paulhurley.co.uk

As you should now by now, I'm awaiting the results for my dissertation, so I can finish M801 and finally get my MSc, to help others, and test out JCE Editor, I've put all my references from my dissertation on line, along with abstracts and URL's where I can,

enjoy....

Agalloco, J. (1995), 'Validation: an unconventional review and reinvention', PDA J Pharm Sci Technol., vol. 49, no. 4, pp. 175-179.
Keywords: problems/review/validation

Akers, J. (1993), 'Simplifiying and improving Process Validation', Journal of Parenteral Science and Technology, vol. 47, no. 6, pp. 281-284.
Keywords: validation

Arnold, N. (2003), 'Using Workshops in LIMS implementation Projects', in Pittcon 2003 (2003),Orlando, Florida, USA, Thermo Corporation, Orlando, Florida,

Avison, D. E. & Fitzgerald, G. (2002), Information Systems Development: Methodologies, Techniques and Tools,
Keywords: computer science/information systems/Management McGraw-Hill Education.

Avison, D. E. & Fitzgerald, G. (2003), 'Where now for development methodologies?', Communications of the ACM, vol. 46, no. 1, pp. 78-82. Link ...
Keywords: standards

Avison, D. E. & Wood-Harper, A. T. (1990), Multiview: An Exploration of Information Systems Development,
Keywords: information systems Alfred Waller Ltd.

Baldeshwiler, A. M. (2003), 'History of FDA good laboratory practices', The Quality Assurance Journal, vol. 7, no. 3, pp. 157-161.DOI: 10.1002/qaj.228 Link ...
Keywords: companies/Development/Drugs/FDA/food/GLP/Good Laboratory Practice/history/Information/quality/quality assurance/quality control/Regulation/state/Study

Balogh, M. & Corbin, V. (2005), 'Taming the Regulatory Beast: Regulation vs Functionalism', Pharmaceutical Technology europe, vol. 17, no. 3, pp. 55-58.
Keywords: GxP/Regulation

Beck, K., Beedle, M., van Bennekum, A., Cockburn, A., Cunningham, W., Fowler, M., Grenning, J., Highsmith, J., Hunt, A., Jeffries, R., Kern, J., Marick, B., Martin, R. C., Mellor, S., Schwaber, K., Sutherland, J., & Thomas, D. (2001), 'Agile Manifesto' [Online], URL Link ... (Accessed 26/5/2005).
Keywords: Agile UR - http:/agilemanifesto.org

Beck, K. (1999), Extreme Programming Explained: Embrace Change, 1st edn, Addison-Wesley, Link ...
Keywords: change/extreme programming/programming/XP .

Benington, H. D. (1987), 'Production of large computer programs', in Proceedings of the 9th international conference on Software Engineering (1987), IEEE Computer Society Press, Los Alamitos, CA, USA, pp. 299-310 Link ...
Keywords: Design/Experimentation/Languages/Management/Methodologies/programming/software engineering

Beynon-Davies, P., Mackay, H., & Tudhope, D. (2000), ''It's lots of bits of paper and ticks and post-it notes and things . . .': a case study of a rapid application development project', Information Systems Journal, vol. 10, no. 3, pp. 195-216. Link ...
Keywords: information systems/Theory

Boehm, B. (1999), 'Making RAD work for your project', Computer, vol. 32, no. 3, pp. 113-114, 117.
Keywords: business reasons/market share/market window/maximum benefit/payback time/product payback/project management/RAD/rapid application development/software development management/software product sales/software prototyping

Boehm, B. (2002), 'Get ready for agile methods, with care', Computer, vol. 35, no. 1, pp. 64-69.
Keywords: agile driven software development methods/agile methods/agile-driven approach/combined approach/comprehensive spectrum/critical technical success factor/Internet browser battle/national air traffic control/plan-driven approach/plan-driven software development methods/planning spectrum/professional aspects/project management/real-world examples/software development/software disasters/software engineering

