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Books by Valentine (Val) Casey
Today software development has truly become a globally sourced commodity. This trend has been fac... more Today software development has truly become a globally sourced commodity. This trend has been facilitated by the availability of highly skilled software professionals in low cost locations in Eastern Europe, Latin America and the Far East. Organisations endeavouring to leverage the opportunities this provides and to avail of the benefits of establishing operations close to emerging markets have embraced this strategy in large numbers. Software testing plays a key role in delivering high quality products and is a labour intensive, complex and expensive activity. In the context of Global Software Development (GSD) to date testing has been perceived as a well defined task that is relatively straightforward and lends itself to being outsourced or offshored. This volume considers this specific topic and demonstrates that testing in a GSD environment is not a simple activity. It is prone to be negatively impacted by all the factors associated with distributed software development.This work also provides practical solutions which can be utilised to address these important issues. While the primary focus of this work is software testing it is also the culmination of 10 years research by the author in the area of GSD. During this period he has considered all aspects of the software development life cycle. This experience and knowledge has been incorporated into this volume. It is therefore relevant to note this work is of value to the wider software community not just to those interested in testing. It specifically considers the establishment of virtual teams and their efficient and effective operation. Therefore this book has relevance to all those interested in implementing or improving a GSD strategy. Its particular strengths are that while it is a scholarly work it is industry based and practical
Papers by Valentine (Val) Casey
Shuili Fadian Xuebao, 2013
Since 2010, two significant international regulations regarding medical device developme... more Since 2010, two significant international regulations regarding medical device development have come into force, the amendment to the European Union (EU) Medical Device Directive (MDD) 2007/47/EC and the United States (US) Food and Drug Administration (FDA) Final rule on Medical Device Data Systems (MDDS). Adherence to these regulations is mandatory to be able to market a medical device in the respective region. The ability to understand these regulations and apply them to a development project can be difficult. The MDDS final rule changes the safety classification of a number of devices from Class III‐high risk to Class I‐ low risk. The aim of this regulation is to make the process of achieving regulatory approval for manufacturers easier. The MDD aims to provide guidance for the development of medical devices to be marketed for use within the EU. It also provides defined pathways which manufacturers can follow in order to achieve...
On 16 April 2011, the US Food and Drug Administration’s (FDA’s) final rule on medical device data... more On 16 April 2011, the US Food and Drug Administration’s (FDA’s) final rule on medical device data systems (MDDSs) came into force. This rule attempts to remove the uncertainty surrounding the safety classification of certain information technology systems used in healthcare. Devices that now meet the criteria of being an MDDS are classified as Class I (general controls). However, this final ruling explicitly precludes specific software applications that meet the definition of an MDDS, such as electronic health record applications and computerised physician order entry applications, as being beyond the scope of an MDDS. Similarly, ambiguity still remains surrounding mobile device applications. The purpose of this article by Martin McHugh, Fergal McCaffery and Valentine Casey is to provide an overview of the FDA’s final rule on the safety classification of an MDDS, how this rule has been amended in comparison to the proposed rule and what this rule means for MDDS manufacturers. In add...
Software development has become a globally sourced commodity. Software development processes such... more Software development has become a globally sourced commodity. Software development processes such as requirements elicitation, development of components and maintenance tasks are often distributed across sites and countries. This research paper focuses on the distribution of the testing process, which is not a straightforward task. The research presented here has examined the management of virtual teams within a distributed testing environment in two multi-national companies in Ireland. This has elicited many issues over and above the ‘socio-cultural’ issues so often discussed. Some of the difficulties encountered include language differences, use of communication tools, different process maturity levels, tools and standards, technical ability and knowledge management. Apart from the management of the testing process, we are also considering the technical issues involved in the global distribution of testing. A related study is being undertaken with teams of students from Masters cl...
Proceedings of the 7th International Conference on Software Paradigm Trends, 2012
Journal of the Brazilian Computer Society, 2010
Globally distributed information systems development has become a key strategy for large sections... more Globally distributed information systems development has become a key strategy for large sections of the software industry. This involves outsourcing projects to third parties or offshoring development to divisions in remote locations. A popular approach when implementing these strategies is the establishment of virtual teams. The justification for embarking on this approach is to endeavor to leverage the potential benefits of labor arbitrage available between geographical locations. When implementing such a strategy organizations must recognize that virtual teams operate differently to collocated teams, therefore, they must be managed differently. These differences arise due to the complex and collaborative nature of information systems development and the impact distance introduces. Geographical, temporal, cultural, and linguistic distance all negatively impact on coordination, cooperation, communication, and visibility in the virtual team setting. In these circumstances, it needs...
