线电导航设备,从功能危害状态分析出发,使用故障树(FTA)等分析手段,分析推导了包括应对失效的定量可用性需求、缓解设计错误的研制保证等级(DAL)需求及衍生需求等设备安全性相关需求。本文中给出的安全性相关需求分析方法,符合SAE ARP 4754A、SAE ARP 4761等设计指南要求,对于高安全性要求的民机机载/地面设备的需求开发与确认具有重要的参考意义。     

大规模集成电路相关测试标准的剖析

集成电路测试是保证集成电路质量、发展的关键手段.CMOS器件进入超深亚微米阶段,集成电路继续向高集成度、高速度、低功耗发展,使得IC在测试和可测试性设计上都面临新的挑战.重点研究了纯数字信号、混合信号和片上系统测试的一些问题和相关标准,包括IEEE 1149.1-1990到IEEE 1149.6-2003,IEEE 1450,IEEE 1500,IEEE-ISTO Nexus 5001等测试标准.总结了集成电路测试标准的特点和最新进展,分析了这些标准在实际应用中存在的一些问题及其局限性,并对今后集成电路测试技术标准的发展给出了预测.     

日本宇航元器件标准体系分析

介绍了日本宇航局(JAXA)元器件标准体系的整体结构,归纳了标准体系规定的元器件可靠性保证的要点,总结了JAXA标准体系中总规范、详细规范的特点以及鉴定的要求;对比分析了JAXA标准体系与美军标、欧洲标准的异同点,为建立我国宇航元器件标准体系提供借鉴.     

Standards as an Enabler for Next Generation Networks

The recession in the telecommunications industry has meant that the traditional telecommunications operators (BT, AT&T, FT, etc) have found it difficult to provide the resources needed to participate effectively in the standards process. Thus, they are not influencing international standards to get what is needed to build the next generation of telecommunications networks. This could mean that the introduction of new services is delayed and that customers may have to pay more for their services than is necessary. A clear priority now is to re-engage operators in standardisation so that the equipment needed to build next generation networks (NGNs) is standardised to operator requirements. This is the only way to get network build costs down to a level where operators can afford to install it. This paper looks at ways of achieving this goal.     

DOCSIS3．0标准的研究与应用

随着有线电视数据业务的发展，DOCSIS2．0标准在部署及运行中已经逐渐不能满足运营商业务发展的需要，DOCSIS3．0标准解决了这些问题。这一新标准能够在降低建设成本的前提下，提供更高的带宽、更优的质量和多业务提供能力，其主要特点在于去耦合设计、通道绑定和模块式构架等。     

IP计费标准的研究进展

随着IP服务的发展,IP计费逐渐成为研究热点.IP计费的标准化是保证多服务提供商环境下计费系统互联互通的关键.本文综合评述了主要标准化组织、著名研究结构和企业的IP计费标准化进展,提出了IP计费标准化工作的重要方向.     

Multimedia Retrieval and Delivery: Essential Metadata Challenges and Standards

Multimedia information retrieval (MIR) and delivery plays an important role in many application domains due to the increasing need to identify, filter, and manage growing amounts of data, notably multimedia information. To efficiently manage and exchange multimedia information, interoperability between coded data and metadata is required and standardization is central to achieving the necessary level of interoperability. In the context of this paper, the term retrieval refers to the process by which a user, human or machine, identifies the content it needs, and the term delivery refers to the adaptive transport and consumption of the identified content in a particular context or usage environment. Both the retrieval and delivery processes may require content and context metadata. This paper will argue that maximum quality of experience depends not only on the content itself (and thus content metadata) but also on the consumption conditions (thus context metadata). Additionally, the rights and protection conditions have become critically important in recent years, especially with the explosion of electronic music commerce and different ldquoshoppingrdquo conditions. This paper will review existing multimedia standards related to information retrieval and adaptive delivery of multimedia content, emphasizing the need for such standards, and will show how these standards can help the development, dissemination, and valorization of MIR research results. Moreover, it will also discuss limitations of the current standards and anticipate what future standardization activities are relevant and needed. Due to space limitations, the paper will mainly concentrate on MPEG standards although many other relevant standards are also reviewed and discussed.     

Problem discovery function: a useful tool for assessing new productintroduction

A quantitative assessment methodology for determining the quantity of real and potential problems during new-product qualification processes is introduced. The process utilizes historical product problem data and applies factors for product complexity, schedule duration, validation stages, product maturity level, corporate commitment to program success, novelty of design, and schedule pressure. Problem discovery trends are developed for historic programs. New products are then scored using these same trends. Predictions concerning the new products and their anticipated set of problems can be drawn. The ability to forecast discovery rates provides significant benefits in terms of substantiated positions for validation duration intensity and resource requirements. Evolution of the problem discovery function process and what improved discovery curves should look like are reviewed with critical discussion     

3G Trials and Developments

This paper summarises the many activities that formed a vigorous and innovative phase of understanding 3rd generation systems and their potential service/product offering.Experience from the introduction of 2nd generation GSM systems showed that, even though based upon strong standards, real hands-on development to validate the design activities was essential for both a workable standard and a smooth and successful service deployment. Trials activities are used to overcome the lack of validation and to bring innovation through integration of capabilities and devices — they consist of two areas. Firstly, a number of test radio systems were examined and used in the validation of network planning tools plus measurement or real throughput figures, and, secondly, some service scenarios were developed and implemented on an all-IP network to demonstrate that IP can deliver a marketable services level. The interaction with wireless systems and the impact of that on the application were also examined.     

Démarche de conception d’une plate-forme monopuce de réception de radiodiffusion numérique DRM

The newdrm standard for digital radio broadcast in theam band requires integrated devices for radio receivers at low cost and very low power. A chipset has been developed based on anarm9 dual-core architecture. This paper introduces the application itself, and then presents the development process followed to design such a chip covering the hardware/software partitioning, the architecture definition and all the validation issues. Therf part that partially drives the baseband is also briefly presented. The legal aspects are also investigated. Then as a conclusion, this paper presents the next steps of this development and the methodological gap in the system on chip design process.     

GPS标准现状及体系分析

GPS是目前技术最先进、应用最广泛的全球卫星导航定位系统,随着GPS技术及产业化发展,国内外发布了大量的GPS相关标准。运用分类、归纳和比较等方法,分析了GPS标准体系结构和GPS标准内容。通过对中美两国GPS标准体系结构分析,得出了GPS系统标准体系由通用基础标准、工程标准和应用标准组成。在此基础上针对COMPASS的发展建设提出了建立COMPASS标准体系结构以及对于具体标准内容制定的建议。     

国内外机载设备电磁环境验证标准分析

RTCA／DO-160G和GJB151A／152A-97都涉及了电磁环境验证,高强度辐射场（HIRF）试验是重点的验证项目,比较分析这两个标准对该项目在测试条件、测试对象及测试方法的差异,得出对于飞机机载设备的传导敏感度和辐射敏感度的试验,采用GJB151A／152A可能会出现要求过高的情况,而采用RTCA／DO-160G则更加方便灵活。