Boehm, B. & Basili, V. R. (2001), 'Top 10 list [software development]', Computer, vol. 34, no. 1, pp. 135-137.
Keywords: accelerated development schedules/defects/flaw reduction/predictable pitfalls/predictive models/project management/quantitative data/software complexity/software developers/software development/software development management/software fault tolerance/software projects/software quality

Boehm, B., Egyed, A., Kwan, J., Port, D., Shah, A., & Madachy, R. (1998), 'Using the WinWin spiral model: a case study', Computer, vol. 31, no. 7, pp. 33-44.
Keywords: case study/cost-effectiveness/formal specification/Integrated Library System/library automation/multimedia applications/multimedia computing/software prototyping/specification/WinWin spiral model

Boehm, B. & Port, D. (1999), 'When models collide: lessons from software systems analysis', IT Professional, vol. 1, no. 1, pp. 49-56.
Keywords: development models/MBASE approach/model clashes/Model-Based System Architecting and Software Engineering/project management/software architecture package/software development management/software systems analysis/systems analysis

 

Boehm, B. & Turner, R. (2003), 'Using risk to balance agile and plan-driven methods', Computer, vol. 36, no. 6, pp. 57-66.
Keywords: agile plan-driven methods/plan-driven approach/plan-driven methods/project developers/project failure/project management/risk management/software development management/tailorable risk-based approach

Boehm, B. & Turner, R. (2004a), 'Balancing agility and discipline: evaluating and integrating agile and plan-driven methods', pp. 718-719
Keywords: Agile/agile development/agile methods/agility/case studies/case study/change/CMMI/customers/Development/ISO standards/ISO-15288/Management/methods/organization/plan-driven methods/process/processes/rapid change/Software/software criticality/software engineering/software process improvement/software standards/Study/UK-DefStan-00-55

Boehm, B. W. (1988), 'A spiral model of software development and enhancement', Computer, vol. 21, no. 5, pp. 61-72.
Keywords: enhancement/IT/process/processes/risk-driven approach/software development/software engineering/software process models/spiral model

Boehm, B. W. (1970), Some information processing implications of air force missions 1970-1980, The Rand Corporation, Santa Monica
Keywords: Information

Boehm, B. W. & Turner, R. (2004b), Balancing Agility and Discipline: A Guide for the Perplexed, Addison-Wesley, Boston Link ...
Keywords: Agile/agility/BASIC/Development/IT/methods/Software/software development .

Bratthall, L. & Jørgensen, M. (2002), 'Can you Trust a Single Data Source Exploratory Software Engineering Case Study?', Empirical Software Engineering, vol. 7, no. 1, pp. 9-26. Link ...
Keywords: case study/Design/evidence/IT/Methodologies/organization/research method/software development/software engineering/triangulation/trustworthiness/validity

Brooks, F. P. (1995), The Mythical Man-Month: Essays on Software Engineering, Anniversary edn, Addison-Wesley, Wokingham, England Link ... .
Keywords: Software/software engineering/software project/software project management/project management/Management/project manager/IT/software system/programming/problems/problem

Brooks, F. P. (1987), 'No Silver Bullet: Essence and Accidents of Software Engineering', IEEE Computing Magazine, vol. 20, no. 4, pp. 10-19.
Keywords: software engineering

Burgess, T. (2001), A general introduction to the design of questionnaires for survey research, University of Leeds, Leeds
Keywords: Design/questionnaires/research/research methods

Buzan, T. & Buzan , B. (1996), The Mind Map Book: How to Use Radiant Thinking to Maximize Your Brain's Untapped Potential, Plume Books.
Keywords: buzan/information science/IT/mind map/process/processes/research/research techniques/Theory

Chantala, K. (2001), 'Using STATA to Analyze data from a Sample Survey' [Online], URL Link ... (Accessed 10/1/2006).
Keywords: STATA/statistical analysis/survey

Chen, W. & Hirschheim, R. (2004), 'A paradigmatic and methodological examination of information systems research from 1991 to 2001', Information Systems Journal, vol. 14, no. 3, pp. 197-235. Link ...
Keywords: case study/Design/empirical study/information systems/interpretivism/IS research/IT/Methodologies/paradigms/positivism/research/research method/research methodology/research methods