ACM Inroads, 2010
Professional software development is normally team based and is recognised as a socio-technical a... more Professional software development is normally team based and is recognised as a socio-technical activity. In recent years, this has been coupled with the increasing popularity of outsourcing and offshoring software development. These are two significant issues, which need to be considered and recognized. As educators, it is important that we prepare our students, at both the undergraduate and postgraduate level to make informed and meaningful contributions to the industry they plan to enter. To facilitate this we need to consider providing modules that outline the benefits and problems associated with globally distributed software development. As research has identified, a key element of any such module is the importance and impact that cultural diversity plays. To facilitate understanding in this area, students can benefit from knowledge of the literature on culture. This can provide essential information which allows them to understand the broader aspects of this important topic. ...
Journal of Software: Evolution and Process, 2013
Communications in Computer and Information Science, 2011
Communications in Computer and Information Science, 2011
Communications in Computer and Information Science, 2011
Traceability is central to medical device software development and essential for regulatory appro... more Traceability is central to medical device software development and essential for regulatory approval. To achieve compliance an effective traceability process needs to be in place. This is difficult to achieve due to the lack of specific guidance which the medical device regulations and standards provides. This has resulted in many medical device companies employing inefficient software traceability processes. In this paper we briefly outline the development and implementation of Med-Trace a lightweight software traceability process assessment and improvement method for the medical device industry.
Communications in Computer and Information Science, 2012
Communications in Computer and Information Science, 2011
Communications in Computer and Information Science, 2012
Communications in Computer and Information Science, 2011
Proceedings of the 2006 international workshop on Global software development for the practitioner - GSD '06, 2006
2006 IEEE International Conference on Global Software Engineering (ICGSE'06), 2006
2008 IEEE International Conference on Global Software Engineering, 2008
Today software development has truly become a globally sourced commodity. This trend has been fac... more Today software development has truly become a globally sourced commodity. This trend has been facilitated by the availability of highly skilled software professionals in low cost locations in Eastern Europe, Latin America and the Far East. Organisations endeavouring to leverage the opportunities this provides and to avail of the benefits of establishing operations close to emerging markets have embraced this strategy in large numbers. Software testing plays a key role in delivering high quality products and is a labour intensive, complex and expensive activity. In the context of Global Software Development (GSD) to date testing has been perceived as a well defined task that is relatively straightforward and lends itself to being outsourced or offshored. This volume considers this specific topic and demonstrates that testing in a GSD environment is not a simple activity. It is prone to be negatively impacted by all the factors associated with distributed software development.This work also provides practical solutions which can be utilised to address these important issues. While the primary focus of this work is software testing it is also the culmination of 10 years research by the author in the area of GSD. During this period he has considered all aspects of the software development life cycle. This experience and knowledge has been incorporated into this volume. It is therefore relevant to note this work is of value to the wider software community not just to those interested in testing. It specifically considers the establishment of virtual teams and their efficient and effective operation. Therefore this book has relevance to all those interested in implementing or improving a GSD strategy. Its particular strengths are that while it is a scholarly work it is industry based and practical
Shuili Fadian Xuebao, 2013
Since 2010, two significant international regulations regarding medical device developme... more Since 2010, two significant international regulations regarding medical device development have come into force, the amendment to the European Union (EU) Medical Device Directive (MDD) 2007/47/EC and the United States (US) Food and Drug Administration (FDA) Final rule on Medical Device Data Systems (MDDS). Adherence to these regulations is mandatory to be able to market a medical device in the respective region. The ability to understand these regulations and apply them to a development project can be difficult. The MDDS final rule changes the safety classification of a number of devices from Class III‐high risk to Class I‐ low risk. The aim of this regulation is to make the process of achieving regulatory approval for manufacturers easier. The MDD aims to provide guidance for the development of medical devices to be marketed for use within the EU. It also provides defined pathways which manufacturers can follow in order to achieve...
