Intro to Agile in an FDA Environment

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Is medical software development changing? A quick review of Waterfall today vs. Agile Software Development tomorrow. One of the biggest advantages of Agile is the integration of testing with development throughout the development process. Testing teams are full participants in requirements, architectural and design reviews, and collaborate with human factors engineers to create acceptance criteria for user stories and implement test cases.

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Intro to Agile in an FDA Environment

  1. 1. Intro to Agile in an FDA Environment ©2014 Pathfinder Software 1
  2. 2. This is a short story of TODAY meeting TOMORROW… TODAY its WATERFALL TOMORROW its AGILE ©2014 Pathfinder Software
  3. 3. WATERFALL… this process can work when all is understood and well defined, and there are no changes, hidden complexities, undiscovered requirements, or defects. ©2014 Pathfinder Software
  4. 4. Once you start adding change into the mix, you start running into waterfall development’s cost of change curve. ©2014 Pathfinder Software
  5. 5. Requirements, design, development and testing are all part of the iterative process, as well as risk management and customer feedback. Instead of treating each of these as fixed phases, Agile explicitly incorporates feedback so that they can evolve and change ©2014 Pathfinder Software
  6. 6. “The Agile process is the universal remedy for software development project failure. Software applications developed through the agile process have three times the success rate of the traditional waterfall method and a much lower percentage of time and cost overruns.” * * Agile Development Methods for Space Operations, Jay Trimble and Chris Webster, NASA Ames Research Center. ©2014 Pathfinder Software
  7. 7. In an Agile process, documentation is updated on a per iteration or per increment basis, with some documentation updated automatically through application of the Agile process and development practices such as test driven development. ©2014 Pathfinder Software
  8. 8. One of the biggest advantages of Agile is the integration of testing with development throughout the development process. Testing teams are full participants in requirements, architectural and design reviews, and collaborate with human factors engineers to create acceptance criteria for user stories and implement test cases. ©2014 Pathfinder Software
  9. 9. Conclusion… By testing stories as soon as they are implemented, testing teams uncover defects and discrepancies early in the process, when they are easiest to fix and have the least impact on other parts of the system. This process also has the benefit of parallelizing independent verification and validation with development, thereby compressing the schedule. Want to learn more? Download our FREE eBOOK  http://pathfindersoftware.com/agile-in-anfda-regulated-environment/ ©2014 Pathfinder Software
  10. 10. Build your next great product http://pathfindersoftware.com T: 888.497.9064 F: 312.803.1941 slideshare@pathf.com ©2014 Pathfinder Software 10

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