Coad, P., De Luca, E., & Lefebvre, E. (1999), Java modeling in color with UML: enterprise components and process, Prentice-Hall, Upper Saddle River, NJ.
Keywords: Java/modeling/Feature Driven development/FDD/process/processes

Cockburn, A. (2000), 'Selecting a project's methodology', Software, IEEE, vol. 17, no. 4, pp. 64-71.
Keywords: Methodologies/methodology differentiation/project management/project methodology selection/software development management/software development projects/software process improvement/software processes/software project experiences

Cockburn, A. (2002), Agile software development, Addison-Wesley Longman Publishing Co., Inc.
Keywords: IT/Methodologies/organization/paradigms/process/processes/programming/software development/software engineering

Cockburn, A. (2003), People and Methodologies in Software development, Doctor Philosophiae, Faculty of Mathematics and Natural Sciences, University of Oslo.
Keywords: Methodologies/Methodology/Software/software development/Development/research/teams/case studies/case study/Study/software development methodologies/software development methodology/development methodologies/development methodology/interaction/FORM/change/verification/IT/schedule/cost

Cockburn, A. (2004), Crystal Clear A Human-Powered Methodology for Small Teams, Addison Wesley Proffesional, Link ... .
Keywords: Methodology/Methodologies/teams

Davis, A. M., Bersoff, E. H., & Comer, E. R. (1988), 'A strategy for comparing alternative software development life cycle models', Software Engineering, IEEE Transactions on, vol. 14, no. 10, pp. 1453-1461.
Keywords: IT/Life Cycle/practitioners/software development/software development life cycle models/software engineering

Edwards, H. M., Thompson, J. B., & Smith, P. (1989a), 'Results of survey of use of SSADM in commercial and government sectors in United Kingdom', Information and Software Technology, vol. 31, no. 1, pp. 21-28. Link ...
Keywords: Design/government/IT/Methodologies/Methodology/organization/problems/process/processes/state/systems analysis

Edwards, H. M., Thompson, J. B., & Smith, P. (1989b), 'Experiences in use of SSADM: Series of case studies. Part 2: Experienced users', Information and Software Technology, vol. 31, no. 8, pp. 420-428. Link ...
Keywords: case studies/case study/government/organization/practitioners

Edwards, H. M., Thompson, J. B., & Smith, P. (1989c), 'Experiences in use of SSADM: Series of case studies. Part 1: First-time users', Information and Software Technology, vol. 31, no. 8, pp. 411-419. Link ...
Keywords: case studies/case study/Design/government/organization/practitioners/process/processes/systems analysis

Eisenhardt, K. M. (1989), 'Building Theories from Case Study Research', The Academy of Management Review, vol. 14, no. 4, pp. 535-550. Link ...
Keywords: case studies/case study/Case study research/evidence/process/processes/research/Theory/validation

EMEA (1998), EUDRALEX Volume 4 - Medicinal Products for Human and Veterinary Use : Good Manufacturing Practice, Eurpean Medicines Agency, London Link ...
Keywords: certification/EU/glossaries/GMP/Good Manufacturing Practice/law/Management/manufacturing/pharmaceutical industry/process/processes/products/quality control/quality management/review/standards/state/validation

European Union (2003), Commision Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use, Report 2003/94/EC, Journal of the European Union, Brussels
Keywords: EU/GMP/Good Manufacturing Practice/law/manufacturing/products

Farrand, P., Hussain, F., & Hennessy, E. (2002), 'The efficacy of the `mind map' study technique', Medical education, vol. 36, no. 5, pp. 426-431. Link ...
Keywords: Design/FORM/IT/medicine/mind map

FDA (1983), Guide to Inspection of Computerised Systems (The Blue Book), US Food and Drug Administration, Maryland, USA Link ... .
Keywords: Systems

FDA (1987), Guideline on general principles of Process Validation, US Food and Drug Administration, Maryland, USA Link ...
Keywords: process/processes/validation/Good Manufacturing Practice/manufacturing/Regulation/pharmaceuticals/medical devices/medical device/FDA/compliance/requirements/products/IT/state

FDA (2002a), General Principles of Software Validation; Final Guidance for Industry and FDA Staff, US Food and Drug Administration, Maryland, USA Link ...

