21 EU Partners distributed team environment Software Quality Plan played a critical role.

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1 Employing a Software Quality Plan within a Distributed Team Environment Dr Noel Carroll, Prof Ita Richardson 1 Overview TRANSFoRm (FP7 Project): to develop a rapid learning healthcare system driven by advanced computational infrastructure that can improve both patient safety and the conduct and volume of clinical research in Europe. 21 EU Partners distributed team environment Software Quality Plan played a critical role. Review how the Software Quality Plan supported the success of the TRANSFoRm project. Building on Work Task 3.5 Software Quality Assurance Framework 2 1

2 TRANSFoRm project 3 Software Development V-Model 4 2

3 SQP -Stages Managing Software Requirements Requirements Management Process Software Architecture and Design Process Managing the Product Design and Coding Developments Product Integration Process Managing Quality Assurance (Verification & Validation) Configuration Management Process Lessons Learned 5 Research Focus TRANSFoRm Software Quality Plan (SQP) Examine how the SQP supported developers to achieve a level of software quality in various tools. Compliance with published software processes and Medical Device Regulations. 6 3

4 Software Development Regulation Issues 7 Medical Devices and Software Software within Medical Devices Up to 70% of budget on software related activities 8 4

5 Medical Device Software Software in Medical Device production lines 9 Medical Device software Software manipulating Clinical data (Health Information Systems) 10 5

6 EU Directives.software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, is a medical device. 11 EU Directives 'medical device' means any instrument, apparatus, appliance, software, material or other article,., intended by its manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease,. injury or handicap, 12 6

7 Research Methods RQ RQ: How did the SQP contribute towards the success of TRANSFoRm (in a distributed team environment)? Software Development Team: Semi-structured interviews SQP Checklist Survey Expert Opinion & Review 31 questions answered 3 teams internationally 13 Results 14 7

8 Summary of Key Findings Key Successes: EU collaboration and effort to ensure success. SQP supported the success of this project and offered guidance on key processes. Key Challenges for Software Development in an International Exploratory Healthcare Research project: Establishing a multi-site developer community which can align its processes with stakeholder requirements. Ensuring that the significant risk of failure is controlled. Managing each partners dynamics, empowerment and need for decision-making. Reporting activities to ensure visibility and transparency of activities within the team. 15 Summary of Key Findings Recommendations for EU Projects where software is developed: Include an initial Work Package which sets up software development strategy and management. Employ a collaboration strategy to build team cohesion and develop partnership links. Emphasise strategy, not technology, at the beginning of a distributive software EU project. Consider such projects as Global Software Development projects and introduce relevant software development methods such as the Global Teaming Model (Richardson et al. 2010; Beecham et al. 2010). 16 8

9 References Richardson, I., Casey, V., Burton, J., & McCaffery, F. (2010). Global software engineering: A software process approach. In Collaborative Software Engineering(pp ). Springer Berlin Heidelberg. Beecham, S., Noll, J., Richardson, I., & Ali, N. (2010). Crafting a global teaming model for architectural knowledge. In Global Software Engineering (ICGSE), th IEEE International Conference on(pp ). IEEE. 17 Acknowledgement This work was partially supported by Science Foundation Ireland Research Centre grant 13/RC/2094 to Lero the Irish Software Research Centre, by Enterprise Ireland grant to ARCH Applied Research in Connected Health Technology Centre, and by European Union grant to TRANSFoRm. 18 9