On 16 April 2011, the US Food and Drug Administration’s (FDA’s) final rule on medical device data... more On 16 April 2011, the US Food and Drug Administration’s (FDA’s) final rule on medical device data systems (MDDSs) came into force. This rule attempts to remove the uncertainty surrounding the safety classification of certain information technology systems used in healthcare. Devices that now meet the criteria of being an MDDS are classified as Class I (general controls). However, this final ruling explicitly precludes specific software applications that meet the definition of an MDDS, such as electronic health record applications and computerised physician order entry applications, as being beyond the scope of an MDDS. Similarly, ambiguity still remains surrounding mobile device applications. The purpose of this article by Martin McHugh, Fergal McCaffery and Valentine Casey is to provide an overview of the FDA’s final rule on the safety classification of an MDDS, how this rule has been amended in comparison to the proposed rule and what this rule means for MDDS manufacturers. In add...
Software development has become a globally sourced commodity. Software development processes such... more Software development has become a globally sourced commodity. Software development processes such as requirements elicitation, development of components and maintenance tasks are often distributed across sites and countries. This research paper focuses on the distribution of the testing process, which is not a straightforward task. The research presented here has examined the management of virtual teams within a distributed testing environment in two multi-national companies in Ireland. This has elicited many issues over and above the ‘socio-cultural’ issues so often discussed. Some of the difficulties encountered include language differences, use of communication tools, different process maturity levels, tools and standards, technical ability and knowledge management. Apart from the management of the testing process, we are also considering the technical issues involved in the global distribution of testing. A related study is being undertaken with teams of students from Masters cl...
Proceedings of the 7th International Conference on Software Paradigm Trends, 2012
Journal of the Brazilian Computer Society, 2010
Globally distributed information systems development has become a key strategy for large sections... more Globally distributed information systems development has become a key strategy for large sections of the software industry. This involves outsourcing projects to third parties or offshoring development to divisions in remote locations. A popular approach when implementing these strategies is the establishment of virtual teams. The justification for embarking on this approach is to endeavor to leverage the potential benefits of labor arbitrage available between geographical locations. When implementing such a strategy organizations must recognize that virtual teams operate differently to collocated teams, therefore, they must be managed differently. These differences arise due to the complex and collaborative nature of information systems development and the impact distance introduces. Geographical, temporal, cultural, and linguistic distance all negatively impact on coordination, cooperation, communication, and visibility in the virtual team setting. In these circumstances, it needs...
ACM Inroads, 2010
Professional software development is normally team based and is recognised as a socio-technical a... more Professional software development is normally team based and is recognised as a socio-technical activity. In recent years, this has been coupled with the increasing popularity of outsourcing and offshoring software development. These are two significant issues, which need to be considered and recognized. As educators, it is important that we prepare our students, at both the undergraduate and postgraduate level to make informed and meaningful contributions to the industry they plan to enter. To facilitate this we need to consider providing modules that outline the benefits and problems associated with globally distributed software development. As research has identified, a key element of any such module is the importance and impact that cultural diversity plays. To facilitate understanding in this area, students can benefit from knowledge of the literature on culture. This can provide essential information which allows them to understand the broader aspects of this important topic. ...
Journal of Software: Evolution and Process, 2013
Communications in Computer and Information Science, 2011
Communications in Computer and Information Science, 2011
Communications in Computer and Information Science, 2011
Traceability is central to medical device software development and essential for regulatory appro... more Traceability is central to medical device software development and essential for regulatory approval. To achieve compliance an effective traceability process needs to be in place. This is difficult to achieve due to the lack of specific guidance which the medical device regulations and standards provides. This has resulted in many medical device companies employing inefficient software traceability processes. In this paper we briefly outline the development and implementation of Med-Trace a lightweight software traceability process assessment and improvement method for the medical device industry.
Communications in Computer and Information Science, 2012
Communications in Computer and Information Science, 2011
Communications in Computer and Information Science, 2012
Communications in Computer and Information Science, 2011
Proceedings of the 2006 international workshop on Global software development for the practitioner - GSD '06, 2006
2006 IEEE International Conference on Global Software Engineering (ICGSE'06), 2006
2008 IEEE International Conference on Global Software Engineering, 2008
2009 Fourth IEEE International Conference on Global Software Engineering, 2009
In this paper we consider the importance of explicit knowledge management, taking into account th... more In this paper we consider the importance of explicit knowledge management, taking into account the growth of global software engineering and the importance of corporate knowledge. We conclude by suggesting specific areas of research which should be considered important for the implementation of knowledge management within global software engineering environments.