FDA (2002b), 'Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach' [Online], URL Link ... (Accessed 6/1/2006b).
Keywords: FDA/GMP/GxP/Risk/Risk Based Approach/quality/review/Information/manufacturing/requirements/Good Manufacturing Practice/products/Regulation/IT/risk management/Management/Systems/standards/innovation/resources/risks/initiative

FDA (2004a), Part 11: Electronic Records; Electronic Signatures,Code of Federal Regulations, Title 21 - Food and Drugs, Chapter I - Food and Drug administration, Office of the Federal Register, Maryland, USA Link ...
Keywords: ERES/GLP/GMP/GxP/Part 11/Regulation/food/Drugs

FDA (2004b), Part 210 and 211- Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General and Current Good Manufacturing Practice for Finished Pharmaceuticals,Code of Federal Regulations, Title 21 - Food and Drugs, Chapter I - Food and Drug administration, Office of the Federal Register, Maryland, USA Link ...
Keywords: GMP/Good Manufacturing Practice/GxP/Regulation/food/Drugs/manufacturing/pharmaceuticals/pharmaceutical

FDA (2004c), Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies,Code of Federal Regulations, Title 21 - Food and Drugs, Chapter I - Food and Drug administration, Office of the Federal Register, Maryland, USA Link ...
Keywords: GLP/Good Laboratory Practice/GxP/Regulation/food/Drugs/services

FDA (2005a), 'Heartsine Technologies, Inc. Issues Worldwide Recall of Certain Automatic External Defibrillators' [Online], URL Link ... (Accessed 1/8/2005a).
Keywords: FDA/recall/models/Model

FDA (2005b), 'LifeScan, Inc. Announces Worldwide Correction Concerning Certain Blood Glucose Meters' [Online], URL Link ... (Accessed 1/8/2005b).
Keywords: FDA/IT/recall/Testing/Systems/change

FDA (2005c), 'Medtronic Announces Additional Devices Affected in Voluntary Recall of Certain Monophasic LifePak ® 500 Automated External Defibrillators' [Online], URL Link ...
Keywords: FDA/IT/message/recall/companies (Accessed 1/8/2005c).

FDA (2005d), 'Voluntary Worldwide Recall of Selected AED20 Automatic External Defibrillators' [Online], URL Link ... (Accessed 1/9/2005d).
Keywords: FDA/IT/message/recall/companies/problem

Fish, M. (2002), 'Using Software Development Methods for LIMS Implementations', in Pittcon 2002 (2002),Chicago, USA, Thermo Corporation,
Keywords: LIMS/software development

Fitzgerald, B. (1997), 'The use of systems development methodologies in practice: a field study', Information Systems Journal, vol. 7, pp. 201-212. Link ...
Keywords: development methodologies/evidence/field study/IS development methodologies/IS development methods and tools/IS development strategies/Methodologies/Methodology/systems development methodologies/systems development techniques

Fitzgerald, B. (1998), 'An empirical investigation into the adoption of systems development methodologies', Information & Management, vol. 34, no. 6, pp. 317-328. Link ...
Keywords: development methodologies/Methodologies/Methodology/process/processes/systems development methodologies

Gane, C. & Sarson, T. (1979), Structural systems analysis : tools and techniques, Prentice-Hall, London.
Keywords: STRADIS/Systems/systems analysis

Garston Smith, H. (2001), 'Considerations for Improving Software Validation', Journal of Validation Technology, vol. 7, no. 2, pp. 150-157.
Keywords: change management/GxP/information technology/IT/Management/organization/pharmaceutical industry/Testing/validation

Gilb, T. & Graham, D. (1993), Software Inspection, 5th edn, Addison-Wesley Longman Publishing Co., Inc., Boston, MA, USA Link ... .
Keywords: Software/software inspection/V Model/IT/defects/productivity/tracking/documentation/comparison/methods/costs/cost/process/processes /research/UK/defect prevention/glossaries

Glass, R. L., Vessey, I., & Ramesh, V. (2002), 'Research in software engineering: an analysis of the literature', Information and Software Technology, vol. 44, no. 8, pp. 491-506. Link ...
Keywords: Field/Level of analysis: profession/methods/Reference discipline: not applicable/research/Research approach: evaluative-other/research method/Research method: literature analysis/research methods/researchers/Software/software engineering/state/Topic: computing research

Glass, R. L. (2004), 'Matching methodology to problem domain', Communications of the ACM, vol. 47, no. 5, pp. 19-21. Link ...
Keywords: Development/development methodologies/development methodology/Methodologies/Methodology/software development/software development methodologies

Glassman, N. R. (2005), 'Review: RefViz 1.0.1', Journal of the Medical Library Association, vol. 93, no. 2, pp. 293-294.
Keywords: data mining/RefViz/review

Hardy, C. J., Thompson, J. B., & Edwards, H. M. (1995), 'The use, limitations and customization of structured systems development methods in the United Kingdom', Information and Software Technology, vol. 37, no. 9, pp. 467-477. Link ...
Keywords: Development/IT/process/processes

Hembeck, H.-W. E. (2002), 'GLP and other Quality Assurance Systems - A comparison', Accreditation and Quality Assurance: Journal for Quality, Comparability and Reliability in Chemical Measurement, vol. 7, no. 7, pp. 266-268. Link ...
Keywords: GLP/quality assurance

Hirsh, C. M. (2000), 'IQ/OQ/PQ: Is it a Definition of Where Science Stops and Dogma Starts ?', Journal of Valdiation Technology, vol. 7, no. 1, pp. 86-89.
Keywords: Comment/GxP/IQ/IT/OQ/PQ/process/processes/state/validation

Hoffmann, A., Kahny-Simonius, J., Plattner, M., Schmidli-Vckovski, V., & Kronseder, C. (1998), 'Computer system validation: An overview of official requirements and standards', Pharmaceutica Acta Helvetiae, vol. 72, no. 6, pp. 317-325.DOI: 10.1016/S0031-6865(97)00028-9   Link ...
Keywords: companies/GAMP/industry/pharmaceutical/pharmaceutical industry/requirements/standards/USA/validation

Howard, D. (2003), 'Swimming around the Waterfall: Introducing and Using Agile Devel', in Extreme Programming and Agile Processes in Software Engineering: 4th International Conference. (2003),Genova, Italy, pp. 138-145 Link ...
Keywords: Agile/Development/extreme programming/IT/Methodology/process/processes/programming/software development/software development process/software development processes/Waterfall/XP/Software/software engineering

ISO (1994), ISO 8402:1994: Quality management and quality assurance -- Vocabulary, International Organization for Standardization, Geneva, Switzerland Link ...
Keywords: quality/quality management/Management/quality assurance

ISPE (2001), The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems, 4th Edition edn, ISPE.

ISPE GAMP Testing SIG (2006), 'Key Principles and Considerations for the Testing of GxP Systems', Pharmaceutical Engineering, vol. 25, no. 6, pp. 92-114.
Keywords: GAMP/GxP/Systems/Testing

Jackson, M. (1983), System Development, Prentice-Hall, Englewood Cliffs.
Keywords: Development/Jackson System development/JSD

Jones, G. W. (1990), Software Engineering, Wiley, New York.
Keywords: Software/software engineering

Kitchenham, B. A. & Pfleeger, S. L. (2002a), 'Principles of survey research part 4: questionnaire evaluation', SIGSOFT Softw.Eng.Notes, vol. 27, no. 3, pp. 20-23.
Keywords: questionnaire/research/survey/USA

Kitchenham, B. A. & Pfleeger, S. L. (2002b), 'Principles of survey research: part 5: populations and samples', SIGSOFT Softw.Eng.Notes, vol. 27, no. 5, pp. 17-20.
Keywords: research/survey/USA

Kitchenham, B. A. & Pfleeger, S. L. (2003), 'Principles of survey research part 6: data analysis', SIGSOFT Softw.Eng.Notes, vol. 28, no. 2, pp. 24-27.
Keywords: data analysis/research/survey/USA

Klein, H. K. & Myers, M. D. (1999), 'A Set of Principles for Conducting and Evaluating Interpretive Field Studies in Information Systems', MIS Quarterly, vol. 23, no. 1, pp. 67-93. Link ... 
Keywords: Field/field study/Study/Information/information systems/information system/Systems

Kontio, J. (1996), 'A case study in applying a systematic method for COTS selection', pp. 201-209
Keywords: case studies/case study/COTS/COTS selection/data analysis/decision makers/problems/quality/Software/software reusability/software selection/Study/systematic reusable off-the-shelf software selection

Kreie, J., Cronan, T. P., Pendley, J., & Renwick, J. S. (2000), 'Applications development by end-users: can quality be improved?', Decision Support Systems, vol. 29, no. 2, pp. 143-152. Link ...
Keywords: Design/Development/empirical study/end-user/Internet/quality/Study/systems analysis

LaPlante, P. A. Personal communication with the author, Subset of data from 'LaPlante, P. A., Neill, C. J., & Jacobs, C. 2002, "Software requirements practices: some real data", in Software Engineering Workshop, 2002. Proceedings. 27th Annual NASA Goddard/IEEE, IEEE, pp. 121-128.'. (Jan. 2006).
Keywords: requirements/Software/software engineering/NASA/IEEE

LaPlante, P. A., Holt, J., & Neill, C. (2002), 'Software Requirements Practices Questionnaire' [Online], URL Link ... (Accessed 19/5/2005).
Keywords: IT/methods/questionnaire/requirements/requirements specification/research/research methods/Software/software engineering/software requirements/specification/state/survey/software requirements specification

LaPlante, P. A., Neill, C. J., & Jacobs, C. (2002), 'Software requirements practices: some real data', in Software Engineering Workshop, 2002. Proceedings. 27th Annual NASA Goddard/IEEE (2002), IEEE, pp. 121-128.DOI 10.1109/SEW.2002.1199458 Link ...
Keywords: Development/empirical data/formal specification/formal verification/Methodologies/Methodology/object-oriented methods/requirements/requirements specification/Software/software requirements/software requirements specification/software requirements validation/specification/statistical analysis/survey/validation/NASA/software engineering

Larman, C. & Basili, V. R. (2003), 'Iterative and incremental developments. a brief history', Computer, vol. 36, no. 6, pp. 47-56.
Keywords: agile methods/Development/history/incremental development/IT/iterative and incremental developments/iterative enhancement/software engineering/software system

Layman, L., Williams, L., & Cunningham, L. (2004), 'Exploring extreme programming in context: an industrial case study', in Agile Development Conference (2004), IEEE, pp. 32-41
Keywords: Agile/agile team/case studies/case study/extreme programming/industrial case study/Methodologies/Methodology/organizational environment/process/processes/programming/project management/quality/Sabre Airline Solutions/Study/team working/XP/XP projects

Leveson, N. G. & Turner, C. S. (1993), 'An investigation of the Therac-25 accidents', Computer, vol. 26, no. 7, pp. 18-41.
Keywords: accidents/Development/government/government policies/government regulation/linear accelerators/medical computing/radiation overdoses/radiation therapy/Regulation/safety-critical systems/Software/software components/software engineering/software-related overdoses/system development/system engineering/system operation/systems engineering/Therac 25/Therac-25/Therac-25 medical electron accelerator

Li, J., Bjoernson, F. O., Conradi, R., & Kampenes, V. B. (2004), 'An empirical study of variations in COTS-based software development processes in Norwegian IT industry', in 10th Internatinal Symposium on Software Metrics (2004), pp. 72-83
Keywords: commercial-off-the-shelf/commercial-off-the-shelf component/companies/COTS/Development/DP industry/empirical study/industry/Internet/interviews/IT/IT industry/process/processes/project management/prototyping/requirements/Risk/risk management/Software/software development/software development management/software development process/software development processes/software packages/software project/software projects/statistical analysis/Study/Waterfall/software metrics

Low, G. C., Henderson-Sellers, B., & Han, D. (1995), 'Comparison of object-oriented and traditional systems development issues in distributed environments', Information & Management, vol. 28, no. 5, pp. 327-340. Link ...
Keywords: application development/case studies/case study/Design/Development/Methodologies/Methodology/research/Study

Lucas, I. (2003), 'Testing Times in Computer Validation', Journal of Validation Technology, vol. 9, no. 2, pp. 153-161.
Keywords: Development/evidence/FORM/IT/problems/requirements/Testing/validation

McCracken, D. D. & Jackson, M. A. (1982), 'Life cycle concept considered harmful', SIGSOFT Softw.Eng.Notes, vol. 7, no. 2, pp. 29-32. Link ...
Keywords: Life Cycle

McDowall, R. D. (2005), 'Effective and practical risk management options for computerised system validation', The Quality Assurance Journal, vol. 9, no. 3, pp. 196-227.DOI: 10.1002/qaj.339 Link ...
Keywords: Management/Risk/risk management/validation/risk assessment/Systems/Regulatory/food/FDA/Regulation/Part 11/electronic records/reviews/review/GxP/Good Laboratory Practice/GLP/Good Manufacturing Practice/manufacturing/GMP/regulatory requirements/requirements/standards/process/processes/risk analysis/Methodologies/Methodology/problem/V-model/V Model/Computer systems

McPhee, C. (2001), Requirements Engineering for Projects with Critical Time-To-Market, Master of Science in Software Engineering, University of Calgary.
Keywords: requirements/requirements engineering/survey/time-to-market

McPhee, C. & Eberlein, A. (2000), 'Requirements Engineering Questionnaire' [Online], URL Link ... (Accessed 23/5/2005).
Keywords: questionnaire/RE/requirements/requirements engineering

Messenger, S. (2006), 'DSDM in Controlled Industries' [Online], Timebox, vol. Issue 28, URL Link ... (Accessed 15/2/2006).
Keywords: DSDM/industry/IT/Agile/agile methods/methods/pharmaceutical/pharmaceutical industry/Software/software development/Development/guidelines/processes/process/Drugs /Systems/Regulatory/requirements/documentation /traceability/Testing/quality

Messenger, S. (2003), 'Introducing DSDM into a Highly Regulated Environment' [Online], URL Link ... (Accessed 10/7/205).
Keywords: DSDM/GxP/Methodology/pharmaceutical

MHRA (2002), Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2002, MHRA.

MHRA (2005), 'MHRA: Medicines and Healthcare Products Regulation Agency' [Online], URL Link ... (Accessed 5/2005).
Keywords: Regulation

Microsoft (2005), 'Microsoft Solutions Framework' [Online], URL Link ... (Accessed 18/8/2005).
Keywords: Agile/agile software development/Development/IT/Life Cycle/Methodologies/Methodology/Microsoft Solutions Framework/MSF/process/processes/Software/software development/software development process/software development processes/development process

Parnas, D. L. & Clements, P. C. (1986), 'A rational design process: How and why to fake it', IEEE Transactions on Software Engineering, vol. 12, no. 2, pp. 251-257. Link ...
Keywords: Design/process/processes/IT/Software/implementation/IS research/research/software design/programming/methods/structured programming/requirements/Methodologies/Methodology/message/Development

PIC/S (2004), Good Practices for Computerised Systems in Regulated "GXP" Environments, Report PI 011-2, Pharmaceutical Inspection Convention, Geneva
Keywords: GxP/Systems/validation

Powell-Evans, K. (1998), 'Streamlining Validation', Pharmaceutical Technology europe, vol. 10, no. 12, pp. 48-52.
Keywords: GMP/IT/Systems/validation

Roberts, T. L., Jr., Gibson, M. L., Fields, K. T., & Rainer, R. K., Jr. (1998), 'Factors that impact implementing a system development methodology', Software Engineering, IEEE Transactions on, vol. 24, no. 8, pp. 640-649.
Keywords: companies/Development/development methodologies/development methodology/empirical research/exploratory factor analysis/external consultants/external support/functional management involvement/functional management support/functional managers/Information/information system/information systems/information systems managers/IT/Management/Methodologies/Methodology/models/organizational transition/practitioners/project management/research/researchers/software engineering/statistical analysis/Study/survey/survey instrument/system development/system development methodologies/system development methodology implementation factors/system life-cycle/system personnel/Systems/transition/USA

Robinson, K. (2003), 'GLPs and the Importance of Standard Operating Procedures', BioPharm International pp. 38-46.
Keywords: companies/Development/food/GLP/Good Laboratory Practice/industry/IT/manufacturing/organization/quality/research/Study/Testing

Royce, W. W. (1970), 'Managing the Development of Large Software Systems', in IEEE Wescon (1970), IEEE, pp. 1-9
Keywords: Development/Software/software system/Systems/IEEE

Schreiber, G., Wielinga, B., de Hoog, R., Akkermans, H., & Van de Velde, W. (1994), 'CommonKADS: A Comprehensive Methodology for KBS Development', IEEE Expert: Intelligent Systems and Their Applications, vol. 9, no. 6, pp. 28-37.DOI: 10.1109/64.363263 Link ...
Keywords: CommonKADS/Methodology/Methodologies/Development/models/Model/organization/IT/Software/software development/Design

Segal, J. (2003), 'The nature of evidence in empirical software engineering', in Software Technology and Engineering Practice, 2003.Eleventh Annual International Workshop on  pp. 40-47.DOI 10.1109/STEP.2003.33
Keywords: change/empirical software engineering/evidence/Field/field study/Software/software engineering/software engineering practice/Study

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Keywords: case studies/case study/research/Software/software engineers/Study/software components/Methodology/Methodologies/problems/problem/IT/requirements/documentation/Agile

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Keywords: Agile/Methodologies/Methodology/survey

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Keywords: companies/Development/development process/evidence/functional requirements/industry/IT/pharmaceutical companies/pharmaceutical industry/process/processes/Regulatory/regulatory authorities/requirements/Software/software engineering/software validation/Testing/validation

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Keywords: case study/case studies/Case study research/Study/research

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Keywords: computer software/Development/DSDM/Methodology/Systems

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Keywords: case studies/case study/end-user/End-User Computing/industry/Information/information system/information systems/information technology/IT/Methodologies/Methodology/organization/research/Study/Systems/UK

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Keywords: change management/FDA/Information/information management/LIMS/Management/manufacturing/problem/process/processes/Software/software engineering/software engineering techniques/Systems/validation

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Keywords: companies/industry/Markets/pharmaceutical/state

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Keywords: compliance/GxP/investment/Regulation/Systems/systems engineering/validation

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Keywords: Development/Systems

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Keywords: food/IT/Regulation/Testing/law/Regulatory/history

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Keywords: Design/Knowledge acquisisiton/knowledge engineering/modelling/Theory

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Keywords: Agile/agile software development/change/Development/feedback/history/IT/Methodologies/Methodology/plan-driven approach/Software/software development

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Keywords: change/Development/development methodologies/development methodology/development process/evidence/Information/information system/information systems/Methodologies/Methodology/methods/practitioners/process/processes/research/research method/research methods/system development/system development methodologies/Systems/systems development/systems development process

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Keywords: IT/Study

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Keywords: case studies/case study/Case study research/Design/methods/research/research methods/Study

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Keywords: case studies/case study/Case study research/research/social sciences/Study

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Keywords: structured analysis/Yourdon/YSM